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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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).
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, United States
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, United States
Specialists in Urology
Naples, Florida, 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
Urology Health Center, PC
Fremont, Nebraska, United States
Capital Region Urological Surgeons, PLLC
Albany, New York, United States
Central Missouri Women's Healthcare, LLC
White Plains, New York, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
...and 2 more locations
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
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).
Time frame: 36 months total
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Time frame: every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.
Time frame: every three months for 36 months
Change in Voiding Diary Parameters.
Time frame: every three months for 36 months
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