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Recruiting NCT07540273

Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Conditions: Overactive Bladder (OAB), Urinary Urgency

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: SEZGIN

Location: Başakşehir Çam and Sakura City Hospital, Department of Urology Istanbul Istanbul

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

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07540273). StuddyBuddy aggregates publicly available trial information.