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