NCT00928395

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

Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Uroplasty, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DEVICE	Urgent PC	The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2009-06-26
• Last updated: 2013-05-16
• Results posted: 2013-05-16

Locations

12 sites across 1 country: United States