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Completed

NCT Number: NCT03000647

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

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

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Villalba

Villalba, Madrid, 28400, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor exercises guided by a physiotherapist

Procedure

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 exercises

Procedure

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

Primary outcomes

  1. 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

  1. Decrease of urinary incontinence severity from baseline

    Time frame: 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

  2. Change in quality of life from baseline

    Time frame: 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

  3. Decrease in the number of urinary leakages from baseline

    Time frame: 4 and 8 weeks

    Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2

  4. Lower urinary tract symptoms from baseline

    Time frame: 4,8 and 12 weeks

    Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2

  5. Adherence

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2016
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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