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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Decrease in the number of urinary leakages from baseline
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Guided Pelvic floor exercises
Pelvic floor exercises guided by a physiotherapist
Intervention: Pelvic floor exercises guided by a physiotherapist (Procedure)
Non-guided pelvic floor exercises
Pelvic floor exercises not guided
Intervention: Non guided pelvic floor exercises (Procedure)
Outcomes
Primary Outcomes
Decrease in the number of urinary leakages from baseline
Time Frame: 12 weeks
Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
Secondary Outcomes
- Decrease in the number of urinary leakages from baseline(4 and 8 weeks)
- Change in quality of life from baseline(4,8 and 12 weeks)
- Adherence(12 weeks)
- Lower urinary tract symptoms from baseline(4,8 and 12 weeks)
- Decrease of urinary incontinence severity from baseline(4,8 and 12 weeks)