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COMPLETED Phase 4

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

NCT00928395 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2009-01
Est. Completion 2012-12
Phase Phase 4

Sponsor

Uroplasty

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00928395

The ClinicalTrials.gov registry entry for NCT00928395 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uroplasty, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00928395 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Michigan, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00928395?

The interventions under investigation include: Urgent PC (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00928395?

This trial is sponsored by Uroplasty, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial