A Trial of Transcutaneous Nerve Stimulation for OAB

Study Overview
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Brief Summary
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Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.

Official Title
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A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: Transcutaneous tibial nerve stimulation
* Other: Sham transcutaneous tibial nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, >18 years of age, with the clinical diagnosis of overactive bladder. Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms. Baseline patient perception of bladder condition score of 2 or higher. Exclusion Criteria: Current or previous percutaneous or sacral neuromodulation therapy Stress predominant urinary incontinence Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron) Intravesical botulinum toxin use within the last 1 year Implanted pacemaker or defibrillator History of epilepsy Unable or unwilling to commit to study treatment schedule Pregnant, or possible pregnancy planned for the duration of the study period Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma) Documented allergy to patch electrodes or their adhesive Abnormal sensory function of the lower limb Metallic implant within the lower limb

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 |
| --- | --- |
| Sham Comparator: Sham<br>Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks | Other: Sham transcutaneous tibial nerve stimulation<br>* Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.<br>|
| Active Comparator: Transcutaneous nerve stimulation<br>Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks | Other: Transcutaneous tibial nerve stimulation<br>* Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) | Patient percention of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Questionnaire Short Form (OAB-q SF) | OAB quality of life questionnaire | 12 weeks | 
| Voiding Diary |  | 12 weeks | 
| 24hr Pad Weights |  | 12 weeks | 
| Physician Assessment of Treatment Benefit |  | 12 weeks |