{"paper_id":"cc5fa737-f00a-4b63-8de2-2ac672c5397b","body_text":"Genitourinary syndrome of menopause (GSM) is a common condition in postmenopausal women, defined by a variety of symptoms including\nvaginal dryness, burning, itching, dyspareunia, urinary urgency, frequency and incontinence, all of which have a notable effect on\nquality of life [ 1 ]. These symptoms are mainly caused by decreased estrogen levels and loss of\npelvic floor strength and if untreated, cause emotional distress, social isolation, anxiety and depression [ 2 ].\nAlthough hormonal therapies, including systemic or local estrogen, are routine for treating GSM, their use is restricted in patients\nwith previous hormone sensitive cancer, necessitating the development of safe, yet effective, non-hormonal therapies [ 3 ].\nIn novel alternatives under consideration, energy-based therapies like diode laser therapy have gained favor by encouraging vaginal\ntissue rejuvenation, boosting local blood supply and maintaining hydration, flexibility and function of the vagina [ 4 ].\nClinical trials have documented that laser treatment relieves symptoms of vaginal atrophy and enhances sexual function and quality of\nlife [ 5 ]. Concurrently, pelvic floor rehabilitation, including by a pelvic floor chair, has been\neffective in treating urinary incontinence, a common comorbidity of GSM [ 6 ]. Combination of these\nmodalities may provide synergistic effects, addressing sexual and urinary symptoms simultaneously. Additional evidence is, however,\nrequired to determine optimal protocols and long-term outcomes [ 7 ]. Therefore, it is of interest\nto compare the effectiveness of adjunctive diode vaginal laser treatment and pelvic floor chair sessions for GSM in postmenopausal\nwomen, utilising validated measuring tools to inform the evidence base for non-hormonal therapies. Through investigating this integrated\nmodel, the study aims to further develop safer, less invasive interventions that have the ability to improve the health and quality of\nlife of women with GSM.\n\nFifty postmenopausal women with genitourinary syndrome of menopause (GSM) ages 45-70 participated in this prospective observational\nstudy at SUN Hospital in Patna, India. Without a control group, participants received pelvic floor chair sessions in addition to diode\nvaginal laser therapy. Postmenopausal women within the designated age range who had been diagnosed with GSM and were not on hormone\nreplacement treatment were eligible for inclusion. Current genital infections, recent pelvic surgery (within the last three months),\nhormone medication use during the previous six months, pregnancy, metallic implant presence, bleeding problems, or tumours were among\nthe exclusion criteria. Based on previous research indicating a medium to high effect size for symptom improvement, the sample size of\n50 was chosen to ensure 80% power at a 5% significance level to identify significant improvements in FSFI and ICIQ-UI SF scores. The\ncourse of treatment comprised three about 20-minute sessions of diode laser therapy spaced four weeks apart (1470 nm wavelength, 17W\npulsed mode, 5 Hz, 50 ms pulse duration). A radial fibre handpiece was placed vaginally and, following the application of lidocaine gel,\nit delivered eight circumferential pulses per centimetre. For a total of twelve sessions, excluding laser days, pelvic floor chair\nsessions were held twice a week for six weeks. Each 28-minute session of the Stingray Emsella chair (up to 2.5 Tesla intensity) produced\nsupramaximal contractions of the pelvic floor. Participants received education on pelvic floor engagement and personalised adjustments\nto the degree of therapy. The FSFI-19, ICIQ-UI SF and VAS scores for vaginal symptoms were used to measure the primary outcomes, which\nincluded improvements in GSM symptoms, sexual function, urine incontinence and general quality of life. Changes in the use of absorbent\npads were among the secondary outcomes. At baseline and three months after therapy, all outcomes were assessed. SPSS version 23 was used\nto analyse the data. Clinical and demographic features were summed together using descriptive statistics. Pre- and post-treatment scores\nwere compared using paired t-tests; p-values <0.05 were deemed statistically significant.\n\nTable 1 (see PDF) reports the baseline characteristics of the 50 study subjects. The participants' mean age was 58.3 years (standard\ndeviation = 5.9). The mean BMI was 28.5 kg/m 2  and the mean menopause duration was 8.5 years. The mean parity (number of\nchildren) was 2.1. With regard to marital status, 40 subjects (80%) were married and 10 subjects (20%) were unmarried or widowed. Just 5\npatients (10%) had a background of gynecological surgery and 30 patients (60%) had a history of previous urinary infection. 12 patients\n(24%) had vaginal infection reported before starting the therapy, while 38 patients (76%) did not have any infection. 35 patients (70%)\nused non-hormonal lubricants and 15 patients (30%) did not. Figure 1 (see PDF) will depict box plots for all continuous variables while\nFigure 2 (see PDF) will plot the column chart to all the remaining characteristics. Table 2 (see PDF) The Visual Analogue Scale (VAS)\nshows improvement in the symptoms of vaginal atrophy. The mean score for vaginal dryness was 75.0 before therapy, but it dropped to 20.0\nafter treatment (p < 0.001). Significant improvements were also observed in vaginal burning, itching, dyspareunia and dysuria;\npre-treatment ratings were 80.4, 78.2, 85.3 and 83.1, respectively, whereas post-treatment levels were 25.4, 24.2, 30.3 and 29.5 (all\np < 0.001). There was an improvement in the overall VAS score from 80.4 to 25.8 (p < 0.001). Figure 3 (see PDF) is a bar chart of\nVaginal Atrophy Symptoms (VAS), showing a significant improvement in VAS scores for each symptom after treatment.\nTable 3 (see PDF) demonstrates the improvement in sexual function as determined by FSFI-19 scores. Significant gains were observed in\nevery domain: overall satisfaction increased from 2.0 to 4.1, lubrication improved from 3.8 to 5.5, discomfort decreased from 2.5 to\n5.0, sexual desire improved from 3.0 to 4.2, sexual arousal improved from 3.3 to 5.2 and orgasm improved from 2.8 to 4.9 (all\np < 0.001). From 17.4 to 25.9, the overall FSFI score increased dramatically (p < 0.001). Sexual Function (FSFI-19) is shown in\nFigure 4 (see PDF), with scores rising after therapy and improvements in a number of aspects. Improvements in a number of domains are\nseen in Figure 4 (see PDF), along with higher post-treatment scores. Table 4 (see PDF) demonstrates the effect on the symptoms of urine\nincontinence as indicated by ICIQ-UI SF. Frequency improved from a pretreatment score of 4.5 to 2.1, urgency dropped from a pretreatment\nmean score of 5.0 to a post-treatment mean score of 2.5 and incontinence episodes likewise fell from 5.1 to 2.6, all of which were\np < 0.001. Additionally, there was a significant improvement in the utilisation of absorbent pads from 3.0 to 1.1 (p < 0.001).\nFrom 14.6 to 7.2, the overall ICIQ-UI SF score dropped (p < 0.001). Urine Incontinence (ICIQ-UI SF) is shown in Figure 5 (see PDF),\nwhere a decline in urine symptom scores indicates improvement following the intervention. The baseline characteristics in\nTable 1 (see PDF) show a study population with an average age of 58.3 years and menopause duration of 8.5 years, with significant\nGSM-related symptoms, including a high prevalence of urinary infections (60%) and prior vaginal infections (24%). Table 2 (see PDF)\nshows a significant decrease in the symptoms of vaginal atrophy, such as dryness (VAS scores from 75.0 to 20.0) and dyspareunia (85.3 to\n30.3), which show the effectiveness of the treatment (p < 0.001). Table 3 (see PDF) shows marked improvement in sexual function with\nthe increase in FSFI scores from 17.4 to 25.9, driven by enhancements in lubrication and satisfaction (p < 0.001). Finally,\nTable 4 (see PDF) confirms significant alleviation of urinary incontinence symptoms, with reductions in urgency, incontinence episodes\nand absorbent pad usage (p < 0.001). Figure 1 (see PDF) presents a box plot that captures the distribution of continuous variables;\nthese include age, BMI and menopausal duration with fairly homogenous characteristics across all the participants under study. A stacked\ncolumn chart for categorical variables such as marital status and lubricant use is displayed in Figure 2 (see PDF), in which 80% of\nrespondents were married and 70% were using non-hormonal lubricants. Figure 3 (see PDF): A bar chart showing significant reductions in\nsymptoms of vaginal atrophy, with visually salient declines in dryness and dyspareunia post-treatment. Figure 4 (see PDF): Improved\nsexual function is represented through a bar chart, where gains are made across FSFI domains, such as lubrication and satisfaction.\nFinally, Figure 5 (see PDF) illustrates a decline in urinary incontinence symptoms by a bar chart, with marked declines in urgency,\nincontinence episodes and absorbent pad usage.\n\nThis prospective observational study demonstrated significant improvements in symptoms of vaginal atrophy and overall sexual\nfunctioning among postmenopausal women with genitourinary syndrome of menopause (GSM) following treatment with diode vaginal laser\ntherapy combined with pelvic floor chair sessions [ 7 ,  8 ].\nValidated assessment tools, including the Female Sexual Function Index (FSFI), International Consultation on Incontinence Questionnaire\nUrinary Incontinence Short Form (ICIQ-UI SF) and Visual Analog Scale (VAS), ensured reliable measurement of treatment outcomes\n[ 9 ,  10 ]. Our findings align with existing literature\nsupporting the efficacy of diode laser therapy which reported notable improvements in vaginal dryness and dyspareunia\n[ 11 ]. The addition of electromagnetic pelvic floor stimulation further contributed to a reduction\nin urinary urgency, frequency and leakage, consistent with findings on magnetic stimulation in stress urinary incontinence\n[ 12 ,  13 ]. Sexual function, particularly in domains such as\nlubrication, arousal and satisfaction, also showed meaningful enhancement, echoing the review on the growing role of laser therapies in\nvulvovaginal atrophy [ 14 ]. The FSFI score in our study rose from 17.4 ± 4.2 to\n25.9 ± 5.0 post-treatment, highlighting the synergistic effect of combining therapies [ 15 ].\nSimilarly, study reveals the role of laser therapy in addressing urinary symptoms and its utility even in complex cases such as breast\ncancer survivors [ 16 ]. However, the absence of a control group limits definitive conclusions and\nfuture randomized controlled trials are needed to validate these findings. Long-term follow-up studies, are essential to assess the\ndurability of benefits and explore potential applications in related conditions such as endometriosis or breast cancer recurrence linked\nto hormonal therapies.\n\nA significant improvement in symptoms of genitourinary syndrome of menopause and sexual function among postmenopausal women with\ndiode laser therapy combined with pelvic floor chair sessions is shown. It effectively alleviated the atrophy of vagina and urinary\nincontinence to enhance quality of life. However, it needs to be validated with high-quality randomized controlled trials and\nsustainability studies for a long duration.","source_license":"CC-BY-4.0","license_restricted":false}