Status:
RECRUITING
At-Home Transcutaneous Tibial Nerve Stimulation for Overactive Bladder in Rural Women
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
American Urogynecologic Society
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
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 S...
Detailed Description
A total of 38 participants who meet the inclusion criteria will be recruited from clinical sites in three rural Oregon counties: 1) Klamath County, 2) Jefferson County, and 3) Coos County. Potential s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07178314
Start Date
October 6 2025
End Date
October 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239