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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000647
• Other study ID #: EC 65-15 HGV
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: March 2018
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis
• Urinary Incontinence

Intervention

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)
• 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

Locations

Country	Name	City	State
Spain	Hospital General de Villalba	Villalba	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View Citation

Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57. Review. Erratum in: J Urol 1999 Jul;162(1):172. — View Citation

Lúcio 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. — View Citation

Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdonà 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. Epub 2006 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence	Comparison of the results (Registered with exercise diary)between the group 1 and 2	12 weeks