An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome

Overactive Bladder Clinical Trial

Official title:

Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131573
• Other study ID #: CR-B-002
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2005
• Last updated: October 25, 2013
• Start date: May 2004
• 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

The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2012
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion criteria:

• Age 18 years and above.

• Diagnosed with urinary urgency-frequency syndrome.

• 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 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 month period.

• Less than one year post partum and/or are breast-feeding.

• Have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement).

• 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 pelvic pain in the absence of voiding dysfunction.

• 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.

• Cannot independently comprehend and complete the 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

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• bion
battery powered bion microstimulator

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Dallas Center for Pelvic Medicine	Dallas	Texas
United States	Milestone Medical Research	Englewood	Colorado
United States	New York University	New York	New York
United States	Overland Park Regional Medical Center	Overland Park	Kansas
United States	The Pelvic and Sexual Health Institute	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	Tucson	Arizona
United States	Walter Reed Army Medical Center	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	Average Number of Voids Per Day		12 months	No
Primary	Freedom From Major Complications		5 years	Yes