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

Primary Purpose

Urinary Incontinence;, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Paula method
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence; focused on measuring Multiple Sclerosis, urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah University Hospital
  • Hadassah Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paula method

Arm Description

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.

Outcomes

Primary Outcome Measures

Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire

Secondary Outcome Measures

quality of life, sexual function and mobility
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;

Full Information

First Posted
June 4, 2013
Last Updated
September 20, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01871337
Brief Title
Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS)
Acronym
UI-MS
Official Title
A Clinical Trial for the Efficacy of Paula Method ( Circular Muscle Exercise) in Women With Multiple Sclerosis Who Suffer From Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence;, Multiple Sclerosis
Keywords
Multiple Sclerosis, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paula method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Paula method
Other Intervention Name(s)
Circular muscle exercises
Intervention Description
The Paula method will be taught to the participants by several registered Paula instructors. Subjects allocated to this intervention will receive one 45-minute group session per week for 12 weeks (with up to 30 minutes for personal questions regarding the exercises). This length of time is crucial because it has been demonstrated that it take three months for women to adequately learn the exercises in order for them to practice independently at home. Participants will be encouraged to practice daily for 15 minutes and report their at- home training.
Primary Outcome Measure Information:
Title
Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire
Time Frame
two years
Secondary Outcome Measure Information:
Title
quality of life, sexual function and mobility
Description
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;
Time Frame
two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adi Vaknin, MD
Organizational Affiliation
Hadassah University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Hadassah Hospital
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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

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