At-home tibial nerve stimulation to treat overactive bladder in rural women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.