Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

Study Overview
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Brief Summary
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This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day voiding diaries to record instances of UI episodes and OAB quality of life.

Official Title
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Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 55-100 years old Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding training diary) Have self-reported bladder symptoms of more than 3 months Are ambulatory and able to use the toilet independently Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe) Able to provide informed consent Capable and willing to follow all study-related procedures Exclusion Criteria: Have primary complaint of stress urinary incontinence Have a pacemaker or implantable defibrillator Had botox injections in the bladder or pelvic floor muscles in the past 12 months Have a current urinary tract or vaginal infection Have an active implantable SNS device (InterStim & Bion) Have been diagnosed with peripheral neuropathy or nerve damage Currently pregnant Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS Treatment Arm<br>This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. | Device: TENS<br>* Transcutaneous electrical nerve stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urge Incontinence Episodes |  | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Micturitions Per Day | Mean number of urinary voids per day (taken over a 3-day period) | Baseline and 8 weeks | 
| Change in Health-related Quality of Life (HRQL) | Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS