Status:
COMPLETED
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Lead Sponsor:
Uroplasty, Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
- Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
- Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
- Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
- Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
- Subjects must remain off all antimuscarinics throughout participation in trial
- Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
- Capable of giving informed consent
- Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years
Exclusion
- Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
- Subjects who were not able or willing to follow original SUmiT Trial study schedule
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00928395
Start Date
January 1 2009
End Date
December 1 2012
Last Update
May 16 2013
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, United States, 95928
2
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, United States, 06830
3
Specialists in Urology
Naples, Florida, United States, 34102
4
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
Grand Rapids, Michigan, United States, 49503