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

Study Overview
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Brief Summary
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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.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Urgent PC Neuromodulation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urgent PC<br> | Device: Urgent PC Neuromodulation System<br>* 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).<br>|
| No Intervention: Sham / Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder