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

October 25, 2013 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom From Major Complications
Time Frame: 5 years
5 years
Number of Leaks Per Day
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Tamara Baynham, PhD, Boston Scientific, Neuromodulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 1, 2004

First Submitted That Met QC Criteria

April 2, 2004

First Posted (Estimate)

April 5, 2004

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-B-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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