An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
NCT ID: NCT00131573
Last Updated: 2013-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2004-05-31
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 bion microstimulator
2
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
bion
battery powered bion microstimulator
Interventions
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bion
battery powered bion microstimulator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
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
Tucson, Arizona, United States
The Department of Urology, Stanford University Medical Center
Stanford, California, United States
Milestone Medical Research
Englewood, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Cornerstone Medical Specialty Center
Woodbury, Minnesota, United States
New York University
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, United States
Dallas Center for Pelvic Medicine
Dallas, Texas, United States
Countries
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Other Identifiers
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CR-B-002
Identifier Type: -
Identifier Source: org_study_id