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Completed Phase 4 Interventional Results available

Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

ClinicalTrials.gov ID: NCT00928395

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.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 3:42 PM EDT

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
Lead sponsor
Uroplasty, Inc
Industry
Enrollment
50 participants

Conditions and interventions

Interventions

Device

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.

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