Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Study Overview
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Brief Summary
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This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.

Official Title
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Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial

Conditions
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Urge Incontinence, Overactive Bladder

Intervention / Treatment
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* Device: transcutaneous tibial nerve stimulation (TTNS)
* Device: transcutaneous electrical stimulation (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 6 episodes urgency incontinence on 3-day voiding diary Duration of symptoms ≥ 3 months Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks No known neurologic disease Ability to complete home sessions and clinic follow up Ability to complete voiding diaries Internet access and proficiency English or Spanish-speaking Exclusion Criteria: Pregnant Known or suspected urinary retention Symptomatic urinary tract infection unresolved at the time of randomization Recurrent urinary tract infection (≥ 3/12 months) Bladder pain syndrome Known or suspected advanced (stage III or IV) pelvic organ prolapse Neurogenic bladder Current or prior bladder malignancy Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation Pacemaker or other implantable device Disease affecting lower extremities Bilateral metallic lower limb implant Incarceration

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>30-minute treatments, twice weekly x12 weeks | Device: transcutaneous tibial nerve stimulation (TTNS)<br>* TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.<br>|
| Sham Comparator: Sham Group<br>30-minute treatments, twice weekly x12 weeks | Device: transcutaneous electrical stimulation (TENS)<br>* The sham intervention is designed to appear almost identical to the TTNS intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Questionnaire (OAB-q) | To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voiding diary | To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence