Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Eligibility

Primary outcome measure(s)

• Change in Overactive Bladder Symptom Score (OABSS) — 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.
• OAB-V8 (Overactive Bladder - V8 Questionnaire) — 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.
• Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) — 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.

Trial sites (1)

Other trials for the same condition