The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
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
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.
A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.
Time frame: 13 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specialists in Urology
Naples, Florida, United States
Mercy Health Partners at the Lakes
Muskegon, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
Grand Rapids, Minnesota, United States
Uroplasty, Inc
Minnetonka, Minnesota, United States
Beaumont Hospital
Royal Oak, Minnesota, United States
Urology Health Center, PC
Fremont, Nebraska, United States
Capital Region Urological Surgeons, PLLC
Albany, New York, United States
...and 5 more locations