Clinical trial NCT03000647: 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
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing-Remitting Multiple Sclerosis
Urinary Incontinence
Keywords: Pelvic floor muscle exercise
Supervision
Physiotherapy
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2016-12-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in the number of urinary leakages from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Decrease of urinary incontinence severity from baseline
timeFrame: 4,8 and 12 weeks
measure: Change in quality of life from baseline
timeFrame: 4,8 and 12 weeks
measure: Decrease in the number of urinary leakages from baseline
timeFrame: 4 and 8 weeks
measure: Lower urinary tract symptoms from baseline
timeFrame: 4,8 and 12 weeks
measure: Adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Villalba
country: Spain
facility: Hospital General de Villalba
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Denise Cuevas, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
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.