Multiple Sclerosis and Overactive Bladder Treatment

August 15, 2022 updated by: Istanbul Medipol University Hospital

The Effect of Different Neuromodulation Techniques in the Treatment of Multiple Sclerosis Patients With Neurogenic Bladder Dysfunction

Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early evaluation of the patients in terms of the urinary system, planning the appropriate treatment and following up at regular intervals are extremely important in terms of preventing urinary system complications. Neuromodulation applications are used reliably in the urological treatment of MS patients. The aim of this study was to compare the efficacy of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in patients with MS reporting lower urinary tract symptoms.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Bladder dysfunction is one of the most disturbing symptoms of MS. The frequency of bladder dysfunction in patients with MS is reported to be %52-97. Urinary symptoms are among the initial symptoms in %10-15 of patients, while it is the only initial symptom in up to %2 of patients. Patients is seen with irritative symptoms (such as frequent urination, urgency, urinary incontinence, nocturia), obstructive symptoms (such as difficulty in initiating urination, inability to urinate, feeling of incomplete emptying, weak urine flow) or mixed type symptoms.In line with these symptoms, early evaluation of MS patients in terms of urinary system, planning of appropriate treatment and regular follow-up are extremely important in terms of preventing urinary system complications. Pharmacotherapy and clean intermittent catheterization are the first step treatments for lower urinary tract symptoms in multiple sclerosis. It has been reported in the literature that electrical nerve stimulation therapy (neuromodulation methods) and behavior change methods (pelvic floor muscle exercise, bladder training, urinary diary keeping) are also used as a second step treatment option due to the side effects of anticholinergic use and lack of motivation and skill in catheterization. It is reported that neuromodulation applications are performed in MS patients and it is a reliable method. Deep brain stimulation, transcranial magnetic stimulation, posterior tibial nerve stimulation, sacral neuromodulation and spinal cord stimulation are generally recommended in the treatment of bladder dysfunction, which is one of the neuromodulation methods. The superiority of these methods to each other is debatable. In line with this information, the aim of the study is to compare the effectiveness of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in MS patients reporting lower urinary tract symptoms.

According to the treatment protocols of the patients to be included in the study; will be divided into 2 groups as transcutaneous posterior tibial nerve stimulation group (8 patients) and repetitive transcranial magnetic stimulation group (8 patients). Which method will be applied to which individual will be determined randomly. Treatment sessions will be carried out for 5 consecutive days in 2 consecutive weeks, 1 time per day for a total of 10 sessions. The urological parameters of the patients in all groups will be evaluated before and after the treatment.

Statistical method(s); Statistical analysis of the data obtained from the study will be done in the Statistical Package for the Social Sciences (SPSS) 22.0 package program. The mean standard deviation, median, minimum and maximum values will be used to define the data. Comparison of continuous variables between groups will be done with Mann Whitney U test, comparison of discrete variables will be done with chi-square test. Spearman or Pearson correlation test will be used to evaluate the correlation between variables. In the data analysis, p < 0.05 level will be considered statistically significant.

Study Type

Interventional

Enrollment (Anticipated)

16

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medipol Mega University Hospital

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-65 years old
  • Woman
  • Volunteer to participate in the study
  • Neurogenic overactive bladder due to MS
  • EDSS <7.0
  • Not benefiting from pharmacological treatment

Exclusion Criteria:

  • With urinary tract infection
  • Diagnosed with diabetes mellitus
  • Using diuretic medication
  • Using clean intermittent catheterization
  • Having a history of different urological diseases
  • Those who have conditions that would be contraindicated for electrical stimulation (pacemaker, brain pacemaker, prosthesis)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Posterior Tibial Nerve Stimulation Group
The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.
Device: Transcutaneous Posterior Tibial Nerve Stimulation
The treatment parameters will be applied with a pulse current time of 200 μsec, a fixed frequency of 10 Hz, a treatment time of 20 minutes, and a current intensity that the patient can tolerate, which will not cause flexion in the big toe or fan movement in the other fingers. Self-adhesive surface electrodes will be used for stimulation. During the treatment, the patient will lie on his back. The negative electrode will be placed 2 cm posterior to the medial malleolus and the positive electrode will be placed 10 cm proximal.
Active Comparator: Repetitive Transcranial Magnetic Stimulation Group
The treatment will be applied with a Power Mag device.
Device: Repetitive Transcranial Magnetic Stimulation
The treatment will be internally cooled 70 mm double coil and 110 mm round coil, accompanied by a physiotherapist and neurologist. The coil will be placed on the precentral gyrus. Practices will be held, with each session lasting 20 minutes. Cortical excitability will be provided by high frequency (HF) stimulation (5-Hz).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urodynamics Test
Time Frame: "10 days" the amount of change after 10 days from the baseline
While the bladder is being filled, it will be carried out to measure the pressures in the bladder and in the abdomen, to examine the nerves that provide bladder contractions, and to explain the cases of urinary incontinence or inability by examining the bladder contraction pressures and electrical activity during urination.
"10 days" the amount of change after 10 days from the baseline
Extended Disability Status Scale (EDSS)
Time Frame: "10 days" the amount of change after 10 days from the baseline
It is the most commonly used scale to assess disability in MS. EDSS scoring is based on the neurological examination results of eight functional systems and the patient's ambulation status. Functional systems are listed as pyramidal, cerebellar, brainstem, sensory, bladder and intestinal, visual, cerebral, and others. A score of 0-10 is given.0 denotes normal neurological examination, 10 denotes death due to MS. 1.0-4.5 refers to fully ambulatory, 5.0-9.5 refers to impaired ambulation. From 7.0 onwards there is wheelchair use and increasingly bed dependency.
"10 days" the amount of change after 10 days from the baseline
Overactive Bladder Questionnaire-V8 (OAB-V8)
Time Frame: "10 days" the amount of change after 10 days from the baseline
The severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and too many (5) it consists of 8 questions that can be graded. The total score can vary between 0 and 40.
"10 days" the amount of change after 10 days from the baseline
Incontinence Quality of Life -I-QOL
Time Frame: "10 days" the amount of change after 10 days from the baseline
It consists of a total of 22 questions with three sub-dimensions. Sub-dimensions; limitation of behaviors (1,2,3,4,10,11,13,20 items), psychosocial influence (5,6,7,9,15,16,17,21,22 items) and social isolation (8,12 ,14,18,19 items). All items are evaluated with a five-point Likert type (1= too much, 2= a quite, 3= moderately, 4= a little, 5= not at all) and the Likert types are recalculated to take a value between 0-100 points in order to better understand the total score calculated. Higher scores indicate better quality of life.
"10 days" the amount of change after 10 days from the baseline
Voiding Diary
Time Frame: "10 days" the amount of change after 10 days from the baseline
It is recommended to present the information given by the patients in an objective way. Although not entirely diagnostic, diary data can reveal normal and abnormal conditions. The 3-day voiding diary is a viable, reliable and valid tool in the evaluation of patients with lower urinary tract symptoms.
"10 days" the amount of change after 10 days from the baseline
Incontinence Severity Index (ISI)
Time Frame: "10 days" the amount of change after 10 days from the baseline
It consists of 2 questions, and the total score is obtained by multiplying the frequency of urinary incontinence and the amount of urine leaked, and the score range varies between 1-12. According to their score, 1-2 points are light; 3-6 points average; 8-9 points indicate severe and 12 points very severe urinary incontinence.
"10 days" the amount of change after 10 days from the baseline

Collaborators and Investigators

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

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Pınar Atak Çakır

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)

June 8, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 26, 2021

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • patak

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No Plan Description

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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