Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

NCT07540273 | Not Yet Recruiting

• 1 other identifier: KAEK-11/05.11.2025.397
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Overactive Bladder (OAB); Urinary Urgency

Keywords

Transcutaneous Tibial Nerve Stimulation; Overactive Bladder; Ambulatory Neuromodulation; Self-Administered Electrical Stimulation; Urinary Urgency

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 4 weeks

Secondary Outcomes (1)

• Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)

  4 weeks

Study Arms (2)

Conventional Clinic-Based TTNS

ACTIVE COMPARATOR

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

Ambulatory Self-Administered TTNS

EXPERIMENTAL

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

Interventions

Ambulatory Transcutaneous Tibial Nerve Stimulation DEVICE

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.

Ambulatory Self-Administered TTNS

Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation DEVICE

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.

Conventional Clinic-Based TTNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SEZGIN: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Department of Urology

Istanbul, Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Veysel Sezgin Sezgin, M.D

CONTACT

+905513895655; veyselsezgin1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. Veysel Sezgin

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TU (1)