An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00080470

Purpose

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.

The device, weighing less than 0.03 ounces and measuring 1.0" x 0.1", stimulates a nerve located in the pelvic region, called the pudendal nerve. It is hoped that stimulation of this nerve can reduce urge and unwanted urination.

Condition	Intervention	Phase
Urinary Incontinence	Device: bion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

At least 50% reduction in the average number of leaks per day from baseline to 12 months post initiation of stimulation on [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Freedom from major complications [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvement in quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	148
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2012
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stimulation On from Inital Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	Device: bion battery powered microstimulator
2: Sham Comparator No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.	Device: bion battery powered microstimulator

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080470

Locations

United States, Arizona
Arizona Health Sciences Center (University of Arizona)
Tucson, Arizona, United States, 85724
United States, California
The Department of Urology, Stanford University Medical Center
Stanford, California, United States, 94305-5118
United States, Colorado
Milestone Medical Research
Englewood, Colorado, United States, 80112
United States, Connecticut
Bladder Control Center of Norwalk
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery
Washington, District of Columbia, United States, 20307-5001
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Cornerstone Medical Specialty Center
Woodbury, Minnesota, United States, 55125
United States, Pennsylvania
The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Dallas Center for Pelvic Medicine
Dallas, Texas, United States, 75231
United States, Washington
Sound Urological Associates
Edmonds, Washington, United States, 98026

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Ken Peters, MD

William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation ( Eureka Moline, Clinical Regulatory Associate )
Study ID Numbers:	CR-B-001
Study First Received:	April 1, 2004
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00080470 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Incontinence
Refractory
Urinary
Urge

Stimulation
Nerve
Microstimulator
Neuromodulation

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urologic Diseases

Urination Disorders
Urinary Incontinence
Urinary Incontinence, Urge

ClinicalTrials.gov processed this record on September 10, 2009