An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
NCT ID: NCT00080470
Last Updated: 2013-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2003-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
bion
battery powered microstimulator
2
No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
bion
battery powered microstimulator
Interventions
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bion
battery powered microstimulator
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Tamara Baynham, PhD
Role: STUDY_DIRECTOR
Boston Scientific, Neuromodulation
Locations
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Arizona Health Sciences Center (University of Arizona)
Tucson, Arizona, United States
The Department of Urology, Stanford University Medical Center
Stanford, California, United States
Milestone Medical Research
Englewood, Colorado, United States
Bladder Control Center of Norwalk
Norwalk, Connecticut, United States
Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery
Washington D.C., District of Columbia, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Cornerstone Medical Specialty Center
Woodbury, Minnesota, United States
The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)
Philadelphia, Pennsylvania, United States
Dallas Center for Pelvic Medicine
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Sound Urological Associates
Edmonds, Washington, United States
Countries
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Other Identifiers
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CR-B-001
Identifier Type: -
Identifier Source: org_study_id