An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
This study is ongoing, but not recruiting participants.
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00080470
First received: April 1, 2004
Last updated: March 2, 2012
Last verified: March 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence |
Device: bion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence |
Resource links provided by NLM:
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: | May 2012 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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 | |
| 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
| Principal Investigator: | Ken Peters, MD | William Beaumont Hospitals |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00080470 History of Changes |
| Other Study ID Numbers: | CR-B-001 |
| Study First Received: | April 1, 2004 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Scientific Corporation:
|
Incontinence Refractory Urinary Urge |
Stimulation Nerve Microstimulator Neuromodulation |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Urge Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013