An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080470
• Other study ID #: CR-B-001
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2004
• Last updated: October 25, 2013
• Start date: June 2003
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2012
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• bion
battery powered microstimulator

Locations

Country	Name	City	State
United States	Dallas Center for Pelvic Medicine	Dallas	Texas
United States	Sound Urological Associates	Edmonds	Washington
United States	Milestone Medical Research	Englewood	Colorado
United States	Baylor College of Medicine	Houston	Texas
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	William Beaumont Hospital	Royal Oak	Michigan
United States	The Department of Urology, Stanford University Medical Center	Stanford	California
United States	Arizona Health Sciences Center (University of Arizona)	Tucson	Arizona
United States	Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery	Washington	District of Columbia
United States	Cornerstone Medical Specialty Center	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Leaks Per Day		12 months	No
Primary	Freedom From Major Complications		5 years	Yes