A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Study Overview
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Brief Summary
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The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.

Official Title
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A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Conditions
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Urge Incontinence, Overactive Bladder

Intervention / Treatment
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* Device: Transcutaneous Electrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer. Patients with urge predominant mixed incontinence. Patients will need to have answered at Yes to leakage related to feeling urgency on the UDI 6 questionnaire. Female Over 18 years of age. English speaking who are able to give informed consent to participate in the study. Patients who have four urinary incontinence episodes. Exclusion Criteria: Stress incontinence desiring surgical management. Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections. Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair. Urethral diverticulum. Daily catheterization due to urinary retention. The use of anticholinergic medications for less than 6 weeks. Patients who have pacemakers in place. Patients with limited mobility requiring a wheelchair. Elevated PVR > 200 cc Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment. Uncorrected Stage 3 prolapse.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tibial Nerve<br>Transcutaneous electrical stimulation will be placed on the posterior tibial nerve. | Device: Transcutaneous Electrical Nerve Stimulation<br> <br> * Other names: TENS device;|
| Active Comparator: Parasacral<br>Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina. | Device: Transcutaneous Electrical Nerve Stimulation<br> <br> * Other names: TENS device;|
| Sham Comparator: Shoulder<br>Transcutaneous electrical stimulation will be placed on the shoulder. | Device: Transcutaneous Electrical Nerve Stimulation<br> <br> * Other names: TENS device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incontinence episodes per day | Patients will self-report the number of incontinence episodes. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bladder voids per day | Patients will self-report the number of times they void their bladder. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical nerve stimulation