SUFU 2020: Interim Pivotal Study Effectiveness Data of a Coin-Sized Tibial Nerve Stimulator for Urgency Urinary Incontinence

Scottsdale, Arizona ( In this study, an eCoin 2 trial, Dr. Alexandra Rogers aimed in a single arm to evaluate the safety and efficacy of the study device for treating urinary urgency incontinence (UUI) after 12 weeks. Percutaneous tibial nerve stimulation is approved to treat overactive bladder syndrome. Therapy drawbacks include high burden to both patient and provider due to frequent office visits which limit long-term maintenance.

The eCoin-2 trial is a pivotal prospective, single-arm study evaluating the safety and efficacy of the study device for treating UUI. The primary efficacy variable is the proportion of subjects achieving >50% improvement in UUI episodes on a 3-day voiding diary. Secondary outcomes include 3-day voiding diary data.

This trail had included men and women ages 18-80 having at least one daily UUI episode on a 3-day voiding diary with intolerance or inadequate response to second or third-line therapy. Subjects previously treated with sacral nerve stimulation were ineligible. Transcutaneous nerve stimulation (TENS) was performed daily for 1 week prior to implantation.

The leadless, primary battery-powered eCoin device is slightly larger than a United States nickel and is implanted subcutaneously in the medial lower leg during an office procedure under local anesthesia. The eCoin delivers automated therapy every 3-4 days. Paired t-tests were used to compare continuous variables between baseline and 12 weeks with differences reported with 95% confidence intervals.

There were 117 subjects,116 are female with a mean age of 64.1(+10.7). At 12 weeks post-activation,84 subjects (72%) achieved at least 50% reduction in UUI episodes. At baseline, subjects had a mean of 13.1 (+9.4) UUI leaks and 31.2 (+9.7) voids on a 3-day voiding diary. At 12 weeks post activation, subjects improved significantly on all measures: UUI leaks were reduced by 8.5 (+8.5) (p<0.001,95%CI (6.9,10.0)) and voids/day reduced by 3.6 (+7.0) (p<0.001,95%CI (2.3,4.9)). In the full cohort and TENS responder cohort (n=73),29% and 40% were dry respectively. There was one related serious adverse event, an infection resolved by device explant.

At the end they concluded that the interim data show eCoin was safe and effective in treating UUI. The authors anticipated reporting on medium-term outcomes as the study progresses, shedding further light on the promise of tibial nerve stimulation.

Presented by: Alexandra Rogers, MD, Urologist, Sansum Clinic, Santa Barbara, California
Co-authors: Rebecca McCrery, MD2, Scott MacDiarmid, MD3, Subhro Sen, MD4, James Lukban, DO5, Bilal Kaaki, MD6, Andrew Shapiro, MD7,Thomas Giudice, MD8, John Nguyen, MD9, Joseph Gauta, MD10, Scott Serels, MD11, Chris Threatt, MD12, Jed Kaminetsky, MD13, Vincent Lucente, MD14, Sonia Dutta, MD15,Peter Sand, MD15, Kimberly Ferrante, MD16
2. Adult/Pediatric Urology & Urogynecology,Alliance Urology,Stanford University Medical School,Colorado Pelvic Floor Consultants,Allen Memorial Hospital,Chesapeake Urology,South Carolina Ob/Gyn,SCPMG,10 Florida Bladder Institute,11 Urology Associates of Norwalk,12 Sequoia Urology Center,13 Manhattan Medical Research,14 The Institute for Female Pelvic Medicine,15 Evanston Continence Center,NorthShore University HealthSystem,16Kaiser Permanente San Diego

Written by: Bilal Farhan, MD, Assistant Professor, Division of Urology, University of Texas, Medical Branch, Texas; @BilalfarhanMD, at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2020, February 25 - February 29, 2020, Scottsdale, Arizona