Effect of tibial nerve stimulation on bladder symptoms in people with MS
Impact of Transcutaneous Tibial Nerve Stimulation on Bladder Storage Symptoms and Quality of Life in People With Multiple Sclerosis- A Randomised Controlled Trial"
NA · Imam Abdulrahman Bin Faisal University · NCT06341673
This study is testing if a new treatment using tibial nerve stimulation can help people with multiple sclerosis manage their bladder symptoms better than a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imam Abdulrahman Bin Faisal University (other) |
| Locations | 1 site (Khobar, Eastern Providence) |
| Trial ID | NCT06341673 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory individuals aged 18 and older with MS who experience at least one bladder storage symptom.
Not a fit: Patients with certain conditions such as indwelling catheters, bladder malignancy, or recent pelvic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder symptoms and quality of life for patients with MS.
How similar studies have performed: While TTNS has shown promise in small studies, this research aims to provide more robust evidence, making it a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Khobar, Eastern Providence
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overactive Bladder Syndrome, Multiple Sclerosis, Overactive bladder, Bladder storage symptoms, Incontinence, Tibial nerve stimulation, Stimulation