Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Urgent PC Neuromodulation System
Intervention description: 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).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Overactive Bladder

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.
    

Eligibility criteria:

        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