Actively Recruiting
Evaluating the Feasibility and Efficacy of At-Home Transcutaneous Tibial Nerve Stimulation (TTNS) for Overactive Bladder in Rural Women
Led by Oregon Health and Science University · Updated on 2025-10-14
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
A
American Urogynecologic Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new self-implemented at-home treatment called Transcutaneous Tibial Nerve Stimulation (TTNS) for women living in rural areas who have not previously been treated for overactive bladder (OAB). This study takes place in three rural communities in Oregon and involves both an interventional treatment and patient interviews to understand participant experiences. The goal is to assess how feasible and effective this device-based therapy is for managing OAB symptoms in this population. Participants will use a transcutaneous electrical nerve stimulation (TENS) device to stimulate the tibial nerve on one ankle during 30-minute sessions, three times per week, over a 12-week period. The device, including electrodes and batteries, will be mailed to each participant along with detailed written and video instructions. The stimulation intensity is personalized to be just above the perception threshold but not painful. Researchers will contact participants regularly to monitor adherence and provide support. During the study, participants will complete questionnaires, keep a 3-day voiding diary, and may take part in interviews after finishing the intervention to share their experiences. The primary outcomes measured include quality of life related to OAB, symptom bother, and urinary frequency before and after the 12-week treatment. Communication and study materials are offered in English or Spanish, and participants' safety and compliance will be closely monitored throughout the study.
CONDITIONS
Brief Title
At-Home Transcutaneous Tibial Nerve Stimulation for Overactive Bladder in Rural Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Aged 18 years or older
- Rural residence as defined by the Federal Office of Rural Health policy
- Clinical diagnosis of overactive bladder with urinary frequency of 8 or more times per day
- Able to complete questionnaires, urination diaries, and interviews in English or Spanish
- Reliable access to telephone or email for communication
- Ambulatory and able to use the toilet independently
You will not qualify if you...
- Unable to consent
- Pregnant or planning to become pregnant during the study period
- Previous treatment for overactive bladder including medication, intravesical botox, or neuromodulation
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 12 weeks
Participants perform self-implemented at-home transcutaneous tibial nerve stimulation (TTNS) using a TENS unit. They apply stimulation to the tibial nerve on one ankle for 30 minutes per session, three times per week for 12 weeks. Participants receive detailed instructions and support through telephone contacts at 2-3 week intervals to check compliance and address questions.
Telephone contacts every 2 to 3 weeks
Duration - Up to several weeks after intervention completion
After completing the intervention, selected participants may be invited for one-on-one video or audio recorded interviews to discuss their experiences with self-managed TTNS at home. These interviews help identify facilitators and barriers to the treatment.
1 to 2 interview sessions (video or audio recorded)
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Department of Ob/Gyn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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