Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms (NCT06263556) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
Turkey (Türkiye)64 participantsStarted 2024-01-17
Plain-language summary
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incontinence Quality of Life (I-QOL)
Timeframe: 6 weeks (Before and after the treatment)
Trial details
NCT IDNCT06263556
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital