Status:
COMPLETED
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00080470
Start Date
June 1 2003
End Date
December 1 2012
Last Update
November 19 2013
Active Locations (11)
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1
Arizona Health Sciences Center (University of Arizona)
Tucson, Arizona, United States, 85724
2
The Department of Urology, Stanford University Medical Center
Stanford, California, United States, 94305-5118
3
Milestone Medical Research
Englewood, Colorado, United States, 80112
4
Bladder Control Center of Norwalk
Norwalk, Connecticut, United States, 06850