Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS)

Not Applicable

Completed

• Conditions: Urinary Incontinence; Multiple Sclerosis
• Interventions: Behavioral: Paula method

• Registration Number: NCT01871337
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

This study will examine whether the Paula method is an effective treatment for UI and the correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise method that significantly decreased urinary incontinence in women with MIX in two randomized controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The secondary aim is to evaluate the effectiveness in terms of MS general physical functioning, quality of life and sexual function and to detect adherence and continuity six months post intervention.

Detailed Description

The patient will be examined by the neurologist at the MS clinic, at the Hadassah University Medical Center. Patients who meet the inclusion criteria will receive an explanation, and will sign informed consent. She will be asked to complete the baseline questionnaires. Than the patient will be assigned to an exercise group. After 12 weeks the patient will be asked to complete post intervention questionnaire. Apart from the weekly lesson, women will be asked to exercise at home for 15 minutes a day. After six months she will be invited again for a neurological examination and filling an additional questionnaire.

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-20
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

women ≥18 years old; who have complained of urine leakage in the past four weeks; MS diagnosed with an Expanded Disability Status Scale (EDSS)≤7.5; literate in Hebrew and/or English; suffering from UI at least in the 4 last weeks prior to recruitment

Exclusion Criteria

pregnant or breastfeeding women, those within 12 weeks of delivery; 6 weeks of abortion; six months of pelvic surgery; symptomatic urinary tract infection (UTI); more than grade 2 genital prolapse, permanent catheterization for urination; women taking medications for UI less then 3 months and women who exercise on regular basis in Paula method.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paula method	Paula method	the Paula method, a circular muscle exercise, invented in Israel by Paula Garbourg.The method is based on the principle that all sphincters in the body are synchronized, with the movement of one affecting the other.One can rehabilitate damaged muscles by contracting and relaxing specific "circular" muscles in other parts of the body.

Primary Outcome Measures

Name	Time	Method
Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire	two years

Secondary Outcome Measures

Name	Time	Method
quality of life, sexual function and mobility	two years	Questionnaire for Urinary Incontinence Diagnosis (QUID); The Incontinence Quality of Life Questionnaire (I -QOL); The Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12); Expanded Disability Status Scale (EDSS);Demographic data questionnaire, General health and Paula Method Evaluation; Long term (6 months after the end of the intervention) questionnaire;

Trial Locations

Locations (2)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Hadassah Hospital; 🇮🇱 Jerusalem, Israel