Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

April 17, 2026 updated by: SEZGIN

A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34200
        • Başakşehir Çam and Sakura City Hospital, Department of Urology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Clinic-Based TTNS
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 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.
Experimental: Ambulatory Self-Administered TTNS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Overactive Bladder Symptom Score (OABSS)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
OAB-V8 (Overactive Bladder - V8 Questionnaire)
Time Frame: Baseline and 4 weeks

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.
Baseline and 4 weeks
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)
Time Frame: 4 weeks

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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEZGIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK-11/05.11.2025.397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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