Hypothesis / aims of study The BlueWind Medical Device, Revi®, is a novel implantable tibial neuromodulation (iTNM) system that uses an external, wearable, battery-operated unit. A Clinician Programmer is used to tailor stimulation parameters for optimization of efficacy.This abstract details quality-of-life (QoL) outcomes for a previously reported prospective, multi-center, single arm pivotal trial evaluating efficacy and safety of iTNM for treatment of urgency urinary incontinence (UUI) in women. Study design, materials and methods Subfascial implantation of the device over the posterior tibial nerve was performed under local anesthesia in 151 female subjects. After initial healing, subjects performed stimulation treatments at home with an external wearable ankle cuff. Voiding diaries were collected at 1,3,6,9,12,18, and 24 months (m) and QoL questionnaires, including the Overactive Bladder Questionnaire (OAB-q), Patient Global Impression of Improvement (PGI-I), and Benefit Satisfaction and Willingness to Continue (BSW), were collected at 6,12, and 24m. The primary endpoint, UUI response rate (≥50% decrease in UUI episodes), was achieved and has been previously reported; UUI response rate was 77.8% (112/144), 82.0% (114/139), and 79.4% (77/97) at 6, 12, and 24m, respectively. Results Consistent QoL benefits were seen throughout 24m (see Figure 1), with clinically significant (≥10 point change) and stable improvements in all domains of the OAB-q. Symptom severity (transformed score), which shows improvement when score decreases, was reduced from 70.3 (n=149) to 32.4 (n=144), 30.6 (n=139), and 31.5 (n=96) at 6m, 12m, and 24m, respectively. HRQL (transformed score), which increases with improvement up to a maximum of 100, was improved from 46.6 (n=149) to 81.1 (n=144), 81.8 (n=139), and 83.3 (n=96) at 6m, 12m, and 24m, respectively. Overall, clinically meaningful QoL improvements were reported in 83.1% (n=142), 85.4% (n=137), and 87.2% (n=94) of participants at 6, 12, and 24m, respectively (≥10-point change in total transformed HRQL score).Importantly, at 24m, 96.8% (91/94) reported treatment benefit, 96.7% (88/91) reported satisfaction, and 100% (94/94) reported a willingness to continue therapy. Subjects who didn’t meet the efficacy endpoint at 24m (N=20; 21%) often still reported appreciable benefit; at 24 months, 83.3% (15/18) acknowledged treatment benefit, 66.7% (12/18) reported satisfaction, and 100% (18/18) reported a willingness to continue therapy. Interpretation of results The OASIS 24m trial findings support both improvement in UUI episodes and improvements across multiple QoL and satisfaction outcome measures. A previous report demonstrated positive efficacy on UUI episodes with 79% of participants noting a ≥50% improvement in UUI at the 24m timepoint, and 56% experiencing ≥75% improvement (1). The current study expanded on these findings with clinically meaningful benefits seen across multiple measures of QoL that were sustained throughout the treatment duration.Burden on QoL was alleviated with significant improvements in OAB-q symptom severity, independent HRQL domains (i.e., coping, concern, sleep, and social), total HRQL, PGI-I, and positive BSW following treatment with the Revi System, in parallel to UUI improvements. The minimally important difference (MID) recommended for the OAB-q and all subscales is a 10-point change post-treatment. iTNM treatment improved all domains by at least 20 points at the 24m timepoint with a mean change of 35 points in the overall HRQL score. Notably, improvements in all QoL measures were reported at the first timepoint (6m) and sustained throughout the current study duration of 24m. Concluding message iTNM has emerged as an effective intervention for UUI. Two-year results of the Revi system demonstrate clinically-relevant and sustained positive impacts to bladder-related QoL, including in those who didn’t meet the primary efficacy endpoint.Figure 1Funding The study was funded by BlueWind Medical Inc. Clinical Trial Yes Registration Number NCT03596671 RCT No Subjects Human Ethics Committee Multicenter study with multiple IRB/ECs. Ethical approval was obtained prior to beginning the study at each institution. Helsinki Yes Informed Consent Yes

ImportanceOveractive bladder is a distressing syndrome that significantly affects quality of life. Transcutaneous tibial nerve stimulation (TTNS) has been proposed as a home-based, patient-centered therapy that could improve access to treatment for this condition.ObjectiveWe aimed to determine the efficacy of 12 weeks of TTNS versus sham therapy in reducing symptomatic bother in ambulatory women with urgency urinary incontinence.Study DesignThis was a double-masked, sham-controlled randomized trial. The primary outcome was the change in Overactive Bladder Questionnaire scores. Secondary outcomes included those with 50% or greater reduction in urgency incontinence episodes on 3-day voiding diaries and Patient Global Impression of Improvement.ResultsOne hundred women were randomized (65 intervention, 35 sham) and included in analysis. Both groups experienced clinically meaningful improvement in Overactive Bladder Questionnaire scores postintervention from baseline, which was not significant between groups (symptom severity: intervention -19.5 +/- 20.2 vs sham -19.4 +/- 20.4, P = 1.0; health-related quality of life -16.6 +/- 18.5 vs -13.8 +/- 16.8, P = 0.5). In the TTNS group, 58.8% of women achieved 50% or greater reduction in urgency incontinence episodes versus 41.7% of women in the sham group (P = 0.2), and 25% versus 18% were "much" or "very much improved" (P = 0.2). A sensitivity analysis confirmed these findings.ConclusionsClinically meaningful reductions in overactive bladder symptoms were observed in both TTNS and sham therapy without significant differences between groups; however, a trend toward greater reduction in incontinence episodes and overall impression of improvement was noted in the active treatment. The therapeutic benefit from regularly connecting with a clinician should be considered when developing new therapies.

PURPOSE:The BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS (Overactive Bladder Stimulation System) study are presented. MATERIALS AND METHODS:The Revi System was implanted in 151 female participants. The primary efficacy and safety end points were assessed at 6 and 12 months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety or they chose to exit the study. RESULTS:Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6, 12, and 24 months (response rates of 78%, 82%, and 79%, respectively). Participants who completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population. In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better." There were no serious adverse events related to the device or the procedure through 24 months. CONCLUSIONS:Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03596671.

Importance The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration ClinicalTrials.gov Identifier: NCT02676973

BACKGROUND:Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE:A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS:A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS:A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS:iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Importance Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement. Objectives The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling. Study Design Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (alpha = .05). Results The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups. Conclusions Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy.

Importance Currently available evidence for efficacy of postoperative antibiotics to prevent postoperative urinary tract infection (UTI) conflicts. Oral antibiotics rely on patient adherence and can cause unwanted systemic effects. Gentamicin is a broad-spectrum antibiotic with rapid bactericidal activity and, when administered intravesically, has no systemic absorption through intact urothelium. Objective We aimed to determine whether a single intravesical instillation of gentamicin at the conclusion of urogynecologic surgery would reduce the proportion of women treated for UTI within 6 weeks postoperatively compared with sham instillation. Study Design This was a multicenter, randomized (stratified by study site, route of prolapse repair ±suburethral sling, with balanced 1:1 randomization), participant-masked, sham-controlled, study. The primary outcome was the proportion of participants treated with antibiotics for UTI within 6 weeks postoperatively. An adjusted multivariable logistic regression model was constructed to determine predictors of postoperative UTI treatment. Results Three hundred seventy participants were randomized (gentamicin, 185; sham, 185), and data from 363 participants were analyzed (gentamicin, 183; sham, 180). Nineteen women in the gentamicin group and 20 women in the sham group were treated for UTI within 6 weeks postoperatively (10.4% vs 11.1%, P = 0.87). There were no adverse events related to the instillations. Increasing age (odds ratio, 1.028 [1.000–1.057]) and number of intraoperative transurethral instrumentations (odds ratio, 1.342 [1.080–1.668]) were independent predictors of postoperative UTI treatment. Conclusions In women undergoing urogynecologic surgery, postoperative intravesical gentamicin did not reduce the incidence of postoperative UTI. The number of intraoperative transurethral instrumentations is an important, potentially modifiable risk factor for postoperative UTI treatment.

(Abstracted from Female Pelvic Med Reconstr Surg 2022;28:20–26) Up to 50% of women will have at least 1 urinary tract infection (UTI) in their lifetime, and 2% to 5% will experience recurrent UTIs (rUTIs). Postmenopausal women are disproportionately affected by both UTI and rUTI.

Purpose: A novel leadless tibial nerve stimulator provides a primary battery-powered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, eCoin®, for treating refractory urgency urinary incontinence. Materials and Methods: This was a prospective, open-label, single arm trial carried out at 15 U.S. medical centers involving 137 subjects with refractory urgency urinary incontinence. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in urgency urinary incontinence episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point. Results: Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat population. Of those 132 subjects, 98% were female, mean±SD age was 63.9±10.9 years, and baseline daily urgency urinary incontinence episodes were 4.3±3.1. The primary efficacy analysis showed 68% (95% CI: 60%–76%) of subjects experienced at least a 50% reduction in urgency urinary incontinence episodes at 48 weeks post-activation; 16% of implanted subjects experienced device-related events through 52 weeks post-implantation. Conclusions: eCoin demonstrated clinical benefit for treating overactive bladder syndrome with automatic delivery of an intermittent low-duty cycle and implanted with a minimally invasive, brief procedure.

OBJECTIVES To evaluate whether progression to maintenance percutaneous tibial nerve stimulation (PTNS) was related to perceived global impression of improvement (PGII) rather than symptom-specific improvement in patient with overactive bladder (OAB). We hypothesize that PGII will predict continuation of PTNS long-term. METHODS This prospective observational study included 90 patients with OAB that initiated PTNS. The PGII and OAB short-form questionnaires (OABq-SF) were used to assess bladder symptom severity and improvement. Those that completed the 12-week induction phase were offered to continue PTNS monthly maintenance or pursue other options. The primary outcome was difference in PGII score between those pursuing maintenance therapy versus other options. Descriptive statistics and mixed effect modeling analysis were employed. RESULTS Seventy patients (78%) completed 12 weeks of PTNS. The majority of completers pursued monthly maintenance (P< .01) and had significantly lower median PGII scores compared with those who sought alternatives (P < .01), while OABq-SF scores did not differ significantly (P = .65). Patients that pursued monthly PTNS maintenance had lower body mass index than those who chose alternative therapies (P < .01). Only 19% continued PTNS therapy for at least 1 year. CONCLUSION More patients pursued PTNS monthly maintenance over any other therapy, and this was significantly associated with lower PGII scores. Global improvement, and not symptom-specific response, predicts long-term PTNS maintenance. No symptom-specific predictors were identified in those who pursued maintenance over other options. One-year continuation rates are low. (c) 2020 Elsevier Inc.

OBJECTIVES:We aimed to compare the efficacy of 2 commonly used contemporary vaginal estrogen administrations versus placebo for the prevention of urinary tract infection (UTI) in postmenopausal women with a clinical diagnosis of recurrent UTI (rUTI).METHODS:This was an investigator-initiated, multicenter, single-blind, randomized, placebo-controlled trial of vaginal estrogen (delivered via ring or cream) compared with placebo. Postmenopausal women with documented rUTI were randomized to receive either vaginal estrogen (via ring or cream) or placebo cream in a 1:1:1 fashion. The primary outcome was occurrence of UTI at 6 months. After 6 months, open-label use of ring or active cream was offered to all participants for an additional 6 months. Because of slower than expected recruitment, sample size calculations and block randomization schema were revised to combine estrogen groups (ring or cream) for statistical comparisons to placebo cream in a 1:1 fashion.RESULTS:Thirty-five women were randomized with 9 dropouts (1 ring, 2 cream, and 6 placebo) prior to the 6 months. Intention-to-treat analysis (assuming dropouts as failures) revealed fewer women treated with vaginal estrogen had a UTI within 6 months versus placebo (11/18 vs 16/17, respectively; P = 0.041). Per-protocol analysis revealed fewer subjects treated with vaginal estrogen had a UTI at 6 months (8/15 vs 10/11, respectively; P = 0.036).CONCLUSIONS:Commonly prescribed forms of vaginal estrogen with contemporary dosing schedules prevent UTIs in postmenopausal women with an active diagnosis of rUTI.

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (PD06)1 Sep 2021PD06-09 PATIENT EXPERIENCE WITH A LEADLESS TIBIAL NERVE STIMULATOR FOR URGENCY URINARY INCONTINENCE Alexandra Rogers, Rebecca McCrery, James Lukban, Scott MacDiarmid, Subhro Sen, James Lukban, Bilal Kaaki, Andrew Shapiro, Thomas Guidice, John Nguyen, Joseph Gauta, Scott Serels, Chris Threatt, Jed Kaminetsky, Vincent Lucente, Sonia Dutta, Peter Sand, and Kimberly Ferrante Alexandra RogersAlexandra Rogers More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , James LukbanJames Lukban More articles by this author , Scott MacDiarmidScott MacDiarmid More articles by this author , Subhro SenSubhro Sen More articles by this author , James LukbanJames Lukban More articles by this author , Bilal KaakiBilal Kaaki More articles by this author , Andrew ShapiroAndrew Shapiro More articles by this author , Thomas GuidiceThomas Guidice More articles by this author , John NguyenJohn Nguyen More articles by this author , Joseph GautaJoseph Gauta More articles by this author , Scott SerelsScott Serels More articles by this author , Chris ThreattChris Threatt More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Vincent LucenteVincent Lucente More articles by this author , Sonia DuttaSonia Dutta More articles by this author , Peter SandPeter Sand More articles by this author , and Kimberly FerranteKimberly Ferrante More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001974.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Third line therapies for refractory overactive bladder (OAB) undertreat patients with only 5% of patients progressing to these invasive and/or burdensome therapies (Du et al.).A novel leadless, fully-implantable tibial nerve stimulator has unique attributes compared to current OAB treatments including automated compliance, a brief procedure using only local anesthetic and reliance on minimal resources. Patient experience with this device (eCoin®) was evaluated after 48 weeks of therapy. METHODS: A prospective, multi-center, single-arm trial was conducted to evaluate the eCoin in treatment of refractory urgency urinary incontinence (UUI). The device is slightly larger than a United States nickel and is implanted subcutaneously in the medial lower leg during an office procedure under local anesthetic, and once activated delivers automated 30-minute therapy sessions every 3-4 days. After 48 weeks of therapy, subjects were queried in a survey about their satisfaction and experience with the device and procedure and their attitudes about the study device as it compares to other therapies. RESULTS: Of the 132 subjects in the intent-to-treat population, 98% were female, mean (SD) age was 63.9 (10.9), and mean (SD) baseline UUI daily episodes was 4.3 (3.1). The primary efficacy analysis showed 68% (95% CI: 60%, 76%) of subjects experienced at least a 50% reduction in UUI episodes at 48 weeks. Patient experience is in line with efficacy results. 89% indicated they would recommend eCoin to friends and family with overactive bladder, and 93% indicated the procedure was easy enough to go through every five years. When directly compared to other OAB treatments, patients chose eCoin over OAB medications (84%), percutaneous tibial nerve stimulation (80%), onabotulinumtoxinA (74%), and sacral neuromodulation (82%). See the figure for response proportions. CONCLUSIONS: The data shows this maintenance-free device with a brief and minimally invasive implantation is well tolerated by patients. Compared to sacral neuromodulation (SNM), in which a recent study on the human experience with SNM surgery demonstrated 50% of subjects post IPG placement would not recommend the surgery to friend/family, eCoin may more effectively penetrate as a third line therapy for refractory UUI (Cohen et. al). Source of Funding: Valencia Technologies © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e103-e103 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alexandra Rogers More articles by this author Rebecca McCrery More articles by this author James Lukban More articles by this author Scott MacDiarmid More articles by this author Subhro Sen More articles by this author James Lukban More articles by this author Bilal Kaaki More articles by this author Andrew Shapiro More articles by this author Thomas Guidice More articles by this author John Nguyen More articles by this author Joseph Gauta More articles by this author Scott Serels More articles by this author Chris Threatt More articles by this author Jed Kaminetsky More articles by this author Vincent Lucente More articles by this author Sonia Dutta More articles by this author Peter Sand More articles by this author Kimberly Ferrante More articles by this author Expand All Advertisement PDF downloadLoading ...

Background: We studied performance on a simulator among senior residents performing vaginal hysterectomy by using an Objective Skills Assessments Test-Simulated Vaginal Hysterectomy (OSAT-SVH). The aim of this study was to determine whether there are differences seen in peer (resident to resident) coaching compared with expert (faculty to resident) coaching. Methods: Participants were thirdand fourth-year OB/GYN residents at two academic institutions, who had performed fewer than five vaginal hysterectomies as primary surgeon. After orientation, participants performed vaginal hysterectomy on a trainer while being coached by either an expert or a peer. The peer coach was a third-year OBGYN resident and was trained by the expert coach before enrollment of the study participants in a separate 3-hour training session. Results: Participants were videotaped performing a second hysterectomy on the model without coaching. A blinded faculty reviewer rated the videotaped hysterectomy using OSAT-SVH. Mean Global Rating Scale (GRS) and procedure-specific checklist (PSC) scores were not statistically significant between the peer and expert groups: GRS 11.6 (SD, 4.5) versus 13.0 (SD, 5.5) (P = 0.59) and PSC 15.0 (SD, 4.4) versus 15.0 (SD, 5.1) (P = 1.0), respectively. Conclusion: This study may provide evidence that a trained resident surgical coach could be as effective as a faculty instructor when teaching the steps of vaginal hysterectomy using a task trainer. Further studies are needed to confirm this finding and to assess if the development of these skills transfers to clinical care.

Background: We studied performance on a simulator among senior residents performing vaginal hysterectomy by using an Objective Skills Assessments Test-Simulated Vaginal Hysterectomy (OSAT-SVH).The aim of this study was to determine whether there are differences seen in peer (resident to resident) coaching compared with expert (faculty to resident) coaching.Methods: Participants were third-and fourth-year OB/GYN residents at two academic institutions, who had performed fewer than five vaginal hysterectomies as primary surgeon.After orientation, participants performed vaginal hysterectomy on a trainer while being coached by either an expert or a peer.The peer coach was a third-year OBGYN resident and was trained by the expert coach before enrollment of the study participants in a separate 3-hour training session.Results: Participants were videotaped performing a second hysterectomy on the model without coaching.A blinded faculty reviewer rated the videotaped hysterectomy using OSAT-SVH.Mean Global Rating Scale (GRS) and procedure-specific checklist (PSC) scores were not statistically significant between the peer and expert groups: GRS 11.6 (SD, 4.5) versus 13.0 (SD, 5.5) (P = 0.59) and PSC 15.0 (SD, 4.4) versus 15.0 (SD, 5.1) (P = 1.0), respectively.Conclusion: This study may provide evidence that a trained resident surgical coach could be as effective as a faculty instructor when teaching the steps of vaginal hysterectomy using a task trainer.Further studies are needed to confirm this finding and to assess if the development of these skills transfers to clinical care.

INTRODUCTION AND OBJECTIVE: Existing options for refractory overactive bladder (OAB) treatment lack appeal to most patients given invasiveness or delivery of therapy, or require significant patient compliance and burden on the provider. A novel, subcutaneously implanted tibial neurostimulator (eCoin) has the potential to address such drawbacks while providing a significant clinical benefit. Presented are interim results from the eCoin-2 pivotal trial, a prospective, multi-center single-arm study evaluating the safety and efficacy of eCoin in treating urgency urinary incontinence (UUI) after 24 weeks. METHODS: At 15 U.S. sites, 133 subjects were implanted with eCoin in the medial lower leg during an office procedure under local anesthesia. We included men and women ages 18-80 with at least one daily UUI episode on a 3-day voiding diary. Subjects were washed off OAB medications prior to baseline. The leadless, primary battery-powered eCoin device is slightly larger than a U.S. nickel and delivers automated therapy every 3-4 days for 30 minutes. The primary efficacy variable is the proportion of subjects achieving ≥50% improvement in UUI episodes (responder rate) after 48 weeks of therapy. Secondary outcomes included 3-day voiding diary data and patient reported outcomes. Paired t-tests were used to compare continuous variables between baseline and 24 weeks with differences reported with 95% confidence intervals. RESULTS: At baseline in all subjects, average age (SD) was 64 (11), BMI was 30.4 (8.8), daily UUI episodes was 4.2 (3.1), and the OABq-SF symptom bother score was 65.7 (20.0). 98.5% of subjects were female. The average procedure time was 20.8 minutes. There was one related serious adverse event, a localized infection resolved by device explant. In 113 subjects available at 24 weeks, all measures showed statistically significant improvement: UUI leaks were reduced by -2.7 (p<0.001, 95%CI (-3.2,-2.1)) and the symptom bother score was improved by 32.6 (p<0.001, 95%CI (-37.6, -27.6)). The responder rate was 70.8%, and 77.8% of patients reported feeling at least better on the PGI-I. In patients with ≥10 daily voids at baseline (n=58), frequency improved by -1.9 (p<0.001, (-2.6, -1.1)) from 12.7 mean voids. CONCLUSIONS: The interim data demonstrates that eCoin is safe and effective in treating UUI, delivering meaningful symptom improvement with minimal invasiveness. The eCoin procedure also appears to have a short learning curve and is an easy to perform office-based procedure. Source of Funding: Research was funded by Valencia Technologies.