Vaginal lasers for treating stress urinary incontinence in women

Background Stress urinary incontinence (SUI) in women is common and can have a profound impact on an individual's quality of life. Vaginal lasers, designed for treating vulvovaginal atrophy, have been explored as a clinic‐based option for treating SUI. However, the effect of vaginal lasers on SUI remains unclear.

To assess the effects of vaginal lasers for treating SUI in women and to summarise the principal findings of relevant economic evaluations. Search methods We performed a comprehensive search using the Cochrane Incontinence Specialised Register (searched 29 April 2024). The Register contains trials identified from multiple databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, and WHO ICTRP (all within the Register). We also handsearched journals and conference proceedings and searched the reference lists of relevant articles. We identified published reports of relevant economic evaluations through electronic literature searches, and performed a literature search for a brief economic commentary (BEC), but found no studies of economic evaluations that compare vaginal lasers with other treatments. Selection criteria We included randomised controlled trials of women with SUI assessing therapy with a vaginal laser versus sham or control treatments or topical treatments. Data collection and analysis Two review authors independently performed study selection, data extraction, and risk of bias assessment, with arbitration from a third review author as needed. We performed statistical analyses using a random‐effects model. We rated the certainty of evidence according to the GRADE approach. Main results We screened 227 references and included nine studies that reported outcomes on 689 women with SUI. The studies were conducted in Europe, North America, and South America. Five studies utilised CO₂ laser and four utilised Er:YAG laser therapy, delivered from one to three treatments occurring 28 to 45 days apart. The studies compared laser therapy to sham or topical therapy; two studies had three comparator arms. The time points for all the reported outcomes ranged from three to 12 months and were therefore considered either short term (less than one year) or medium term (one to five years). Generally, the certainty of evidence was downgraded due to concerns of risk of bias and imprecision and judged to be very low. Vaginal lasers versus sham or control treatments (such as topical lubricant) All nine studies, reporting outcomes for 689 women, investigated this comparison. There may be no difference in the number of continent women between women who underwent vaginal laser compared to those who underwent sham or control treatments in the short term; however, the CI is sufficiently wide enough to include both greater and fewer continent women with vaginal laser compared with sham or control treatment (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.72 to 3.10; I² = 81%; 3 studies, 196 women; very low‐certainty evidence). There may be more continent women among those who underwent vaginal laser compared to those who underwent sham or control treatments in the medium term (one to five years, RR 2.88, 95% CI 1.48 to 5.60; I² = not applicable; 1 study, 76 women; very low‐certainty evidence). Vaginal lasers may improve patient‐reported incontinence measures (International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF)) compared to sham or control treatment in the short term (mean difference (MD) −1.42 points, 95% CI −2.41 to −0.43; I²= 54%; 8 studies, 632 women; very low‐certainty evidence). However, the point estimate for improvement does not meet the prespecified minimally clinical importance difference. This implies that the improvement may not represent a clinically significant (noticeable) difference for patients. There may be similar improvement in patient‐reported continence measures between vaginal laser and sham in the medium term (MD −1.62 points, 95% CI −5.64 to 2.40; I²= not applicable; 1 study, 76 women; very low‐certainty evidence), but the evidence is very uncertain. There were no major adverse events in either the vaginal laser or sham or control treatment groups. Vaginal lasers versus topical treatments (such as topical oestrogen) One study involving 48 women provided evidence for this comparison. The number of continent women (objective measure as reported by the trialists) at less than one year after treatment was not reported. We are uncertain whether the improvement in patient‐reported incontinence (ICIQ‐UI SF) at less than one year differed between women who underwent vaginal laser versus those who received topical oestrogen (MD −1.61, 95% CI −4.71 to 1.49; 1 study, 48 women; very low‐certainty evidence). There were no major adverse events in either the vaginal laser or topical oestrogen arm in the short term. Authors' conclusions Vaginal lasers may have little to no effect on SUI as measured by both clinical assessment and patient‐reported outcome measures in the short term (less than one year) compared to sham or control treatments or topical treatments, but the evidence is very uncertain. In the medium term, while the evidence is very uncertain, there may be more continent women among those who received vaginal laser compared to those who received sham; however, there may be little to no difference between groups in patient‐reported incontinence. There were no major adverse events associated with any intervention or comparator. Future studies that incorporate more medium‐ and long‐term data, data stratified by type of incontinence (stress, mixed, or urgency) and by symptom severity or patient comorbidities will improve the quality of evidence. Plain language summary What are the benefits and risks of vaginal lasers for treating stress urinary incontinence in women? Key messages • In the short term, vaginal lasers may make little or no difference to the number of continent women, and while vaginal lasers may improve patient‐reported incontinence compared to sham, the improvement is small and may not make a noticeable difference for patients. We have very low confidence in these results. • In the medium term, there may be more continent women among those who received vaginal laser compared to those who received sham; however, there may be little to no difference in patient‐reported incontinence. We have very low confidence in these results. • There were no major unwanted effects reported in women receiving vaginal laser, sham or lubricant, or topical oestrogen. What is stress urinary incontinence? Stress urinary incontinence is uncontrolled leakage of urine on effort or exertion. What are treatments for stress urinary incontinence? Stress urinary incontinence has traditionally been treated with pelvic floor physical therapy, topical oestrogen creams, vaginal inserts or pessaries (a removable device inserted into the vagina to support the pelvic organs), and surgeries such as urethral injections or urethral slings. Vaginal lasers are a clinic‐based therapy that in recent years has been explored as a treatment for stress urinary incontinence, but their safety and effectiveness remain uncertain. Some professional medical societies have issued warnings against the use of energy‐based devices like vaginal lasers for treating urinary incontinence due to the lack of strong safety and effectiveness data. What did we want to find out? We wanted to find out if vaginal lasers are better than sham or control treatments (such as topical lubricant) or topical treatment (such as topical oestrogen) in improving incontinence outcomes in the short and long term. We also wanted to find out if vaginal lasers are associated with any unwanted effects. What did we do? We searched for studies that compared vaginal laser with sham or control treatments (such as topical lubricant) or topical treatment (such as topical oestrogen) in women with stress urinary incontinence. We compared and summarised the results of the studies and rated our confidence in the evidence based on factors such as study methods and sizes. What did we find? We found nine studies involving a total of 689 women with stress urinary incontinence. Nine studies compared vaginal lasers to either sham or lubricant, and one study compared vaginal lasers to topical oestrogen. Seven studies reported short‐term data (less than one year), and two studies reported short‐ and medium‐term data (one to five years). We have very low confidence in the following results. • In the short term, the number of continent women (objective measure as reported by the researchers) may be similar between vaginal laser and sham or lubricant. In the medium term, there may be more continent women among those undergoing vaginal laser versus sham or lubricant. • In the short term, vaginal lasers may improve patient‐reported incontinence compared to sham, but the improvement is small and may not make a noticeable difference for patients. In the medium term, there may be similar improvement in patient‐reported continence measures between vaginal laser and sham treatments. • There may be similar improvement in patient‐reported urinary incontinence between women who received vaginal laser and those who received topical oestrogen cream. • There were no major unwanted effects reported in women receiving vaginal laser, sham or lubricant, or topical oestrogen. What are the limitations of the evidence? We have very low confidence in the evidence because it is possible that people in the studies were aware of which treatment they were getting; not all studies provided data about everything that we were interested in; and there are not enough studies to be certain about the results. The included studies measured success in different ways and at different time points, which made combining the results challenging. How up‐to‐date is this evidence? The evidence is current to 29 April 2024. Summary of findings Summary of findings 1. Vaginal lasers compared to sham or control treatment (such as topical lubricant) for treating stress urinary incontinence in women. | Vaginal lasers compared to sham or control treatment (such as topical lubricant) for treating stress urinary incontinence in women | ||||||| | Patient or population: women with SUI Intervention: vaginal lasers Comparison: sham or control treatment (such as topical lubricant) Setting: outpatient or ambulatory care | ||||||| | Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Comments | || | Risk with sham or control treatment (topical lubricant) | Risk difference with vaginal lasers | |||||| | Number of continent women: (objective measure as reported by the trialists), short term (< 1 year) | 196 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 | RR 1.50 (0.72 to 3.10) | 274 per 1000 | 137 more per 1000 (77 fewer to 575 more) | || | Improvement in patient‐reported incontinence: short term (< 1 year) | CO₂ laser | 213 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 | ‐ | ‐ | MD 1.25 lower (3.57 lower to 1.07 higher) | | | Er:YAG laser | 419 (5 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 | ‐ | ‐ | MD 1.60 lower (2.63 lower to 0.57 lower) | || | Number of major adverse events: Clavien‐Dindo III, IV, V, short‐term (< 1 year) | 689 (9 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 | ‐ | ‐ | ‐ | No major adverse events were reported in the included studies. | | | Number of continent women: (objective measure as reported by the trialists), medium term (1 to 5 years) | 76 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 3 | RR 2.88 (1.48 to 5.60) | 211 per 1000 | 396 more per 1000 (101 more to 968 more) | || | Improvement in patient‐reported incontinence: medium term (1 to 5 years) | 76 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 3 | ‐ | MD 1.62 lower (5.64 lower to 2.40 higher) | ||| | Number of major adverse events: Clavien‐Dindo III, IV, V; short to medium term (1 to 5 years) | ‐ | ‐ | ‐ | ‐ | ‐ | No medium‐term data on major adverse events were reported in the included studies. | | | *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; SUI: stress urinary incontinence | ||||||| | GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | 1We downgraded three levels for serious risk of bias and very serious risk of imprecision with high risk of bias for two domains and CIs that span the null. 2We downgraded three levels for serious risk of bias and very serious risk of imprecision due to several studies with unclear or high risk of bias in many domains. 3We downgraded three levels for serious risk of bias and very serious risk of imprecision due to one study with unclear and high risk of bias for two domains and wide CIs for the intervention effect. Summary of findings 2. Vaginal lasers compared to topical treatments (such as topical oestrogen) for treating stress urinary incontinence in women. | Vaginal lasers compared to topical treatments (such as topical oestrogen) for treating stress urinary incontinence in women | |||||| | Patient or population: women with SUI Intervention: vaginal lasers Comparison: topical treatments (such as topical oestrogen) Setting: ambulatory or outpatient care | |||||| | Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Comments | | | Risk with topical oestrogen | Risk difference with vaginal laser | ||||| | Number of continent women: (objective measure as reported by the trialists), short term (< 1 year) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported | | Improvement in patient‐reported incontinence: short term (< 1 year) | 48 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 | MD −1.61 (−4.71 to 1.49) | ‐ | MD 1.61 lower (4.71 lower to 1.49 higher) | | | Number of major adverse events: Clavien‐Dindo III, IV, V | 48 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 | ‐ | ‐ | No adverse events were reported in the included studies. | | | Number of continent women: (objective measure as reported by the trialists), short to medium term (1 to 5 years) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported | | Improvement in patient‐reported incontinence: short to medium term (1 to 5 years) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported | | Number of major adverse events: Clavien‐Dindo III, IV, V; short to medium term (1 to 5 years) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported | | *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; SUI: stress urinary incontinence | |||||| | GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | 1We downgraded three levels for serious risk of bias and very serious risk of imprecision due to one study with unclear risk of bias for all but two domains and wide CIs for the intervention effect. 2We downgraded two levels for serious risk of bias and serious risk of imprecision due to several studies with unclear risk of bias in many domains. While precision was not estimable because the event rate is 0 in both groups, if you estimate an event rate of 1 in both groups, the risk ratio of 1, then 0 fewer per 1000 events with 95 CIs from 10 fewer to 18 more is the absolute effect. This leads to downgrading for imprecision because the CI crosses the null.

For a glossary of terms used, see Appendix 1. Description of the condition Urinary incontinence (UI) is a public health problem that affects 200 million people worldwide (Norton 2006). Stress urinary incontinence (SUI) is the "complaint of involuntary leakage on effort or exertion, or on sneezing, or coughing", which affects up to 35% of adult women (Abrams 2017; Luber 2004). It is caused by the weakening of the pelvic floor muscles, urethral sphincter, and the connective tissues (such as collagen) present in the pelvic floor (Abrams 2017; Davila 2011). Risk factors for SUI include vaginal childbirth, pelvic surgery, pregnancy, age, obesity, and smoking (Davila 2011). Despite the prevalence of incontinence among women, few seek treatment for the condition, which can lead to a decrease in quality of life (Davila 2011; Gafni‐Kane 2016). On average, it has been estimated that the annual direct medical costs of SUI for one year (1998 USD) are USD 5642, and USD 4208 for indirect workplace costs (Birnbaum 2004). Current treatments for stress urinary incontinence include pelvic floor muscle training (physical therapy, physiotherapy, kinesiotherapy), continence pessaries and vaginal inserts, urethral bulking agents, synthetic midurethral slings, and autologous fascial pubovaginal slings (Kobashi 2017). Description of the intervention Vaginal lasers for treating vulvovaginal atrophy were first introduced in 2014 (Salvatore 2014). They have been promoted as a method to treat the genital, sexual, and urinary symptoms related to menopause (collectively termed genitourinary syndrome of menopause (GSM)) and SUI. However, the published evidence supporting the use of vaginal lasers for SUI is mixed (Shobeiri 2019). Laser treatment is typically delivered by a physician in an outpatient setting over several sessions (Issa 2018; Karcher 2016). It involves introducing a laser probe device into the vagina to deliver the laser energy based on each manufacturer’s protocol (Issa 2018). People undergo two to three treatments at intervals between two and eight weeks (Karcher 2016). How the intervention might work A laser works by sending energy from an electrical current through a medium such as glass, crystal, or gas. This process heats the vaginal tissues in a controlled fashion which breaks down collagen and leads to the growth of new collagen (Franic 2019; Issa 2018; Lin 2019). The growth of new collagen in tissues around the urethra is thought to contribute to improved SUI symptoms by decreasing urethral and bladder neck mobility (Lin 2019). Vaginal lasers utilise carbon dioxide (CO₂) or erbium:yttrium‐aluminium‐garnet (Er:YAG) as the medium through which the electrical current travels. Lasers are subcategorised into ablative or non‐ablative, the latter being less invasive (Issa 2018). Ablative and non‐ablative lasers can be further categorised into either conventional or fractional energy delivery (Issa 2018). Fractional lasers divide the laser beam into many treatment zones, treating only a fraction of the skin at a time. In general, CO₂ lasers are fractional and ablative, while Er:YAG lasers are fractional and non‐ablative; however, depending on the setting and brands, microablative and non‐ablative modes are available. Lasers with the same medium can function in different methods, and results cannot always be generalised between types of lasers, even if the medium is the same. Brand names for CO₂ lasers include MonaLisa Touch by Cynosure (Westford, MA), FemiLift by Alma (Buffalo Grove, IL), and FemTouch by Lumenis (Yokneam, Israel). Brand names for Er:YAG lasers include IntimaLase by Fotona (Ljubljana, Slovenia). Why it is important to do this review SUI is common and can have a profound impact on an individual's quality of life (Minassian 2013). Vaginal laser treatment has been marketed to patients and clinicians as a non‐invasive, clinic‐based, and accessible option for women suffering from SUI (Issa 2018; Shobeiri 2019). However, evidence regarding the use of vaginal lasers to treat SUI is lacking (Conté 2017; NICE 2021; Pergialiotis 2017). Stringent examination of the current evidence within a Cochrane review is especially pertinent since, to date, none of the established guidelines on urinary incontinence comment on the use of vaginal lasers (Burkhard 2018; Kobashi 2017; NICE 2019; NICE 2021). It is also important to evaluate the safety of vaginal lasers for treating SUI. This is especially true in the context of recent warnings against the use of energy‐based devices (including lasers) for treating vaginal symptoms related to menopause, urinary incontinence, or sexual function by the US Food and Drug Administration (FDA) (FDA 2018). The International Society for the Study of Vulvovaginal Disease (ISSVD) and the International Continence Society (ICS) do not recommend using vaginal lasers in SUI (Preti 2019), as they cannot draw conclusions from the currently available data to recommend the use of vaginal lasers in safe clinical practice (Preti 2019). National Institute for Health and Care Excellence (NICE) guidelines recommend that vaginal lasers only be used in the context of research due to inadequate efficacy data for SUI (NICE 2021). Thus, the basis of this review is to summarise the evidence on the use of vaginal laser treatment of SUI to help guide treatment recommendations or conclusions.

To assess the effects of vaginal lasers for treating stress urinary incontinence in women and to summarise the principal findings of relevant economic evaluations.

Criteria for considering studies for this review Types of studies We included randomised controlled trials (RCTs) and quasi‐randomised studies (studies where allocation is not necessarily at random, such as by date of birth or by day of the week) assessing vaginal lasers for treating SUI in women. We also included cluster‐RCTs. We excluded cross‐over studies. For the economic evaluation, we planned to include studies evaluating the cost‐effectiveness of vaginal lasers for treating SUI in women. Types of participants We included studies of adult women with SUI diagnosed based on validated questionnaires (SUI domains from the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF), Urogenital Distress Inventory – Short Form (UDI‐6)) or urodynamic studies. We only included studies reporting on women with mixed urinary incontinence (MUI), prior surgeries for SUI, GSM, or vaginal atrophy if the findings for SUI were reported separately for each group. We excluded studies of women with urge incontinence alone, overactive bladder (OAB), or with neurogenic bladder or cognitive impairment. Types of interventions We included studies that use vaginal lasers alone as an intervention. We excluded studies combining vaginal lasers with other therapies. We included the following comparisons. Vaginal lasers versus sham or control treatments (such as topical lubricant) Vaginal lasers versus topical treatments (such as topical oestrogen) We developed summary of findings tables for the above comparisons. Types of outcome measures Primary outcomes Number of continent women after treatment (objective measure as reported by the trialists). Improvement in urinary incontinence (as measured by the mean change or final mean value on patient‐reported incontinence scales from validated questionnaires such as ICIQ‐UI SF). Sirls 2015 reported that the recommended minimally important differences (MID) for the ICIQ‐UI SF are a decrease of at least 5 points at 12 months or 4 points beyond 24 months. Number of major adverse events (Clavien‐Dindo III, IV, V; Dindo 2004). Secondary outcomes Number of continent women after treatment (subjective measure assessed by a score of 0 on the ICIQ‐UI SF). Improvement in incontinence‐specific quality of life (as measured by the mean change or final mean value on patient‐reported Urinary Distress Inventory (UDI) or Urinary Impact Questionnaire (UIQ) or the Incontinence Quality of Life Questionnaire (I‐QOL) or the KHQ). The recommended MID has been estimated to be an 11‐point decrease for the UDI and a 16‐point decrease for the UIQ (Barber 2010). The MID for the KHQ has been estimated to be 5 to 10 points (CADTH 2017). The MID for the I‐QOL for between treatment comparisons is 2.5 (Yalcin 2006). Improvement in other subjective clinical measures of stress urinary incontinence (as measured by mean change or final mean value on three‐day voiding diary). Improvement in patient‐reported general quality of life (mean change from baseline or final mean value as measured on the SF‐36 or similar general quality of life scales). The MID for SF‐36 for urinary incontinence has not been reported in the literature. However, the Reliable Change Index subscale indicates that the magnitude of change considered to be statistically reliable and clinically significant for general health perceptions is 24.8, 35.9 for social functioning and 17 for physical functioning (Ferguson 2002). Improvement in patient‐reported sexual function (as measured by the mean change or final mean values on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) or the Female Sexual Function Index (FSFI)). The MID for the FSFI has been estimated to range between 0.1 and 1 point on each of the tool's five subdomains (Krychman 2018). Number of minor adverse events (Clavien‐Dindo I‐II; Dindo 2004).

and timing of outcome measures When available, we used the Clavien‒Dindo system to classify adverse events (Dindo 2004). If this was not reported by trialists, we judged the severity of the complications by the information in the trial reports. We grouped the length of outcome duration into short term (less than one year) and medium term (one to five years). Main outcomes for summary of findings tables Number of continent women after treatment (objective measure as reported by the trialists). Improvement in urinary incontinence (as measured by the mean change or final mean value on patient‐reported incontinence scales from validated questionnaires such as ICIQ‐UI SF). Number of major adverse events (e.g. development of urethral stricture, emergency department visits, unplanned surgeries, vaginal stenosis). We measured all outcomes for the summary of findings tables in the short term (less than one year) and medium term (one to five years). Search methods for identification of studies We did not impose any language or other limits on the searches described below. Electronic searches Search for clinical effectiveness studies We identified relevant trials from the Cochrane Incontinence Specialised Register. For more details of the search methods used to build the Specialised Register, please see the Group's webpages where details of the Register's development (from inception) and the most recent searches performed to populate the Register can be found. To summarise, the Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In‐Process, In‐Data‐Review and Other Non‐Indexed Citations, MEDLINE Epub Ahead of Print, MEDLINE Daily, ClinicalTrials.gov, and WHO ICTRP (all within the Register). Many of the trials in the Cochrane Incontinence Specialised Register are also contained in CENTRAL. The date of the most recent search was 29 April 2024. The terms used to search the Cochrane Incontinence Specialised Register are provided in Appendix 2. Search for economic evaluations We performed electronic literature searches designed to identify published reports of relevant economic evaluations to inform the brief economic commentary (BEC) (see 'Incorporating economic evidence' in the Methods). We searched the following databases. NHS Economic Evaluation Database (NHS EED) on the Centre for Reviews and Dissemination website (covering the earliest record in NHS EED, dating from 1968, up to and including 31 December 2014, when their coverage ended) As NHS EED is no longer actively updated, we performed additional searches of the following databases to identify eligible studies added to these databases from 1 January 2015 onwards: MEDLINE (OvidSP) (covering 1 January 1946 to 2024); and Embase (OvidSP) (covering 1 January 1974 to 2024). The date of the most recent search was 29 April 2024. Details of the electronic searches, including the search strategies used, are provided in Appendix 3. Searching other resources We attempted to identify other potentially eligible trials or publications by searching the reference lists of included studies, reviews, meta‐analyses, and health technology assessment reports. We contacted the authors of the included studies to identify any additional studies we may have missed. We contacted drug and device manufacturers for ongoing or unpublished studies. We searched abstract proceedings of relevant conference proceedings and journals, specifically those of the American Urological Association, European Association of Urology, Society for Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, and American Urogynecologic Society, from 2017 to 2024 for unpublished studies. Data collection and analysis We conducted data collection and analysis in accordance with the methods specified in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019). Selection of studies Two review authors (PBR, PG, GMI, HS, or RP) independently screened the abstracts and titles of studies identified by the electronic search for eligibility. We sought full‐text reports for all potentially eligible trials and determined the eligibility of these trials for inclusion according to predefined criteria. Any differences were resolved by discussion or by referral to a third review author (JQC) for arbitration if needed. For studies identified in trial registries (unpublished studies), we contacted the authors or institutions recorded in the registry to request trial reports. We attempted to obtain translations for papers in languages other than English in order to assess these for eligibility. Data extraction and management Two review authors (GMI and IC, HS, RP, or DR) independently performed data extraction using standardised, pre‐piloted data extraction forms. Any differences were resolved by discussion or by referral to a third review author (PG) for arbitration if needed. One review author (GMI) entered data into RevMan; a second review author (IC) verified the integrity of the data entry (RevMan 2025). We extracted data as needed for the calculation of summary statistics and measures of variance. For dichotomous outcomes, we attempted to obtain numbers of events and totals for the population for a 2 × 2 table, as well as summary statistics with corresponding measures of variance. For continuous outcomes, we attempted to obtain means and standard deviations (SDs). In the event of duplicate publications, companion documents, or multiple reports relating to a primary study, we maximised the yield of information by mapping all publications to unique studies and collating all the available data. We used the most complete data set aggregated across all known publications. Assessment of risk of bias in included studies Two review authors (GMI and DR, HS, or RP) independently evaluated risk of bias in the included studies using Cochrane's RoB 1 tool (Higgins 2011). Any differences were resolved by discussion or by referral to a third review author (PG) for arbitration if needed. We evaluated the following domains: selection bias (random sequence generation and allocation concealment); performance bias (blinding of participants and personnel); detection bias (blinding of outcome assessors); attrition bias (incomplete outcome data); reporting bias (selective reporting); and other sources of bias. Measures of treatment effect We considered continuous and categorical data for this review. For categorical data with dichotomous outcomes, we generated risk ratios (RR) with 95% confidence intervals (CIs). For continuous outcomes, we generated the mean difference (MD) and 95% CIs. If different studies used different measures to assess the same outcome, we expressed the data as standardised mean differences (SMDs) with 95% CIs. Unit of analysis issues The unit of analysis was the individual participant. We planned to take into account the level at which randomisation occurred, such as cluster‐randomised trials, and multiple observations of the same outcome. For cluster‐randomised trials, the unit of analysis was the individual; we accounted for clustering in data in accordance with the methods outlined in Chapter 23 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019). For multi‐arm trials, we planned to extract only data from relevant interventions and avoid a unit of analysis error by combining groups to create a single pair‐wise comparison. Dealing with missing data We entered data as reported by the trialists, using the intention‐to‐treat (ITT) principle whenever possible. We attempted to obtain missing data or clarification of methods from the trialists. If ITT was not possible, we performed an available‐case analysis. We evaluated attrition rates and critically appraised the issue of missing data. We did not impute missing data. Assessment of heterogeneity If there were sufficient data to perform meta‐analysis, we identified heterogeneity through visual inspection of the forest plots to assess the amount of overlap of CIs and by using the I² statistic to assess the impact of heterogeneity on the meta‐analysis (Higgins 2019). We interpreted the I² statistic as follows (Deeks 2019): 0% to 40%: may not be important; 30% to 60%: may indicate moderate heterogeneity; 50% to 90%: may indicate substantial heterogeneity; 75% to 100%: considerable heterogeneity. If we identified heterogeneity, we attempted to determine possible causes by examining individual study and subgroup characteristics. Assessment of reporting biases We attempted to obtain study protocols to assess selective outcome reporting. If at least 10 studies were available for meta‐analysis, we planned to assess publication bias through creation and visual inspection of funnel plots. Data synthesis In the case of sufficient available studies, we planned to perform a meta‐analysis employing a random‐effects model for pooling data using RevMan (RevMan 2025). If meta‐analysis was not possible, we performed a narrative synthesis to summarise the primary and secondary outcomes. Subgroup analysis and investigation of heterogeneity Factors including patient characteristics (severity of SUI at baseline, obesity, concomitant prolapse, prior surgeries for SUI, concomitant vaginal atrophy, concomitant urge incontinence), laser type, and provider experience may impact outcomes. In the case of sufficient data, we planned the following subgroup analyses. Type of laser (CO₂ laser versus Er:YAG laser). Severity of incontinence at baseline based on ICIQ‐UI SF (Klovning 2009): slight to moderate (1 to 12) versus severe and very severe (13 to 19). Obese participants versus non‐obese participants. Based on the available data, we performed subgroup analyses for type of laser (CO₂ laser versus Er:YAG laser), but could not perform our other preplanned subgroup analyses. Sensitivity analysis We planned to perform sensitivity analysis for the primary and secondary outcomes by excluding studies with high risk of bias; however, these were precluded by insufficient data. Incorporating economics evidence Following the search outlined in Search methods for identification of studies, we planned to develop a BEC to summarise the availability and principal findings of the full economic evaluations that compare vaginal lasers with other treatments or different types of vaginal lasers (Aluko 2022); however, this was precluded by insufficient data. Summary of findings and assessment of the certainty of the evidence We prepared summary of findings tables using GRADEpro GDT for the comparisons pre‐stated in Types of interventions. We used the GRADE approach to assess the certainty of evidence related to the main outcomes for summary of findings tables as presented in Types of outcome measures (Schünemann 2019). We assessed the overall certainty of evidence for these outcomes, downgrading certainty from high by one level for serious, or by two levels for very serious study limitations (risk of bias), indirectness of evidence, serious inconsistency, imprecision of effect estimates, or potential publication bias. We justified all decisions to downgrade the certainty of evidence using footnotes.

Description of studies See the PRISMA flow diagram (Figure 1); Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies.

of the search Search for clinical effectiveness studies Our search of the Cochrane Incontinence Specialised Register yielded 271 references. We found four additional records (not within the Register) through handsearching for publications of ongoing trials. After excluding duplicates, we screened the titles and abstracts of 227 references, of which 140 were judged to be irrelevant and 87 went on to full‐text assessment. Based on full‐text review, we excluded 53 reports of 29 studies and assessed 10 reports of 7 studies as ongoing. We ultimately included 9 studies from 24 associated references in our quantitative analysis. The details of reference screening can be found in the PRISMA flow diagram (Figure 1). Search for economic evaluations The literature search produced 15 records for screening, but none met the inclusion criteria for the review. The economic search found no economic evaluations assessing the cost‐effectiveness of vaginal lasers for treating SUI in women. The details of reference screening can be found in the PRISMA flow diagram (Figure 2). Included studies A summary of study characteristics is provided in Table 3; for details, see Characteristics of included studies. 1. Study characteristics. | Reference ID | Reference Type | Location | Design | No. of Participants | Mean Age (SD) | Inclusion Criteria | Laser Type | Laser Power (Intervention) | Number & Frequency (Intervention) | Comparator Arm(s) | Outcome measures reported | Measurement time points | | Aguiar 2020 | Peer‐reviewed manuscript | Brazil | RCT | 72 | 57.28 (5.15) | Women >50 yrs, amenorrheic for 1 year, with complaints of vaginal dryness or urinary symptoms related to GSM for at least 6 months | CO2 Laser (SmartXide2 V2LR MonaLisa Touch; DEKA, Florence, Italy) | Vaginal canal: 40W | 3 treatments delivered 30‐45 days apart | 1) Conjugated vaginal estrogen (Promestriene) 2) Vaginal lubricant (KY Jelly(R)) | ICIQ‐UI‐SF; ICIQ‐UI‐OAB; Vaginal Health Index; Vaginal Maturation, FSFI | Baseline, 14 weeks | | Salvatore 2021 | Peer‐reviewed manuscript | Greece, Italy | RCT | 60 (only 23 having SUI) | Laser: 57 (6.9) Sham: 58.4 (6.0) | Postmenopausal women with GSM. Vaginal dryness and dyspareunia related to GSM had to be the two most bothersome symptoms | CO2 Laser (SmartXide2 V2LR MonaLisa Touch; DEKA, Florence, Italy) | Vaginal canal: 30 W Introitus 24 W | 3 treatments delivered 30 days apart | Sham laser treatment | 10 cm VAS for GSM symptoms; FSFI; UDI‐6 | Baseline, 4 months | | Seki 2022 | Peer‐reviewed manuscript | Brazil | RCT | 153 enrolled (139 randomised) | Laser: 50.2 (8.7) RFA: 59.2 (9.6) Sham: 50.6 (8.6) | Women with stress urinary incontinence confirmed by a stress test. | CO2 Laser (FemiLift, Alma, Nuremberg, Germany) | 1Hz, 100 W potency and 100 mJ/1.0 cm2 fluency | 3 treatments delivered 30 days apart | 1) Radiofrequency ablation (Linly, Loktal Medical Electronics, Brazil) 2) Sham laser treatment | Cough Stress Test, 1‐h pad test, 7 day voiding diary, I‐QOL, ICIQ‐UI‐SF, FSFI, subjective impression of improvement | Baseline, 1, 6, 12 months | | Blaganje 2018 | Peer‐reviewed manuscript | Slovenia | RCT | 114 | Laser: 39.95 (6.36) Sham: 41.84 (5.67) | Premenopausal (35‐65 yrs), sexually active women with at least one vaginal delivery and clinical diagnosis of SUI using clinical exam, urodynamics, Q‐tip test. | 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) | 10 J/cm2 Fluence | 1 treatment | Sham laser treatment | ICIQ‐UI‐SF; PISQ‐12; FSFI; perineometry measures | Baseline, 3 months | | O'Reilly 2024 | Peer‐reviewed manuscript | United Kingdom, Switzerland, Ireland, Greece, Slovenia | RCT | 110 | Not Reported | Adult women with clinical SUI and urodynamic diagnosis of SUI refractory to one previous conservative treatment | Er:YAG Laser (Incontilase, Dynamis, Fotona, Slovenia) | Not reported | 2 sessions delivered 30 days apart | Sham laser treatment | 1h pad weight test (>50% reduction in pad weight); 3 day voiding diary; adverse events; KHQ; PISQ‐12; PGI‐I | Baseline, 3 and 6 months. Active arm had additional 12 month follow‐up. | | Edell 2023 | Abstract | Canada | RCT | 134 | Not reported | Women with clinical diagnosis of SUI, as confirmed by patient medical history and clinical symptoms | Er: YAG Laser | Not reported | 2 treatments, 6 weeks apart | Placebo “sham” group (same procedure but no LASER energy applied to tissue | Primary: self‐reported symptom of no urinary incontinence with ICIQ‐UI Short Form (question 3) validated questionnaire at 6‐months; secondary: 24‐hour pad test, UDI‐6, IIQ‐7, KHQ, and PISQ‐12 | Baseline, 6 weeks, 6 months | | Tu 2023 | Abstract | Canada | RCT | 55 | Not reported | Women experiencing SUI and stress‐pre‐ dominant mixed urinary incontinence (SMUI) for minimum of 6 months | 2940NM Er:YAG LASER (Intravaginal IncontiLase) | Not reported | 2 sessions, 4 weeks apart | Sham laser | VAS pain scale, use of pain‐relieving medication, incidence and severity of adverse events, reduction of leakage measured by 24‐hour pad weight test and number of used pads, reduction in number of incontinence episodes measured by 3‐day voiding diary, reduction of SUI symptoms measured by ICIQ‐UI SF questionnaire and patient satisfaction measured by patient global impression of improvement (PGI‐I). | Baseline, 6 months | | Temtanakitpaisan 2023 | Peer‐reviewed manuscript | Thailand | RCT | 64 enrolled, 59 randomised | Laser: 49.7 (10.9) Sham: 52.8 (11.8) | Women with SUI and mixed urinary incontinence, stress predominant | CO2 lasers (transvaginal fractional microablative, MonaLisa TouchTM; Deka, Florence, Italy) | 40 W, 1000 μs of pulse duration, and 1000 μm spacing | 3 sessions, 28–35 days apart | Sham laser | ICIQ‐UI SF questionnaire, pelvic floor US | Baseline and 3 months | | Alexander 2022 | Peer‐reviewed manuscript | Australia | RCT | 113 enrolled, 101 randomised | Laser: 51.5 (10.6) Sham: 54.6 (11.2) | Women aged 18 to 80 years with objective and subjective stress urinary incontinence | CO2 laser (FemTouch (Lumenis, Yokneam Illit, Israel) delivery system in conjunction with the AcuPulse CO2 laser system (Lumenis) and the AcuScan 120 Microscanner (Lumenis)) | 7.5 to 12.5 mJ, depending on stage of treatment | 3 treatments, 4 weeks apart | Sham laser | Primary outcome: subjective stress urinary incontinence rate; secondary outcome: objective stress urinary incontinence, change in the disease‐specific patient‐reported outcomes, health‐related QoL, and adverse effects | Baseline and 3 months | DIVA: Day to day Impact of Vaginal Aging; Er:YAG: erbium‐doped yttrium aluminium garnet laser; FSFI: Female Sexual Function Index; GSM: Genitourinary Symptoms of Menopause; ICIQ‐UI SF: International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form; I‐QOL: Incontinence Quality of Life Questionnaire; KHQ: King's Health Questionnaire; OAB: Overactive Bladder; PGI‐I: Patient Global Impression of Improvement; PISQ‐12: Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire‐12; RCT: Randomised Controlled Trial; UDI‐6: Urinary Distress Inventory‐6; VAS: Visual Analog Scale Design We included nine parallel‐group RCTs that randomised a total of 807 women and reported outcomes on 689 women with SUI. Two trials were multi‐arm studies (Aguiar 2020; Seki 2022). All studies were set in academic, tertiary care referral centres. Seven studies had short‐term follow‐up (less than one year) (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; Salvatore 2021; Temtanakitpaisan 2023; Tu 2023), while two studies provided short‐ and medium‐term follow‐up (one to five years) (O'Reilly 2024; Seki 2022). Sample sizes Sample sizes ranged from 60 (Salvatore 2021) to 134 participants (Edell 2023). Participants Inclusion criteria varied widely across studies. All studies included adult women. One study was limited to postmenopausal women (aged more than 50 years) (Aguiar 2020), while another was limited to "premenopausal women (aged 35 to 65)" (Blaganje 2018). Inclusion criteria for urinary incontinence varied and were poorly defined. Four studies mentioned urinary incontinence within the inclusion criteria (Aguiar 2020; Blaganje 2018; Salvatore 2021; Seki 2022). However, these were vaguely defined, and only one study was restricted to urodynamic diagnosis of SUI (O'Reilly 2024). One trial excluded women with mixed or urge incontinence (Blaganje 2018). Two trials primarily included women with GSM, but reported separate data for SUI (Aguiar 2020; Salvatore 2021). Three trials excluded women with pelvic organ prolapse (Blaganje 2018; Salvatore 2021; Seki 2022). Two trials excluded women with prior surgery for SUI (Aguiar 2020; Seki 2022). Interventions Five trials used CO₂ lasers (Aguiar 2020; Alexander 2022; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023). Among these, the SmartXide2V2LR System (MonaLisa Touch; Deka, Florence, Italy) was used in three studies (Aguiar 2020; Salvatore 2021; Temtanakitpaisan 2023), while the FemiLift CO₂ laser was used in two studies (Alexander 2022; Seki 2022). The Er:YAG laser was used in four studies (Blaganje 2018; Edell 2023; O'Reilly 2024; Tu 2023). The power parameters, when described, were 30 to 40 W with the CO₂ laser. Studies used differing handpieces and treated different parts of the vagina and vulva. The number of laser treatments ranged from one (Blaganje 2018) to two (Edell 2023; O'Reilly 2024; Tu 2023) or three (Aguiar 2020; Alexander 2022; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023). Among the eight trials with repeating treatments, the frequency of laser treatments was monthly (Aguiar 2020; Alexander 2022; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023) or six weeks apart (Edell 2023). Outcomes Outcomes were measured in the short term (less than one year) and medium term (one to five years) and ranged from three (Blaganje 2018) to 12 months (O'Reilly 2024; Seki 2022). The trials reporting the primary outcomes for this review were as follows. Number of continent women (objective measure as reported by the trialists) (Alexander 2022; Salvatore 2021; Seki 2022). Improvement in patient‐reported urinary incontinence (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). This was measured using the ICIQ‐UI SF. Number of major adverse events (Clavien‐Dindo III, IV, V) (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). The trials reporting the secondary outcomes for this review were as follows. Number of continent women by patient‐reported measures (Blaganje 2018; Edell 2023; O'Reilly 2024; Seki 2022). This was measured using the ICIQ‐UI SF question 3 or 6c/e equal to 0. Improvement in incontinence‐specific quality of life measures (Alexander 2022; O'Reilly 2024; Salvatore 2021; Seki 2022). Study authors used the KHQ (O'Reilly 2024), I‐QOL (Seki 2022), Incontinence Impact Questionnaire Short Form (IIQ‐7) (Alexander 2022), and UDI‐6 (Salvatore 2021). Data for women with SUI alone, separate from those with mixed or urgency incontinence, were not available from Salvatore 2021, thereby precluding the incorporation of data from this study in the data synthesis (Salvatore 2021). Improvement in clinical measures of urinary incontinence (O'Reilly 2024; Seki 2022). Improvement in patient‐reported sexual function (Aguiar 2020; Blaganje 2018; O'Reilly 2024; Salvatore 2021; Seki 2022). These studies used the FSFI (Aguiar 2020; Salvatore 2021; Seki 2022) or the PISQ‐12 (Blaganje 2018; O'Reilly 2024). Data for Aguiar 2020 and Salvatore 2021 were not stratified by type of UI (stress, mixed, urgency) and were therefore not included in our data synthesis. Other outcome measures evaluated in the included studies were scales of symptoms of GSM (dysuria, dyspareunia, vaginal dryness, burning sensation, vaginal itching) (Salvatore 2021), as well as vaginal tissue outcomes (Aguiar 2020) and pelvic floor muscle strength as measured by perineometry (Blaganje 2018). Excluded studies We excluded 53 reports of 29 studies. Three studies were not randomised (Gaspar 2018; Ivan 2014; Okui 2019), while 11 studies had an incorrect patient population, with most including women with GSM but not UI (Athanasiou 2020; Cruff 2021; Cruz 2018; Eftekhar 2021; Ghorbani 2019; NCT03238053; NCT03995797; Paraiso 2018; Quick 2021; Ruanphoo 2020; Singwongsa 2019). While two of these studies included women with incontinence, they did not provide specific data on outcomes for women with SUI as compared to those with mixed or urgency incontinence (Paraiso 2018; Quick 2021). A further six studies had the wrong comparator (Alquzwini 2020; Da Fonesca 2023; Espitia De La Hoz 2017; RBR‐4ckch8; Rocha‐Rangel 2024; Viguera 2020), and six studies had the wrong intervention (Lauterbach 2022; Mousa 2021; NCT03316950; NCT04959084; NCT05097456; NCT05557799). We excluded one study because the trial registration indicated that the trial had been withdrawn and was never opened (NCT04253067). Details of the excluded studies can be found in the PRISMA flow diagram (Figure 1) and in Characteristics of excluded studies. Ongoing studies Ten reports of seven ongoing studies met our inclusion criteria (ACTRN12617000099325; ChiCTR1900021044; NCT03671694; NCT03996070; NCT04636749; NCT04643353; Salinas Peña 2019). For further details, see Characteristics of ongoing studies. Risk of bias in included studies Visual representations of the risk of bias in the included trials are presented in Figure 3 and Figure 4. Details on risk of bias for each included are provided in Characteristics of included studies. We did not have a sufficient number of studies (at least 10) to assess publication bias through the creation and visual inspection of funnel plots. Allocation Random sequence generation All studies except one (Tu 2023) described the method of random sequence generation and were judged to be at low risk of bias (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023). Allocation concealment Six studies described the method of allocation concealment and were rated as at low risk of bias (Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Temtanakitpaisan 2023). The remaining studies did not address the issue of allocation concealment and were thus assessed as at unclear risk of bias (Aguiar 2020; Seki 2022; Tu 2023). Blinding Blinding of participants and personnel (performance bias) One study blinded both participants and personnel by using sham laser settings and was deemed at low risk of bias (Salvatore 2021). Four studies reported blinding of participants but not personnel and were deemed at high risk of bias (Blaganje 2018; O'Reilly 2024; Seki 2022; Tu 2023). The remaining studies did not address the issue of blinding of participants and personnel and were thus assessed as at unclear risk of bias (Aguiar 2020; Edell 2023). Blinding of outcome assessment (detection bias) Four studies blinded outcome assessors and were deemed at low risk of bias (Blaganje 2018; Edell 2023; Salvatore 2021; Seki 2022). One study did not blind outcome assessors and was deemed at high risk of bias (Alexander 2022). The remaining studies did not address the issue of blinding of outcome assessors and were thus assessed as at unclear risk of bias (Aguiar 2020; O'Reilly 2024; Temtanakitpaisan 2023; Tu 2023). Incomplete outcome data Seven studies were at low risk of attrition bias because there was no differential attrition (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; Salvatore 2021; Temtanakitpaisan 2023; Tu 2023) and an ITT analysis was performed (Aguiar 2020). Two studies were at high risk of bias for incomplete outcome data due to unbalanced rates of attrition between trial arms (O'Reilly 2024; Seki 2022). For Seki 2022, unpublished data were provided by the authors via email for per‐protocol but not ITT analysis. Selective reporting Four studies had an associated trial registration that was consistent with the reported findings; we therefore judged these studies to be at low risk of reporting bias (Alexander 2022; Blaganje 2018; O'Reilly 2024; Seki 2022). We were unable to locate the registration record for two studies and therefore assessed these trials as at unclear risk of reporting bias (Aguiar 2020; Temtanakitpaisan 2023). We assessed three studies as at high risk of reporting bias because the trial registration had many more outcome measures listed than were reported within the manuscript (Edell 2023; Salvatore 2021; Tu 2023). Other potential sources of bias We did not identify any other potential sources of bias in the included studies and therefore deemed all studies as at low risk of bias (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). Effects of interventions All effects of interventions listed below reflect short‐ (less than one year) and medium‐term (one to five years) outcomes, as no long‐term outcomes (greater than five years) were reported in any of the included studies. Table 1; Analysis 1.1; Analysis 1.2; Analysis 1.3; Analysis 1.4; Analysis 1.6; Analysis 1.7; Analysis 1.8; Analysis 1.9; Analysis 1.10; Analysis 1.11; Analysis 1.12; Analysis 1.13; Analysis 1.14 Table 2; Analysis 2.1; Analysis 2.3 Vaginal lasers versus sham or control treatments (such as topical lubricant) All nine studies investigated this comparison (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). Primary outcomes Number of continent women after treatment (objective measure as reported by the trialists), short term (less than one year) Three studies reported this outcome (Alexander 2022; Salvatore 2021; Seki 2022). There was no evidence of a difference in the number of continent women between women who underwent vaginal laser and those who underwent sham or control treatments (RR 1.50, 95% CI 0.72 to 3.10; I² = 81%; n = 196; very low‐certainty evidence; Analysis 1.1; Table 1); however, the CI is sufficiently wide enough to include both greater and fewer women continent with vaginal laser compared with sham or control treatments. Number of continent women after treatment (objective measure as reported by the trialists), medium term (one to five years) One study reported this outcome (Seki 2022). There may be more continent women among those who underwent vaginal laser compared to those who underwent sham or control treatments (RR 2.88, 95% CI 1.48 to 5.60; I² = not applicable; n = 76; very low‐certainty evidence; Analysis 1.2; Table 1). Improvement in patient‐reported urinary incontinence, short term (less than one year) Eight studies reported this outcome (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Seki 2022; Temtanakitpaisan 2023; Tu 2023). Vaginal lasers may improve patient‐reported incontinence measures on the ICIQ‐UI SF (MD −1.42 points, 95% CI −2.41 to −0.43; I²= 54%; n = 632; very low‐certainty evidence; Analysis 1.3; Table 1). The point estimates and CIs do not meet previously published thresholds of MID for the ICIQ‐UI SF of a five‐point decrease at 12 months (Sirls 2015). This implies that the improvement may not represent a clinically significant difference for patients. Subgroup analysis was performed between laser types and is detailed below. Improvement in patient‐reported urinary incontinence, medium term (one to five years) One study reported this outcome (Seki 2022). There was similar improvement in patient‐reported incontinence measures on the ICIQ‐UI SF between women undergoing vaginal laser and those receiving sham (MD −1.62 points, 95% CI −5.64 to 2.40; I²= not applicable; n = 76; very low‐certainty evidence; Analysis 1.4; Table 1). The point estimates and CIs do not meet previously published thresholds of MID for the ICIQ‐UI SF of a five‐point decrease at 12 months (Sirls 2015). This implies that the improvement may not represent a clinically significant difference for patients. Number of major adverse events (less than one year) Nine studies reported this outcome (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). There were no major adverse events reported in the studies (9 RCTs; n = 689; very low‐certainty evidence; Table 1). Number of major adverse events (one to five years) Not reported. Secondary outcomes Number of continent women after treatment (subjective measure assessed by a score of 0 on the ICIQ‐UI SF), short term (less than one year) Four studies reported this outcome (Alexander 2022; Blaganje 2018; O'Reilly 2024; Seki 2022). The effect on the numbers of continent women, as measured by a score of 0 on the ICIQ‐UI SF, is uncertain (RR 2.48, 95% CI 0.62 to 9.93; I² = 34%; n = 419; very low‐certainty evidence; Analysis 1.6). Subgroup analysis was performed between laser types and is detailed below. Number of continent women after treatment (subjective measure assessed by a score of 0 on the ICIQ‐UI SF), medium term (one to five years) One study reported this outcome (Seki 2022). The effect on the numbers of continent women, as measured by a score of 0 on the ICIQ‐UI SF, is uncertain (RR 2.00, 95% CI 0.19 to 21.14; I² = not applicable; n = 76; very low‐certainty evidence; Analysis 1.7). Improvement in incontinence‐specific quality of life, short term (less than one year) Four studies reported this outcome (Alexander 2022; O'Reilly 2024; Salvatore 2021; Seki 2022), using three separate measures: the KHQ (O'Reilly 2024), I‐QOL (Seki 2022), and UDI‐6 (Salvatore 2021). Data for women with SUI alone, separate from those with mixed or urgency incontinence, were not available from Salvatore 2021, thereby precluding the incorporation of data from this study in the meta‐analysis (Salvatore 2021). In the short term, improvement in incontinence‐specific quality of life may be similar between women with SUI undergoing vaginal laser versus those receiving sham (MD 0.03, 95% CI −13.22 to 13.27; I² = 46%; n = 141; Analysis 1.8). The MID for the KHQ has been estimated to be 5 to 10 points (CADTH 2017). The MID for the I‐QOL for between treatment comparisons is 2.5 (Yalcin 2006). Subgroup analysis was performed between laser types and is detailed below. Improvement in incontinence‐specific quality of life, medium term (one to five years) One study reported this outcome using the I‐QOL (Seki 2022). In the medium term, improvement in incontinence‐specific quality of life may be similar between women with SUI undergoing vaginal laser and those receiving sham (MD 7.00, 95% CI −10.10 to 24.10; I² = not applicable; n = 76; Analysis 1.9). Improvement in other subjective clinical measures of stress urinary incontinence (as measured by mean change or final mean value on three‐day voiding diary), short term (less than one year) Two studies reported change in mean number of daily voids (O'Reilly 2024; Seki 2022). There may be no evidence of a difference in change in the number of voids on three‐day voiding diary between women who underwent vaginal laser therapy and those who received sham (MD −0.60, 95% CI −1.75 to 0.54; I² = 0%; n = 139; Analysis 1.10). Improvement in other subjective clinical measures of stress urinary incontinence (as measured by mean change or final mean value on three‐day voiding diary), medium term (one to five years) One study reported change in mean number of daily voids (Seki 2022). There may be no evidence of a difference in change in the number of voids on three‐day voiding diary between women who underwent vaginal laser therapy and those who received sham (MD −0.79, 95% CI −2.99 to 1.41; I² = not applicable; n = 76; Analysis 1.11). Improvement in patient‐reported general quality of life Not reported. Improvement in patient‐reported sexual function (as measured by the mean change or final mean values on the FSFI or PISQ‐12), short term (less than one year) Six studies reported change in patient‐reported sexual function, three using the FSFI (Aguiar 2020; Salvatore 2021; Seki 2022) and three using the PISQ‐12 (Alexander 2022; Blaganje 2018; O'Reilly 2024). However, Aguiar 2020 and Salvatore 2021 did not report these outcomes among women with SUI alone, separate from those with mixed or urgency incontinence, thereby precluding incorporation of the data from these studies in the meta‐analysis. The meta‐analysis therefore included four studies (Alexander 2022; Blaganje 2018; O'Reilly 2024; Seki 2022). Based on these data, there may be no evidence of a difference in improvement in patient‐reported sexual function between women who underwent vaginal laser therapy versus those who received sham (SMD 0.21, 95% CI −0.06 to 0.48; I² = 31%; n = 318; Analysis 1.12). Subgroup analysis was performed between laser types and is detailed below. Improvement in patient‐reported sexual function (as measured by the mean change or final mean values on the FSFI or PISQ‐12), medium term (one to five years) One study reported change in patient‐reported sexual function and measured this outcome using the FSFI (Seki 2022). There may be no evidence of a difference in improvement in patient‐reported sexual function between women who underwent vaginal laser therapy versus those who received sham (MD 2.80, 95% CI −6.12 to 11.72; I² = not applicable; n = 76; Analysis 1.13). Number of minor adverse events (Clavien‐Dindo I, II) Seven studies reported this outcome (Aguiar 2020; Alexander 2022; Blaganje 2018; O'Reilly 2024; Salvatore 2021; Seki 2022; Tu 2023). Women who underwent vaginal laser may have a greater risk of adverse events than women who underwent sham treatment, based on five studies that reported minor adverse events (RR 3.75, 95% CI 1.56 to 9.02; I² = 58%; n = 475; Analysis 1.14). Vaginal lasers versus topical treatments (such as topical oestrogen) One study investigated this comparison (Aguiar 2020). Primary outcomes Number of continent women after treatment (objective measure as reported by the trialists) Not reported. Improvement in patient‐reported urinary incontinence We are uncertain whether improvement in patient‐reported urinary incontinence, as measured by the ICIQ‐UI SF, differed between women who underwent vaginal laser versus those who received topical oestrogen cream (MD −1.61, 95% CI −4.71 to 1.49; I² = not applicable; n = 48; very low‐certainty evidence; Analysis 2.1; Table 2). Number of major adverse events There were no major adverse events reported in any treatment arm (Table 2) (Aguiar 2020). Secondary outcomes Number of continent women after treatment (subjective measure assessed by a score of 0 on the ICIQ‐UI SF) Not reported. Improvement in incontinence‐specific quality of life Not reported. Improvement in other subjective clinical measures of stress urinary incontinence (as measured by mean change or final mean value on three‐day voiding diary) Not reported. Improvement in patient‐reported general quality of life Not reported. Improvement in patient‐reported sexual function (as measured by the mean change or final mean values on the FSFI) One study reported change in patient‐reported sexual function and measured this outcome using the FSFI (Aguiar 2020). However, this study did not report FSFI outcomes among women with SUI alone, separate from those with mixed or urgency incontinence. As such, the data could not be incorporated into the data synthesis. Number of minor adverse events (Clavien‐Dindo I, II) There were no minor adverse events reported among women randomised to vaginal laser versus topical oestrogen (effect not estimable; n = 48; Analysis 2.3) (Aguiar 2020). Subgroup analyses Type of laser (CO₂ laser versus Er:YAG laser) We were only able to conduct subgroup analysis based on laser type for the following analyses for the comparison of vaginal laser versus sham or control treatments. Improvement in patient‐reported incontinence, short term (less than one year) We included four studies of Er:YAG (Blaganje 2018; Edell 2023; Temtanakitpaisan 2023; Tu 2023) and three of CO₂ laser (Aguiar 2020; Alexander 2022; Seki 2022) in the meta‐analysis. The subgroup analyses were consistent with the pooled analysis (test for subgroup differences yielded Chi² = 0.07, df = 1 (P = 0.79), I² = 0%). Vaginal lasers may improve patient‐reported incontinence measures on the ICIQ‐UI SF (CO₂ laser: MD −1.25, 95% CI −3.57 to 1.07; n = 113; Er:YAG laser: MD −1.60, 95% CI −2.63 to −0.57; n = 419) (Analysis 1.3). Again, the point estimates and CIs do not meet previously published thresholds of MID for the ICIQ‐UI SF of a five‐point decrease at 12 months (Sirls 2015). This implies that the improvement may not represent a clinically significant difference for patients. Number of continent women by patient‐reported measures, short term (less than one year) We included two studies of CO₂ laser (Alexander 2022; Seki 2022) and two of Er:YAG laser (Blaganje 2018; Edell 2023) in the meta analysis. The subgroup analyses were consistent with the pooled analysis (test for overall effect: z = 1.28, P = 0.20, test for subgroup differences yielded Chi² = 0.09, df = 1 (P = 0.76), I² = 0%). There may be similar numbers of continent women, as assessed using patient‐reported measures, between vaginal laser and sham, based on laser type (CO₂ laser: MD 1.87, 95% CI 0.10 to 34.48; n = 173; Er:YAG laser: MD 3.20, 95% CI 0.53 to 19.50; n = 419) (Analysis 1.6). However, since the CI is sufficiently wide enough to include both greater and fewer women continent with vaginal laser compared with sham or control treatments, the effect is very uncertain. Improvement in patient‐reported sexual function, short term (less than one year) We included two studies of CO₂ laser (Alexander 2022; Seki 2022) and two of Er:YAG laser (Blaganje 2018; O'Reilly 2024) in the meta‐analysis. The subgroup analyses were consistent with the pooled analysis (test for subgroup differences: Chi² = 2.95, df = 1 (P = 0.09), I² = 66.1%). There may be no difference in improvement in patient‐reported sexual function between women who underwent vaginal laser therapy versus those who received sham, based on laser type (CO₂ laser: SMD −0.01, 95% CI −0.35 to 0.33; n = 134; Er:YAG laser: SMD 0.38, 95% CI 0.09 to 0.68; n = 184; Analysis 1.12). Severity of incontinence at baseline based on the ICIQ‐UI SF We were unable to perform subgroup analysis, as this was reported by only one study for one outcome: improvement in urinary incontinence (patient‐reported incontinence) (Blaganje 2018). Obese participants versus non‐obese participants Not reported. Sensitivity analysis We planned to perform a sensitivity analysis for the primary and secondary outcomes by excluding studies with high risk of bias; however, all studies had at least one domain at high risk of bias or several domains (more than two) where the risk of bias was unclear. We were therefore unable to perform this sensitivity analysis.

