NCT00080470CompletedPhase 3
Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Boston Scientific Corporation22 sites in 1 country148 target enrollmentStarted: June 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 148
- Locations
- 22
- Primary Endpoint
- Number of Leaks Per Day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Number of Leaks Per Day
Time Frame: 12 months
Freedom From Major Complications
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (22)
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