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Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Sponsor: SEZGIN • ClinicalTrials.gov ID: NCT07540273

Registry updated: 2026-09-18

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Description

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

Interventions

Ambulatory Transcutaneous Tibial Nerve Stimulation (Device)
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 (Device)
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.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 to 65 years * Clinical diagnosis of overactive bladder (OAB) * Working in an office setting or spending most of the day at home, suitable for using a portable TENS device Exclusion Criteria: * Pregnancy * Cardiac pacemaker * Epilepsy * Metal implant in the ankle area * Open wound or skin disease at the electrode site * Active urinary tract infection * Neurological disease affecting bladder function * Previous surgery for urinary incontinence or OAB * Current anticholinergic or beta-3 agonist use for OAB * Cognitive impairment preventing proper device use

Conditions

Overactive Bladder (OAB) Urinary Urgency

Locations

Başakşehir Çam and Sakura City Hospital, Department of Urology — Istanbul, Istanbul, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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