Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.

Detailed Description
-----------------
Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS. According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.

Official Title
-----------------
Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Lifestyle recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a diagnosis of MS and having at least two of the lower urinary symptoms Not having an attack in the last 1 month, No change in medical treatment in the last 3 months Expanded disability status scale-EDSS score is less than 6.5 Not having any cognitive problems that would hinder cooperation and understanding Those who use digital devices such as computers, laptops, smartphones and tablets Volunteering to participate in the study Exclusion Criteria: Pregnancy status Active urinary tract infection Another neurological disease that can cause incontinence A history of malignancy Prostate surgery Those with missing evaluation parameters Those who do not regularly participate in treatment programs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly divided into two groups (control and exercise) for treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group | Other: Exercise<br>* Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.<br>Other: Lifestyle recommendations<br>* Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms<br>|
| Active Comparator: Control group<br>Lifestyle recommendations will be given to the control group | Other: Lifestyle recommendations<br>* Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence symtoms | Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form | change from baseline at 8 weeks | 
| Overactive bladder symptoms | Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8 | change from baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder functions | bladder functions will be evaluated with voiding diary | change from baseline at 8 weeks | 
| Quality of life level | Quality of life will be evaluated with King's Health Questionnaire | change from baseline at 8 weeks | 
| subjective perception of improvement | subjective perception of improvement will be evaluated with a 4-item Likert-type scale | after treatment (8th week) | 
| patient satisfaction | patient satisfaction will be evaluated with a 5-item Likert-type scale | after treatment (8th week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower Urinary Tract Symptoms, Multiple Sclerosis, Pelvic Floor Muscle Training