Impact of TTNS on Bladder Symptoms Among People With MS, A RCT

Launched by HAWRA AL-DANDAN · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called transcutaneous tibial nerve stimulation (TTNS) on bladder symptoms in people with multiple sclerosis (MS) who experience issues like frequent urination or a sudden urge to go. TTNS is a non-invasive therapy, meaning it doesn’t require surgery or any invasive procedures, and can be done at home. The researchers will compare the effects of TTNS to a placebo treatment (sham TTNS) to see if it really helps improve bladder symptoms and the overall quality of life for participants.

To be eligible for this trial, participants must be at least 18 years old, able to walk with or without assistance, and have at least one bladder symptom. They should also be able to understand instructions in Arabic and be willing to consent to the study. However, certain individuals will be excluded, such as those with specific medical conditions, recent surgeries, or infections. Participants can expect to be involved in the study for a period of six months, during which their bladder symptoms and quality of life will be assessed at different points. If TTNS proves effective, it may become a standard treatment option for managing bladder issues in people with MS.

Gender

ALL

Eligibility 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