Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

NCT06263556 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-02-16

No results posted yet for this study

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.

Conditions

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: 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.

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Principal Investigators

  • Sibel CAGLAR · Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  • Arda can Kasap · Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2024-11-05
Completion
2024-12-05

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263556 on ClinicalTrials.gov