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

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