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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131573
Recruitment Status : Completed
First Posted : August 19, 2005
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: bion Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome
Study Start Date : May 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: 1
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

Sham Comparator: 2
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Device: bion
battery powered bion microstimulator

Primary Outcome Measures :
  1. Average Number of Voids Per Day [ Time Frame: 12 months ]
  2. Freedom From Major Complications [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00131573

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
Study Director: Tamara Baynham, PhD Boston Scientific, Neuromodulation

Responsible Party: Boston Scientific Corporation Identifier: NCT00131573     History of Changes
Other Study ID Numbers: CR-B-002
First Posted: August 19, 2005    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013
Last Verified: October 2013

Keywords provided by Boston Scientific Corporation:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms