Relapsing-Remitting Multiple Sclerosis, Urinary Incontinence
Conditions
Keywords
Pelvic floor muscle exercise, Supervision, Physiotherapy
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
Interventions
PROCEDUREPelvic floor exercises guided by a physiotherapist
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)
PROCEDURENon guided pelvic floor exercises
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
Sponsors
Universidad Rey Juan Carlos
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Adherence | 12 weeks | Comparison of the results (Registered with exercise diary)between the group 1 and 2 |
Countries
Spain
Outcome results
None listed