Sacral Neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence – results from a randomised study with a One-stage implant procedure

Sacral Neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence – results from a randomised study with a One-stage implant procedure | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Sacral Neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence – results from a randomised study with a One-stage implant procedure Jakob Duelund-Jakobsen, Steen Buntzen, Lilli Lundby, Søren Laurberg, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7120621/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Dec, 2025 Read the published version in Techniques in Coloproctology → Version 1 posted 12 You are reading this latest preprint version Abstract In Sacral Neuromodulation(SNM), the stimulation intensity is set at the sensory threshold(ST) level. However, subsensory stimulation at 50% of ST has proven effective in reducing faecal incontinence episodes. Aim : To explore the relationship between functional outcomes and varying subsensory stimulation amplitude in newly implanted patients. Method : This randomised, double-blinded study was designed to include patients with ≥ 1faecal incontinence episodes/week despite maximal conservative therapy. As part of another trial, patients were offered a one-stage procedure. Postoperatively, patients were randomised into two groups. G-1: Received stimulation at 0.05 volts, 50 and 90% of ST in 3x4-week periods, followed by 12-weeks stimulation at the ST. G-2: Received stimulation with 90% of the ST in in 3x4-week periods, followed by 12-weeks stimulation at ST. Patients were evaluated after each period using St. Marks’s Incontinence Score, Visual-Analog-Scale(VAS) for patient satisfaction regarding social function, bowel function and quality-of-life, along with a bowel habit diary. Results : Seventy-three patients with a median age of 60(IQR:50–69) completed the trial. Faecal incontinence episodes were significantly reduced at all follow-ups, with no differences between groups. The only statistical difference between groups was deltaVAS for bowel function after 4-weeks. In G-1 with ultralow stimulation amplitude (0.05 volts - equivalent to 9.6(IQR:6.5–13.4)% of ST) the improvement compared to baseline was 30(IQR:10–50) points significantly lower than G-2 with an improvement of 50(IQR:10–70) points (p-value: 0.05). Conclusion : Subsensory stimulation is feasible in newly implanted patients with faecal incontinence. An amplitude of 0.05 volts, is as effective on the functional outcomes as stimulation with higher amplitudes. Faecal incontinence Sacral Neuromodulation Quality of Life Functional outcome What does this paper add to the existing literature? This is the first paper to document that Sacral Neuromodulation at an ultralow stimulation amplitude of 0.05 volts is equally effective in reducing incontinence episodes and symptom scores compared to stimulation at higher amplitudes. Further, subsensory stimulation is, for the first time, shown to be effective immediately after implantation in patients with faecal incontinence. INTRODUCTION Faecal incontinence (FI) has substantial negative implications for the affected individual and their family. Additionally, it is associated with a high level of stigma and has a major negative impact on the quality of life [ 2 , 3 ]. FI affects approximately 16% of the population but may be referred to as the “silent affliction“ since the magnitude of the problem is likely to be underestimated because most individuals are reluctant to consult healthcare providers [ 4 , 5 ]. The latest recent guideline for management of FI recommends first-line conservative treatment such as fibre supplements, constipating drugs, biofeedback therapy, or transanal irrigation[ 6 ]. These treatments have been proven effective in approximately 72% of patients attending a specialist nurse-led clinic[ 7 ]. If conservative treatment is insufficient to improve continence satisfactorily, Sacral Neuromodulation (SNM) may be considered[ 6 ]. Since its introduction in 1995, SNM has proven to be an effective long-term minimally invasive treatment [ 8 – 10 ]. SNM is approved as a two-stage procedure. The first stage (Stage-I) is performed with a temporary or permeant lead connected to an extension wire that is externalised and connected to an extracorporeal neurostimulator. The treatment response is evaluated after 2–3 weeks before the final decision for a complete implant (Stage-II). Transitioning from Stage-I to Stage-II typically requires a ≥ 50% reduction in incontinence episodes or the number of days impacted by incontinence. With the introduction of the standardised implantation technique [ 11 ], the number of patients proceeding from Stage-I (≥ 50% symptom reduction) to Stage-II is approaching 90% [ 12 , 13 ]. The stimulation amplitude has been traditionally set at an individual threshold corresponding to the perception of stimulation, known as the sensory threshold (ST). It has been documented in a randomised trial and in following prospective trials that the stimulation amplitude in patients suffering from FI can be set 50% below ST without compromising treatment efficacy[ 14 , 15 ]. The present evidence of subsensory stimulation (below ST) is shown in patients stimulated for several years at the ST. We currently lack knowledge about subsensory stimulation and its effectiveness on functional outcomes immediately after implantation. Subsensory stimulation offers several advantages. Firstly, it would eliminate the patient’s discomfort associated with stimulation at the ST. Secondly, reducing the energy consumption of the neurostimulator would increase its life expectancy, subsequently lowering treatment costs. Thirdly, the theoretical risk of nerve damage from electrical stimulation is decreased as less energy is delivered to the surrounding tissue. This randomised, double-blinded study was as part of another study[ 13 ] designed to investigate the relationship between functional outcomes and different subsensory stimulation amplitudes in “de novo” implanted patients with FI. MATERIALS AND METHODS Patients were recruited from three tertiary referral centres for FI treatment: Aarhus University Hospital, Hvidovre University Hospital, Denmark, and the University Hospital of North Norway, Tromsoe. Study inclusion started in November 2016 and ended in November 2019. Patients diagnosed with idiopathic FI or FI due to an external anal sphincter defect of ≤ 160 o were eligible. The integrity of the anal sphincter was assessed using transanal ultrasound. All patients should report weekly FI after maximal conservative therapy had been attempted. A complete list of inclusion and exclusion criteria has been published previously[ 13 ]. As part of another trial recently published[ 13 ], these patients had a one-stage implantation, without a prior test(Stage-1) if they, during the operation, had a motor response (contraction) of the external anal sphincter in ≥ 3 poles and at least one pole of the quadripolar leads with a motor threshold ≤ 1.5 mAmp[ 13 ]. The permanent lead Model 3889 (Quadripolar lead for electrical stimulation®, Medtronic, Minneapolis, MN) and a neurostimulator InterStim-II (Medtronic, Minneapolis, MN) were used. If the patients did not fulfil the perioperative requirement for a one-stage implant, they were excluded from the study and offered a conventional stage-I test. Perioperative, the amplitude needed to elicit a contraction of the external anal sphincter was evaluated using the Verify® system (Medtronic). The Verify® system stimulates with a constant current technology and the amplitude is reported in mAmp. The permanent implant (InterStim-II) provides electrical stimulation using a constant voltage basis (Volt). Both systems provide the same energy to the nerve as long as the resistance in the electrical circuit remains unchanged[ 16 ]. The implantations were performed in deep sedation or general anaesthesia to document the motor response during lead placement. All patients received pre-operative intravenous prophylactic antibiotics. Patients fulfilling the perioperative criteria were randomised on the day after surgery using sealed envelopes into one of two groups (Table 1 ). Participants and data assessor(JDJ) were blinded during the study phase, only the programming nurses were aware of the actual randomisation group. During the first 12 weeks after one-stage implantation, the stimulation amplitude was increased after four weeks for patients in group one(G-1) from 0.05 volts (lowest possible setting) to 50% and subsequently after four weeks to 90% of ST. In group two(G-2), patients were during the first 12 weeks stimulated at 90% of ST, but the patients were seen by the programming nurses and the stimulation status of the neurostimulator were recorded to ensure blinding of the patients. All patients were stimulated at the ST in the following 12 weeks (week 13 to 24) (Table 1 ). Thereafter, the study ended, and patients were followed up according to standard practise in each centre. Table 1 Week 1–4 Week 5–8 Week 9–12 Week 13–24 Group 1 0.05 Volts 50% of ST 90% of ST ST Group 2 90% of ST 90% of ST 90% of ST ST Stimulation amplitude during the different trial periods. ST: Sensory threshold At baseline and during each stimulation period, patients were requested to complete a series of questionnaires (overall satisfaction with bowel function, social function and quality of life was assessed using a numerical visual analogue scale (VAS) range 0-100, where 100 indicates excellent function and 0 indicates poor function[ 17 ], St. Marks Incontinence Score[ 18 ]), and a three-week bowel habit diary. ETHICS The protocol for the study was approved by the Regional Committee on Biomedical Research Ethics, Denmark and the Patient Protection Representative Norway (SJO125) and registered at ClinicalTrials.gov (August 22. 