Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Women and men >18 years of age
A score of > 4 on the OAB-q short form for urgency (question 1)
Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
Self-reported bladder symptoms present > 3 months
Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
Off all antimuscarinics for at least 2 weeks prior to enrollment
Capable of giving informed consent
Ambulatory and able to use a toilet independently, without difficulty
Capable and willing to follow all study-related procedures

Exclusion Criteria

Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
Neurogenic bladder
Botox use in bladder or pelvic floor muscles in the past year
Pacemakers or implantable defibrillators
Primary complaint of stress urinary incontinence
Current urinary tract infection (UTI)
Current vaginal infection
Current use of InterStim
Current use of Bion
Current use of TENS in the pelvic region, back or legs
Previously been treated with PTNS
Use of investigational drug/device therapy within the past 4 weeks
Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy)
Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function

Arm && Interventions

Group	Intervention	Description
Urgent PC	Urgent PC Neuromodulation System	-

Primary Outcome Measures

Name	Time	Method
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.	13 weeks	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.

Secondary Outcome Measures

Name	Time	Method

Locations (14): Capital Region Urological Surgeons, PLLC
🇺🇸
Albany, New York, United States
Alliance Urology Specialists
🇺🇸
Greensboro, North Carolina, United States
Athena Urology
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Issaquah, Washington, United States
Specialists in Urology
🇺🇸
Naples, Florida, United States
Gregory L. Davis, M.D., FACOG, Inc.
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Chico, California, United States
Greenwich Urological Associates, P.C.
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Greenwich, Connecticut, United States
Mercy Health Partners at the Lakes
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Muskegon, Michigan, United States
Uroplasty, Inc
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Minnetonka, Minnesota, United States
Beaumont Hospital
🇺🇸
Royal Oak, Minnesota, United States
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
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Grand Rapids, Minnesota, United States
Urology Health Center, PC
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Fremont, Nebraska, United States
Central Missouri Women's Healthcare, LLC
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White Plains, New York, United States
University of Oklahoma
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Oklahoma City, Oklahoma, United States
Virginia Urology
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Richmond, Virginia, United States