Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Public ClinicalTrials.gov record NCT00928395. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00928395
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2008
- Primary completion
- Aug 31, 2012
- Completion
- Nov 30, 2012
- Last update posted
- May 15, 2013
2009 – 2012
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gregory L. Davis, M.D., FACOG, Inc. | Chico | California | 95928 | — |
| Greenwich Urological Associates, P.C. | Greenwich | Connecticut | 06830 | — |
| Specialists in Urology | Naples | Florida | 34102 | — |
| Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan | Grand Rapids | Michigan | 49503 | — |
| Mercy Health Partners at the Lakes | Muskegon | Michigan | 49444 | — |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Urology Health Center, PC | Fremont | Nebraska | 68025 | — |
| Capital Region Urological Surgeons, PLLC | Albany | New York | 12208 | — |
| Central Missouri Women's Healthcare, LLC | White Plains | New York | 10604 | — |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
| Athena Urology | Issaquah | Washington | 98027 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00928395, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 15, 2013 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00928395 live on ClinicalTrials.gov.