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Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder
Sponsor: SEZGIN
Summary
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are: * Does using TENS at home during daily activities reduce the number of urgency episodes? * Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment? Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation): * Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions. * Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period. Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width). Participants will: * Complete bladder symptom questionnaires before and after the study * Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage * Answer quality of life questions at the start and at 4 weeks
Official title: A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-15
Completion Date
2026-12-15
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Ambulatory Transcutaneous Tibial Nerve Stimulation
Participants will use a portable TENS device at home during daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Participants will receive training on correct electrode placement and device use at the first clinic visit.
Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
Participants will receive TTNS at the clinic twice per week for 2 weeks (4 sessions total), each lasting 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Sessions will be administered by a trained healthcare professional.
Locations (1)
Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, Istanbul, Turkey (Türkiye)