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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pelvic floor exercises guided by a physiotherapist
Non guided pelvic floor exercises
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Pelvic floor muscle exercise, Supervision, Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital General de Villalba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Guided Pelvic floor exercises

Non-guided pelvic floor exercises

Arm Description

Pelvic floor exercises guided by a physiotherapist

Pelvic floor exercises not guided

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Decrease of urinary incontinence severity from baseline
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
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
Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2
Lower urinary tract symptoms from baseline
Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2
Adherence
Comparison of the results (Registered with exercise diary)between the group 1 and 2

Full Information

First Posted
December 14, 2016
Last Updated
July 9, 2019
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03000647
Brief Title
Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis, Urinary Incontinence
Keywords
Pelvic floor muscle exercise, Supervision, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Pelvic floor exercises
Arm Type
Active Comparator
Arm Description
Pelvic floor exercises guided by a physiotherapist
Arm Title
Non-guided pelvic floor exercises
Arm Type
Active Comparator
Arm Description
Pelvic floor exercises not guided
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor exercises guided by a physiotherapist
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Non guided pelvic floor exercises
Intervention Description
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 Outcome Measure Information:
Title
Decrease in the number of urinary leakages from baseline
Description
Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Decrease of urinary incontinence severity from baseline
Description
Comparison of the results: Questions 1, 2 and 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF) between the group 1 and 2
Time Frame
4,8 and 12 weeks
Title
Change in quality of life from baseline
Description
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
Time Frame
4,8 and 12 weeks
Title
Decrease in the number of urinary leakages from baseline
Description
Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2
Time Frame
4 and 8 weeks
Title
Lower urinary tract symptoms from baseline
Description
Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2
Time Frame
4,8 and 12 weeks
Title
Adherence
Description
Comparison of the results (Registered with exercise diary)between the group 1 and 2
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Cuevas, BSc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Villalba
City
Villalba
State/Province
Madrid
ZIP/Postal Code
28400
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16699915
Citation
Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdona S, Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):189-94. doi: 10.1007/s00192-006-0131-9. Epub 2006 May 13.
Results Reference
background
PubMed Identifier
3756405
Citation
Gilpin SA, Gilpin CJ, Dixon JS, Gosling JA, Kirby RS. The effect of age on the autonomic innervation of the urinary bladder. Br J Urol. 1986 Aug;58(4):378-81. doi: 10.1111/j.1464-410x.1986.tb09089.x.
Results Reference
background
PubMed Identifier
20976816
Citation
Lucio AC, Campos RM, Perissinotto MC, Miyaoka R, Damasceno BP, D'ancona CA. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2010 Nov;29(8):1410-3. doi: 10.1002/nau.20941.
Results Reference
background
PubMed Identifier
10218095
Citation
De Ridder D, Vermeulen C, Ketelaer P, Van Poppel H, Baert L. Pelvic floor rehabilitation in multiple sclerosis. Acta Neurol Belg. 1999 Mar;99(1):61-4.
Results Reference
background
PubMed Identifier
10022678
Citation
Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57. Erratum In: J Urol 1999 Jul;162(1):172.
Results Reference
background
PubMed Identifier
31183535
Citation
Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.
Results Reference
derived

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

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