Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis

Detailed Description
-----------------
Subjects of the study should conduct a specific training in pelvic floor exercises. They were randomly assigned into 2 groups: Group A only received written instructions for exercises to be performed at home; Group B received written instructions and, in addition, exercises were performed in a 30 minutes weekly session with a physiotherapist guiding them

Official Title
-----------------
Assessment of the Effectiveness of Guided by a Physiotherapist Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence (UI) in Patients With Relapsing-Remitting (RR) Multiple Sclerosis

Conditions
-----------------
Relapsing-Remitting Multiple Sclerosis, Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Pelvic floor exercises guided by a physiotherapist
* Procedure: Non guided pelvic floor exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Relapsing-Remitting Multiple Sclerosis Diagnosed with Urinary Incontinence Minimental Sate Examination (MMSE) scale: More than 24 Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5 Willing to participate in the study Having Signed an informed consent Exclusion Criteria: Diagnosed with another neurological disease Diagnosed with kidney diseases Having a Relapse of the disease in the last 6 months In Women: Pregnancy os postpartum < 6 months Having gone through surgery for urinary incontinence or prolapses or prostate diseases Having gone through other treatment for pelvic floor MMSE scale: Under 24 EDSS scale: Bladder function 5-6 or not knowing; EDSS 7-10 ICIQ-SF scale: Severity 19-21 Not willing to participate or sign the informed consent form or not able to understand the study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided Pelvic floor exercises<br>Pelvic floor exercises guided by a physiotherapist | Procedure: Pelvic floor exercises guided by a physiotherapist<br>* Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home)<br>|
| Active Comparator: Non-guided pelvic floor exercises<br>Pelvic floor exercises not guided | Procedure: Non guided pelvic floor exercises<br>* Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the number of urinary leakages from baseline | Difference in the mean number of leakages (Registered for 3 days with a bladder diary) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of urinary incontinence severity from baseline | Comparison of the results: Questions 1, 2 and 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF) between the group 1 and 2 | 4,8 and 12 weeks | 
| Change in quality of life from baseline | Comparison of the results (Question 3 of the questionnaire ICIQ-SF and second part (13 questions) of the Overactive Bladder questionnaire (OABQ-SF) between the group 1 and 2 | 4,8 and 12 weeks | 
| Decrease in the number of urinary leakages from baseline | Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2 | 4 and 8 weeks | 
| Lower urinary tract symptoms from baseline | Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2 | 4,8 and 12 weeks | 
| Adherence | Comparison of the results (Registered with exercise diary)between the group 1 and 2 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic floor muscle exercise, Supervision, Physiotherapy