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NCT00928395 · ClinicalTrials.gov registry record · Phase 4
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
A Phase 4 study of Urinary Bladder, Overactive, sponsored by Uroplasty.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 12
- Study locations
NCT00928395: Completed Phase 4 study of Urinary Bladder, Overactive, sponsored by Uroplasty.
NCT00928395 is a Phase 4 study of Urinary Bladder, Overactive that has completed, run by Uroplasty. The registered enrollment target is 50 participants, below the 359-participant average among 9 other Urinary Bladder, Overactive trials with a reported enrollment target (86% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928395, a Phase 4 study of Urinary Bladder, Overactive, has completed, sponsored by Uroplasty.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
Primary Outcome
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
Conditions Studied
Interventions
- DEVICE Urgent PC
Study Locations (12)
Michigan
- Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan - Grand Rapids
- Mercy Health Partners at the Lakes - Muskegon
- Beaumont Hospital - Royal Oak
New York
- Capital Region Urological Surgeons, PLLC - Albany
- Central Missouri Women's Healthcare, LLC - White Plains
California
- Gregory L. Davis, M.D., FACOG, Inc. - Chico
Connecticut
- Greenwich Urological Associates, P.C. - Greenwich
Florida
- Specialists in Urology - Naples
Nebraska
- Urology Health Center, PC - Fremont
North Carolina
- Alliance Urology Specialists - Greensboro
Virginia
- Virginia Urology - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT00928395 record still lists
NCT00928395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 359-participant average among 9 other Urinary Bladder, Overactive trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Urinary Bladder, Overactive appearing as the primary indexed condition, and to 1 intervention - of which Urgent PC is the first listed.
NCT00928395 lists 12 locations in 9 states (Michigan, New York, California).
Frequently Asked Questions
What is clinical trial NCT00928395 about?
NCT00928395 is a clinical study titled "Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms". This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the ...
What is the current status of trial NCT00928395?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2009-01. Estimated completion is 2012-12.
What conditions does trial NCT00928395 study?
This clinical trial studies the following conditions: Urinary Bladder, Overactive.
What interventions are being tested in trial NCT00928395?
The interventions under investigation include: Urgent PC (DEVICE).
Who is sponsoring clinical trial NCT00928395?
This trial is sponsored by Uroplasty, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00928395 being conducted?
This trial has 12 study locations across California, Connecticut, Florida, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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