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

NCT07178314 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Transcutaneous Tibial Nerve Stimulation (TTNS)

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.

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Sara Cichowski · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178314 on ClinicalTrials.gov