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Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 50 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06263556
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sibel CAGLARArda can Kasap
Principal Investigator Affiliation	Bakirkoy Dr. Sadi Konuk Research and Training HospitalBakirkoy Dr. Sadi Konuk Research and Training Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Turkey
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Lower Urinary Tract Symptoms

Additional Details

This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table. At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered. Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.

Arms & Interventions

Arms

Experimental: Pelvic floor exercises and Transcutaneous tibial nerve stimulation

Patients in this group will receive pelvic floor exercise program as described before and transcutaneous tibial nerve stimulation (TTNS). The intervention will comprise 12 session of transcutaneous tibial nerve stimulation (Twice a week, for 6 continuous weeks). Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned according to the protocol used by Booth et al and Sonmez et al, with the negative electrode 2 cm behind the medial malleolus, and positive electrode 10 cm proximal to it. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe). Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. The intensity level of the stimulation current (range 0-50 mA) will be determined once hallux reaction is observed, according to patient's tolerance.

Sham Comparator: Pelvic floor exercises and Sham Stimulation

Patients in this group will receive pelvic floor exercise program as described before and Sham stimulation. The intervention will comprise 12 session of sham stimulation. (Twice a week, for 6 continuous weeks) Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned According to the protocol used by Booth et al, with the negative electrode 2 cm behind the lateral malleolus, and positive electrode 10 cm proximal to it, therefore avoiding the posterior tibial nerve. The stimulation current will be reduced to 2 mA once the tingling sensation is obtained and patients will be informed that they may not feel electrical sensation during the session. Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. If willing, patients in this group will receive TTNS treatment after the study is completed.

Interventions

Behavioral: - Pelvic floor exercises

Patients will be informed about pelvic floor muscles functions and written material will be given for home training. Exercise program will be planned as 1 set, 3 times per day. Each set will include 10 pelvic floor contractions. Patient will be instructed to squeeze their pelvic muscles and keep them contracted for 8 seconds. Due to fatigue and spasticity patients may experience, patients will set their own resting periods between contractions. Patients will be told to avoid contracting abdominal and gluteal muscles and avoid holding their breathe during the exercise. Patients will be instructed to perform exercise as following: Lie on your back. Take a deep breathe. Relax your abdominal muscles as you breathe out. Focus on your pelvic floor muscles. Squeeze your muscles as you are trying to stop the flow of your urine and stay contracted for 8 seconds, then relax. Repeat when you feel ready. You need to repeat this 10 times. Repeat this exercise 3 times per day

Device: - Transcutaneous posterior tibial nerve stimulation

Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before.

Device: - Sham stimulation

Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Istanbul, Turkey

Status

Recruiting

Address

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, ,

Site Contact

Sibel CAGLAR

[email protected]

+905333365651

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