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

NCT ID: NCT03000647

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

Conditions

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Relapsing-Remitting Multiple Sclerosis Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Guided Pelvic floor exercises

Pelvic floor exercises guided by a physiotherapist

Group Type ACTIVE_COMPARATOR

Pelvic floor exercises guided by a physiotherapist

Intervention Type 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

Pelvic floor exercises not guided

Group Type ACTIVE_COMPARATOR

Non guided pelvic floor exercises

Intervention Type 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

Interventions

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Pelvic 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)

Intervention Type PROCEDURE

Non 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denise Cuevas, BSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Locations

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Hospital General de Villalba

Villalba, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 16699915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3756405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20976816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10218095 (View on PubMed)

Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.

Reference Type BACKGROUND
PMID: 10022678 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31183535 (View on PubMed)

Other Identifiers

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EC 65-15 HGV

Identifier Type: -

Identifier Source: org_study_id

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