Effect of tibial nerve stimulation on bladder symptoms in people with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in managing bladder storage symptoms among individuals with multiple sclerosis (MS). It employs a randomized, sham-controlled, double-blind design to compare the effects of active TTNS against a placebo treatment. The study aims to provide high-quality evidence regarding the efficacy of this non-invasive treatment for neurogenic lower urinary tract dysfunction, which is prevalent in MS patients. Participants will be recruited based on specific inclusion criteria, and the study will follow standardized protocols for conducting and reporting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ambulatory (with or without assistive device)
* Aged ≥18 years old
* Able to understand spoken and written Arabic Language
* Self-reported with at least one bladder storage symptom such as urinary frequency urinary urgency, nocturia, with or without urge urinary incontinence
* Willing to give written informed consent
* Able to understand how to complete the study outcome measures

Exclusion Criteria:

People with MS will be excluded if they have one or more of the following criteria at randomization:

* Indwelling urethral catheter
* Indwelling suprapubic catheter
* Bladder malignancy
* Diabetic mellitus
* Pregnant women or plan to be pregnant during the study intervention
* Recent pelvic related surgery \<1 year
* Pacemaker or other metallic internal devices
* Urinary tract infections (UTIs) during recruitment phase
* Unable to understand the instructions relating to operating the unit
* Having a bladder BOTOX-injection in the last 12-month

Where it's running

• King Fahd Hospital of the University
  Khobar, Eastern Providence, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Dr Hawra AL Dandan, PhD — Imam Abdulrahman Bin Faisal University
• Study coordinator: Dr Hawra Al Dandan, PhD
• Email: hdandan@iau.edu.sa
• Phone: +966555901977

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.