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Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

NCT07540273 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • SEZGIN

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-10-15
Completion
2026-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540273 on ClinicalTrials.gov