Clinical trial NCT00080470: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Official title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Keywords: Incontinence
Refractory
Urinary
Urge
Stimulation
Nerve
Microstimulator
Neuromodulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2004-04-05
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Age 18 years and above.
2. Diagnosed with urinary urge incontinence.
3. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
4. Have normal upper urinary tract function.
5. Be capable of giving informed consent.
6. Be capable and willing to follow all study related procedures.

Key Exclusion Criteria:

1. Have any active implantable device regardless of whether stimulation status is ON or OFF.
2. Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
3. Less than one year post partum and/or are breast-feeding.
4. Have any passive implant that contains metal or electrically conductive materials.
5. Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
6. Have conditions requiring diathermy procedures.
7. Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
8. Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
9. Have history of coagulopathy or bleeding disorder.
10. Have a history of pelvic pain as primary diagnosis.
11. Have anatomical restrictions such that the study device placement is not possible.
12. Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
13. Have a life expectancy of less than 1 year.
14. Cannot independently comprehend and complete the QoL questionnaires.

Primary outcomes:
measure: Number of Leaks Per Day
timeFrame: 12 months
measure: Freedom From Major Complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Health Sciences Center (University of Arizona)
state: Arizona
city: Stanford
country: United States
facility: The Department of Urology, Stanford University Medical Center
state: California
city: Englewood
country: United States
facility: Milestone Medical Research
state: Colorado
city: Norwalk
country: United States
facility: Bladder Control Center of Norwalk
state: Connecticut
city: Washington
country: United States
facility: Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery
state: District of Columbia
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Woodbury
country: United States
facility: Cornerstone Medical Specialty Center
state: Minnesota
city: Philadelphia
country: United States
facility: The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Center for Pelvic Medicine
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Edmonds
country: United States
facility: Sound Urological Associates
state: Washington
Study officials:
affiliation: Boston Scientific, Neuromodulation
name: Tamara Baynham, PhD
role: STUDY_DIRECTOR
References: