An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
October 25, 2013 updated by: Boston Scientific Corporation
Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome
The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.
Study Overview
Study Type
Interventional
Enrollment (Actual)
118
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
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Arizona
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Tucson, Arizona, United States, 85724-5077
- Arizona Health Sciences Center
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California
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Stanford, California, United States, 94305-5118
- The Department of Urology, Stanford University Medical Center
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Colorado
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Englewood, Colorado, United States, 80112
- Milestone Medical Research
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District of Columbia
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Washington, District of Columbia, United States, 20307-5001
- Walter Reed Army Medical Center
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Kansas
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Overland Park, Kansas, United States, 66214
- Overland Park Regional Medical Center
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Minnesota
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Woodbury, Minnesota, United States, 55125
- Cornerstone Medical Specialty Center
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New York
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New York, New York, United States, 10016
- New York University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- The Pelvic and Sexual Health Institute
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Texas
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Dallas, Texas, United States, 75231
- Dallas Center for Pelvic Medicine
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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:
- Age 18 years and above.
- 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.
Key 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 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.
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.
|
battery powered bion microstimulator
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Sham Comparator: 2
No stimulation until 45 days post-implant.
Stimulation On from 45 days post-implant and on.
|
battery powered bion microstimulator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Average Number of Voids Per Day
Time Frame: 12 months
|
12 months
|
|
Freedom From Major Complications
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2004
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 17, 2005
First Submitted That Met QC Criteria
August 17, 2005
First Posted (Estimate)
August 19, 2005
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-002
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.