An Implantable Microstimulator for the Treatment of Urinary Urgency-Frequency Syndrome - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00131573

Purpose

The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome. This device, which weighs less than 0.03 ounces and measures 1" x 0.1", is implanted into the pelvis to stimulate the pudendal nerve. Stimulation of this nerve is intended to reduce urinary urge and unwanted urination.

Condition	Intervention	Phase
Overactive Bladder	Device: bion	Phase III

U.S. FDA Resources

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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

At least a 50% reduction in the number of excess voids per day [ 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:	118
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2012
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stimulation On from Initial 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 bion 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 bion 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 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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131573

Locations

United States, Arizona
Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5077
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, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Kansas
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66214
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, New York
New York University
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
The Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Dallas Center for Pelvic Medicine
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Ken Peters, MD

William Beaumont Hospitals

More Information

Responsible Party:	Boston Scientific Corporation ( Eureka Moline, Clinical Regulatory Associate )
Study ID Numbers:	CR-B-002
Study First Received:	August 17, 2005
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00131573
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Urgency-Frequency
Syndrome
Urinary
Refractory
Stimulation
Nerve

Neuromodulation
Microstimulator
bion
Pudendal
Overactive bladder

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009