NCT06263556

Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
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: 1. Lie on your back. Take a deep breathe. Relax your abdominal muscles as you breathe out. 2. 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. 3. Repeat when you feel ready. You need to repeat this 10 times. 4. 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.

Timeline

• Start date: 2024-01-17
• Primary completion: 2024-11-05
• Completion: 2024-12-05
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

1 site across 1 country: Turkey (Türkiye)