NCT07178314 At-Home Transcutaneous Tibial Nerve Stimulation for Overactive Bladder in Rural Women
| NCT ID | NCT07178314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Overactive Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2026-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study contains a mixed-methods design consisting of a single-arm, interventional study and prospective patient interviews evaluating a novel self-implemented at-home Transcutaneous Tibial Nerve Stimulation (TTNS) treatment protocol for management of treatment naïve overactive bladder (OAB) among rural-dwelling women. This study will be conducted in 3 rural Oregon communities where Oregon Health \& Science University satellite campuses are located.
Eligibility Criteria
Inclusion Criteria: * Rural residence (as defined by the Federal Office of Rural Health policy confirmed with the "Am I rural?" tool) * Clinical diagnosis of overactive bladder (OAB) with urinary frequency \>= 8 times per day * Able to complete questionnaires, urination diaries, and interview in English or Spanish * Have reliable access to a telephone or email for communication * Ambulatory and able to use the toilet independently Exclusion Criteria: * Unable to consent * Pregnancy or planning to become pregnant during the study period * Previous treatment for OAB including medication, intravesical botox, and/or neuromodulation use * Presence of pacemaker or implantable defibrillator * Indwelling metal in both ankles * Presence of leg ulcers, open wounds, or skin conditions affecting lower legs * Absence of sensation in the lower legs * Active urinary tract infection * Predominantly stress urinary incontinence * Active malignancy * Neurogenic bladder * Subjective complaint of pelvic or