Summary of main results We included nine RCTs with a total of 807 primarily postmenopausal women with SUI in the review. Outcome data were available for 689 women with SUI. Data were reported for all primary outcomes, but the number of continent women (objective measure as reported by trialists) was not available for the comparison of vaginal lasers versus topical treatments (such as topical oestrogen). Data were not available from either comparison for one secondary outcome (improvement in patient‐reported general quality of life). Seven studies assessed outcomes in the short term (less than one year), and two studies provided data for both short‐ and medium‐term outcomes (one to five years). Based on the available evidence, we are very uncertain about the effect of vaginal lasers compared to sham or control treatments or topical treatments (such as topical oestrogen). Vaginal lasers versus sham or control treatments (such as topical lubricant) All nine studies, reporting outcomes for 689 women, investigated this comparison (Aguiar 2020; Alexander 2022; Blaganje 2018; Edell 2023; O'Reilly 2024; Salvatore 2021; Seki 2022; Temtanakitpaisan 2023; Tu 2023). In the short term, there was no evidence of a difference in the number of continent women between women who underwent vaginal laser compared to those who underwent sham or control treatments; however, the CI is sufficiently wide enough to include both greater and fewer women continent with vaginal laser compared with sham or control treatments. In the medium term, limited evidence (one trial) suggests there may be more continent women among those who underwent vaginal laser compared to those who underwent sham or control treatments. In the short term, vaginal lasers may improve patient‐reported incontinence measures (ICIQ‐UI SF) compared to sham or control treatment. However, the point estimate for improvement does not meet the prespecified minimally clinical importance difference. This implies that the improvement may not represent a clinically significant (noticeable) difference for patients. In the medium term, there may be similar improvement in patient‐reported continence measures between vaginal laser and sham. There were no major adverse events in either the vaginal laser or sham or control treatment groups (Table 1). Vaginal lasers versus topical treatments (such as topical oestrogen) One study involving 48 women investigated this comparison (Aguiar 2020). The number of continent women after treatment by trialists' assessment was not reported. We are uncertain if there is a difference in improvement in patient‐reported urinary incontinence, as measured by the ICIQ‐UI SF, between women who underwent vaginal laser versus those who received topical oestrogen cream. There were no major adverse events in either the vaginal laser or topical oestrogen group (Table 2). Overall completeness and applicability of evidence We performed an extensive systematic review using the Cochrane Incontinence Specialised Register, which contains trials identified from nine databases, in addition to handsearching of journals and conference proceedings. This search yielded nine RCTs from a variety of geographical areas. We found that the majority of trials provided evidence regarding our primary outcomes and used consistent patient‐reported measurement tools. We contacted all trial authors and incorporated additional unpublished data received by correspondence into our analyses for two trials (O'Reilly 2024; Seki 2022). The majority of studies included postmenopausal women in their 50s with SUI, therefore our results may not be applicable to premenopausal women. Four trials used CO₂ lasers (Aguiar 2020; Alexander 2022; Salvatore 2021; Seki 2022), and five used Er:YAG lasers (Blaganje 2018; Edell 2023; O'Reilly 2024; Temtanakitpaisan 2023; Tu 2023). We were only able to perform subgroup analysis comparing outcomes based on type of laser (CO₂ versus Er:YAG) for Analysis 1.3, Analysis 1.6, and Analysis 1.12. These subgroup comparisons found no difference in outcomes based on laser type. No studies stratified outcomes based on women's obesity status, and only one study provided one secondary outcome measure based on women's severity of incontinence. For this reason, we were unable to perform these planned subgroup analyses. Two studies included data on women with stress, mixed, and urinary incontinence within the context of GSM and were excluded because the outcome data were not stratified by type of incontinence (Paraiso 2018; Quick 2021). Similarly, in the case of studies that provided data on women with stress, mixed, and urgency incontinence, where not all outcomes were stratified based on type of incontinence, these data were excluded (Aguiar 2020). We attempted to contact the authors of any such studies to either obtain unpublished data or verify that our interpretation of data stratified by incontinence type was correct. We received no responses to our requests. It is important to note that there are seven ongoing studies, and that the results of this systematic review and meta‐analysis may change as these studies are completed. Since none of the included studies reported that any women experienced major complications, we cannot estimate the relative effect of vaginal laser on major complications. Quality of the evidence The findings in this review are based on nine RCTs, most with relatively small sample sizes and short follow‐up time of less than one year. We downgraded the certainty of evidence for several reasons. Few studies blinded both participants and personnel (performance bias), and even fewer blinded outcome assessors (detection bias). In addition, attrition bias was often difficult to assess. Furthermore, we consistently downgraded the certainty of evidence for imprecision due to wide CIs and findings that, while statistically significant, crossed thresholds of minimally important clinical differences. For all of our primary outcomes, we had very low certainty of evidence due to these limitations. Potential biases in the review process We conducted all aspects of this review to comply with the study protocol and based on Cochrane guidance. We made every attempt to reduce bias in the review process, including a comprehensive search that was not limited by language or publication type. Additionally, two review authors independently performed study screening, data extraction, and risk of bias assessment. However, despite our comprehensive literature search, the possibility remains that some studies could have been missed. We made contact with the authors of nine ongoing clinical trials to verify their status, and, assuming that these are all ongoing based on their trial registration, it is possible that some have not been published due to negative findings, which would be concerning for publication bias. Literature on the use of vaginal lasers in women predominantly focuses on postmenopausal women with GSM, which encompasses SUI. Three of the included studies obtained data on SUI from women with GSM (Aguiar 2020; Blaganje 2018; Salvatore 2021), while only two included studies had SUI as a primary inclusion criterion (O'Reilly 2024; Seki 2022). We included only SUI outcomes if they were reported separately based on our a priori protocol. Despite this, our results may not be generalisable to women with SUI who do not have GSM, such as premenopausal women. The two lasers used in the included studies were the CO₂ laser (MonaLisa) and the Er:YAG Laser (Fotona). Other lasers are available in different modes, and data from our review may not be generalisable to different lasers. The results of this study were limited to RCTs in accordance with the published protocol. This was motivated not only by Cochrane guidance, but also prior knowledge of a large body of RCTs based on published systematic reviews. Although it is possible that evidence from well‐designed non‐RCTs may have provided higher‐quality evidence for select outcomes, this appears unlikely. Agreements and disagreements with other studies or reviews Several systematic reviews have been performed on the topic of vaginal lasers for treating SUI. These are henceforth listed chronologically with a brief discussion of the reviews' conclusions. Conté 2017 performed a non‐systematic review and identified seven prospective cohort studies, published in French, finding that while "the difference between the pre‐operative and post‐operative ICIQ‐UI‐SF scores was statistically significantly different in all studies ... the efficacy of vaginal laser treatments for SUI has not been assessed in comparative studies". Pergialiotis 2017 performed a systematic review and included 13 case‐control, case series, or cohort studies; they were not able to identify any RCTs. The authors concluded that "vaginal laser therapy seems to be a promising method for treating SUI. However, available evidence is drawn from studies at significant risk of bias due to low‐quality research methodology. Randomised trials are needed to allow us to draw firm conclusions, as it is expected that in women will increasingly frequently seek minimally invasive treatment modalities for SUI". Franic 2019 performed a non‐systematic review and included 24 studies, one of which was an RCT (Blaganje 2018). The authors found that "in average 1.9 laser sessions per patient, an average reduction in ICIQ‐UI SF scores was 5.9, and an average 1‐hour pad test reduction was 16 grams with an average continence rate after laser treatment of 44.5%". Ratz 2019 performed a narrative review, published in German, and included nine studies, two of which were RCTs (Blaganje 2018; Cruz 2018). We excluded Cruz 2018 from our study due to the fact that it included women who had vulvovaginal atrophy (dyspareunia, dryness, or burning), and SUI was not evaluated. The authors concluded in their abstract that "the research available is still limited: randomized controlled studies in particular are lacking. All the data published to date demonstrate a response to laser therapy with minimal side effects, high patient compliance and satisfaction, and a long‐term response for a minimum of 12 months". Mackova 2020 performed a systematic review and narrative data synthesis, finding 30 cohort studies and one RCT (Blaganje 2018). They concluded that "laser therapy seems to have a beneficial effect on prolapse and urinary incontinence, yet the level of evidence remains low. In terms of short‐term safety, no major problems seem to emerge, neither during nor after the application". Alsulihem 2020 performed a systematic review and found 23 case series, two non‐randomised trials, and two RCTs evaluating vaginal lasers for SUI and overactive bladder (Aguiar 2020; Blaganje 2018). The authors concluded that "in general the quality of reported studies is weak and even if complications seem minimal, long‐term safety data is lacking. We strongly believe that before considering wide spreading of laser for the treatment of SUI and OAB, additional good‐quality studies with extended follow up, systematic reporting of adverse events, and objective measures of outcomes (urodynamic, 24‐hour pad test, voiding diaries) are required". Ranjbar 2022 performed a systematic review of prospective RCTs and found four studies involving 431 participants (Aguiar 2020; Blaganje 2018; Lauterbach 2022; Seki 2022). Three of the included studies used CO₂ lasers (Aguiar 2020; Blaganje 2018), and one used Er:YAG laser (Seki 2022). We excluded Lauterbach 2022 from our analysis due to wrong population and intervention. Lauterbach 2022 randomised women who had already experienced a temporary significant improvement in symptoms following CO₂ laser treatments for SUI and had experienced a decline in treatment efficacy to a single dose of maintenance vaginal laser therapy. Ranjbar 2022 concluded that "SUI treatment with CO2‐laser and Erbium: YAG‐laser therapy is a quick, intuitive, well‐tolerated procedure that successfully improves incontinence‐related symptoms. After further refinement, it has the potential to minimize the frequency of surgical intervention for SUI patients". Brief economic commentary To supplement the main systematic review assessing the clinical effects of vaginal lasers for treating SUI in women, we sought to identify economic evaluations on the subject. We found no economic studies assessing the cost‐effectiveness of vaginal lasers compared to other interventions. The apparent shortage of relevant economic evaluations indicates that economic evidence regarding vaginal lasers for SUI in women is currently lacking. Authors' conclusions Implications for practice. Based on the current evidence summarised in this review, vaginal lasers appear to have little to no effect on stress urinary incontinence (SUI) as measured by both clinical assessment and patient‐reported outcome questionnaires in the short term (less than one year) compared to sham or control treatments or topical therapy, but the evidence is very uncertain. While there was statistically significant improvement in International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF) scores among women who underwent vaginal laser therapy versus no vaginal laser, the point estimate was below the previously published minimally important differences (MIDs), implying that there may be no noticeable clinical difference for patients. We were able to perform preplanned subgroup analysis to compare outcomes between CO₂ and Er:YAG laser types for a limited number of outcomes and found that in each subgroup analysis the results were consistent with the pooled analysis, indicating no differences based on laser type. No authors provided data stratified by woman's obesity status, and only one study stratified one secondary outcome based on SUI severity, therefore we cannot comment on the outcomes of vaginal laser for specific subsets of women. We did not find any increase in major adverse events among women undergoing vaginal laser treatment as compared to sham or control treatments or topical therapy. In fact, there were no major adverse events reported among any women. Women undergoing vaginal laser may have a greater risk of minor adverse events than those undergoing sham treatment. Implications for research. Several implications for research can be drawn from our review. Our confidence in the conclusions is limited by the very low‐certainty evidence. This fact underscores the importance of following CONSORT guidelines when designing and registering randomised controlled trials. We were not able to assess the effect of laser settings on outcomes. We were unable to conduct some of our pre‐planned subgroup analyses due to lack of data, though for some outcomes we were able to compare types of laser (CO₂ to Er:YAG). Similarly, data stratifying participants based on severity of incontinence or patient comorbidity were not provided. The majority of data were in the short term (less than one year), while very few studies provided medium‐term (one to five years) data, and no studies provided data beyond five years. Finally, we excluded data from several studies because they pooled results from women with heterogenous subtypes of incontinence (SUI, mixed, and urgency urinary incontinence). Future studies may benefit from designs that clearly present outcomes among women with differing types of incontinence, severity of incontinence, and patient comorbidities. Given the importance of patient‐reported outcome measures for SUI, standardised, validated, patient‐reported outcome measures (such as the ICIQ‐UI SF) should be consistently collected and reported. Many studies included in this review utilised the Urogenital Distress Inventory – Short Form (UDI‐6) to evaluate change in incontinence‐specific quality of life. To our knowledge, no MID has been established for the UDI‐6 (although MID has been established for the UDI). Efforts to clarify the MID for the UDI‐6 may improve the clinical interpretation of our findings. There are currently seven ongoing, registered randomised controlled trials evaluating the effect of vaginal lasers on SUI. The largest implication for research is to follow‐up on the outcomes of these registered trials and incorporate them into updated systematic reviews and meta‐analyses. History Protocol first published: Issue 6, 2020

We would like to acknowledge all the patients that participated in the included trials and to the investigators for conducting the trials. We would like to thank the following members of the Cochrane Incontinence editorial base for their invaluable help and support in the production of this review: Luke Vale, Lindsey Elstub (former Managing Editor), Eugenie Johnson, Claire Eastaugh. Editorial and peer‐reviewer contributions The following people conducted the editorial process for this article: Sign‐off Editor (final editorial decision): Luke Vale, Coordinating Editor of the Cochrane Incontinence Group, Toby Lasserson, Deputy Editor‐in‐Chief; Managing Editor (selected peer reviewers, collated peer‐reviewer comments, provided editorial guidance to authors, edited the article): Anne‐Marie Stephani, Cochrane Central Editorial Service; Editorial Assistant (conducted editorial policy checks and supported the editorial team): Leticia Rodrigues, Cochrane Central Editorial Service; Copy Editor (copy editing and production): Lisa Winer, Cochrane Central Production Service; Peer reviewers (provided comments and recommended an editorial decision): Valerie Wells, Research Associate – Information Scientist MRC/CSO Social and Public Health Sciences Unit School of Health and Wellbeing, University of Glasgow (search); Christian Phillips, Consultant Gynaecologist and Urogynaecologist, Hampshire Hospitals and Visiting Professor University of Winchester (clinical); Nuala Livingstone, Cochrane Evidence Production and Methods Directorate (methods). One additional peer reviewer provided clinical peer review but chose not to be publicly acknowledged. Appendices Appendix 1. Glossary of terms Ablation: the removal of body tissue Erbium:yttrium‐aluminium‐garnet (Er:YAG): a type of medium for laser energy Fractional laser: a type of laser treatment that divides laser beam into many treatment zones, targeting only a fraction of the skin at a time. This is opposed to conventional lasers, which do not divide the laser beam. Laser: a device that generates a beam of light that can be used for many purposes, including surgery. Vaginal stenosis: a narrowing or shortening of the vagina due to the formation of fibrous tissue. This can occur after genital surgery. Vulvovaginal atrophy: thinning and drying of the vaginal skin which occurs in low oestrogen states (such as after menopause) Appendix 2. Search terms for clinical effectiveness studies The search terms used to search the Cochrane Incontinence Specialised Register are given below: (design.cct* OR design.rct*) AND (topic.urine.incon.*) AND (intvent.surg.laser*) All searches were of the keyword field of EndNote 2018. Appendix 3. Search methods for the brief economic commentary We performed electronic literature searches designed to identify published reports of relevant economic evaluations to inform the brief economic commentary (BEC) (see 'Incorporating economic evidence' in the Methods). We searched the Cochrane Incontinence Specialised Register of Economic Evaluations (EEs) which consists of searches of: NHS Economic Evaluation Database (EED) on the UK Centre for Reviews and Dissemination (CRD) website (covering from the earliest record in NHS EED, dating from 1968, up to and including 31 December 2014 when their coverage ended) As NHS EED is no longer actively updated, we performed additional searches of the following databases to identify eligible studies added to these databases from 1 January 2015 onwards: MEDLINE on OvidSP (covering 1 January 1946 to June Week 5 2022); and Embase (on OvidSP) (covering 1 January 1974 to to 2022 Week 27). The search terms used to search the Cochrane Incontinence Specialised Register of Economic Evaluations are given below: (topic.urine.incon.*) AND (intvent.surg.laser*) All searches were of the keyword field of EndNote 2018. The economic evaluation search filters applied to our MEDLINE and Embase search strategies for the BEC are those formerly used by the UK Centre for Reviews and Dissemination (CRD) to identify published reports of full economic evaluations for indexing on NHS EED. These economic evaluation search filters remain freely available on the CRD Databases web-pages (CRD 2015). The other search lines in the MEDLINE and Embase search strategies for the BEC are adapted from the electronic search strategies run for our Cochrane Incontinence Specialised Register along with additional terms for this population developed specifically for this review. Similarly, our NHS EED search strategy for the BEC is adapted from search strategies run for our Specialised Register and based on textword and MeSH terms (capturing relevant P‐I‐C concepts) used to identify eligible studies of intervention effects. We followed the current economic methods guidance (Aluko 2022). The search strategies used in MEDLINE and Embase to populate the Cochrane Incontinence Specialised Register of EEs are given below. The original search of NHS EED to begin populating the Specialised Register of EEs is given at the end of this Appendix. MEDLINE on OvidSP (covering 1 January 1946 to June Week 5 2022) was last searched on 11 July 2022 | 1. | Economics/ | | 2. | exp "costs and cost analysis"/ | | 3. | Economics, Dental/ | | 4. | exp economics, hospital/ | | 5. | Economics, Medical/ | | 6. | Economics, Nursing/ | | 7. | Economics, Pharmaceutical/ | | 8. | (economic$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab. | | 9. | (expenditure$ not energy).ti,ab. | | 10. | value for money.ti,ab. | | 11. | budget$.ti,ab. | | 12. | or/1‐11 | | 13. | ((energy or oxygen) adj cost).ti,ab. | | 14. | (metabolic adj cost).ti,ab. | | 15. | ((energy or oxygen) adj expenditure).ti,ab. | | 16. | or/13‐15 | | 17. | 12 not 16 | | 18. | letter.pt. | | 19. | editorial.pt. | | 20. | historical article.pt. | | 21. | or/18‐20 | | 22. | 17 not 21 | | 23. | exp animals/ not humans/ | | 24. | 22 not 23 | | 25. | (incontinen$ or continen$).tw. | | 26. | exp urinary incontinence/ | | 27. | nycturia.tw. | | 28. | ((bladder or detrusor or vesic$) adj5 (instability or stab$ or unstable or irritab$ or hyperreflexia or dys?ynerg$ or dyskinesi$ or irritat$)).tw. | | 29. | (urin$ adj2 (leak$ or urge$ or frequen$)).tw. | | 30. | dribbl$.tw. | | 31. | bladder, neurogenic/ | | 32. | ((bladder or detrusor or vesic$) adj2 (hyper$ or overactiv$)).tw. | | 33. | (spinal adj2 bladder$).tw. | | 34. | (bladder$ adj2 (neuropath$ or neurogen$ or neurolog$)).tw. | | 35. | (nervous adj1 (pollakisur$ or pollakiur$)).tw. | | 36. | urinary bladder, overactive/ | | 37. | exp enuresis/ | | 38. | enure$.tw. | | 39. | bedwet$.tw. | | 40. | bed‐wet$.tw. | | 41. | (bed adj5 wet$).tw. | | 42. | (diurnal adj5 wet$).tw. | | 43. | diurnal‐wet$.tw. | | 44. | ((daytime or day‐time or nighttime or night‐time or nightime) adj5 wet$).tw. | | 45. | (void$ adj2 dysfunct$).tw. | | 46. | ((urin$ or bladder) adj5 sphincter$).tw. | | 47. | (urethra$ adj2 sphincter$).tw. | | 48. | (bladder adj2 neck).tw. | | 49. | (vesic$ adj1 (neck$ or cervi$)).tw. | | 50. | (detrusor adj1 sphincter$).tw. | | 51. | or/25‐50 | | 52. | 24 and 51 | Embase (on OvidSP) (covering 1 January 1974 to to 2022 Week 27) was last searched on 11 July 2022 | 1. | Health Economics/ | | 2. | exp Economic Evaluation/ | | 3. | exp Health Care Cost/ | | 4. | pharmacoeconomics/ | | 5. | (econom$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab. | | 6. | (expenditure$ not energy).ti,ab. | | 7. | (value adj2 money).ti,ab. | | 8. | budget$.ti,ab. | | 9. | or/1‐8 | | 10. | letter.pt. | | 11. | editorial.pt. | | 12. | note.pt. | | 13. | or/10‐12 | | 14. | 9 not 13 | | 15. | (metabolic adj cost).ti,ab. | | 16. | ((energy or oxygen) adj cost).ti,ab. | | 17. | ((energy or oxygen) adj expenditure).ti,ab. | | 18. | 15 or 16 or 17 | | 19. | 14 not 18 | | 20. | animal/ | | 21. | exp animal experiment/ | | 22. | nonhuman/ | | 23. | (rat or rats or mouse or mice or hamster or hamsters or animal or animals or dog or dogs or cat or cats or bovine or sheep).ti,ab,sh. | | 24. | 20 or 21 or 22 or 23 | | 25. | exp human/ | | 26. | human experiment/ | | 27. | 25 or 26 | | 28. | 24 not (24 and 27) | | 29. | 19 not 28 | | 30. | conference abstract.pt. | | 31. | 29 not 30 | | 32. | incontinence/ or mixed incontinence/ or stress incontinence/ or urge incontinence/ or urine incontinence/ | | 33. | continence/ | | 34. | overactive bladder/ | | 35. | micturition disorder/ or lower urinary tract symptom/ or pollakisuria/ | | 36. | urinary dysfunction/ or bladder instability/ or detrusor dyssynergia/ or neurogenic bladder/ or urinary urgency/ or urine extravasation/ | | 37. | (incontinen$ or continen$).tw. | | 38. | ((bladder or detrusor or vesic$) adj5 (instab$ or stab$ or unstab$ or irritab$ or hyperreflexi$ or dys?ynerg$ or dyskinesi$ or irritat$)).tw. | | 39. | (urin$ adj2 leak$).tw. | | 40. | ((bladder or detrusor or vesic$) adj2 (hyper$ or overactiv$)).tw. | | 41. | (bladder$ adj2 (neuropath$ or neurogen* or neurolog$)).tw. | | 42. | (nervous adj pollakisur$).tw. | | 43. | or/32‐42 | | 44. | 31 and 43 | NHS EED on CRD website was searched on 14 June 2019 (in all fields) | Line | Search | | 1 | MeSH DESCRIPTOR pelvic floor EXPLODE ALL TREES IN NHSEED | | 2 | MeSH DESCRIPTOR pelvic floor disorders EXPLODE ALL TREES IN NHSEED | | 3 | MeSH DESCRIPTOR Urinary Bladder, Neurogenic EXPLODE ALL TREES IN NHSEED | | 4 | MeSH DESCRIPTOR Urinary Bladder, overactive EXPLODE ALL TREES IN NHSEED | | 5 | ((incontinen* ) OR (continen*)) IN NHSEED | | 6 | ((floor adj2 pelvi* ) OR (pelvi* adj2 floor)) IN NHSEED | | 7 | ((nycturia)) IN NHSEED | | 8 | (((urin* or bladder) adj5 sphincter*) OR (sphincter* adj5 (urin* or bladder))) IN NHSEED | | 9 | (((bladder OR detrusor OR vesic*) ADJ5 (instability OR stab* OR unstable OR irritab* OR hyperreflexia OR dysynerg* OR dyskinesi* OR irritat*)) OR ((instability OR stab* OR unstable OR irritab* OR hyperreflexia OR dysynerg* OR dyskinesi* OR irritat*) ADJ5 (bladder OR detrusor OR vesic*) )) IN NHSEED | | 10 | ((urethra* ADJ2 sphincter*) OR (sphincter* ADJ2 urethra* )) IN NHSEED | | 11 | ((bladder ADJ2 neck) OR (neck ADJ2 bladder )) IN NHSEED | | 12 | ((urin* ADJ2 (leak* OR urge* OR frequen*)) OR ((leak* OR urge* OR frequen*) ADJ2 urin* )) IN NHSEED | | 13 | (dribbl*) IN NHSEED | | 14 | ((vesic* ADJ1 (neck* OR cervi*)) OR ((neck* OR cervi*) ADJ1 vesic*)) IN NHSEED | | 15 | (((bladder OR detrusor OR vesic*) ADJ2 (hyper* OR overactiv*)) OR ((hyper* OR overactiv*) ADJ2 (bladder OR detrusor OR vesic*))) IN NHSEED | | 16 | ((detrusor ADJ1 sphincter*) OR (sphincter* ADJ1 detrusor)) IN NHSEED | | 17 | ((spinal ADJ2 bladder*) OR (bladder* ADJ2 spinal)) IN NHSEED | | 18 | ((bladder* ADJ2 (neuropath* OR neurogen* OR neurolog*)) OR ((neuropath* OR neurogen* OR neurolog*) ADJ2 bladder*)) IN NHSEED | | 19 | ((nervous ADJ1 (pollakisur* OR pollakiur*)) OR ((pollakisur* OR pollakiur*) ADJ1 nervous)) IN NHSEED | | 20 | (MeSH DESCRIPTOR urinary incontinence EXPLODE ALL TREES) IN NHSEED | | 21 | #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 | Key: $ or * = truncation symbol; tw. = titles and abstracts; / = MeSH or Emtree term; exp = exploded MeSH or Emtree term; adjn = within n words, in any order on Ovid, in fixed order on CRD; ? character may or may not be present. Data and analyses Comparison 1. Vaginal lasers versus sham or control treatments (such topical lubricant). | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1.1 Number of continent women (objective measure as reported by the trialists), short term (< 1 year) | 3 | 196 | Risk Ratio (M‐H, Random, 95% CI) | 1.50 [0.72, 3.10] | | 1.2 Number of continent women (objective measure as reported by the trialists), medium term (1 to 5 years) | 1 | 76 | Risk Ratio (M‐H, Random, 95% CI) | 2.88 [1.48, 5.60] | | 1.3 Improvement in patient‐reported incontinence, short term (< 1 year) | 8 | 632 | Mean Difference (IV, Random, 95% CI) | ‐1.42 [‐2.41, ‐0.43] | | 1.3.1 CO2 Laser | 3 | 213 | Mean Difference (IV, Random, 95% CI) | ‐1.25 [‐3.57, 1.07] | | 1.3.2 Er:YAG Laser | 5 | 419 | Mean Difference (IV, Random, 95% CI) | ‐1.60 [‐2.63, ‐0.57] | | 1.4 Improvement in patient‐reported incontinence, medium term (1 to 5 years) | 1 | 76 | Mean Difference (IV, Random, 95% CI) | ‐1.62 [‐5.64, 2.40] | | 1.4.1 CO2 Laser | 1 | 76 | Mean Difference (IV, Random, 95% CI) | ‐1.62 [‐5.64, 2.40] | | 1.5 Number of major adverse events (Clavien‐Dindo III‐V), short term (< 1 year) | 9 | 689 | Risk Ratio (IV, Random, 95% CI) | Not estimable | | 1.6 Number of continent women by patient‐reported measures, short term (< 1 year) | 4 | 419 | Risk Ratio (M‐H, Random, 95% CI) | 2.48 [0.62, 9.93] | | 1.6.1 CO2 Laser | 2 | 173 | Risk Ratio (M‐H, Random, 95% CI) | 1.87 [0.10, 34.48] | | 1.6.2 Er:YAG Laser | 2 | 246 | Risk Ratio (M‐H, Random, 95% CI) | 3.20 [0.53, 19.50] | | 1.7 Number of continent women by patient‐reported measures, medium term (1 to 5 years) | 1 | 76 | Risk Ratio (M‐H, Random, 95% CI) | 2.00 [0.19, 21.14] | | 1.8 Improvement in incontinence‐specific quality of life, short term (< 1 year) | 3 | 241 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐13.22, 13.27] | | 1.8.1 ER: YAG | 1 | 83 | Mean Difference (IV, Random, 95% CI) | ‐66.80 [‐137.20, 3.60] | | 1.8.2 CO2 Laser | 2 | 158 | Mean Difference (IV, Random, 95% CI) | 1.39 [‐0.55, 3.32] | | 1.9 Improvement in incontinence‐specific quality of life, medium term (1 to 5 years) | 1 | 76 | Mean Difference (IV, Random, 95% CI) | 7.00 [‐10.10, 24.10] | | 1.9.1 CO2 Laser | 1 | 76 | Mean Difference (IV, Random, 95% CI) | 7.00 [‐10.10, 24.10] | | 1.10 Improvement in clinical measures of urinary incontinence (mean number of voids on 3‐day voiding diary), short term (< 1 year) | 2 | 139 | Mean Difference (IV, Random, 95% CI) | ‐0.60 [‐1.75, 0.54] | | 1.11 Improvement in clinical measures of urinary incontinence (mean number of voids on 3‐day voiding diary), medium term (1 to 5 years) | 1 | 76 | Mean Difference (IV, Random, 95% CI) | ‐0.79 [‐2.99, 1.41] | | 1.12 Improvement in patient‐reported sexual function, short term (< 1 year) | 4 | 318 | Std. Mean Difference (IV, Random, 95% CI) | 0.21 [‐0.06, 0.48] | | 1.12.1 CO2 Laser | 2 | 134 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.35, 0.33] | | 1.12.2 Er:YAG Laser | 2 | 184 | Std. Mean Difference (IV, Random, 95% CI) | 0.38 [0.09, 0.68] | | 1.13 Improvement in patient‐reported sexual function, medium term (1 to 5 years) | 1 | 76 | Mean Difference (IV, Random, 95% CI) | 2.80 [‐6.12, 11.72] | | 1.14 Number of minor adverse events (Clavien‐Dindo I, II), short term (< 1 year) | 7 | 475 | Risk Ratio (IV, Random, 95% CI) | 3.75 [1.56, 9.02] | | 1.14.1 ER:YAG Laser | 3 | 237 | Risk Ratio (IV, Random, 95% CI) | 4.76 [1.71, 13.30] | | 1.14.2 CO2 Laser | 4 | 238 | Risk Ratio (IV, Random, 95% CI) | 2.16 [0.28, 16.72] | Comparison 2. Vaginal lasers versus topical treatments (such as topical oestrogen). | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 2.1 Improvement in patient‐reported incontinence, short term (< 1 year) | 1 | 48 | Mean Difference (IV, Random, 95% CI) | ‐1.61 [‐4.71, 1.49] | | 2.2 Number of major adverse events (Clavien‐Dindo III‐V), short term (< 1 year) | 1 | 48 | Risk Ratio (IV, Random, 95% CI) | Not estimable | | 2.3 Number of minor adverse events (Clavien‐Dindo I, II), short term (< 1 year) | 1 | 48 | Odds Ratio (IV, Random, 95% CI) | Not estimable | Characteristics of studies Characteristics of included studies [ordered by study ID] Aguiar 2020. | Study characteristics | || | Methods | Enrolment: 72 participants Allocation: randomised Intervention model: RCT Masking: Open label | | | Participants | Inclusion criteria: women aged 50 years or older, who were amenorrhoeic for at least 1 year, with clinical complaints of vaginal dryness or urinary symptoms related to GSM, and who did not use hormonal treatment for at least prior last 6 months and any kind of medication for OAB (oral antimuscarinic or oral β3‐adrenoceptor agonists). Exclusion criteria: previous bilateral oophorectomy; body mass index (BMI) 30 kg/m2; contraindications to local oestrogen use, including recent myocardial infarction, severe hypertension, diabetes mellitus, thromboembolic disorders, previous breast or endometrial cancer, or abnormal postmenopausal bleeding. Women undergoing behavioural treatment for depression or taking antidepressant medications, those with any other psychiatric disorders, HIV‐positive women on antiretroviral therapy, women with a history of previous radiation therapy, and women with prior surgery for stress urinary incontinence were also excluded. | | | Interventions | Group I: CO2 laser (n = 24): procedure: CO2 laser (SmartXide2V2LR System, MonaLisa Touch; Deka, Florence, Italy) for 3 treatments with 1 month intervals Group II: vaginal oestrogen (n = 24): vaginal promestriene 3 times weekly for 12 weeks Group III: lubricant (n = 24): vaginal lubricant gel (the lubricant gel used contained glycerin and hydroxyethylcellulose as the lubricant, with chlorhexidine gluconate, gluconodeltalactone, methylparaben, and sodium hydroxide as antiseptic and preservative additives – KYjelly) that was self‐administered with sexual activity over a period of 12 weeks. | | | Outcomes | Primary outcome: ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline ICIQ‐OAB Outcome type: continuous outcome Reporting: fully reported Range: 0‐16 Direction: lower is better Data value: change from baseline Secondary outcome: Vaginal Health Index Outcome type: continuous outcome Range: 1‐5 Direction: lower is better Female Sexual Function Index (FSFI) Outcome type: continuous outcome Reporting: fully reported Range: 2‐36 Direction: higher is better Data value: change from baseline Major Adverse Events (Clavien‐Dindo III, IV, V) Outcome type: adverse event Reporting: fully reported Notes: urethral stricture, emergency department visits, unplanned surgery, vaginal stenosis, Clavien‐Dindo III, IV, V Minor Adverse Events (discomfort during procedure ‐pain), vaginal discharge, de novo urinary urgency, vaginal bleeding) Outcome type: adverse event Reporting: fully reported Direction: lower is better Notes: Clavien‐Dindo I, II Discomfort, vaginal discharge, de novo urinary urgency, dyspareunia, vaginal swelling, redness, vaginal dryness. | | | Study funding sources | Sponsorship source: not disclosed | | | Notes | Study Data collection time: baseline and 14 weeks | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized into three treatment groups: Group 1: intravaginal fractional CO 2 laser; Group 2: promestriene; Group 3: vaginal lubricant. Randomization was performed in a 1:1 ratio according to a randomization sequence performed using the Microsoft Excel program for Windows 2007 (Microsoft Corporation, Redmond, WA)" Comment: this was considered adequate for random sequence generation. | | Allocation concealment (selection bias) | Unclear risk | Quote: "The participant numbers and treatment codes were assigned after confirming the inclusion and exclusion criteria." Comment: unclear whether allocation was concealed from investigators. | | Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: none Comment: no mention of blinding of participants and personnel in the manuscript. | | Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: none Comment: no mention of blinding of outcome assessment. | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | Quote: "Statistical analyses were performed according to intention to treat (ITT) methodology, with the last observation being carried forward", From Figure 1, 7 were lost to follow up in the Lubricant group versus 5 in the promesteriene and 2 in the laser group. Comment: ITT analysis was used, however there were greater losses to follow‐up in the control arms. | | Selective reporting (reporting bias) | Unclear risk | Quote: "Brazilian Registry of Clinical Trials (Rebec) (UTN: U1111‐1220‐1620)" Comment: trial is registered but review authors were unable to locate the trial registration based on the details provided in the manuscript. | | Other bias | Low risk | None | Alexander 2022. | Study characteristics | || | Methods | Enrolment: 113 enrolled, 101 randomised Allocation: randomised Intervention model: RCT Masking: participant blinded | | | Participants | Inclusion criteria: women aged 18 to 80 years with objective and subjective stress urinary incontinence. Participants had participated in or declined PFMT previously and had a negative urinalysis and a normal cervical screening test within the recommended time frame. Exclusion criteria: POP stage >2, pregnancy, previous surgery in the treatment area within 12 months, active genital infection, systemic steroid use in last 3 months, vaginal lubricant use within 7 days, recurrent urinary tract or genital herpes, transvaginal mesh or sling implant, and serious systemic disease or chronic condition that could interfere with study compliance. | | | Interventions | Group I (n=52): FemTouch (Lumenis, Yokneam Illit, Israel) delivery system in conjunction with the AcuPulse CO2 laser system (Lumenis) and the AcuScan 120 Microscanner (Lumenis) to provide fractional treatment for 3 treatments, 4 weeks apart, with increasing energy and density settings. Group II (n= 49): Sham treatment was performed with an identical protocol; however, an inactive pedal was used so no energy was delivered. | | | Outcomes | Primary outcome: Question 6 ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐8 Direction: lower is better Data value: change from baseline Secondary outcome: PGI‐I Outcome type: continuous outcome Reporting: fully reported Range: 1‐7 Direction: lower is better Data value: change from baseline ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline ICIQ‐OAB Outcome type: continuous outcome Reporting: fully reported Range: 0‐16 Direction: lower is better Data value: change from baseline IIQ‐7 Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline PISQ‐12 Outcome type: continuous outcome Reporting: fully reported Range: 0‐48 Direction: lower is better Data value: change from baseline EQ‐5D scores Outcome type: 3 levels for 5 domains ‐ categorical Reporting: fully reported Range: level 1‐3 Direction: lower is better Data value: change from baseline

SUI (cough stress test, positive and median pad weight) Outcome type: continuous Reporting: fully reported Direction: lower is better Data value: change from baseline Adverse events Outcome type: continuous Reporting: fully reported Direction: lower is better Data value: VAS score and participant complaints (vaginal bleeding, de novo urge incontinence) | | | Study funding sources | Partial funding was obtained during the study from the Continence Foundation of Australia (M21005/3176612). | | | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized with equal probability to CO2 laser or sham treatment using a central computer‐generated random sequence allocating participants using blocks of 4, 6, and 8. The sequence was unknown to the investigators and the randomization code was released to the treating doctor after the participant had been recruited." Comment: this was considered adequate for random sequence generation. | | Allocation concealment (selection bias) | Low risk | Quote: "The sequence was unknown to the investigators and the randomization code was released to the treating doctor after the participant had been recruited." Comment: This was considered adequate for allocation concealment | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants but not investigators (including those involved in treatment and data collection) were blinded to the allocation throughout treatment and follow‐up. Participants were informed of their allocation after the 3‐month review." Comment: high risk of blinding of bias since personnel were not blinded | | Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Participants but not investigators (including those involved in treatment and data collection) were blinded to the allocation throughout treatment and follow‐up. Participants were informed of their allocation after the 3‐month review" Comment: high risk of bias since outcome assesors were not blinded | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | Quote "Of the 101 participants who commenced treatment and follow‐up, 2 participants (1 from each group) withdrew consent before the primary time point, and 2 participants in the laser arm did not re‐ turn for the 1‐ or 3‐month follow‐up, resulting in 97 participants for whom outcome data were available at both follow‐up point" Comment: low risk of bias since loss to follow‐up was balanced. | | Selective reporting (reporting bias) | Low risk | Quote "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372035&isReview=true" Comment: Trial is registered and consistent with results | | Other bias | Low risk | None | Blaganje 2018. | Study characteristics | || | Methods | Estimated enrolment: 60 Allocation: randomised Intervention model: parallel assignment Masking: single‐blinded (participants) | | | Participants | Included criteria: female patients with UI, pre‐menopausal (age 35‐65), sexually active, at least 1 vaginal delivery, diagnosis of SUI Excluded criteria: POP > stage I, inability to perform pelvic floor muscle contraction, mixed urinary incontinence and urge urinary incontinence, infection, previous gynaecologic surgery, radiation | | | Interventions | Group I (n = 57): procedure: IncontiLase Laser with SMOOTH settings once Group II (n = 57): procedure: Sham Laser once | | | Outcomes | Primary Outcome ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline ICIQ‐UI score of 0 Outcome type: dichotomous outcome Direction: lower is better Female Sexual Function Index (FSFI) Outcome type: continuous outcome Reporting: fully reported Range: 2‐36 Direction: lower is better Data value: change from baseline Secondary outcome: PISQ‐12 Outcome type: continuous outcome Reporting: fully reported Range: 0‐48 Direction: higher is better Discomfort after procedure (% of patients who ranked procedure as "poor or fair") Outcome type: dichotomous outcome Reporting: fully reported Perineometer ‐ muscle stamina Outcome type: continuous outcome Direction: higher is better Perineometer ‐ Maximal Contraction Pressure Outcome type: continuous outcome Reporting: fully reported Unit of measure: hPa Perineometer ‐ average contraction pressure Outcome type: continuous outcome Unit of measure: hPa Major Adverse Events (Clavien Dindo III, IV, V) Outcome type: adverse event Reporting: fully reported Notes: urethral stricture, emergency department visits, unplanned surgery, vaginal stenosis Minor Adverse Events (Clavien Dindo I, II) Outcome type: adverse event Reporting: fully reported Direction: lower is better Notes: discomfort, vaginal discharge, de novo urinary urgency, dyspareunia, vaginal swelling, redness, vaginal dryness | | | Study funding sources | Sponsorship source: None specified | | | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "114 patients were included in the study and randomized (1:1) by random drawing of sealed envelopes into one of the two groups; laser or sham group." Comments: adequate method for random sequence generation. | | Allocation concealment (selection bias) | Low risk | Quote: "drawing of sealed envelopes" Comments: adequate for allocation concealment | | Allocation concealment (selection bias) | Low risk | Quote: "drawing of sealed envelopes" Comments: adequate for allocation concealment | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Support: patients and personnel performing outcome assessment were blinded. Physicians performing the procedure were not. Comments: adequate blinding of participants. Physicians performing the procedure were not blinded. | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Support: patients and personnel performing outcome assessment were blinded. Physicians performing the procedure were not. Comments: adequate blinding of participants. Physicians performing the procedure were not blinded. | | Blinding of outcome assessment (detection bias) All outcomes | Low risk | Support: patients and personnel performing outcome assessment were blinded. Physicians performing the procedure were not. Comments: adequate blinding of outcome assessors | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | Quote: "112/114 patients concluded the study (Fig 1)." Comments: very low loss to follow‐up and balanced between groups | | Selective reporting (reporting bias) | Low risk | Quote: "NCT03296241" Comments: no differences between trial registration and manuscript methods were identified. | | Other bias | Low risk | None | Edell 2023. | Study characteristics | || | Methods | Enrolment: 134 participants Allocation: randomised Intervention model: RCT Masking: Double‐blinded | | | Participants | Inclusion criteria: Adult patients with a clinical diagnosis of SUI (primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including positive cough test, 24‐hour pad test >3 grams) and seeking treatment at a tertiary care hospital. Exclusion criteria: not specified | | | Interventions | Group I (n=23): Vaginal Er‐YAG LASER treatment group (two treatments, six weeks apart) Group II (n=61): Placebo “sham” group (same procedure but no LASER energy applied to tissue). | | | Outcomes | Primary outcome ICIQ‐UI SF at 6 months Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline Secondary outcome 24 Hour Pad Test Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline UDI‐6 Outcome type: continuous outcome Reporting: fully reported Range: 0‐100 Direction: lower is better IIQ‐7 Outcome type: continuous outcome Reporting: Range: 0‐21 Direction: lower is better KHQ Outcome type: continuous outcome Reporting: Range: 0‐100 Direction: lower is better PISQ‐12 Outcome type: continuous outcome Reporting: fully reported Range: 0‐48 Direction: higher scores indicate better sexual function. Data value: change from baseline | | | Study funding sources | Canadian Institute of Health Research grant #39051 Clinical Trial Yes | | | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: Participants were randomized (randomization table with allocation concealment by opaque sequentially numbered sealed envelopes) | | Allocation concealment (selection bias) | Low risk | Quote: Participants were randomized (randomization table with allocation concealment by opaque sequentially numbered sealed envelopes) | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: Given the nature of the sham procedure, providers cannot be blinded. | | Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: Study states that outcome assessors were blinded. | | Incomplete outcome data (attrition bias) All Outcomes | Unclear risk | Quote: "134 patients were enrolled, with 67/73 (91.78%) in the LASER treatment group and 58/61 (95%) in the sham treatment group reaching the primary outcome measure at 6 months post treatment." Comment: unclear how many participants in each group were lost to follow‐up. | | Selective reporting (reporting bias) | High risk | Quote: NCT03671694. Comment: Trial registration notes adverse effects as an outcome, which is not reported. | | Other bias | Low risk | None | O'Reilly 2024. | Study characteristics | || | Methods | Actual enrolment: 135 participants Allocation: randomised Intervention model: parallel assignment Masking: single (participant) | | | Participants | Inclusion criteria: adult female, 18 years of age or older; clinical and UDS diagnosis of SUI; no significant improvement in urinary incontinence from at least one previous conservative treatments, such as behavioural measures, pelvic floor muscle training or the use of absorbent pads Exclusion criteria: pre‐existing bladder pathology including prior radiation treatment; pregnancy; BMI > 35; radical pelvic surgery or previous incontinence surgery; urinary tract infection or other active infections of urinary tract or bladder; endometriosis; any form of pelvic organ prolapse greater than stage 2, according to POP‐Q; diagnosis of urge incontinence; diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers‐Danlos / Marfans etc. Incomplete bladder emptying; vesicovaginal fistula; faecal incontinence; unwillingness or inability to complete follow‐up schedule; unwillingness or inability to give Informed Consent; failure to comply with diary requirements during extended baseline period | | | Interventions | Group I: (n=73) Fotona Dynamis Er:YAG Laser System Group II:(n=37) sham Fotona Dynamis Er:YAG Laser System with Sham handpiece; sham treatment with a sham handpiece and parameter presentations masked | | | Outcomes | Primary outcomes: Reduction in 1‐hour pad weight at 6 months Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline Major Adverse Events (Clavien‐Dindo III, IV, V) Outcome type: adverse event Reporting: fully reported Notes: urethral stricture, emergency department visits, unplanned surgery, vaginal stenosis, Clavien‐Dindo III, IV, V. Minor Adverse Events (discomfort during procedure ‐ pain), vaginal discharge, de novo urinary urgency, vaginal bleeding Outcome type: adverse event Reporting: fully reported Direction: lower is better Notes: Clavien‐Dindo I, II Discomfort, vaginal discharge, de novo urinary urgency, dyspareunia, vaginal swelling, redness, vaginal dryness. Secondary outcome: Reduction in 1‐hour pad weight at 12 months Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline Change in mean cough stress test score at 6 and 12 months Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline King's Health Questionnaire (KHQ) Outcome type: continuous outcome Range: 0‐100 Direction: lower is better Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ‐12) Outcome type: continuous outcome Reporting: fully reported Range: 0‐48 Direction: higher scores indicate better sexual function. Data value: change from baseline ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline Leakage frequency as recorded by a 3‐day bladder diary Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline | | | Study funding sources | Fotona d.o.o Slovenia supplied the laser equipment for the study. | | | Notes | Emailed authors, who provided unpublished data. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "Randomization was computer‐generated" Comment: Adequate random sequence generation performed | | Allocation concealment (selection bias) | Low risk | Quote: "with allocation concealment by opaque sequentially numbered sealed envelopes." Comments: allocation was concealed to study team members | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The active group received an active laser therapy using the Er:YAG laser (IncontiLase® protocol, Fotona, Slovenia), while the sham group received treatment with a sham hand piece in which the laser light was physically blocked from reaching the tissue. This was a single blind clinical trial with the participants being blinded to allocation." Comments: participants were blinded to the allocation but the personnel were not | | Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The active group received an active laser therapy using the Er:YAG laser (IncontiLase® protocol, Fotona, Slovenia), while the sham group received treatment with a sham hand piece in which the laser light was physically blocked from reaching the tissue. This was a single blind clinical trial with the participants being blinded to allocation." Comments: No mention of blinding of outcome assessors. | | Incomplete outcome data (attrition bias) All Outcomes | High risk | Quote: "Data on primary outcome was not available for 20 patients (pad test was not performed in 6 patients, 2 patients were lost to follow‐up, 2 patients missed their follow up appointment and 4 patients discontinued treatment. 1 patient was incorrectly randomized)" Comment: 18% attrition and unclear whether attrition was balanced between groups. | | Selective reporting (reporting bias) | Low risk | Quote: Trial was registered: NCT03098992 Comment: Outcomes in trial registration match with reported outcomes in abstract. | | Other bias | Low risk | None | Salvatore 2021. | Study characteristics | || | Methods | Estimated enrolment: 60 Allocation: randomised Intervention model: Placebo‐controlled Masking: Double‐blind | | | Participants | Inclusion criteria: adult women with genitourinary symptoms of menopause, with vaginal dryness and dyspareunia as the two most bothersome symptoms Exclusion criteria: vulvodynia, vulvovaginitis, any vulvovaginal pathology, dryness, and dyspareunia caused by reasons other than genitourinary syndrome of menopause, prior treatment with intravaginal energy‐based devices, use of non‐hormonal/hormonal local therapies, other pathologies that could interfere with participants' compliance to protocol, pelvic organ prolapse > stage 2 according to POP‐Q staging, history of gynaecological and/or breast cancer. | | | Interventions | Group I (n = 30): procedure: CO2 laser (SmartXide2V2LR System, MonaLisa Touch; Deka, Florence, Italy) for 3 treatments and 1 month interval in between Group II: (n = 30): procedure: Sham Laser for 3 treatments and 1 month interval in between | | | Outcomes | Primary outcome: Clinical evaluation of incontinence (dryness and dyspareunia) Outcome type: dichotomous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline Secondary Outcomes: UDI‐6 Outcome type: continuous outcome Reporting: fully reported Range: 0‐100 Direction: lower is better Data value: change from baseline Female Sexual Function Index (FSFI) Outcome type: continuous outcome Reporting: fully reported Range: 2‐36 Direction: higher is better Data value: change from baseline VAS ‐ dysuria Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline VAS ‐ dyspareunia Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline VAS ‐ vaginal dryness Outcome type: continuous outcome Direction: lower is better Data value: change from baseline VAS ‐ burning sensation Outcome type: continuous outcome Direction: lower is better Data value: change from baseline VAS ‐ vaginal itching Outcome type: continuous outcome Direction: lower is better Data value: change from baseline Major adverse events (Clavien Dindo III, IV, V) Outcome type: adverse event Reporting: fully reported Notes: urethral stricture, emergency department visits, unplanned surgery, vaginal stenosis Minor adverse events (discomfort during procedure ‐ pain), vaginal discharge, de novo urinary urgency, vaginal bleeding Outcome type: adverse event Reporting: fully reported Direction: lower is better Notes: Clavien Dindo I, II, discomfort, vaginal discharge, de novo urinary urgency, dyspareunia, vaginal swelling, redness, vaginal dryness | | | Study funding sources | Sponsorship source: none | | | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "Participants were equally assigned by 1:1 block randomiza‐ tion to either active or sham treatment using the free online program Sealed Envelope (https://www.sealedenvelope.com/ simple‐randomiser/v1/lists). The block sizes were 4, 6, and 8." Comment: a centralised, web‐based randomisation tool was used for sequence generation. | | Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was performed using the sealed opaque envelopes rationale. The envelopes were locked in a safe place with limited access for the aforementioned authorized nurse who had no other involvement in the study." Comments: allocation was concealed to all study members and patients, except for a nurse putting the laser settings into the machine | | Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: participants could not guess in which group they were allocated, as they were naïve to intravaginal energy‐based device treatment, were informed that the laser treatments might not produce any discomfort, the laser’s screen was covered, and the sound of the laser was standard independent of the laser energy. Comments: participants and personnel were blinded to the settings on the laser. Physicians delivering the laser therapy were not involved in the study in any way. Patients were niave to therapy and therefore could not guess the intervention versus control group. | | Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: They were the only responsible parties with access to the participants’ allocation; no other implementa‐ tion to the study’s protocol or the participants was allowed. Participants could not guess in which group they Comment: the outcome assessors were blinded to the allocation. | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | Quote: Two participants in the active group dropped out of the study for personal reasons irrelevant to the study. Comment: all patients in the sham group were followed up, 2 patients in the laser group did not receive the intervention and were not included in the | | Selective reporting (reporting bias) | High risk | Quote: none Comment: NCT03754205 was reviewed. The clinical trial states 24 month follow‐up is anticipated. The primary outcome in the trial registration is consistent with the study, visual analog scale difference in dyspareuni and dryness. However, the following secondary outcomes were listed in the clinical trial registration and not reported in the manuscript: "Day to Day Impact of vaginal aging (DIVA)," "Patient Global Impression of Improvement," "3 day voiding diary," "ICIQ‐Female Lower Urinary Tract Symptoms (ICIQ‐FLUTS)," "King's Health Questionnaire," "Vaginal Maturation Value," "Vaginal Health Index Score," "Epithelial Thickness," "Number, size, and density of Blood Vessels," "Cultures of vaginal samples" "Polymerase Chain Reaction" | | Other bias | Low risk | none | Seki 2022. | Study characteristics | || | Methods | Estimated enrolment: 139 Allocation: randomised Intervention model: parallel assignment Masking: Double‐blind | | | Participants | Inclusion criteria: women with predominant SUI confirmed by clinical evaluation. Exclusion criteria: prolapse stage > 2 POPQ, use of topical oestrogen therapy in the past 6 months, active HPV or herpes, abnormal vaginal bleeding. | | | Interventions | Group I (n = 47): procedure: radiofrequency Linly Loktal Medical Electronics for 3 treatments and 30 day intervals in between Group II: CO2 Laser (n = 42) CO2 Laser ‐ Femilif for 3 treatments and 30 day intervals in between Group III (n = 50): Sham Laser Linly Loktal Medical Electronics, and Femilif LTB ‐ turned off for 3 treatments and 30 day intervals in between | | | Outcomes | Primary Outcome: Subjective impression of improvement in SUI, defined as “better” or “much better” on the Likert scale; Objective cure was a composite outcome, defined when the women presented three negative tests: stress test (tested with comfortably full bladder in a gynaecological and standing position) Voiding diary (mean # of voids) Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Data value: change from baseline Pad weight test Outcome type: continuous outcome Reporting: fully reported Unit of measure: grams Direction: lower is better Post‐procedure pain (Visual Analog Scale) Outcome type: continuous outcome Reporting: partially reported Direction: lower is better Data value: change from baseline Secondary Outcomes: ICIQ‐UI SF Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline Female Sexual Function Index (FSFI) Outcome type: continuous outcome Reporting: fully reported Range: 2‐36 Direction: higher is better Data value: change from baseline Incontinence Quality of LIfe Questionnaire (I‐QOL) Outcome type: continuous outcome Range: 0‐100 Reporting: partially reported Direction: higher is better Data value: change from baseline Minor adverse events (Clavien Dindo I, II) Outcome type: adverse event Reporting: fully reported Direction: lower is better Notes: discomfort, vaginal discharge, de novo urinary urgency, dyspareunia, vaginal swelling, redness, vaginal dryness Major adverse events (Clavien Dindo III, IV, V) Outcome type: adverse event Reporting: fully reported Notes: urethral stricture, emergency department visits, unplanned surgery, vaginal stenosis | | | Study funding sources | Sponsorship source: not specified | | | Notes | Emailed authors for additional information. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "Block randomization was performed using a computerized random number generator (Microsoft (R) Excel) and the list was kept by the nurse in charge of the protocol, who scheduled the treatment sessions." Comment: this was considered adequate for random sequence generation | | Allocation concealment (selection bias) | Unclear risk | Quote: "Block randomization was performed using a computerized random number generator (Microsoft (R) Excel) and the list was kept by the nurse in charge of the protocol, who scheduled the treatment sessions." Comment: unclear whether allocation was concealed from investigators. | | Allocation concealment (selection bias) | Unclear risk | Quote: "Block randomization was performed using a computerized random number generator (Microsoft (R) Excel) and the list was kept by the nurse in charge of the protocol, who scheduled the treatment sessions." Comment: unclear whether allocation was concealed from investigators. | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "All participants and the outcome assessors were blinded to the intervention group, and only the physician who performed hte treatment application was aware of it." Comment: adequate blinding of participants. Physicians performing the procedure were not blinded. | | Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All participants and the oucome assessors were blinded to the intervention group, and only the physician who performed hte treatment application was aware of it." Comment: adequate blinding of outcome assessors. | | Incomplete outcome data (attrition bias) All Outcomes | High risk | Quote: "A total of 153 women with SUI were enrolled, and 139 were randomized to have CO2 laser (42), RF (47), or to [sham] (50). A total of 114 women, 38 in each group, reached the 12 month follow‐up." "Subjective improvement and objectie cure results were also described by intention‐to‐treat (ITT) and per protocol (PP) analysis" Comment: Data shows significant attrition (18%), however attrition was not balanced across groups (12 discontinued sham vs 8 discontinued RF vs 4 discontinued laser) | | Selective reporting (reporting bias) | Low risk | Quote: "The study was registered at Brazilian National Clincial Trials (REBEC RBR‐33jphr). Comment: the trial reporting matches registration | | Other bias | Low risk | None | Temtanakitpaisan 2023. | Study characteristics | || | Methods | Enrolment: 64 enrolled, 59 randomised Allocation: randomised Intervention model: RCT Masking: Open label | | | Participants | Inclusion criteria: Women with SUI and mixed urinary incontinence, stress predominant Exclusion criteria: history of recurrent UTI, previous anti‐incontinence surgery, body mass index (BMI) > 30 kg/m2, use of hormonal treatments in postmenopausal women, current use of drug treatment for urinary incontinence, pain in the vagina with or without sexual intercourse, pregnancy, current active vaginal infections, abnormal uterine bleeding with unknown causes, and a history of vaginal laser treatment | | | Interventions | Group I (n=29): CO2 laser treated with transvaginal fractional microablative CO2 lasers (MonaLisa Touch; Deka, Florence, Italy). Group II (n=30): Women in the sham group were treated in the same manner as the intervention group but with no energy administered. | | | Outcomes | ICIQ‐UI SF questionnaireOutcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline Pelvic floor US Bladder neck at rest, at Valsalva, and descent (mm); levator hiatal area at rest, on Valsalva and differences (cm3) Outcome type: continuous Reporting: fully reported Data value: change from baseline, change between groups | | | Study funding sources | Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand | | | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Quote: "The participants who met the inclusion criteria were randomly allocated using computer generated randomization into two groups." Comment: This was deemed adequate for random sequence generation | | Allocation concealment (selection bias) | Low risk | Quote: All randomization sequences were kept in sequentially numbered opaque seal envelopes. Comment: This was deemed adequate for allocation concealment | | Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants and assessor were blinded" Comment: Personnel were not blinded | | Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Participants and assessor were blinded" Comment: Outcome assessors were blinded | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | none | | Selective reporting (reporting bias) | Unclear risk | This trial was registered with the Thai Clinical Trial Register (TCTR20190131004). | | Other bias | Low risk | None | Tu 2023. | Study characteristics | || | Methods | Enrolment: 55 participants Allocation: randomised Intervention model: RCT Masking: Single blinded | | | Participants | Inclusion criteria: Women experiencing stress urinary incontinence and stress‐predominant mixed urinary incontinence with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Exclusion criteria: Not specified | | | Interventions | Group I (n=20): combination of intraurethral and intravaginal 2940nm Er:YAG laser treatment Group II (n=20): intravaginal 2940nm Er:YAG laser treatment only Group III (n=15): sham control | | | Outcomes | Primary outcome VAS pain scale Outcome type: continuous outcome Reporting: not reported Direction: lower is better Use of pain‐relieving medication Outcome type: continuous outcome Reporting: fully reported Direction: lower is better Incidence and severity of complications Outcome type: continuous Reporting: fully reported Direction: lower is better Uroflow and post void residual (PVR) Outcome type: continuous outcome Reporting: not reported Direction: lower is better Data value: change from baseline IPSS Outcome type: continuous outcome Reporting: fully reported Range: 0‐35 Direction: lower is better Data value: change from baseline Secondary outcome 3‐day voiding diary (incontinence episodes per day) Outcome type: continuous outcome Reporting: fully reported Direction: lower is better 24‐Hour Pad‐Weight Test Outcome type: continuous outcome Reporting: fully reported Direction: lower is better ICIQ‐UI Outcome type: continuous outcome Reporting: fully reported Range: 0‐21 Direction: lower is better Data value: change from baseline PGI‐I Outcome type: continuous outcome Reporting: fully reported Range: 1‐7 Direction: lower is better | | | Study funding sources | || | Notes | || | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | The study states "randomly allocated" without further details on random sequence generation | | Allocation concealment (selection bias) | Unclear risk | The study states "randomly allocated" without further details on allocation concealment | | Blinding of participants and personnel (performance bias) All outcomes | High risk | The study was single‐blinded (patient only). | | Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Does not specify whether or not outcome assessors are blinded. | | Incomplete outcome data (attrition bias) All Outcomes | Low risk | All but one participant completed the study and/or had outcome data. | | Selective reporting (reporting bias) | High risk | NCT03676894. Several of intended outcome measures are not reported, including: tolerability of the 2940nm Er:YAG laser technique by VAS pain scale [ Time Frame: 18 months ]; safety of intra‐urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR) [ Time Frame: 18 months ]; safety of intra‐urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS) [ Time Frame: 18 months ]. Study also does not report up until 18 months. | | Other bias | Low risk | None | BMI: body mass index FSFI: Female Sexual Function Index HPV: human papillomavirus ICIQ‐OAB: International Consultation on Incontinence Questionnaire Overactive Bladder Module ICIQ‐UI SF: International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form I‐QOL: Incontinence Quality of LIfe Questionnaire OAB: overactive bladder PISQ‐12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire POPQ: Pelvic Organ Prolapse Quantification PT: physical therapy RCT: randomised controlled trial SD: standard deviation SUI: stress urinary incontinence UDI‐6: Urinary Distress Inventory, Short Form VAS: visual analogue scale Characteristics of excluded studies [ordered by study ID] | Study | Reason for exclusion | |---|---| | Alquzwini 2020 | Wrong Comparator (Colporrhaphy) | | Athanasiou 2020 | Wrong population (women with history of gynaecological cancer) | | Bianchi‐Ferraro 2020 | Wrong Population | | Cruff 2021 | Wrong Population | | Cruz 2018 | Wrong population (no stress urinary incontinence) | | Da Fonesca 2023 | Wrong Comparator | | Eftekhar 2021 | Wrong population (mixed urinary Incontinence without separate results for SUI) | | Espitia De La Hoz 2017 | Wrong comparator (physical therapy) | | Gaspar 2018 | Wrong study design (not randomised) | | Ghorbani 2019 | Wrong Population | | Ivan 2014 | Wrong study design (not randomised) | | Lauterbach 2022 | Wrong Intervention | | Mousa 2021 | Wrong intervention | | NCT02419729 | Wrong Population | | NCT03238053 | Wrong population (no stress urinary incontinence data) | | NCT03316950 | Wrong intervention (hybrid fractional laser) | | NCT03995797 | Wrong population (women with pelvic organ prolapse; no stress urinary incontinence) | | NCT04253067 | Study Withdrawn | | NCT04959084 | Wrong intervention (laser acupuncture) | | NCT05097456 | Wrong Intervention | | NCT05557799 | Wrong Intervention | | Okui 2019 | Wrong study design (not randomised) | | Paraiso 2018 | Wrong outcome (SUI not presented separately from urge incontinence) | | Quick 2021 | Wrong outcome (data for SUI not presented separately from urge incontinence) | | RBR‐4ckch8 | Wrong comparator (physiotherapy) | | Rocha‐Rangel 2024 | Wrong Comparator (Physiotherapy) | | Ruanphoo 2020 | Wrong population (no stress urinary incontinence) | | Singwongsa 2019 | Wrong population (no stress urinary incontinence) | | Viguera 2020 | Wrong comparator (physical therapy) | SUI: stress urinary incontinence Characteristics of ongoing studies [ordered by study ID] ACTRN12617000099325. | Study name | Carbon dioxide (CO2) Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study | | Methods | Allocation: RCT Procedure for enrolling a subject and allocating the treatment: participants will be randomised with equal probability to CO2 laser or sham using a central computer‐generated random allocation. Subjects will be randomised in order of entry into the study. Methods used to generate the sequence in which subjects will be randomised: computer‐generated random allocation Masking/blinding: blinded (masking used); participants; outcome assessors Intervention assignment: parallel | | Participants | Inclusion criteria: all participants with symptoms of stress urinary incontinence; between the ages of 18‐80 years with objective stress urinary incontinence (based on one of three objective measures of either positive cough stress test or urodynamic stress incontinence or positive 24h pad weigh test (> 4 g)); desire conservative management; participants will have had supervised pelvic floor muscle therapy in the last 12 months; capable of providing informed consent and able to return for follow up; negative urinalysis; normal Papanicolaou (PAP) test within the last 2 years; minimum age: 18 years; maximum age: 80 years Exclusion criteria: pregnant subjects; previous surgery in the treatment area in the last year; active genital infection; subject presenting with abnormal PAP result from the last three years with any of the findings according to the Bethesda (2001) system classification; systemic steroids use within the last 3 months; vaginal lubricants within 7 days prior to enrolment; recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year); pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system; transvaginal mesh or sling implant; serious systemic disease or any chronic condition that could interfere with study compliance; any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety | | Interventions | Group I: fractionated CO2 surgical laser using the Lumenis Acupulse CO2 laser system and the AcuScan 120 microscanner to provide fractional treatment, delivered by a consultant urogynaecologist. Mode of delivery will be face to face and will be provided individually. Through the use of the scanner, the laser energy is delivered in a fractional manner, from 7.5‐12.5 millijoule with a 5‐25% density, a penetration depth of 600 micro millimeter from the 10 o’clock to 2 o’clock position, starting at the top of the vagina up to 5 mm from the introitus. (Lumenis protocol). This will be delivered over 3 x 5 minute sessions, once every 4 weeks over 3 months and be performed in an urban urogynaecological clinic. Group II: sham treatment ‐ participants will attend the urban urogynaecological clinic and be seen face to face. They will have the Lumenis Acupulse CO2 microscanner inserted into the vagina but no laser energy will be delivered. They will attend for 3 x 5 minutes sessions, once every 4 weeks over 3 months for sham treatment. They will cross over to active treatment at the 4 month if there is no improvement in subjective symptoms of SUI. | | Outcomes | Primary outcomes: to assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ‐UI) of the CO2 surgical laser against sham 3 months after treatment Secondary outcomes: objective cure rate (negative cough stress test 3, 6 and 12 months after treatment); procedure‐related safety by participant assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (VAS) 3 months after last treatment; subjective outcomes of overactive bladder symptoms using ICIQ OAB questionnaire (3, 6 and 12 months post last treatment); change in sexual function using PISQ‐12, following both treatments (3, 6 and 12 months post last treatment); effect of prolapse stage by clinical examination using the pelvic organ prolapse quantification system (3, 6 and 12 months post last treatment); cost effectiveness between the laser versus sham using the EQ5D (12 months post last treatment); subject satisfaction using PGI‐I (3, 6 and 12 months post last treatment); quality of life using IIQ (3, 6 and 12 months post last treatment); subjective outcomes of stress incontinence symptoms using ICIQ UI SF questionnaires (3, 6 and 12 months post last treatment) | | Starting date | 01/02/2017 | | Contact information | Principal investigator: Dr Lin Li Ow Address: Monash Health, Pelvic Floor Department, 823‐865 Centre Road, Bentleigh East Victoria, 3165, Australia Phone: +613 992 88588 Fax: +613 992 88338 Email: [email protected] Contact person for public queries Name: Ms Alison Leitch Address: Monash Health, Pelvic Floor Unit, 823‐865 Centre Road, Bentleigh East Victoria, 3165, Australia Phone: +613 99288588 Fax: +613 992 88338 Email: [email protected] Contact person for scientific queries Name: Dr Lin Li Ow Address: Monash Health, Pelvic Floor Unit, 823‐865 Centre Road, Bentleigh East Victoria, 3165, Australia Phone: +613 99288588 Fax: +613 992 88338 Email: [email protected] | | Notes | ChiCTR1900021044. | Study name | A randomized controlled trial of laser treatment in women with stress urinary incontinence | | Methods | RCT | | Participants | Inclusion criteria: women aged over 18 years; patients diagnosed with urodynamic stress incontinence (USI); willing to give written consent and compliance to participate in the study. Exclusion criteria: patients with mixed urinary incontinence with predominant urge urinary incontinence; patients who had recurrent USI that failed previous surgical treatment, e.g. tension free vaginal tape surgery or injection of bulking agent; patients with pregnancy or lactating; patients with stage II or above pelvic organ prolapse; patients with undiagnosed vaginal bleeding, injury or active infection; patients currently in‐use of photosensitive drugs; patients refuse to participate in the study. | | Interventions | Group I: laser therapy with two phases 20 minutes 2 times with 4 weeks apart versus Group II: sham procedure with zero intensity settings 20 minutes 2 times with 4 weeks apart | | Outcomes | Reduction in PFDI Urinary Distress Inventory Stress Subscale scores between both groups; symptoms of SUI according to question 20‐22 of PFDI; symptoms of SUI according to the 3 days bladder diary; Visual Analog Scale (VAS); reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups; reduction in other domains of PFDI and PFIQ; reduction in ICIQ‐UI SF score; tolerability of intravaginal laser treatment; satisfactory of intravaginal laser treatment; complications or adverse effect of intravaginal laser treatments; anal tone and pelvic floor muscle strength by Oxford scale; need for surgical treatment for stress urinary incontinence | | Starting date | 24 December 2018 | | Contact information | Lai Loi Lee [email protected] 1E, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China | | Notes | NCT03671694. | Study name | Laser Vaginal Treatment for SUI | | Methods | Estimated enrolment: 182 participants Allocation: randomised Intervention model: parallel assignment Intervention model description: RCT Masking: triple (participant, investigator, outcome assessor) Masking description: only the care provider (who is not involved with recruitment or evaluation of patients' outcomes) will be aware of the treatment assignments | | Participants | Inclusion criteria: female patient, aged 18 years or older at the time of enrolment; primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation; for a duration of at least 3 months (patient can be re‐screened after this time interval has passed); the patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it; objective proof of SUI: Observation of urine leakage by cough and Valsalva (positive stress test) at a bladder volume of ≤ 300 cm3; bladder capacity ≥ 200 cm3; post void residual ≤ 100 cm3 with stage I or lower pelvic organ prolapse Exclusion criteria: patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is <12 months postpartum Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula); patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum; current chemo/radiotherapy; history of pelvic radiation; systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury); current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms; history of synthetic sling; pelvic surgery < 3 months; current evaluation or treatment for chronic pelvic pain; patient has pelvic organ/vaginal prolapse extending to or out of the vaginal opening; participation in another treatment intervention that might interfere with the results of this trial; patient has a medical condition or disorder that may limit life expectancy or that may cause non‐compliance with the protocol (e.g. unable to perform self‐evaluations and/or accurately report medical history, urinary symptoms, and/or data); patient has ambulatory 24 hour pad test, where the increased pad weight is < 3 grams; patient is non‐ambulatory (ambulatory with assistive devices allowed) | | Interventions | Group I: laser treatment; Erbium‐YAG laser treatment to the vagina Group II: sham treatment; sham treatment with laser placebo | | Outcomes | Primary outcome: SUI cure using ICIQ questionnaire: The International Consultation on Incontinence Questionnaire (ICIQ) is a subjective measure of the severity of urinary loss and quality of life for those with incontinence. With the short form, there are 3 questions with a multi‐choice selection of responses with each response having an assigned score. The total score (additive from the 3 questions) are between 0 ‐ 21. Higher scores are indicative of greater severity. Six months post‐treatment. Secondary outcome: number of participants with any reported adverse effects: local burn, bleeding, irritation, infection, vaginal discharge etc. Six, 12 and 24 months post‐treatment. | | Starting date | 19 September 2018 | | Contact information | Joanne Lawrence, BSc 4164806100 ext 2309 [email protected] | | Notes | NCT03996070. | Study name | VESPER: Stress Urinary Incontinence STUDY (VESPER‐SUI) | | Methods | Estimated enrolment: 23 participants Allocation: randomised Intervention model: parallel assignment Masking: single (participant) | | Participants | Inclusion criteria: adult female, 18 years of age or older; clinical and UDS diagnosis of SUI; SUI on 1‐hour Pad weight test between 2 g and 25 g (SUI I: 2‐10 g, SUI II: 11‐25 g); no significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training Exclusion criteria: pre‐existing bladder pathology including prior radiation treatment; pregnancy; BMI > 35; radical pelvic surgery or previous incontinence surgery; urinary tract infection or other active infections of urinary tract or bladder; SUI on 1 hour pad weight test > 25 g (SUI III: > 25 g); any form of pelvic organ prolapse greater than stage 2, according to POP‐Q; diagnosis of urge incontinence; diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers‐Danlos/Marfans etc.; incomplete bladder emptying; vesicovaginal fistula; faecal incontinence; unwillingness or inability to complete follow‐up schedule; unwillingness or inability to give informed consent; failure to comply with diary requirements during extended baseline period | | Interventions | Group I: treatment with laser therapy: Erbium YAG laser Group II: sham with sub‐therapeutic dose regimen; laser with Erbium YAG Laser | | Outcomes | Primary outcome: change in standardised 1hr pad weight test from baseline to 6 months following treatment compared with the sham arm. Secondary outcomes: change in cough stress test from baseline to 6 months post treatment; change in cough stress test from baseline to 12 months post treatment; change in 1‐hour pad weight test from baseline to 12 months post treatment; International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF) from baseline to 6 months post treatment; International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF) from baseline to 12 months post treatment; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ‐12) from baseline to 6 months post treatment; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ‐12) from baseline to 12 months post treatment; Patient's Global Impression of Improvement (PGII) at 6 months post treatment; Patient's Global Impression of Improvement (PGII) at 12 months post treatment; pain visual analogue scale | | Starting date | 1 September 2019 | | Contact information | No contact information provided. | | Notes | NCT04636749. | Study name | Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence | | Methods | Estimated Enrolment: 80 participants Allocation: Randomised Intervention Model: Parallel Assignment Masking: Single (Participant) | | Participants | Inclusion criteria: women above 18 with SUI Exclusion criteria: recurrent pelvic inflammatory disease; vaginal operation in the previous year; women with abnormal uterine bleeding; women with diagnosed genital herpes infection; any concurrent lower genital tract infection | | Interventions | Group 1: procedure: Erbium Laser Group 2: procedure: Sham Laser | | Outcomes | Primary outcome: Cough test and Pad test Secondary outcome: Urinary distress index 6 questionnaire; Female sexual function questionnaire; Urinary incontinence and sexuality questionnaire | | Starting date | March 9, 2021 | | Contact information | Contact: Naama Farago, MD 972‐509267806 [email protected] | | Notes | NCT04643353. | Study name | Use of Non‐ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence. (VELSUI) | | Methods | Estimated Enrolment: 53 participants Allocation: randomised Intervention model: parallel assignment Masking: single (participant) | | Participants | Inclusion criteria: The presence of mild (score 1‐2) to moderate (3‐6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorised by the four‐level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1‐2, moderate= 3‐6, severe=8‐9, very severe=12). Exclusion criteria: Any previous PFE‐treatment in the last year for the same problem; previous surgery for incontinence or prolapse; severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD); prolapse grade III or more; pregnancy; vaginal bleeding, injuries or infection in the treated area | | Interventions | Group 1: procedure: Erbium Laser: YAG 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting for 3 visits with a 4 weeks interval Group 2: Pelvic floor exercises, up to 2x 9 sessions with a pelvic floor physiotherapist of choice | | Outcomes | Primary outcome: subjective success rate (cure or improvement) of SUI [ Time Frame: 6 months after last treatment ] using the UDI‐6 questionnaire Secondary outcome: Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI‐6); Assessment of the objective success rate by means of the cough stress test (CST); Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI); Assessment of the degree of discomfort of the treatment procedure by the patient; Assessment of the longevity of the effect of laser therapy; Assessment of sexual function; Assessment of treatment compliance in the PFE‐group | | Starting date | November 27, 2020 | | Contact information | Contact: Ann‐Sophie Page 003216340017 ann‐[email protected] | | Notes | Salinas Peña 2019. | Study name | Effect of Hybrid Laser 10600+1540 nm on GSM | | Methods | Estimated enrolment: 30 participants Allocation: randomised Intervention model: parallel assignment Masking: double (participant, outcome assessor) | | Participants | Inclusion criteria: 45 to 65 years old; menopausal women (defined as 1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia); atrophic vaginal epithelium measured with the VMV values of 0‐49%; to have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM; women able to understand, accept and signed the Informed Consent; women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude Exclusion criteria: VMV 50‐64% (moderate) 65‐100% (high oestrogenic effect on the vaginal epithelium); impossibility of introducing the laser device History or other energy‐based vaginal therapy within 6 months prior to enrolment; being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study; being on regular and effective topical oestrogen therapy within the last 3 months; being on concomitant anticoagulants therapy; patients suffering of epileptic attacks and immunosuppressive diseases; daily and effective use of moisturisers, lubricants or probiotics; previous pelvic radiotherapy or brachytherapy; gynaecologic or rectal cancer less than 5 years ago; breast cancer with anti‐oestrogenic therapy Bladder emptying dysfunction; women operated on UI; subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises. Genital prolapse grade III or higher, according to the simplified POPQ classification; being on effective pharmacological treatment for overactive bladder. Taking diuretics; patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's); insulin‐dependent diabetes mellitus (IDDM) or non‐dependent insulin poorly controlled; Body Mass Index (BMI) > 40 kg/m2; active urinary tract infection; haematuria; women who present active or recurrent genital herpes; undiagnosed metrorrhagia; abnormal last cervical cytology; developmental disability, cognitive impairment and/or serious mental health illness; language barrier; women who refuse to participate in the study | | Interventions | Group I: Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment Group II: sham with Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment | | Outcomes | Primary outcome: obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0‐49%) to moderate or high estrogenization (50‐64%) measured with VMV. The results will be compared between the treatment and the control arm. 3 and 9 months post laser treatments. Secondary outcomes: change to vaginal pH < 5; decrease in GSM symptoms on VAS scale 0‐10: vaginal dryness, burning, itching, and dyspareunia, dysuria (0: complete absence of symptoms, 10: worst possible symptoms); change in ICIQ‐SF score from moderate to mild incontinence, or from mild to nil incontinence; improvement in quality of life related to incontinence by decreasing score in the interference with everyday life question; change in Sandvik test score from moderate to mild incontinence, or from mild to nil incontinence; decrease in GSM urinary symptoms for dysuria and nocturia on VAS scale 0‐10; score on the Patient Global Impression of Improvement (better and much better); score on degree of patient satisfaction, as satisfied and very satisfied; safety outcome variables recorded across study duration. All measured at 3 and 9 months post laser treatment, except safety evaluation, which is to be measured at 61 days (at each treatment) | | Starting date | May 15, 2019 | | Contact information | Contact: Juan Salinas Peña, MD+34 34 977 310 300 [email protected] | | Notes | AICD: automated implantable cardioverter defibrillator BMI: body mass index DIVA: day‐to‐day Impact of vaginal aging questionnaire EQ5D: EuroQol 5 Dimensions FSFI: Female Sexual Function Index GSM: genitourinary syndrome of menopause HPV: human papillomavirus ICIQ‐FLUTS: International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms ICIQ‐SF: International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form ICS: International Continence Society IDDM: insulin‐dependent diabetes mellitus IIQ: Incontinence Impact Questionnaire KHQ: King's Health Questionnaire PAP: Papanicolaou PFIQ‐7: Pelvic Floor Impact Questionnaire PGI‐I: Patients Global Impression of Improvement PGI‐S: Patient Global Impression of Severity Scale PISQ‐12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire POP: pelvic organ prolapse POP‐Q: Pelvic Organ Prolapse Quantification RCT: randomised controlled trial RF: radiofrequency STI: sexually transmitted disease SUI: stress urinary incontinence UDI‐6: Urinary Distress Inventory, Short Form UDS: urodynamic studies UI: urinary incontinence USI: urodynamic stress incontinence UTI: urinary tract infection VAS: visual analogue scale VMV: vaginal maturation value VVA: vulvovaginal atrophy Differences between protocol and review We made the following changes between the protocol and the review. We included the King's Health Questionnaire and the Incontinence Quality of Life Questionnaire as measures for improvement in incontinence‐specific quality of life. We clarified the description of the third primary outcome, number of major adverse events, to specify that these were Clavien‐Dindo III, IV, V events. We clarified the description of the last secondary outcome, number of minor adverse events, to specify that these were Clavien‐Dindo I, II events. Contributions of authors GMI: conceptualised the review and oversaw all aspects of its completion, performed study screening, data abstraction, risk of bias assessment, analysis, and drafted the review, developed summary of findings tables. IC: performed study screening, performed data abstraction and risk of bias assessment, provided critical input (clinical and methodological) to the review. HS: performed study screening, data extraction, risk of bias assessment, and critical review, commentary and revision of review. RP: performed study screening, data extraction, risk of bias assessment, and critical review, commentary and revision of review. DR: performed study screening, data abstraction, and risk of bias assessment, provided critical input (clinical and methodological) to the review. PBR: performed study screening and risk of bias assessment, provided critical input (clinical and methodological) to the review. SW: performed literature search, provided critical input (methodological) to the review. GOL: conducted economic analysis. JQC: arbitrated study screening and data extraction, provided critical input (clinical and methodological) to the review. PD: oversaw data abstraction and risk of bias assessment, provided critical input (clinical and methodological) to the review, oversaw GRADE ratings. PG: performed study screening, arbitrated data abstraction and risk of bias assessment, provided critical input (clinical and methodological) to the review. Sources of support Internal sources - National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), USA Dr Ippolito receives grant funding to support her research activity from the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) Awards K‐12 DK111011‐06 (2021 to present) and T32‐DK007782 (2019 to 2020). External sources - National Institute for Health Research, UK This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Incontinence. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, NHS, or the Department of Health and Social Care. Declarations of interest GMI: has been awarded grant funding for separate projects not related to this review from the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), and from the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) F32 DK126232 and T32 DK007782. IC: has taken part in a one‐time consulting event for Nuvectra regarding a potential bladder neurostimulation device. This took place in 2018 over two hours to give feedback on the benefits and drawbacks of neuromodulation for the bladder in general. HS: none RP: none DR: none PBR: none SW: I am employed by, and a member of, Cochrane Incontinence's editorial base staff. The single largest funder of Cochrane Incontinence was the National Institute for Health Research (NIHR), UK via Cochrane Infrastructure funding to Cochrane Incontinence (via Newcastle University). GOL: none JQC: has served as a consultant for Allergan, Astellas, Medtronic, and UroCure. He has received grant funding from the NIH/NIDDK. He owns stocks and shares in Merck. He has received royalties from UpToDate. He has held a compensated position on the Examination Committee for the American Board of Urology. He has had travel expenses paid by SUFU and by the American Urological Association. PD: member of Cochrane Urology Editorial Team; the author was not involved in the editorial process. PG: none New

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Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: a randomized controlled trial. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2018;224:153-8. [CLINICALTRIALS.GOV: NCT03296241] [DOI: 10.1016/j.ejogrb.2018.03.038] [PMID: ] [DOI] [PubMed] [Google Scholar] - Lukanovic A, Blaganje M, Scepanovic D, Zgur L. Laser thermotherapy in pelvic floor dysfunction, randomised placebo controlled study (Abstract 623). Neurourology and Urodynamics 2014;33(6):920. [sr-incont64445] [Google Scholar] - NCT03296241. Non-ablative Er:Yttrium aluminum garnet laser for stress urinary incontinence (SUI) [Non-ablative Er: yttrium aluminum garnet (Er: YAG) laser therapy effect on stress urinary incontinence (SUI) related quality of life and sexual function: a randomized controlled trial]. clinicaltrials.gov/show/NCT03296241 (first received 28 September 2017). - NCT03296241. 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Laser and microablative radiofrequency for stress urinary incontinence: a double blind randomized controlled trial - one year follow-up (Abstract 104). International Urogynecology Journal 2020;31(Suppl 1):S54. [DOI: 10.1007/s00192-020-04555-3] [DOI] [Google Scholar] - Seki AS, Bianchi-Ferraro Amhdm, Fonseca ES, Sartori MG, Di Bella Zikdj. Use of CO2 LASER and microablative radiofrequency in coital incontinence treatment. A randomized, controlled trial (abstract number 118). International Urogynecology Journal 2022;33(Suppl 2):S262‐S263. [DOI: 10.1007/s00192-022-05295-2] [DOI] [Google Scholar] - Seki AS, Bianchi-Ferraro Amhdm, Fonsenca ES, Sartori MG. Use of CO2 laser and microablative radiofrequency in coital incontinence treatment. a randomized, controlled trial (Abstract: short oral 118). Female Pelvic Medicine & Reconstructive Surgery 2022;28(6 Suppl):S67. 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to studies excluded from this review Alquzwini 2020 {published data only} - Alquzwini TS. A comparison between anteroposterior colporrhaphy and erbium YAG laser interventions in the treatment of postpartum stress urinary incontinence: promising win for the erbium YAG laser. Systematic Reviews in Pharmacy 2020;11(11):476-81. [DOI: 10.31838/srp.2020.11.69] [DOI] [Google Scholar] Athanasiou 2020 {published data only} - Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, et al. A study protocol of vaginal laser therapy in gynecological cancer survivors Sep 2 Published Online 2019/09/03. Climacteric 2019;23(1):53-8. [DOI: 10.1080/13697137.2019.1646720] [DOI] [PubMed] [Google Scholar] - Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, et al. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric 2020;23(1):53-8. 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Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause (New York, N.Y.) 2018;25(1):21-8. [DOI: 10.1097/GME.0000000000000955] [sr-incont92949] [DOI] [PubMed] [Google Scholar] - Da Cruz VL, NCT02419729. Evaluation of fractional CO2 laser treatment efficacy and comparison to vaginal estrogen therapy in postmenopausal women with vulvovaginal atrophy. clinicaltrials.gov/show/NCT02419729 (first received 17 April 2015). [sr-incont78785] Da Fonesca 2023 {published data only} - Da Fonseca LC, Giarreta FB, Peterson TV, Locali PK, Baracat EC, Ferreira EA, et al. A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence. Neurourology and Urodynamics 2023;42:1445–1454. [DOI: ] [DOI] [PubMed] [Google Scholar] - NCT03301142. 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Laser treatment of genito-urinary syndrome in women [Laser treatment of genito-urinary syndrome in women with breast and endometrial cancer and menopausal women]. clinicaltrials.gov/show/NCT03238053 (first received 03 August 2017). [sr-incont78796] NCT03316950 {published data only} - NCT03316950. Radiofrequency and hybrid fractional laser for vaginal rejuvenation [A randomized, placebo-controlled trial evaluating radiofrequency and hybrid fractional laser for vaginal rejuvenation]. clinicaltrials.gov/show/NCT03316950 (first received 23 October 2017). [sr-incont78794] NCT03995797 {published data only} - NCT03995797. VESPER: pelvic organ prolapse study (VESPER:POP) [Randomised, sham controlled trial of fotona smooth erbium yag laser in the treatment of pelvic organ prolapse]. clinicaltrials.gov/show/nct03995797 (first received 24 June 2019). [sr-incont78800] NCT04253067 {published data only} - NCT04253067. A single-blind, randomized study to compare fCO2 laser therapy versus sham for treatment of SUI in women (LaserSUI) [A single-blind, randomized study to compare the efficacy and safety of fractional carbon dioxide laser therapy versus sham for treatment o. https://clinicaltrials.gov/show/NCT04253067. - NCT04253067. A single-blind, randomized study to compare fCO2 laser therapy versus sham for treatment of SUI in women (LaserSUI) [A single-blind, randomized study to compare the efficacy and safety of fractional carbon dioxide laser therapy versus sham for treatment of stress urinary incontinence symptoms in women]. clinicaltrials.gov/show/NCT04253067 (first received 05 February 2020). [sr-incont78806] NCT04959084 {published data only} - NCT04959084. Laser acupuncture and pelvic floor training on stress urinary incontinence postmenopausal [Effectiveness of laser acupuncture and pelvic floor training on stress urinary incontinence in obese postmenopausal women]. clinicaltrials.gov/ct2/show/NCT04959084 (first received 13 July 2021). - NCT04959084. Laser acupuncture and pelvic floor training on stress urinary incontinence postmenopausal. https://clinicaltrials.gov/show/NCT04959084. NCT05097456 {published data only} - NCT05097456. Carbon dioxide acupulse laser treatment versus sham treatment and stress urinary incontinence symptoms. https://clinicaltrials.gov/show/NCT05097456. NCT05557799 {published data only} - NCT05557799. Photobiomodulation in post menopause genitourinary syndrome. https://clinicaltrials.gov/show/NCT05557799. Okui 2019 {published data only} - Okui N, Yoda KK, Vizintin Z. 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