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NOT YET RECRUITING
NCT07540273
NA

Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Sponsor: SEZGIN

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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)