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

This study is testing a new way to manage overactive bladder (OAB) for women living in rural areas. It uses a device called Transcutaneous Tibial Nerve Stimulation (TTNS), which involves using a TENS unit at home to stimulate a nerve in your ankle. The study aims to see if this self-administered treatment can improve your quality of life and reduce bothersome symptoms like frequent urination. They are looking for rural women, aged 18 or older, who have been diagnosed with OAB and urinate at least 8 times a day. Success will be measured by changes in your quality of life, how much your symptoms bother you, and how often you urinate over a 12-week period. The current status of this study is unclear.

Study design
This is a single-arm study, meaning all 38 participants will receive the TTNS treatment. It is an interventional study, focusing on how a specific treatment affects participants.
What's involved
You would perform self-implemented at-home Transcutaneous Tibial Nerve Stimulation for 30 minutes, three times a week for 12 weeks. You will also complete questionnaires and a 3-day urination diary at the start and end of the study.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be evaluated upon enrollment and after 12 weeks of intervention.

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NCT07178314

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

Recruiting
NAAges 18+InterventionalTreatment
Oregon Health and Science University
~38 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Transcutaneous Tibial Nerve Stimulation (TTNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overactive Bladder questionnaire short form (OAB-q SF) Health-related Quality of life
Measured over Evaluated upon enrollment and following 12 weeks of intervention
+2 more outcomes measured

Conditions

Overactive Bladder

Explore related trials

Overactive Bladder

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Sara Cichowski · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Women's Health Research Unit Department of Ob/Gyn
[email protected]
503-494-3666
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overactive Bladder questionnaire short form (OAB-q SF) Health-related Quality of lifeEvaluated upon enrollment and following 12 weeks of intervention

    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.

  • Overactive Bladder questionnaire short form (OAB-q SF) symptom botherEvaluated upon enrollment and following 12 weeks of intervention

    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.

  • 24-hour voiding frequency3-day voiding diary completed upon enrollment and following 12 weeks of intervention

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