Recruiting

TTNS

Sponsor:

Oregon Health and Science University

Code:

NCT07178314

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS)

Study Details

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

Study ID

NCT07178314

Start date

Oct 6, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Overactive Bladder questionnaire short form (OAB-q SF) symptom bother [ Time Frame: Evaluated upon enrollment and following 12 weeks of intervention ]
  • 24-hour voiding frequency [ Time Frame: 3-day voiding diary completed upon enrollment and following 12 weeks of intervention ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Department of Ob/Gyn

503-494-3666whru@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Transcutaneous Tibial Nerve Stimulation (TTNS)
  • Rural Healthcare

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-10-14.