Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
RECRUITING
Istanbul
Contact Information
Primary
Sibel CAGLAR
dr.sibelcaglar@gmail.com
+905333365651
Backup
Arda Can KASAP
drardakasap@gmail.com
+905384590119
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2024-12-05
Participants
Target number of participants: 64
Treatments
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.
Sponsors
Leads: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

This content was sourced from clinicaltrials.gov