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

Not Applicable

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis; Urinary Incontinence
• Interventions: Procedure: Non guided pelvic floor exercises; Procedure: Pelvic floor exercises guided by a physiotherapist

• Registration Number: NCT03000647
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Status Verified: 2018-03
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-guided pelvic floor exercises	Non guided pelvic floor exercises	Pelvic floor exercises not guided
Guided Pelvic floor exercises	Pelvic floor exercises guided by a physiotherapist	Pelvic floor exercises guided by a physiotherapist

Primary Outcome Measures

Name	Time	Method
Decrease in the number of urinary leakages from baseline	12 weeks	Difference in the mean number of leakages (Registered for 3 days with a bladder diary)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General de Villalba; 🇪🇸 Villalba, Madrid, Spain