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

RecruitingNAAges 18 Years - anyAllHawra Al-Dandan
NCT06341673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardiz

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📋 Eligibility rules (as published)
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
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What it tests

  • Active Transcutaneous Electrical Nerve Stimulation (TENS)
  • Sham Transcutaneous Electrical Nerve Stimulation (TENS)
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Where

1 site
King Fahd Hospital of the University
Khobar, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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