An interventional study of Ambulatory Transcutaneous Tibial Nerve Stimulation and Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation in Overactive Bladder (OAB) and Urinary Urgency, sponsored by SEZGIN. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by SEZGIN · Not applicable, Interventional, and Treatment
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:
Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):
Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).
Participants will:
Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate. It may also cause frequent urination during the day and night, and sometimes urine leakage. Transcutaneous tibial nerve stimulation (TTNS) is a safe, non-invasive treatment that uses mild electrical impulses through the skin near the ankle to calm bladder activity. The posterior tibial nerve at the ankle shares the same spinal nerve roots (L4-S3) that control the bladder.
Current TTNS protocols require regular clinic visits on a fixed schedule. This study introduces an ambulatory approach where participants use a portable TENS device in their daily life when urgency symptoms occur, rather than attending scheduled clinic sessions.
This is a prospective, single-center, randomized controlled trial conducted at Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey. A total of 30 to 50 adults aged 18 to 65 with a clinical diagnosis of OAB who have not improved enough with lifestyle changes and behavioral therapy will be enrolled.
Participants will be randomly placed into one of two groups:
Group 1 - Conventional TTNS: Clinic-based sessions, twice per week for 2 weeks (4 sessions total), each lasting 30 minutes.
Group 2 - Ambulatory TTNS: Participants will receive a portable TENS device and use it at home during daily activities when they experience urgency, over a 4-week follow-up period.
Both groups will use the same stimulation settings: 20 Hz frequency and 200 µs pulse width. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. The intensity will be set at a comfortable level just below the point that causes muscle movement.
Outcomes will be measured at baseline and at 4 weeks using OAB symptom scores (OAB-V8 and/or OABSS), a 3-day voiding diary (urinary frequency, urgency episodes, incontinence episodes), and quality of life questionnaires. Treatment adherence, patient satisfaction, and any side effects will also be recorded.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →This is the only study on the registry with SEZGIN as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive transcutaneous tibial nerve stimulation (TTNS) at the clinic twice per week for 2 weeks (4 sessions total). Each session will last 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold.
Device: Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
Participants will be provided with a portable TENS device and instructed to self-administer TTNS during their 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 will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. Participants will receive training on correct electrode placement and device use at the first visit.
Device: Ambulatory Transcutaneous Tibial Nerve Stimulation
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.
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.
Change in Overactive Bladder Symptom Score (OABSS)
OABSS is a 4-item self-administered questionnaire measuring the frequency of daytime urination, nighttime urination, urgency, and urgency urinary incontinence. Total score ranges from 0 to 15. Higher scores indicate more severe OAB symptoms and worse outcome.
Time frame: Baseline and 4 weeks
OAB-V8 (Overactive Bladder - V8 Questionnaire)
Description: OAB-V8 is an 8-item patient-reported questionnaire assessing the bothersomeness of overactive bladder symptoms. Each item is scored from 0 (not at all) to 5 (a very great deal), yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom burden and worse outcome.
Time frame: Baseline and 4 weeks
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
The ICIQ-OAB is a patient-reported outcome measure assessing the frequency and bothersomeness of overactive bladder symptoms including daytime urinary frequency, nocturia, urgency, and urgency urinary incontinence. It consists of 4 items, each rated on a symptom frequency scale. Total score ranges from 0 to 16. Higher scores indicate more severe overactive bladder symptoms and worse outcome.
Time frame: Baseline and 4 weeks
Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)
Description: The PGI-I is a single-item patient-reported outcome measure assessing the patient's perception of overall improvement following treatment. The scale ranges from 1 to 7, where 1 = "very much better" and 7 = "very much worse." Lower scores indicate greater patient satisfaction and better outcome. The PGI-I is widely used in urological and overactive bladder clinical trials to assess treatment satisfaction.
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 4 months is below that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.