Effect of nerve stimulation on urinary symptoms in MS patients
Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
NA · Bakirkoy Dr. Sadi Konuk Research and Training Hospital · NCT06263556
This study is testing whether a new nerve stimulation treatment can help improve bladder issues for people with multiple sclerosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital (other gov) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06263556 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS). It is a single-centered, prospective, randomized controlled trial where participants will be divided into two groups to receive either TTNS or sham stimulation. The study will assess changes in urinary symptoms and quality of life using various questionnaires and measurements before and after the intervention. Participants will also keep a bladder diary to track their symptoms over a three-day period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 with a diagnosis of multiple sclerosis and lower urinary tract symptoms.
Not a fit: Patients with severe mental disabilities, cognitive deficits, or those with EDSS scores greater than or equal to 7 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for MS patients suffering from debilitating urinary symptoms.
How similar studies have performed: Other studies have shown promising results with similar nerve stimulation approaches for LUTS, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer Adults (Age 18-50) * Diagnosis of Multiple Sclerosis * Expanded Disability Status Scale (EDSS) 0-6,5 * Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency) * Diagnosis of bladder disfunction with Urodynamic study within 1 months Exclusion Criteria: * Age less then 18 * Pacemaker or implantable defibrillator usage * Diabetic polyuria * Bleeding diathesis or severe bleeding tendency * Pelvic floor disfunction or nerve damage effecting tibial nerve * Currently pregnant or planning pregnancy * Active urinary infection * Active malignancy * Severe mental disability * Cognitive deficit * Expanded Disability Status Scale (EDSS) greater than or equal to 7 * Unable to attend to TPTNS treatment 2 times a week * Urodynamic findings of bladder outlet obstruction * Surgical history because of urinary incontinence * Urologic surgical history because of lower urinary track disfunction or symptoms * Diagnosis of prostatic enlargement * Diagnosis of pelvic organ prolapse
Where this trial is running
Istanbul
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital — Istanbul, Turkey (RECRUITING)
Study contacts
- Principal investigator: Sibel CAGLAR — Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study coordinator: Sibel CAGLAR
- Email: dr.sibelcaglar@gmail.com
- Phone: +905333365651
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: Multiple Sclerosis, Lower Urinary Tract Symptoms, Lower Urinary Track Symptoms, LUTS, Posterior tibial nerve stimulation, TPTNS, TTNS