2017 - NCT03261622). Medtronic was notified about the study but did not participate in its the planning, completion, or reporting. In case of unexpected adverse events related to the study, patients were covered by national healthcare insurance. Statistical analysis A sample size calculation (based on a non-inferiority study design) was conducted to ensure the number of patients needed to determine that a one-stage implantation is non-inferior to a Stage I + II procedure[ 13 ]. In total, 60 patients were planned for inclusion. To account for dropout and possible infection leading to explanation, the target for inclusion was 75 patients. Each department could include a maximum of 30 patients. A sample size calculation or power calculation was not performed for the randomised part of the trial. Baseline data are presented as median and interquartile range (IQR) or mean and standard deviation(SD). Data obtained during follow-up are presented as delta values (baseline vs specific period) for enhanced visualisation of differences. Wilcoxon signed-rank test was used to compare results obtained at the initiation of this study and follow-up at four, eight and 12 weeks between the two randomisation groups. The paired t-test was used to compare the baseline and 24-week follow-ups. In case of missing values, the result of that specific question/score was discharged at the specific follow-up. Values of P ≤ 0.05 were considered statistically significant. All statistical analyses were conducted using Stata version 10.1. (Stata Corporation, 4905 Lakeway Drive, TX 77846, USA). RESULTS Eighty-five patients were eligible, of whom 76 (72 females) gave written consent to participate. Three patients were excluded during the trial. One patient developed a deep infection on the fourth day after implantation. Consequently, the neurostimulator and electrode were explanted, and two patients withdrew consent to participate before the study was initiated. Seventy-three patients (70 females) with a median age of 60 (IQR: 50–69) years completed the trial, and their results are presented. Twenty-nine patients were implanted in Tromsoe, Norway, 26 patients were implanted in Aarhus, Denmark, and 18 patients were implanted in Hvidovre, Denmark. Out of the 70 females included, 64 had given birth to a median of 2(IQR: 2–3) children. The aetiology of FI was obstetric anal sphincter injury in 38 patients of whom 23 (61%) had previously undergone primary sphincter repair. At baseline, before SNM, an external anal sphincter defect was observed on ultrasound in 19 patients with a median 90 o (IQR: 50–120) degree defect. In the remaining 35 patients the aetiology was unknown and registered as idiopathic. Of the 73 patients completing the study, 40 patients were randomised to G-1 and 33 patients to G-2. The baseline demographics and scores did not differ between groups (Table 2 ). Table 2 Baseline demographics and scores for included patients and peroperative stimulations results including sensory threshold at first programming. Median and (IQR). Group 1 Group 2 P-value Baseline Number of patients 40 33 Age (years) 59.5(45.5–66) 61(51–72) 0.148 Gender (females) 37 33 0.111 Parity 2(1–3) 2(2–3) 0.113 Body Mass Index 27.2(23.7–33.6) 25.9(22.6–29.3) 0.159 External anal sphincter defect < 160 o 36% 26% 0.368 St. Mark’s Incontinence Score 18(17–20) 18(16-19.5) 0.469 VAS bowel function 17.5(10–40) 23(5–43) 0.851 VAS social function 40(15–50) 50(20–55) 0.573 VAS lifestyle 40(10–50) 50(25–70) 0.260 Inc. episode pr. three weeks 12(6–24) 13(9–20) 0.508 Peroperative stimulation results and sensory threshold Motor response (mAmp): Pole 0 Pole 1 Pole 2 Pole 3 0.8 (0.5–1.8) 1.0(0.5–1.5) 0.5(0.5-1.0) 1.0(0.5–1.5) 1.0(0.5–1.6) 1.0(0.5–1.5) 0.6(0.5-1) 1.0(1.0–2) 0.418 0.496 0.222 0.134 Sensory threshold (volt): 0.53(0.38–0.78) 0.60(0.40–0.80) 0.693 Peroperative stimulation results and sensory threshold The peroperative inclusion criteria were met for all patients, including a motor threshold in ≥ 3 poles and at least one pole of the quadripolar lead with a motor threshold ≤ 1.5 mAmp. The mean number of poles with a motor response was 3.9 (SD.0.33). In 86% of patients, a motor response was achieved at all four poles of the quadripolar lead. The median stimulation amplitude required to achieve a motor response in any pole of the quadripolar leads were non-significant different between G-1 or G-2 (Table 2 ). The ST at the initial programming the day after surgery was median 0.55 (IQR: 0.4–0.8) volts, with non-significant differences between groups (p-value: 0.693) (Table 2 ). Comparisons between G-1 and G-2 Both groups improved in all evaluated parameters during the first four weeks after implantation (Table 3). The only statistically significant difference between the two groups was observed in the delta VAS for bowel function. In G-1 with ultralow stimulation amplitude (0.05 volts - equivalent to 9.6 (IQR: 6.5–13.4) per cent of ST) the median improvement in the VAS for bowel function was 30 (IQR:10–50) points significantly lower than G-2 stimulated at 90% of the ST in which a median improvement of 50 (IQR: 10–70) points was obtained (p-value: 0.05). In the following two randomisation rounds, where the stimulation intensity was increased in G-1 to 50% of the ST (week 5 to 8) and 90% of the ST (week 9–12) compared to G-2 with a stable stimulation amplitude of 90% of the ST, no statistically significant difference was observed between the groups (Table 3). Table 3 Comparison between randomisation groups from week one to twelve. Delta values: Baseline – specific follow-up. Median and (IQR) Week 1-4 5-8 9-12 Group 1 0.05 Volts Group 2 90% of ST P-value Wilcoxon rank-sum test(MW) Group 1 50% of ST Group 2 90% of ST P-value Wilcoxon rank-sum test(MW) Group 1 90% of ST Group 2 90% of ST P-value Wilcoxon rank-sum test(MW) Delta St. Mark’s Incontinence score 4(1-7) 4(1-7) 0.902 4.5(2.5-9) 3.5(2-9.5) 0.625 5(3-8) 4.5(1-11) 0.853 Delta incontinence episodes 8.5(4-21) 9(5-14) 0.988 8(4-19) 12(6-18) 0.347 11(2-20) 11(6-15) 0.743 Reduction FI.-episodes (%) 78 (54-95) 71(53-92) 0.732 81(60-100) 91(63-100) 0.732 80(61-100) 89(59-100) 0.387 Delta VAS Bowel function 30(10-50) 50(25-70) 0.05* 30(10-60) 50(10-70) 0.256 35(9-55) 49(25-60) 0.194 Delta VAS Social function 20(5-40) 25(5-50) 0.676 20(5-55) 25(10-60) 0.532 30(10-50) 30(5-45) 0.936 Delta VAS Lifestyle 25(10-40) 10(0-40) 0.492 28(10-50) 25(0-50) 0.738 30(10-49) 30(10-50) 0.937 Uncorrected p-value: 0.0496 Comparison between baseline and 24-week follow-up There was no significant difference between the groups in any evaluated parameters at the latest follow-up after 24 weeks (week 13–24), where all patients had been stimulated at the ST (data not shown). The median stimulation amplitude in weeks 13 to 24 was 0.5 (IQR: 0.4–0.78) volts in G-1 and 0.9 (IQR: 0.4–1.25) in G-2, with no significant differences between groups (p-value: 0.222). Analysed as a group, the number of incontinence episodes per three weeks at the latest follow-up was significantly reduced from baseline with a median of 12(IQR: 6–19) (p-value: <0.001) episodes. The median reduction in incontinence episodes compared to baseline was 87.5 (IQR: 75–100) per cent. A 50% or higher reduction in incontinence episodes compared to baseline was obtained in 92% of the patients. The St. Mark’s Incontinence Score at the latest follow-up was significantly reduced from baseline with a median of 6 (IQR: 1.5–11) (p-value: <0.001) points. The VAS for patient satisfaction with bowel function at the latest follow-up improved significantly from baseline with a median of 50 (IQR: 25–70) (p-value: <0.001) points. DISCUSSION This randomised multicentre study is the first to demonstrate that subsensory stimulation is effective in newly implanted patients. Stimulation with 0.05 volts equivalent to 9.6 (IQR: 6.5–13.4) per cent of the ST is equally effective in reducing incontinence episodes and symptoms scores as stimulation with 50–90% of the ST. The patient’s VAS for bowel function in period one (0.05 volts vs 90% of the ST) was the only score with a significantly better outcome in G-2(90% of the ST) compared to G-1(0.05 volts) (Table 3). All other scores were not significantly different throughout the study period. This indicates that the difference may be explained by a Type I error, implying it is a false positive rather than a factual finding. When the study was planned, we included a group with ultra-low stimulation intensity. The intensity was set at 0.05 volts, which is the lowest possible setting, with the InterStim-II neurostimulator still being turned on. We chose a low setting because we believed it would be difficult to recruit patients for the trial with a period where the neurostimulator was turned off. We expected 0.05 volts to be equivalent to 2–5% of ST based on previous results [ 14 , 15 ]. This stimulation intensity is expected to be too low to depolarise the afferent nerve fibres, making it effective as a placebo stimulation. All patients included were implanted in accordance with the standardised implantation technique[ 11 ]. Furthermore, a motor response (contraction) of the external anal sphincter must occur in ≥ 3 poles and at least one pole of the quadripolar lead, with a motor threshold ≤ 1.5 mAmp to qualify for inclusion. With these strict implantation criteria, the motor threshold, and subsequently the ST obtained at implantation were much lower than expected during the planning phase. Electrical nerve activation relies on a critical current to activate ion channels responsible for the influx of positive ions that initiate action potentials[ 19 ]. Our trial results indicate that an ultra-low stimulation intensity, equivalent to 9.6% of the ST, may be sufficient to activate these ion channels, as the efficacy of the treatment was not affected by the ultra-low amplitude stimulation. Further, electrophysiological studies should be conducted to determine the minimal electrical threshold required for nerve modulation in SNM. The efficacy in reducing incontinence episodes was 71–91%, with no difference observed between the stimulation groups during the randomised period (Table 3). Such improvement is unlikely to be solely attributed to a placebo effect. However, the possibility of a placebo effect remains a potential confounding factor when studying functional disorders. Knowles et al. documented in a randomised double-blinded trial evaluating Percutaneous Tibial Nerve Stimulation vs placebo that 31% of patients receiving shame stimulation experienced a 50% or higher reduction in incontinence episodes[ 20 ]. Tan et al. published in 2020 a systematic review and meta-analysis aimed to quantify placebo effects and responses following sham electrical nerve stimulation for FI and constipation a total of ten papers were analysed[ 21 ]. They concluded that “Sham stimulation is associated with clinical and statistically meaningful improvements in symptoms of fecal incontinence and constipation, as well as quality of life scores, highlighting the importance of sham controls in nerve stimulation trials. Noncontrolled studies should be interpreted with caution“. Recently, Vollebregt et al. published the results from a randomised cross-over trial assessing the impact of SNM ON vs OFF(or ultra-low stimulation 0.05 volts)[ 22 ]. The trial was terminated due to a lack of recruitments, and the results were based on only 16 out of the 90 planned participants. They found that SNM conferred a non-significant reduction in faecal incontinence episodes compared to sham. The current study was designed with the expectation that 0.05 volts of stimulation would be ineffective and, therefore, could be regarded as a placebo, as discussed above. The current study confirms previous publications that subsensory stimulation is effective[ 14 , 15 ]. We have found that the stimulation amplitude can be further reduced from 50% below the ST to 9.6 (IQR: 6.5–13.4) per cent of the ST without compromising treatment efficacy. Further, it is documented that subsensory stimulation is effective in patients not previously stimulated at or above the ST. The timeframe of this study was extended due to the global coronavirus disease pandemic, and our ethical approval allowed us to follow the patients only for 24 weeks. Further, research with longer follow-ups of patients stimulated at the subsensory stimulation level is needed to clarify its efficacy over time. Conclusion Sub-sensory stimulation is feasible in newly implanted patients and an amplitude of 0.05 volts equivalent to 9.6 (IQR: 6.5–13.4) per cent of the sensory threshold, is as effective in reducing incontinence episodes and symptom scores as stimulation set at 90% of the sensory threshold. Declarations Financial support: The Danish Agency for Science, Technology and Innovation funded part of the study, while the participating departments covered the remaining expenses. Meeting presentation: Oral presentation at the ESCP-2022 meeting in Dublin, Ireland and APFM-2022 Svolvaer, Lofoten, Norway. Data share: Trial data can be assessed by request to corresponding author. Conflicts of interest: All authors have received honoraria from Medtronic as speakers at meetings and/or as medical advisory board members. The study, design, performance, analysis, and reporting were conducted without Medtronic’s influence. Author Contribution All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data. JDJ and MR drafted the work. SB, LL, SL and MS revised it critically for important intellectual content;approved the version to be published; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. References ClinicalTrials.gov identifier: NCT00919672. Garcia, J.A., et al., Breaking the cycle of stigmatization: managing the stigma of incontinence in social interactions. Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society / WOCN, 2005. 32 (1): p. 38-52. Makol, A., M. Grover, and W.E. Whitehead, Fecal incontinence in women: causes and treatment. Women's health (London, England), 2008. 4 (5): p. 517-528. Johanson, J.F. and J. Lafferty, Epidemiology of fecal incontinence: the silent affliction. The American Journal of Gastroenterology, 1996. 91 (1): p. 33-36. Whitehead, W.E., et al., Fecal Incontinence Diagnosed by the Rome IV Criteria in the United States, Canada, and the United Kingdom. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2019. Assmann, S.L., et al., Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterol J, 2022. 10 (3): p. 251-286. Duelund-Jakobsen, J., et al., Nurse-led clinics can manage faecal incontinence effectively: results from a tertiary referral centre. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2015. 17 (8): p. 710-715. Matzel, K.E., et al., Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet, 1995. 346 (8983): p. 1124-1127. Janssen, P.T., et al., Fecal incontinence treated by sacral neuromodulation: Long-term follow-up of 325 patients. Surgery, 2017. 161 (4): p. 1040-1048. Duelund-Jakobsen, J., et al., Sacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database. International journal of colorectal disease, 2016. 31 (2): p. 421-428. Matzel, K.E., et al., Sacral Neuromodulation: Standardized Electrode Placement Technique. Neuromodulation, 2017. 20 (8): p. 816-824. Rydningen, M.B., et al., Sacral neuromodulation for faecal incontinence following obstetric sphincter injury - outcome of percutaneous nerve evaluation. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2017. 19 (3): p. 274-282. Duelund-Jakobsen, J., et al., One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study. Colorectal Dis, 2024. 26 (5): p. 968-973. Duelund-Jakobsen, J., et al., Improved longevity and efficacy of sacral nerve stimulation by simple adjustments at follow-up. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2019. Duelund-Jakobsen, J., et al., Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Annals of Surgery, 2013. 257 (2): p. 219-223. Lehur, P.A., et al., Programming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence-Recommendations for Day-to-Day Practice. Neuromodulation, 2020. 23 (8): p. 1121-1129. Duelund-Jakobsen, J., et al., Functional results and patient satisfaction with sacral nerve stimulation for idiopathic faecal incontinence. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2012. 14 (6): p. 753-759. Vaizey, C.J., et al., Prospective comparison of faecal incontinence grading systems. Gut, 1999. 44 (1): p. 77-80. Cameron, M.A., et al., Differential effect of brief electrical stimulation on voltage-gated potassium channels. J Neurophysiol, 2017. 117 (5): p. 2014-2024. Knowles, C.H., et al., Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial. Lancet (London, England), 2015. 386 (10004): p. 1640-1648. Tan, K., et al., Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis. Neuromodulation, 2020. 23 (8): p. 1108-1116. Vollebregt, P.F., et al., Efficacy and Mechanism Evaluation , in Clinical effectiveness of subsensory sacral neuromodulation in adults with faecal incontinence: the SUBSoNIC crossover RCT and mechanistic study . 2024, National Institute for Health and Care Research Copyright © 2024 Vollebregt et al.: Southampton (UK). Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 24 Dec, 2025 Read the published version in Techniques in Coloproctology → Version 1 posted Editorial decision: Revision requested 31 Aug, 2025 Reviews received at journal 08 Aug, 2025 Reviews received at journal 05 Aug, 2025 Reviewers agreed at journal 30 Jul, 2025 Reviews received at journal 26 Jul, 2025 Reviewers agreed at journal 25 Jul, 2025 Reviewers agreed at journal 24 Jul, 2025 Reviewers agreed at journal 24 Jul, 2025 Reviewers invited by journal 22 Jul, 2025 Editor assigned by journal 16 Jul, 2025 Submission checks completed at journal 14 Jul, 2025 First submitted to journal 14 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7120621","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":489146458,"identity":"c1a083a4-237d-4a6a-ba02-ee0078bf8bb9","order_by":0,"name":"Jakob Duelund-Jakobsen","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABEklEQVRIiWNgGAWjYBACxgY2BmYGBjYGCQYeEN8mASycUEC8lrQEIBuoxQCfPWAtDDAthyFaGPBoYW4/lvi4gIFPXrK99/CHjzvO5/HLdyd+eGDAIM8vdgC7w3rSDhvPYGAznM1zLk1y5pnbxZJtvJslgA4znDk7AYdf0tukeRjYGOdJ5Jgx87bdTtxwjHcDSEuCwW0cWvqfg7XYA7UYf/7bdg6kZfMPvFpmpB0DaUmcLZFjIM3YdgCkZRt+W2Y8Swb5JXlmD9AvvW3JiTPbcrdZJBhI4PSLYX+aITDEjtnOOA4MsZ9tdon9zGc33/xRYSPPL41DSwPIqn/HMCQksCoHAXkIVYNTwSgYBaNgFIwCBgDsClx5AbSGPwAAAABJRU5ErkJggg==","orcid":"","institution":"Aarhus University Hospital","correspondingAuthor":true,"prefix":"","firstName":"Jakob","middleName":"","lastName":"Duelund-Jakobsen","suffix":""},{"id":489146459,"identity":"3b8ae52c-ea7e-4814-9fec-af63563571a5","order_by":1,"name":"Steen Buntzen","email":"","orcid":"","institution":"Aarhus University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Steen","middleName":"","lastName":"Buntzen","suffix":""},{"id":489146460,"identity":"e6d3843b-1f3b-484a-982e-0767e38e4a18","order_by":2,"name":"Lilli Lundby","email":"","orcid":"","institution":"Aarhus University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Lilli","middleName":"","lastName":"Lundby","suffix":""},{"id":489146461,"identity":"7ddae1bc-6772-4ce6-bd4e-74ec5e63ebec","order_by":3,"name":"Søren Laurberg","email":"","orcid":"","institution":"Aarhus University","correspondingAuthor":false,"prefix":"","firstName":"Søren","middleName":"","lastName":"Laurberg","suffix":""},{"id":489146462,"identity":"30743bd5-afb4-4e3e-9030-4a15a293e6e3","order_by":4,"name":"Michael Sørensen","email":"","orcid":"","institution":"Hvidovre University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"","lastName":"Sørensen","suffix":""},{"id":489146463,"identity":"97bf1dca-d688-49a7-87b2-ff960993c9c2","order_by":5,"name":"Mona Rydningen","email":"","orcid":"","institution":"University Hospital of North Norway","correspondingAuthor":false,"prefix":"","firstName":"Mona","middleName":"","lastName":"Rydningen","suffix":""}],"badges":[],"createdAt":"2025-07-14 11:23:42","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7120621/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7120621/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s10151-025-03254-9","type":"published","date":"2025-12-24T15:57:59+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":99172547,"identity":"717d4524-a466-41a3-b4de-0018f0903022","added_by":"auto","created_at":"2025-12-29 16:11:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":631098,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7120621/v1/e30a4d2e-1a36-4f6d-abbd-74aec4ec92ad.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Sacral Neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence – results from a randomised study with a One-stage implant procedure","fulltext":[{"header":"What does this paper add to the existing literature?","content":"\u003cp\u003eThis is the first paper to document that Sacral Neuromodulation at an ultralow stimulation amplitude of 0.05 volts is equally effective in reducing incontinence episodes and symptom scores compared to stimulation at higher amplitudes. Further, subsensory stimulation is, for the first time, shown to be effective immediately after implantation in patients with faecal incontinence.\u003c/p\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003eFaecal incontinence (FI) has substantial negative implications for the affected individual and their family. Additionally, it is associated with a high level of stigma and has a major negative impact on the quality of life [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. FI affects approximately 16% of the population but may be referred to as the \u0026ldquo;silent affliction\u0026ldquo; since the magnitude of the problem is likely to be underestimated because most individuals are reluctant to consult healthcare providers [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe latest recent guideline for management of FI recommends first-line conservative treatment such as fibre supplements, constipating drugs, biofeedback therapy, or transanal irrigation[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. These treatments have been proven effective in approximately 72% of patients attending a specialist nurse-led clinic[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. If conservative treatment is insufficient to improve continence satisfactorily, Sacral Neuromodulation (SNM) may be considered[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSince its introduction in 1995, SNM has proven to be an effective long-term minimally invasive treatment [\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. SNM is approved as a two-stage procedure. The first stage (Stage-I) is performed with a temporary or permeant lead connected to an extension wire that is externalised and connected to an extracorporeal neurostimulator. The treatment response is evaluated after 2\u0026ndash;3 weeks before the final decision for a complete implant (Stage-II). Transitioning from Stage-I to Stage-II typically requires a\u0026thinsp;\u0026ge;\u0026thinsp;50% reduction in incontinence episodes or the number of days impacted by incontinence. With the introduction of the standardised implantation technique [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], the number of patients proceeding from Stage-I (\u0026ge;\u0026thinsp;50% symptom reduction) to Stage-II is approaching 90% [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The stimulation amplitude has been traditionally set at an individual threshold corresponding to the perception of stimulation, known as the sensory threshold (ST). It has been documented in a randomised trial and in following prospective trials that the stimulation amplitude in patients suffering from FI can be set 50% below ST without compromising treatment efficacy[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. The present evidence of subsensory stimulation (below ST) is shown in patients stimulated for several years at the ST. We currently lack knowledge about subsensory stimulation and its effectiveness on functional outcomes immediately after implantation. Subsensory stimulation offers several advantages. Firstly, it would eliminate the patient\u0026rsquo;s discomfort associated with stimulation at the ST. Secondly, reducing the energy consumption of the neurostimulator would increase its life expectancy, subsequently lowering treatment costs. Thirdly, the theoretical risk of nerve damage from electrical stimulation is decreased as less energy is delivered to the surrounding tissue.\u003c/p\u003e\u003cp\u003eThis randomised, double-blinded study was as part of another study[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] designed to investigate the relationship between functional outcomes and different subsensory stimulation amplitudes in \u0026ldquo;de novo\u0026rdquo; implanted patients with FI.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cp\u003ePatients were recruited from three tertiary referral centres for FI treatment: Aarhus University Hospital, Hvidovre University Hospital, Denmark, and the University Hospital of North Norway, Tromsoe. Study inclusion started in November 2016 and ended in November 2019.\u003c/p\u003e\u003cp\u003ePatients diagnosed with idiopathic FI or FI due to an external anal sphincter defect of \u0026le;\u0026thinsp;160\u003csup\u003eo\u003c/sup\u003e were eligible. The integrity of the anal sphincter was assessed using transanal ultrasound. All patients should report weekly FI after maximal conservative therapy had been attempted. A complete list of inclusion and exclusion criteria has been published previously[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAs part of another trial recently published[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], these patients had a one-stage implantation, without a prior test(Stage-1) if they, during the operation, had a motor response (contraction) of the external anal sphincter in \u0026ge;\u0026thinsp;3 poles and at least one pole of the quadripolar leads with a motor threshold\u0026thinsp;\u0026le;\u0026thinsp;1.5 mAmp[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The permanent lead Model 3889 (Quadripolar lead for electrical stimulation\u0026reg;, Medtronic, Minneapolis, MN) and a neurostimulator InterStim-II (Medtronic, Minneapolis, MN) were used. If the patients did not fulfil the perioperative requirement for a one-stage implant, they were excluded from the study and offered a conventional stage-I test. Perioperative, the amplitude needed to elicit a contraction of the external anal sphincter was evaluated using the Verify\u0026reg; system (Medtronic). The Verify\u0026reg; system stimulates with a constant current technology and the amplitude is reported in mAmp. The permanent implant (InterStim-II) provides electrical stimulation using a constant voltage basis (Volt). Both systems provide the same energy to the nerve as long as the resistance in the electrical circuit remains unchanged[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe implantations were performed in deep sedation or general anaesthesia to document the motor response during lead placement. All patients received pre-operative intravenous prophylactic antibiotics.\u003c/p\u003e\u003cp\u003ePatients fulfilling the perioperative criteria were randomised on the day after surgery using sealed envelopes into one of two groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Participants and data assessor(JDJ) were blinded during the study phase, only the programming nurses were aware of the actual randomisation group. During the first 12 weeks after one-stage implantation, the stimulation amplitude was increased after four weeks for patients in group one(G-1) from 0.05 volts (lowest possible setting) to 50% and subsequently after four weeks to 90% of ST. In group two(G-2), patients were during the first 12 weeks stimulated at 90% of ST, but the patients were seen by the programming nurses and the stimulation status of the neurostimulator were recorded to ensure blinding of the patients. All patients were stimulated at the ST in the following 12 weeks (week 13 to 24) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Thereafter, the study ended, and patients were followed up according to standard practise in each centre.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWeek 1\u0026ndash;4\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWeek 5\u0026ndash;8\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eWeek 9\u0026ndash;12\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eWeek 13\u0026ndash;24\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup 1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.05 Volts\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e50% of ST\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e90% of ST\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eST\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup 2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e90% of ST\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e90% of ST\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e90% of ST\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eST\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eStimulation amplitude during the different trial periods. ST: Sensory threshold\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAt baseline and during each stimulation period, patients were requested to complete a series of questionnaires (overall satisfaction with bowel function, social function and quality of life was assessed using a numerical visual analogue scale (VAS) range 0-100, where 100 indicates excellent function and 0 indicates poor function[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], St. Marks Incontinence Score[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]), and a three-week bowel habit diary.\u003c/p\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eETHICS\u003c/span\u003e\u003c/p\u003e\u003cp\u003e The protocol for the study was approved by the Regional Committee on Biomedical Research Ethics, Denmark and the Patient Protection Representative Norway (SJO125) and registered at ClinicalTrials.gov (August 22. 2017 - NCT03261622). Medtronic was notified about the study but did not participate in its the planning, completion, or reporting. In case of unexpected adverse events related to the study, patients were covered by national healthcare insurance.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eA sample size calculation (based on a non-inferiority study design) was conducted to ensure the number of patients needed to determine that a one-stage implantation is non-inferior to a Stage I\u0026thinsp;+\u0026thinsp;II procedure[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. In total, 60 patients were planned for inclusion. To account for dropout and possible infection leading to explanation, the target for inclusion was 75 patients. Each department could include a maximum of 30 patients. A sample size calculation or power calculation was not performed for the randomised part of the trial. Baseline data are presented as median and interquartile range (IQR) or mean and standard deviation(SD). Data obtained during follow-up are presented as delta values (baseline vs specific period) for enhanced visualisation of differences. Wilcoxon signed-rank test was used to compare results obtained at the initiation of this study and follow-up at four, eight and 12 weeks between the two randomisation groups. The paired t-test was used to compare the baseline and 24-week follow-ups. In case of missing values, the result of that specific question/score was discharged at the specific follow-up. Values of P \u0026le; 0.05 were considered statistically significant. All statistical analyses were conducted using Stata version 10.1. (Stata Corporation, 4905 Lakeway Drive, TX 77846, USA).\u003c/p\u003e\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003e Eighty-five patients were eligible, of whom 76 (72 females) gave written consent to participate. Three patients were excluded during the trial. One patient developed a deep infection on the fourth day after implantation. Consequently, the neurostimulator and electrode were explanted, and two patients withdrew consent to participate before the study was initiated.\u003c/p\u003e\u003cp\u003eSeventy-three patients (70 females) with a median age of 60 (IQR: 50\u0026ndash;69) years completed the trial, and their results are presented. Twenty-nine patients were implanted in Tromsoe, Norway, 26 patients were implanted in Aarhus, Denmark, and 18 patients were implanted in Hvidovre, Denmark. Out of the 70 females included, 64 had given birth to a median of 2(IQR: 2\u0026ndash;3) children.\u003c/p\u003e\u003cp\u003eThe aetiology of FI was obstetric anal sphincter injury in 38 patients of whom 23 (61%) had previously undergone primary sphincter repair. At baseline, before SNM, an external anal sphincter defect was observed on ultrasound in 19 patients with a median 90\u003csup\u003eo\u003c/sup\u003e (IQR: 50\u0026ndash;120) degree defect. In the remaining 35 patients the aetiology was unknown and registered as idiopathic.\u003c/p\u003e\u003cp\u003eOf the 73 patients completing the study, 40 patients were randomised to G-1 and 33 patients to G-2. The baseline demographics and scores did not differ between groups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline demographics and scores for included patients and peroperative stimulations results including sensory threshold at first programming. Median and (IQR).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eGroup 1\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGroup 2\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eBaseline\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of patients\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e59.5(45.5\u0026ndash;66)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e61(51\u0026ndash;72)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.148\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender (females)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.111\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParity\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2(1\u0026ndash;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2(2\u0026ndash;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.113\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBody Mass Index\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27.2(23.7\u0026ndash;33.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25.9(22.6\u0026ndash;29.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.159\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExternal anal sphincter defect\u0026thinsp;\u0026lt;\u0026thinsp;160\u003csup\u003eo\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e36%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.368\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSt. Mark\u0026rsquo;s Incontinence Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e18(17\u0026ndash;20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e18(16-19.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.469\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVAS bowel function\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17.5(10\u0026ndash;40)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e23(5\u0026ndash;43)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.851\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVAS social function\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e40(15\u0026ndash;50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e50(20\u0026ndash;55)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.573\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVAS lifestyle\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e40(10\u0026ndash;50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e50(25\u0026ndash;70)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.260\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInc. episode pr. three weeks\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12(6\u0026ndash;24)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e13(9\u0026ndash;20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.508\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePeroperative stimulation results and sensory threshold\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMotor response (mAmp):\u003c/p\u003e\u003cp\u003ePole 0\u003c/p\u003e\u003cp\u003ePole 1\u003c/p\u003e\u003cp\u003ePole 2\u003c/p\u003e\u003cp\u003ePole 3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\u003cp\u003e0.8 (0.5\u0026ndash;1.8)\u003c/p\u003e\u003cp\u003e1.0(0.5\u0026ndash;1.5)\u003c/p\u003e\u003cp\u003e0.5(0.5-1.0)\u003c/p\u003e\u003cp\u003e1.0(0.5\u0026ndash;1.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\u003cp\u003e1.0(0.5\u0026ndash;1.6)\u003c/p\u003e\u003cp\u003e1.0(0.5\u0026ndash;1.5)\u003c/p\u003e\u003cp\u003e0.6(0.5-1)\u003c/p\u003e\u003cp\u003e1.0(1.0\u0026ndash;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\u003cp\u003e0.418\u003c/p\u003e\u003cp\u003e0.496\u003c/p\u003e\u003cp\u003e0.222\u003c/p\u003e\u003cp\u003e0.134\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSensory threshold (volt):\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.53(0.38\u0026ndash;0.78)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.60(0.40\u0026ndash;0.80)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.693\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003ePeroperative stimulation results and sensory threshold\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe peroperative inclusion criteria were met for all patients, including a motor threshold in \u0026ge;\u0026thinsp;3 poles and at least one pole of the quadripolar lead with a motor threshold\u0026thinsp;\u0026le;\u0026thinsp;1.5 mAmp. The mean number of poles with a motor response was 3.9 (SD.0.33). In 86% of patients, a motor response was achieved at all four poles of the quadripolar lead. The median stimulation amplitude required to achieve a motor response in any pole of the quadripolar leads were non-significant different between G-1 or G-2 (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The ST at the initial programming the day after surgery was median 0.55 (IQR: 0.4\u0026ndash;0.8) volts, with non-significant differences between groups (p-value: 0.693) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cb\u003eComparisons between G-1 and G-2\u003c/b\u003e\u003c/p\u003e\u003cp\u003eBoth groups improved in all evaluated parameters during the first four weeks after implantation (Table\u0026nbsp;3). The only statistically significant difference between the two groups was observed in the delta VAS for bowel function. In G-1 with ultralow stimulation amplitude (0.05 volts - equivalent to 9.6 (IQR: 6.5\u0026ndash;13.4) per cent of ST) the median improvement in the VAS for bowel function was 30 (IQR:10\u0026ndash;50) points significantly lower than G-2 stimulated at 90% of the ST in which a median improvement of 50 (IQR: 10\u0026ndash;70) points was obtained (p-value: 0.05).\u003c/p\u003e\u003cp\u003eIn the following two randomisation rounds, where the stimulation intensity was increased in G-1 to 50% of the ST (week 5 to 8) and 90% of the ST (week 9\u0026ndash;12) compared to G-2 with a stable stimulation amplitude of 90% of the ST, no statistically significant difference was observed between the groups (Table\u0026nbsp;3).\u003c/p\u003e\u003cp\u003eTable 3\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eComparison between randomisation groups from week one to twelve.\u003c/p\u003e\n\u003cp\u003eDelta values: Baseline \u0026ndash; specific follow-up. Median and (IQR)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"83%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eWeek\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 29px;\"\u003e\n \u003cp\u003e1-4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 28px;\"\u003e\n \u003cp\u003e5-8\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e9-12\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003eGroup 1\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.05\u003c/p\u003e\n \u003cp\u003eVolts\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eGroup 2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e90% of ST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eP-value\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eWilcoxon rank-sum test(MW)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eGroup 1\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e50% of ST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003eGroup 2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e90% of ST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003eP-value\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eWilcoxon rank-sum test(MW)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003eGroup 1\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e90% of ST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eGroup 2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e90% of ST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003eP-value\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eWilcoxon rank-sum test(MW)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eDelta St. Mark\u0026rsquo;s Incontinence score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e4(1-7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e4(1-7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.902\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e4.5(2.5-9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e3.5(2-9.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.625\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e5(3-8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e4.5(1-11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.853\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eDelta incontinence episodes\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e8.5(4-21)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e9(5-14)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.988\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e8(4-19)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e12(6-18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.347\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e11(2-20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e11(6-15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.743\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eReduction FI.-episodes (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e78 (54-95)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e71(53-92)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.732\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e81(60-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e91(63-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.732\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e80(61-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e89(59-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.387\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eDelta VAS\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBowel function\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e30(10-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e50(25-70)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.05*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e30(10-60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e50(10-70)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.256\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e35(9-55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e49(25-60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.194\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eDelta VAS\u003c/p\u003e\n \u003cp\u003eSocial function\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e20(5-40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e25(5-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.676\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e20(5-55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e25(10-60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.532\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e30(10-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e30(5-45)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.936\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003eDelta VAS\u003c/p\u003e\n \u003cp\u003eLifestyle\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e25(10-40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e10(0-40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.492\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e28(10-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e25(0-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.738\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e30(10-49)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e30(10-50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.937\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cul\u003e\n \u003cli\u003eUncorrected p-value: 0.0496\u003c/li\u003e\n\u003c/ul\u003e\u003cp\u003e\u003cb\u003eComparison between baseline and 24-week follow-up\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThere was no significant difference between the groups in any evaluated parameters at the latest follow-up after 24 weeks (week 13\u0026ndash;24), where all patients had been stimulated at the ST (data not shown). The median stimulation amplitude in weeks 13 to 24 was 0.5 (IQR: 0.4\u0026ndash;0.78) volts in G-1 and 0.9 (IQR: 0.4\u0026ndash;1.25) in G-2, with no significant differences between groups (p-value: 0.222). Analysed as a group, the number of incontinence episodes per three weeks at the latest follow-up was significantly reduced from baseline with a median of 12(IQR: 6\u0026ndash;19) (p-value: \u0026lt;0.001) episodes. The median reduction in incontinence episodes compared to baseline was 87.5 (IQR: 75\u0026ndash;100) per cent. A 50% or higher reduction in incontinence episodes compared to baseline was obtained in 92% of the patients. The St. Mark\u0026rsquo;s Incontinence Score at the latest follow-up was significantly reduced from baseline with a median of 6 (IQR: 1.5\u0026ndash;11) (p-value: \u0026lt;0.001) points.\u003c/p\u003e\u003cp\u003eThe VAS for patient satisfaction with bowel function at the latest follow-up improved significantly from baseline with a median of 50 (IQR: 25\u0026ndash;70) (p-value: \u0026lt;0.001) points.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis randomised multicentre study is the first to demonstrate that subsensory stimulation is effective in newly implanted patients. Stimulation with 0.05 volts equivalent to 9.6 (IQR: 6.5\u0026ndash;13.4) per cent of the ST is equally effective in reducing incontinence episodes and symptoms scores as stimulation with 50\u0026ndash;90% of the ST. The patient\u0026rsquo;s VAS for bowel function in period one (0.05 volts vs 90% of the ST) was the only score with a significantly better outcome in G-2(90% of the ST) compared to G-1(0.05 volts) (Table\u0026nbsp;3). All other scores were not significantly different throughout the study period. This indicates that the difference may be explained by a Type I error, implying it is a false positive rather than a factual finding.\u003c/p\u003e\u003cp\u003eWhen the study was planned, we included a group with ultra-low stimulation intensity. The intensity was set at 0.05 volts, which is the lowest possible setting, with the InterStim-II neurostimulator still being turned on. We chose a low setting because we believed it would be difficult to recruit patients for the trial with a period where the neurostimulator was turned off. We expected 0.05 volts to be equivalent to 2\u0026ndash;5% of ST based on previous results [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. This stimulation intensity is expected to be too low to depolarise the afferent nerve fibres, making it effective as a placebo stimulation. All patients included were implanted in accordance with the standardised implantation technique[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Furthermore, a motor response (contraction) of the external anal sphincter must occur in \u0026ge;\u0026thinsp;3 poles and at least one pole of the quadripolar lead, with a motor threshold\u0026thinsp;\u0026le;\u0026thinsp;1.5 mAmp to qualify for inclusion. With these strict implantation criteria, the motor threshold, and subsequently the ST obtained at implantation were much lower than expected during the planning phase. Electrical nerve activation relies on a critical current to activate ion channels responsible for the influx of positive ions that initiate action potentials[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Our trial results indicate that an ultra-low stimulation intensity, equivalent to 9.6% of the ST, may be sufficient to activate these ion channels, as the efficacy of the treatment was not affected by the ultra-low amplitude stimulation. Further, electrophysiological studies should be conducted to determine the minimal electrical threshold required for nerve modulation in SNM.\u003c/p\u003e\u003cp\u003eThe efficacy in reducing incontinence episodes was 71\u0026ndash;91%, with no difference observed between the stimulation groups during the randomised period (Table\u0026nbsp;3). Such improvement is unlikely to be solely attributed to a placebo effect. However, the possibility of a placebo effect remains a potential confounding factor when studying functional disorders. Knowles et al. documented in a randomised double-blinded trial evaluating Percutaneous Tibial Nerve Stimulation vs placebo that 31% of patients receiving shame stimulation experienced a 50% or higher reduction in incontinence episodes[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Tan et al. published in 2020 a systematic review and meta-analysis aimed to quantify placebo effects and responses following sham electrical nerve stimulation for FI and constipation a total of ten papers were analysed[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. They concluded that \u0026ldquo;Sham stimulation is associated with clinical and statistically meaningful improvements in symptoms of fecal incontinence and constipation, as well as quality of life scores, highlighting the importance of sham controls in nerve stimulation trials. Noncontrolled studies should be interpreted with caution\u0026ldquo;. Recently, Vollebregt et al. published the results from a randomised cross-over trial assessing the impact of SNM ON vs OFF(or ultra-low stimulation 0.05 volts)[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. The trial was terminated due to a lack of recruitments, and the results were based on only 16 out of the 90 planned participants. They found that SNM conferred a non-significant reduction in faecal incontinence episodes compared to sham. The current study was designed with the expectation that 0.05 volts of stimulation would be ineffective and, therefore, could be regarded as a placebo, as discussed above.\u003c/p\u003e\u003cp\u003eThe current study confirms previous publications that subsensory stimulation is effective[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. We have found that the stimulation amplitude can be further reduced from 50% below the ST to 9.6 (IQR: 6.5\u0026ndash;13.4) per cent of the ST without compromising treatment efficacy. Further, it is documented that subsensory stimulation is effective in patients not previously stimulated at or above the ST.\u003c/p\u003e\u003cp\u003eThe timeframe of this study was extended due to the global coronavirus disease pandemic, and our ethical approval allowed us to follow the patients only for 24 weeks. Further, research with longer follow-ups of patients stimulated at the subsensory stimulation level is needed to clarify its efficacy over time.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eSub-sensory stimulation is feasible in newly implanted patients and an amplitude of 0.05 volts equivalent to 9.6 (IQR: 6.5\u0026ndash;13.4) per cent of the sensory threshold, is as effective in reducing incontinence episodes and symptom scores as stimulation set at 90% of the sensory threshold.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cu\u003eFinancial support:\u003c/u\u003e The Danish Agency for Science, Technology and Innovation funded part of the study, while the participating departments covered the remaining expenses.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eMeeting presentation:\u003c/u\u003e Oral presentation at the ESCP-2022 meeting in Dublin, Ireland and APFM-2022 Svolvaer, Lofoten, Norway.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eData share:\u003c/u\u003e Trial data can be assessed by request to corresponding author.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eConflicts of interest:\u003c/u\u003e All authors have received honoraria from Medtronic as speakers at meetings and/or as medical advisory board members. The study, design, performance, analysis, and reporting were conducted without Medtronic\u0026rsquo;s influence.\u0026nbsp;\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data. JDJ and MR drafted the work. SB, LL, SL and MS revised it critically for important intellectual content;approved the version to be published; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003e\u003cem\u003eClinicalTrials.gov identifier: NCT00919672.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eGarcia, J.A., et al., \u003cem\u003eBreaking the cycle of stigmatization: managing the stigma of incontinence in social interactions.\u003c/em\u003e Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society / WOCN, 2005. \u003cstrong\u003e32\u003c/strong\u003e(1): p. 38-52.\u003c/li\u003e\n\u003cli\u003eMakol, A., M. Grover, and W.E. Whitehead, \u003cem\u003eFecal incontinence in women: causes and treatment.\u003c/em\u003e Women\u0026apos;s health (London, England), 2008. \u003cstrong\u003e4\u003c/strong\u003e(5): p. 517-528.\u003c/li\u003e\n\u003cli\u003eJohanson, J.F. and J. Lafferty, \u003cem\u003eEpidemiology of fecal incontinence: the silent affliction.\u003c/em\u003e The American Journal of Gastroenterology, 1996. \u003cstrong\u003e91\u003c/strong\u003e(1): p. 33-36.\u003c/li\u003e\n\u003cli\u003eWhitehead, W.E., et al., \u003cem\u003eFecal Incontinence Diagnosed by the Rome IV Criteria in the United States, Canada, and the United Kingdom.\u003c/em\u003e Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2019.\u003c/li\u003e\n\u003cli\u003eAssmann, S.L., et al., \u003cem\u003eGuideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.\u003c/em\u003e United European Gastroenterol J, 2022. \u003cstrong\u003e10\u003c/strong\u003e(3): p. 251-286.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eNurse-led clinics can manage faecal incontinence effectively: results from a tertiary referral centre.\u003c/em\u003e Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2015. \u003cstrong\u003e17\u003c/strong\u003e(8): p. 710-715.\u003c/li\u003e\n\u003cli\u003eMatzel, K.E., et al., \u003cem\u003eElectrical stimulation of sacral spinal nerves for treatment of faecal incontinence.\u003c/em\u003e Lancet, 1995. \u003cstrong\u003e346\u003c/strong\u003e(8983): p. 1124-1127.\u003c/li\u003e\n\u003cli\u003eJanssen, P.T., et al., \u003cem\u003eFecal incontinence treated by sacral neuromodulation: Long-term follow-up of 325 patients.\u003c/em\u003e Surgery, 2017. \u003cstrong\u003e161\u003c/strong\u003e(4): p. 1040-1048.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eSacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database.\u003c/em\u003e International journal of colorectal disease, 2016. \u003cstrong\u003e31\u003c/strong\u003e(2): p. 421-428.\u003c/li\u003e\n\u003cli\u003eMatzel, K.E., et al., \u003cem\u003eSacral Neuromodulation: Standardized Electrode Placement Technique.\u003c/em\u003e Neuromodulation, 2017. \u003cstrong\u003e20\u003c/strong\u003e(8): p. 816-824.\u003c/li\u003e\n\u003cli\u003eRydningen, M.B., et al., \u003cem\u003eSacral neuromodulation for faecal incontinence following obstetric sphincter injury - outcome of percutaneous nerve evaluation.\u003c/em\u003e Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2017. \u003cstrong\u003e19\u003c/strong\u003e(3): p. 274-282.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eOne-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study.\u003c/em\u003e Colorectal Dis, 2024. \u003cstrong\u003e26\u003c/strong\u003e(5): p. 968-973.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eImproved longevity and efficacy of sacral nerve stimulation by simple adjustments at follow-up.\u003c/em\u003e Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2019.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eSacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study.\u003c/em\u003e Annals of Surgery, 2013. \u003cstrong\u003e257\u003c/strong\u003e(2): p. 219-223.\u003c/li\u003e\n\u003cli\u003eLehur, P.A., et al., \u003cem\u003eProgramming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence-Recommendations for Day-to-Day Practice.\u003c/em\u003e Neuromodulation, 2020. \u003cstrong\u003e23\u003c/strong\u003e(8): p. 1121-1129.\u003c/li\u003e\n\u003cli\u003eDuelund-Jakobsen, J., et al., \u003cem\u003eFunctional results and patient satisfaction with sacral nerve stimulation for idiopathic faecal incontinence.\u003c/em\u003e Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2012. \u003cstrong\u003e14\u003c/strong\u003e(6): p. 753-759.\u003c/li\u003e\n\u003cli\u003eVaizey, C.J., et al., \u003cem\u003eProspective comparison of faecal incontinence grading systems.\u003c/em\u003e Gut, 1999. \u003cstrong\u003e44\u003c/strong\u003e(1): p. 77-80.\u003c/li\u003e\n\u003cli\u003eCameron, M.A., et al., \u003cem\u003eDifferential effect of brief electrical stimulation on voltage-gated potassium channels.\u003c/em\u003e J Neurophysiol, 2017. \u003cstrong\u003e117\u003c/strong\u003e(5): p. 2014-2024.\u003c/li\u003e\n\u003cli\u003eKnowles, C.H., et al., \u003cem\u003ePercutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial.\u003c/em\u003e Lancet (London, England), 2015. \u003cstrong\u003e386\u003c/strong\u003e(10004): p. 1640-1648.\u003c/li\u003e\n\u003cli\u003eTan, K., et al., \u003cem\u003ePlacebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis.\u003c/em\u003e Neuromodulation, 2020. \u003cstrong\u003e23\u003c/strong\u003e(8): p. 1108-1116.\u003c/li\u003e\n\u003cli\u003eVollebregt, P.F., et al., \u003cem\u003eEfficacy and Mechanism Evaluation\u003c/em\u003e, in \u003cem\u003eClinical effectiveness of subsensory sacral neuromodulation in adults with faecal incontinence: the SUBSoNIC crossover RCT and mechanistic study\u003c/em\u003e. 2024, National Institute for Health and Care Research \u003c/li\u003e\n\u003cli\u003eCopyright \u0026copy; 2024 Vollebregt et al.: Southampton (UK).\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"techniques-in-coloproctology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"tcol","sideBox":"Learn more about [Techniques in Coloproctology](http://link.springer.com/journal/10151)","snPcode":"10151","submissionUrl":"https://submission.nature.com/new-submission/10151/3","title":"Techniques in Coloproctology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Faecal incontinence, Sacral Neuromodulation, Quality of Life, Functional outcome","lastPublishedDoi":"10.21203/rs.3.rs-7120621/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7120621/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eIn Sacral Neuromodulation(SNM), the stimulation intensity is set at the sensory threshold(ST) level. However, subsensory stimulation at 50% of ST has proven effective in reducing faecal incontinence episodes.\u003c/p\u003e\u003cp\u003e\u003cb\u003eAim\u003c/b\u003e: To explore the relationship between functional outcomes and varying subsensory stimulation amplitude in newly implanted patients.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethod\u003c/b\u003e: This randomised, double-blinded study was designed to include patients with \u0026ge;\u0026thinsp;1faecal incontinence episodes/week despite maximal conservative therapy. As part of another trial, patients were offered a one-stage procedure. Postoperatively, patients were randomised into two groups. G-1: Received stimulation at 0.05 volts, 50 and 90% of ST in 3x4-week periods, followed by 12-weeks stimulation at the ST. G-2: Received stimulation with 90% of the ST in in 3x4-week periods, followed by 12-weeks stimulation at ST. Patients were evaluated after each period using St. Marks\u0026rsquo;s Incontinence Score, Visual-Analog-Scale(VAS) for patient satisfaction regarding social function, bowel function and quality-of-life, along with a bowel habit diary.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e: Seventy-three patients with a median age of 60(IQR:50\u0026ndash;69) completed the trial. Faecal incontinence episodes were significantly reduced at all follow-ups, with no differences between groups. The only statistical difference between groups was deltaVAS for bowel function after 4-weeks. In G-1 with ultralow stimulation amplitude (0.05 volts - equivalent to 9.6(IQR:6.5\u0026ndash;13.4)% of ST) the improvement compared to baseline was 30(IQR:10\u0026ndash;50) points significantly lower than G-2 with an improvement of 50(IQR:10\u0026ndash;70) points (p-value: 0.05).\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e: Subsensory stimulation is feasible in newly implanted patients with faecal incontinence. An amplitude of 0.05 volts, is as effective on the functional outcomes as stimulation with higher amplitudes.\u003c/p\u003e","manuscriptTitle":"Sacral Neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence – results from a randomised study with a One-stage implant procedure","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-24 10:31:34","doi":"10.21203/rs.3.rs-7120621/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-08-31T08:48:57+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-09T00:27:14+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-06T03:14:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"338138636363868799595421553003204080281","date":"2025-07-30T11:33:02+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-07-26T16:56:04+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"212314290901259282627500941139026779402","date":"2025-07-25T05:23:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"304250247492691354880965445050460528958","date":"2025-07-25T01:58:58+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"216255524843368572086709717084916182618","date":"2025-07-24T09:36:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-07-22T09:15:10+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-16T21:08:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-14T14:42:44+00:00","index":"","fulltext":""},{"type":"submitted","content":"Techniques in Coloproctology","date":"2025-07-14T11:20:01+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"techniques-in-coloproctology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"tcol","sideBox":"Learn more about [Techniques in Coloproctology](http://link.springer.com/journal/10151)","snPcode":"10151","submissionUrl":"https://submission.nature.com/new-submission/10151/3","title":"Techniques in Coloproctology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"bf48c7cf-14db-4a54-99cb-f301e4ced9db","owner":[],"postedDate":"July 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-29T16:07:40+00:00","versionOfRecord":{"articleIdentity":"rs-7120621","link":"https://doi.org/10.1007/s10151-025-03254-9","journal":{"identity":"techniques-in-coloproctology","isVorOnly":false,"title":"Techniques in Coloproctology"},"publishedOn":"2025-12-24 15:57:59","publishedOnDateReadable":"December 24th, 2025"},"versionCreatedAt":"2025-07-24 10:31:34","video":"","vorDoi":"10.1007/s10151-025-03254-9","vorDoiUrl":"https://doi.org/10.1007/s10151-025-03254-9","workflowStages":[]},"version":"v1","identity":"rs-7120621","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7120621","identity":"rs-7120621","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}