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

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.
 
ClinicalTrials.gov Identifier: NCT00080470
Recruitment Status : Completed
First Posted : April 5, 2004
Results First Posted : October 10, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: bion Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Study Start Date : June 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2012

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Arms and Interventions
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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


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

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

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00080470


Locations
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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
Dallas Center for Pelvic Medicine
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Sound Urological Associates
Edmonds, Washington, United States, 98026
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Tamara Baynham, PhD Boston Scientific, Neuromodulation
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00080470    
Other Study ID Numbers: CR-B-001
First Posted: April 5, 2004    Key Record Dates
Results First Posted: October 10, 2013
Last Update Posted: November 19, 2013
Last Verified: October 2013
Keywords provided by Boston Scientific Corporation:
Incontinence
Refractory
Urinary
Urge
 Stimulation
Nerve
Microstimulator
Neuromodulation
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations