Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

February 9, 2024 updated by: Sibel Caglar Okur, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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: Sham stimulation
Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Quality of Life (I-QOL)
Time Frame: 6 weeks (Before and after the treatment)
I-QOL is used for evaluation of quality of life in patients with incontinence. It comprises 22 questions presented under three subscales: limiting behavior, psychosocial impact, and social embarrassment. All the questions are based on a five-point Likert scale (1 = a lot, 2 = quite a bit, 3 = moderate, 4 = a little, and 5 = not at all). Points obtained by each question are added together which results in a total point of 0 to 110. This total point is then recalculated to take a value between 0-100 for better understand. Higher scores indicate a better quality of life. Validation of turkish version is available.
6 weeks (Before and after the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-void residue (PVR)
Time Frame: 6 weeks (Before and after the treatment)
Post-void residue (PVR) will be calculated with ultrasonography. Evaluation will be made by same person in all patients after urination, in supine position transabdominally with 2-5 Mhz convex probe using E-Saote Mylab Seven (Italy) device.
6 weeks (Before and after the treatment)
Bladder diary
Time Frame: 6 weeks (Before and after the treatment)
2 or 3 day bladder diary is recommended by European Association of Urology in patients with lower urinary track symptoms. Urination frequency, urgency, incontinence and nocturia will be evaluated using 3 day bladder diary.
6 weeks (Before and after the treatment)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time Frame: 6 weeks (Before and after the treatment)
ICIQ-SF allows the assessment of incontinence's severity, frequency and its impact on quality of life. ICIQ-SF scoring is also a practical and reliable method for baseline and post-treatment evaluation of patients with urge incontinence. It contains six questions. First and second questions are about demographics and the sixth question is about conditions that lead to incontinence. First, second and sixth questions have no point value. Total score varies between 0 and 21 and is obtained by adding third, fourth and fifth question's points. Higher scores indicate greater problems with incontinence. Validation of turkish version is available.
6 weeks (Before and after the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Sibel CAGLAR, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Study Chair: Arda Can KASAP, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

November 5, 2024

Study Completion (Estimated)

December 5, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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