Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.

Detailed Description
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Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.

Official Title
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Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: PTNS treatment
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men > 18 years of age Self-reported failed conservative care of behavioral modifications and/or oral medications An above normal urinary frequency as recorded on initial 3-day voiding diary Self-reported bladder symptoms greater than or equal to 3 months On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks Capable of giving informed consent Ambulatory and able to use toilet independently without difficulty Capable and willing to follow all study-related procedures Exclusion Criteria: Pregnant or planning to become pregnant during study duration Diagnosis of neurogenic bladder Botox use in bladder or pelvic floor muscles within past 12 months Pacemakers or implantable defibrillators Current urinary tract infection Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study. Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening. Use of investigational drug/device therapy within past 4 weeks Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

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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No

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
Interventional Model Description: Randomized, single blind parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active PTNS treatment<br>One-week induction consisting of three active PTNS treatments, each 2 hours long | Device: PTNS treatment<br>* One-week induction consisting of three active PTNS treatments, each 2 hours long<br>* Other names: Urgent PC Neuromodulation System;|
| Sham Comparator: Sham treatment<br>One-week induction consisting of three sham treatments, each 2 hours long | Device: Sham treatment<br>* One-week induction consisting of three active PTNS treatments, each 2 hours long<br>* Other names: Simulated treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in GRA for Overall Bladder Symptoms | Number of subjects reporting Moderately or Markedly Improved responses on the GRA after 3 interventions | One week post induction (+/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Urinary Frequency on 3 Day Voiding Diary | Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline. | Baseline and 1 week post induction (+/- 3 days) | 
| Change From Baseline Nocturia in 3 Day Voiding Diary | Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids. | Baseline and one week post induction (+/- 3 days) | 
| Change From Baseline in Degree of Urgency in 3 Day Voiding Diary | Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | Baseline and 1 week post induction (+/- 3 days) | 
| Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary | Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | Baseline and one week post induction (+/- 3 days) | 
| Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF) | Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms. | Baseline and 1 week post induction (+/- 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Urgency, Urinary Frequency, Urge Incontinence