Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSEZGIN

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

SEZGIN

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Sponsor institution