An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
- Conditions
- Urinary Incontinence
- Interventions
- Device: bion
- Registration Number
- NCT00080470
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- Age 18 years and above.
- Diagnosed with urinary urge incontinence.
- Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
- Have normal upper urinary tract function.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
Key
- Have any active implantable device regardless of whether stimulation status is ON or OFF.
- Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
- Less than one year post partum and/or are breast-feeding.
- Have any passive implant that contains metal or electrically conductive materials.
- Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
- Have conditions requiring diathermy procedures.
- Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
- Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
- Have history of coagulopathy or bleeding disorder.
- Have a history of pelvic pain as primary diagnosis.
- Have anatomical restrictions such that the study device placement is not possible.
- Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
- Have a life expectancy of less than 1 year.
- Cannot independently comprehend and complete the QoL questionnaires.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 bion No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on. 1 bion Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
- Primary Outcome Measures
Name Time Method Number of Leaks Per Day 12 months Freedom From Major Complications 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Arizona Health Sciences Center (University of Arizona)
🇺🇸Tucson, Arizona, United States
Bladder Control Center of Norwalk
🇺🇸Norwalk, Connecticut, United States
The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Sound Urological Associates
🇺🇸Edmonds, Washington, United States
The Department of Urology, Stanford University Medical Center
🇺🇸Stanford, California, United States
Cornerstone Medical Specialty Center
🇺🇸Woodbury, Minnesota, United States
Milestone Medical Research
🇺🇸Englewood, Colorado, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery
🇺🇸Washington, District of Columbia, United States
Dallas Center for Pelvic Medicine
🇺🇸Dallas, Texas, United States