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

NCT03000647 | Completed

• 1 other identifier: EC 65-15 HGV
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsing-Remitting Multiple Sclerosis; Urinary Incontinence

Keywords

Pelvic floor muscle exercise; Supervision; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Decrease in the number of urinary leakages from baseline

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

  12 weeks

Secondary Outcomes (5)

• Decrease of urinary incontinence severity from baseline

  4,8 and 12 weeks

• Change in quality of life from baseline

  4,8 and 12 weeks

• Decrease in the number of urinary leakages from baseline

  4 and 8 weeks

• Lower urinary tract symptoms from baseline

  4,8 and 12 weeks

• Adherence

  12 weeks

Study Arms (2)

Guided Pelvic floor exercises

ACTIVE COMPARATOR

Pelvic floor exercises guided by a physiotherapist

Procedure: Pelvic floor exercises guided by a physiotherapist

Non-guided pelvic floor exercises

ACTIVE COMPARATOR

Pelvic floor exercises not guided

Procedure: Non guided pelvic floor exercises

Interventions

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)

Guided Pelvic floor exercises

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

Non-guided pelvic floor exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Hospital General de Villalba

Villalba, Madrid, 28400, Spain

Location

Related Publications (6)

• 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.

  PMID: 16699915 BACKGROUND

• 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.

  PMID: 3756405 BACKGROUND

• 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.

  PMID: 20976816 BACKGROUND

• 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.

  PMID: 10218095 BACKGROUND

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

  PMID: 10022678 BACKGROUND

• 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.

  PMID: 31183535 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Denise Cuevas, BSc

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 22, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 11, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)