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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz48 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsing-Remitting Multiple Sclerosis Urinary Incontinence

Interventions

Pelvic floor exercises guided by a physiotherapistPROCEDURE

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)

Non guided pelvic floor exercisesPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with Relapsing-Remitting Multiple Sclerosis 2. Diagnosed with Urinary Incontinence 3. Minimental Sate Examination (MMSE) scale: More than 24 4. Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5 5. Willing to participate in the study 6. Having Signed an informed consent Exclusion Criteria: 1. Diagnosed with another neurological disease 2. Diagnosed with kidney diseases 3. Having a Relapse of the disease in the last 6 months 4. In Women: Pregnancy os postpartum \< 6 months 5. Having gone through surgery for urinary incontinence or prolapses or prostate diseases 6. Having gone through other treatment for pelvic floor 7. MMSE scale: Under 24 8. EDSS scale: Bladder function 5-6 or not knowing; EDSS 7-10 9. ICIQ-SF scale: Severity 19-21 10. Not willing to participate or sign the informed consent form or not able to understand the study

Locations (1)

Hospital General de Villalba

Villalba, Madrid, Spain

Outcomes

Primary Outcomes

Decrease in the number of urinary leakages from baseline

Difference in the mean number of leakages (Registered for 3 days with a bladder diary)

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 4,8 and 12 weeks

Adherence

Comparison of the results (Registered with exercise diary)between the group 1 and 2

Time frame: 12 weeks

Data from ClinicalTrials.gov

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