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

NCT07178314 | Recruiting FDA Device

• 1 other identifier: STUDY00028373
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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

Overactive Bladder

Keywords

Transcutaneous Tibial Nerve Stimulation (TTNS); Rural Healthcare

Outcome Measures

Primary Outcomes (3)

• Overactive Bladder questionnaire short form (OAB-q SF) Health-related Quality of life

  A 13-item survey assessing health-related quality of life. Assessed on a scale from 1 to 100 with a higher score representing a better quality of life.

  Evaluated upon enrollment and following 12 weeks of intervention

• Overactive Bladder questionnaire short form (OAB-q SF) symptom bother

  A 13-item survey assessing symptom bother related to overactive bladder. Assessed on a scale from 1 to 100 with a higher score representing more bother, which is a worse outcome.

  Evaluated upon enrollment and following 12 weeks of intervention

• 24-hour voiding frequency

  Mean 24-hour voiding frequency based on a 3-day voiding diary

  3-day voiding diary completed upon enrollment and following 12 weeks of intervention

Study Arms (1)

Rural Women Treated with Transcutaneous Tibial Nerve Stimulation

EXPERIMENTAL

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.

Device: Transcutaneous Tibial Nerve Stimulation (TTNS)

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.

Also known as: TTNS, TENS Unit

Rural Women Treated with Transcutaneous Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• American Urogynecologic Society: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Cichowski

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All study participants will receive the intervention.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)