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

Phase 4

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Urgent PC	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).

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline	36 months total	The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).

Secondary Outcome Measures

Name	Time	Method
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.	every three months for 36 months
Change in Voiding Diary Parameters.	every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.	every three months for 36 months

Locations (12): Alliance Urology Specialists
🇺🇸
Greensboro, North Carolina, United States
Gregory L. Davis, M.D., FACOG, Inc.
🇺🇸
Chico, California, United States
Greenwich Urological Associates, P.C.
🇺🇸
Greenwich, Connecticut, United States
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Mercy Health Partners at the Lakes
🇺🇸
Muskegon, Michigan, United States
Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Capital Region Urological Surgeons, PLLC
🇺🇸
Albany, New York, United States
Urology Health Center, PC
🇺🇸
Fremont, Nebraska, United States
Central Missouri Women's Healthcare, LLC
🇺🇸
White Plains, New York, United States
Virginia Urology
🇺🇸
Richmond, Virginia, United States
Athena Urology
🇺🇸
Issaquah, Washington, United States
Specialists in Urology
🇺🇸
Naples, Florida, United States