About this trial
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
Qualifiers
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
Disqualifiers
Pregnancy
Cardiac pacemaker
Epilepsy
Metal implant in the ankle area
Trial design
Treatments tested in this trial
- Ambulatory Transcutaneous Tibial Nerve Stimulation
- Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
Treatment groups
Sponsors and collaborators
SEZGIN
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution