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

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Procedure: Pelvic floor exercises guided by a physiotherapist; Procedure: Non guided pelvic floor exercises

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villalba, Madrid, Spain, 28400
      • Hospital General de Villalba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Guided Pelvic floor exercises; Pelvic floor exercises guided by a physiotherapist	Procedure: 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)
ACTIVE_COMPARATOR: Non-guided pelvic floor exercises; Pelvic floor exercises not guided	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4,8 and 12 weeks
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	4,8 and 12 weeks
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	4 and 8 weeks
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	4,8 and 12 weeks
Adherence	Comparison of the results (Registered with exercise diary)between the group 1 and 2	12 weeks

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Denise Cuevas, BSc, Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Physiotherapy; Pelvic floor muscle exercise; Supervision
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Multiple Sclerosis; Sclerosis; Urinary Incontinence; Multiple Sclerosis, Relapsing-Remitting; Enuresis
• Other Study ID Numbers: EC 65-15 HGV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO