INTRODUCTION:The health of the pelvic floor depends on the integrity of its muscles, connective tissue, ligaments, and their innervation. The female pelvic floor may be more vulnerable to repetitive heavy loads in a military environment than the male pelvic floor because of anatomical and physiological differences. The study aim was to identify and explore possible differences in the female pelvic floor conditions between active military and civilian women with similar demographics.To identify and explore possible differences in the conditions of the female pelvic floor between active military women and civilian women with similar demographics. MATERIALS AND METHODS:Military active and civilian women aged 18-39 years, with no history of pelvic floor surgery and not currently undergoing treatment for pelvic floor dysfunction, were invited to participate in the study under the appropriate regulatory approvals. The following data were acquired for enrolled subjects: age, weight, height, parity, and level of physical exercise. Additionally, urogynecological complaints (prolapse, incontinence, pelvic pain, vaginal tissue atrophy), the subjective questionnaire for the Pelvic Floor Distress Inventory-20, 52 biomechanical parameters with the Vaginal Tactile Imager (VTI), and the Biomechanical Integrity score (BI-score) with its five components were collected to objectively quantify tissue elasticity, pelvic support, and functions. RESULTS:Seventy-three women were enrolled in a civilian group and 100 in a military group. Both groups had similar demographic data. The physical load in the civilian group was significantly lower than in the military group, which included high-intensity training, boot camp, powerlifting, CrossFit, and others. At least one urogynecological disorder was found in 17.8% of the women in the civilian group and 42.0% of the women in the military group. Among them, pelvic organ prolapse was found in 4.1% versus 37.0%; incontinence in 13.7% versus 20.0%; and pelvic pain in 4.1% versus 5.0%. The average pelvic index was 24.7 in the civilian group and 50.0 in the military group (P = 9.3 × 10-5). Further, 23 of 52 biomechanical parameters demonstrated a statistically significant difference (P < .05) between the groups. Among these 23 parameters, 10 VTI parameters showed negative changes for vaginal tissue elasticity, nine parameters showed negative changes in pelvic support strength, and four parameters showed positive changes in pelvic functions in the military versus civilian group (muscle contractive strength and mobility). In terms of the BI-score components (measured in units of standard deviation from normal conditions), the values were 0.28 and -0.42 for tissue elasticity (P = 1.1 × 10-6), 0.19 and -0.41 for pelvic support (P = 3.0 × 10-6), -0.20 and -0.21 for pelvic muscle contraction (P = .42), 0.05 and -0.15 for muscle relaxation (P = .25), and -0.19 and 0.14 for muscle mobility (P = .013). The BI-score was worse in the military group, with an average value of -0.38, compared to the civilian group, which had an average value of 0.03 (P = .015). CONCLUSIONS:Collected data suggest a negative association between high-intensity physical training, common in the military, and urogynecological health, compared to that of the civilian cohort with the same demographic. Biomechanical markers have been identified that can objectively detect deterioration of the pelvic floor compared to normal conditions. Women's health in the military requires significant attention and advanced quantitative diagnostic techniques.
OnabotulinumtoxinA is an FDA-approved treatment for adults with overactive bladder (OAB) who have an inadequate response to, or are intolerant of, oral pharmacotherapies including anticholinergics or beta-3 agonists. However, procedural practices of onabotulinumtoxinA intradetrusor injection vary among practitioners and can affect patient experience. To address this, a panel of six high-volume intravesical onabotulinumtoxinA providers with 100 years of combined experience convened to discuss the best office practices when treating patients with OAB. These key best practices include counseling patients on available OAB therapies, including onabotulinumtoxinA, at the initial consultation in accordance with established AUA and SUFU guidelines in a way that is easily understood. An office setting is preferred over a hospital or surgery center when performing the procedure. Staff involvement, from scheduling to post-procedure, is essential for establishing the relationships necessary to optimize patient experience and encourage compliance and retreatment. Experts generally recommend using a viscous lidocaine bladder instillation for an anesthetic 15 min prior to the reconstitution of onabotulinumtoxinA with 5 to 10 mL of normal saline. A range of one to 20 injection sites is acceptable, with a smaller number preferred. Starting in the lower bladder, experts recommend using a slower speed of injection to improve distribution and decrease patient discomfort. Subsequent treatments should be regularly scheduled at six-month intervals with the option of re-treating earlier if symptoms return, but no sooner than 12 weeks. For office intravesical onabotulinumtoxinA procedures, optimization of the patient experience by the physician and their staff, starting with the initial visit through the post-treatment follow-up, is key to long-term patient compliance.
Introduction Urgency urinary incontinence (UUI), an important subset of overactive bladder (OAB), manifests with symptoms such as urgency, frequency, and incontinence, severely impacting quality of life. Neuromodulation therapies, including sacral nerve stimulation (SNM), percutaneous tibial nerve stimulation (PTNS), and implanted tibial nerve stimulation (ITNS), are FDA-approved for treating UUI. Traditional neuromodulation involves sensory and motor response evoking amplitudes, but emerging evidence suggests that sensory and sub-sensory settings might enhance treatment outcomes by influencing brain activation. Aim This study investigates the efficacy of sensory and sub-sensory programming of the eCoin® ITNS (Valencia Technologies Corporation, Valencia, California, USA) in reducing UUI episodes. The eCoin ITNS is a fully implantable device providing low-duty cycle tibial nerve stimulation. Methods The ESSENCE (Effectiveness of Sensory and Sub-sensory Stimulation Amplitudes Using eCoin Implantable Tibial Nerve Stimulation in Reducing Urgency Urinary Incontinence Episodes) study was conducted as a double-blind, randomized, controlled trial, and 36 subjects with UUI across five U.S. centers were enrolled, aiming to evaluate changes in UUI episodes and quality of life over three months. Participants were randomized to sensory or sub-sensory stimulation groups, with the sensory group activated to the amplitude at which stimulation was first felt and the sub-sensory group set 25% below this threshold. UUI episodes were recorded using three-day voiding diaries, and quality of life was assessed via the Overactive Bladder Symptom Quality of Life Questionnaire (OABq) to assess the primary endpoint of reduction from baseline in the number of UUI episodes per day on the three-day voiding diary. Results Results demonstrated a mean reduction in UUI episodes of 2.1 per day for the sensory group and 2.73 per day for the sub-sensory group from a pooled baseline of 5.53. Both groups reported improvements in health-related quality of life (HRQL) and patient satisfaction. These findings align with previous studies on SNM, demonstrating both sub-sensory and sensory settings are effective, potentially enhancing patient comfort and device longevity. Conclusion The ESSENCE study indicates that both sensory and sub-sensory amplitude settings of eCoin ITNS show a reduction in UUI episodes, improve quality of life, and increase patient satisfaction, offering the potential for optimizing neuromodulation therapies.
elvic organ prolapse (POP) is a common condition that significantly impairs a woman's quality of life. Currently a range of interventions from non-surgical to surgical options exist, all with their unique advantages and disadvantages. Among these, the EnPlace system stands out as a truly minimally invasive transvaginal percutaneous device designed to repair apical POP by bilaterally anchoring sutures to the sacrospinous ligaments. Readers will familiarize themselves with the EnPlace, relevant historical studies, and the technique for EnPlace transvaginal percutaneous sacrospinous ligament fixation for hysteropexy or colposuspension
This study is aimed at developing and validating a new integral parameter, the Biomechanical Integrity score (BI-score) of the female pelvic floor for stress urinary incontinence conditions. A total of 130 subjects were included in the observational cohort study; 70 subjects had normal pelvic floor conditions, and 60 subjects had stress urinary incontinence (SUI). A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t test, correlation) to identify the VTI parameters sensitive to the pelvic SUI conditions. Twenty-seven parameters were identified as statistically sensitive to SUI development. They were subdivided into five groups to characterize tissue elasticity (group 1), pelvic support (group 2), pelvic muscle contraction (group 3), involuntary muscle relaxation (group 4), and pelvic muscle mobility (group 5). Every parameter was transformed to its standard deviation units using the dataset for normal pelvic conditions, similar to the T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups 1–5 and to the BI-score in standard deviation units. The p value for the BI-score has p = 4.0 × 10–28 for SUI versus normal conditions. Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the SUI BI-score in future research and clinical applications.
OBJECTIVE:To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). The 1-year pivotal study was extended through 2 years. The ITNS is a novel and recently FDA-approved therapy. METHODS:A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory UUI to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the OAB questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of UUI episodes. The primary safety measure was device-related adverse events (AEs). RESULTS:Seventy-two subjects completed the 96-week evaluation. Around 78% (95% CI: 67%-87%) experienced at least 50% reduction in UUI episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their UUI episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. Around 91.3% did not require additional medications for OAB. No serious or unanticipated AEs were reported in this extension phase. CONCLUSION:The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating OAB patients with UUI. The findings support it as an excellent treatment option for refractory patients.
Study Objective: To compare the economic difference in terms of overall costs between two Ambulatory Surgical Unit (ASU) settings in which a midurethral single incision sling (MSIS) can be performed. Design: A retrospective cohort study was carried out, examining the implanting of an MSIS performed at two different ASU settings by a single surgeon. Total cost was determined by assessing differences in charges and subsequent reimbursement associated with the procedure at each ASU setting. Time was measured using an EMR system for tracking both patient entry/exit from the facility as well as intraoperative time. Adverse events commonly associated with the procedure and patient-reported unanticipated adverse events were collected. A validated Surgical Satisfaction Questionnaire was adminis-tered postoperatively.Setting: University Health Network Teaching Hospital.Patients: A total of 125 women with stress urinary incontinence. Intervention: MSIS.Measurement and Main Results: Between January 2016 until August 2020, 125 women underwent an MSIS procedure. The total office-based ASU (O-ASU) charges averaged $4564.00 (reimbursement of $2642.07). The total hospital-based ASU (H-ASU) charges averaged $40 136 (reimbursement of $9000), as well as an anesthesia average charge of $800 (reim-bursement of $500). The average O-ASU total patient encounter time was 53.76 minutes versus 344.702 minutes for the H-ASU. There was no difference between commonly associated or unanticipated adverse events nor global patient satisfaction. Conclusions: Based on overall cost, total encounter time, and global patient satisfaction, a certified O-ASU is an optimal site of care for MSIS for surgical management of female stress urinary incontinence. Journal of Minimally Invasive Gyne-cology (2023) 30, 665-671.& COPY; 2023 Published by Elsevier Inc. on behalf of AAGL.
Objective The objective of this study is to evaluate factors associated with obstetric anal sphincter injury and identify modifiable risks. Methods A retrospective case-control study was performed in women who gave birth at our institution between May 2008 and December 2012. Patients who had a third- or fourth-degree lacerations were compared with those who did not. Parity, stretch marks, age, body mass index, tobacco use, fetal weight, operative delivery, labor, and second stage duration were compared between groups. Multivariate direct logistic regression was conducted on all patients who had complete data to calculate the adjusted odds ratio. Results We identified 299 patients with third- or fourth-degree lacerations and 8,459 patients without third- or fourth-degree lacerations during the time frame. Duration of second stage between 1 hour and 2 hours (P < 0.0001), duration of second stage greater than 2 hours (P < 0.0001), midline or unknown type episiotomy (P < 0.0001), mediolateral episiotomy (P < 0.0001), vacuum delivery (P < 0.0001), forceps delivery (P < 0.0001), fetal weight greater than 4,000 g (P < 0.0001), and antepartum stress urinary incontinence (P < 0.006) were associated with a significant increase in high-risk lacerations. This study did not find a statistically significant association between parity and these lacerations. Conclusions We, as others, found that episiotomy and operative delivery were modifiable risks of obstetrical care. Furthermore, even a short second stage of labor (1-2 hours) was associated with significant risk of injury.
The aim of this study is to develop and validate a new integral parameter, the Biomechanical Integrity score (BI-score), for the characterization of the female pelvic floor. A total of 253 subjects with normal and pelvic organ prolapse (POP) conditions were included in the multi-site observational, case-control study; 125 subjects had normal pelvic floor conditions, and 128 subjects had POP stage II or higher. A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t-test, correlation) to identify the VTI parameters sensitive to the pelvic conditions. Twenty-six parameters were identified as statistically sensitive to POP development. They were subdivided into five groups to characterize (1) tissue elasticity, (2) pelvic support, (3) pelvic muscle contraction, (4) involuntary muscle relaxation, and (5) pelvic muscle mobility. Every parameter was transformed to its standard deviation units against the patient age similar to T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups (1)–(5) and the BI-score in standard deviation units. The p-value for the BI-score has p = 4.3 × 10−31 for POP versus normal conditions. A reference BI-score curve against age for normal pelvic floor conditions was defined. Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the BI-score in future research and practical applications.
Objective The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. Methods This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. Results Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%–90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%–95%) of participants were considered responders with 36% (95% CI, 20%–57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. Conclusions The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.
PURPOSE:To compare the safety and durability of a single intravesical trigonal-only versus 20 trigone-sparing injections of OnabotulinumtoxinA (BTA) for refractory OAB. METHODS:A chart review of all idiopathic OAB patients treated with BTA from January 2016 to December 2018 was performed. Outcomes measures included: inter-injection interval, post-void residual (PVR), urinary tract infections (UTI), urinary retention requiring catheterization, and procedure time (min). Statistical analyses were performed using independent sample t-tests. RESULTS:Baseline characteristics were comparable for the two groups, data on 69 treatments (19 patients trigone-only) were compared to 105 treatments (26 patients trigone-sparing). There were no differences in the inter-injection intervals or rates of UTI. The trigone-only group exhibited a lower mean PVR (113 ml vs 160 ml, p < 0.02), lower proportion with PVR > 150 ml (23% vs. 39%, p < 0.03), lower rate of urinary retention (5.3% vs. 17.4%, p < 0.02), and shorter procedure time (4.3 min vs. 5.7 min, p < 0.01). There were no cases of vesico-ureteral reflux. CONCLUSION:While interpretation remains speculative, the results of this observational study suggest that a single trigone-only injection appears to be as safe and durable as multiple trigone-sparing injections but maybe quicker to perform and appears to have a lower impact on voiding function. Larger series and adequately powered prospective randomized clinical trials are warranted to validate the findings of this pilot study.
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 ...
OBJECTIVES To evaluate the safety and efficacy of the eCoin a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS Responders were defined as those who had a >= 50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns
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.