RecruitingNot ApplicableNCT07178314

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

Evaluating the Feasibility and Efficacy of At-Home Transcutaneous Tibial Nerve Stimulation (TTNS) for Overactive Bladder in Rural Women


Sponsor

Oregon Health and Science University

Enrollment

38 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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

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Interventions

DEVICETranscutaneous 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.


Locations(1)

Oregon Health & Science University

Portland, Oregon, United States

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NCT07178314


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