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

Completed · Phase 4

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT00771264

Run by

Uroplasty, Inc

People needed

220

Starts

2008-09-01

Expected to finish

2009-06-01

Last updated by the study team

2012-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Central Missouri Women's Healthcare, LLC — White Plains, New York, United States
• Alliance Urology Specialists — Greensboro, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Virginia Urology — Richmond, Virginia, United States
• Athena Urology — Issaquah, Washington, United States

Full record on ClinicalTrials.gov

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