At-home tibial nerve stimulation to treat overactive bladder in rural women
Evaluating the Feasibility and Efficacy of At-Home Transcutaneous Tibial Nerve Stimulation (TTNS) for Overactive Bladder in Rural Women
We will test whether a self‑administered at‑home tibial nerve stimulation using a preset TENS unit can reduce overactive bladder symptoms in treatment‑naïve rural women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT07178314 on ClinicalTrials.gov |
What this trial studies
This is a single‑arm interventional study with prospective patient interviews enrolling 38 treatment‑naïve women with overactive bladder who live in three rural Oregon counties. Participants will be trained (remotely or with mailed materials) to use a preset transcutaneous electrical nerve stimulation (TENS) device for tibial nerve stimulation at home and will complete bladder diaries and questionnaires. Consent, screening, and follow-up are offered in English or Spanish, with phone/web or mailed paper options to accommodate limited internet access. The study combines quantitative symptom tracking with qualitative interviews to understand usability and experience of the self‑implemented protocol.
Who should consider this trial
Good fit: Women living in designated rural Oregon counties with a clinical diagnosis of overactive bladder who urinate at least eight times per day, have not had prior OAB treatments, can use a TENS device, and can complete study materials in English or Spanish are ideal candidates.
Not a fit: People with pacemakers or defibrillators, indwelling metal in both ankles, absent lower‑leg sensation, active urinary tract infection, neurogenic bladder, predominately stress urinary incontinence, active malignancy, or prior OAB therapies are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide an easy, low‑risk at‑home option to reduce urinary frequency for rural women who lack access to clinic‑based therapies.
How similar studies have performed: Percutaneous tibial nerve stimulation has shown symptom improvements in prior work and early pilot studies of transcutaneous TTNS are promising, but fully self‑administered at‑home protocols remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 organ prolapse outside of vaginal introitus * Subjective symptoms of incomplete bladder emptying * Epilepsy * Peripheral artery disease affecting both legs
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Sara Cichowski — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.