At-Home Transcutaneous Tibial Nerve Stimulation for Overactive Bladder in Rural Women

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT07178314
Status
Recruiting
Apply to this trial

Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Tibial Nerve Stimulation (TTNS) — DEVICE
    Participants will perform self-implemented at-home transcutaneous tibial nerve stimulation using a transcutaneous electrical nerve stimulation (TENS) unit. Participants will be instructed to use the TENS unit to deliver stimulation to the tibial nerve on one ankle for a 30-minute session, three times per week for 12 weeks upon receipt of the device. Intensity will be based on the participant's tolerance, just above the perception threshold but not painful.

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rural Women Treated with Transcutaneous Tibial Nerve Stimulation
    Participants will undergo a self-implemented at-home Transcutaneous Tibial Nerve Stimulation (TTNS) treatment protocol for management of treatment naive overactive bladder (OAB) among rural dwelling women.

Primary Outcome Measure

Overactive Bladder questionnaire short form (OAB-q SF) Health-related Quality of life [ Time Frame: Evaluated upon enrollment and following 12 weeks of intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Women's Health Research Unit
[email protected]
503-494-3666

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By research site
Oregon Health & Science University· Portland, OR

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