Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Boston Scientific Corporation11 sites in 1 country148 target enrollmentJune 2003

ConditionsUrinary Incontinence

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Boston Scientific Corporation
Enrollment: 148
Locations: 11
Primary Endpoint: Number of Leaks Per Day
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.