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

I

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status

Completed

Conditions

Relapsing-Remitting Multiple Sclerosis
Urinary Incontinence

Treatments

Procedure: Non guided pelvic floor exercises
Procedure: Pelvic floor exercises guided by a physiotherapist

Study type

Interventional

Funder types

Other

Identifiers

NCT03000647
EC 65-15 HGV

Details and patient eligibility

About

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

Full 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

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Guided Pelvic floor exercises
Active Comparator group
Description:
Pelvic floor exercises guided by a physiotherapist
Treatment:
Procedure: Pelvic floor exercises guided by a physiotherapist
Non-guided pelvic floor exercises
Active Comparator group
Description:
Pelvic floor exercises not guided
Treatment:
Procedure: Non guided pelvic floor exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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