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

NCT ID: NCT01871337

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-09-30

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.

Conditions

Urinary Incontinence; Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paula method

Intervention Type: BEHAVIORAL

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.

Interventions

Paula method

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Circular muscle exercises

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adi Vaknin, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital

Locations

Hadassah University Hospital

Jerusalem, , Israel

Hadassah Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

UI_MS_HMO

Identifier Type: -

Identifier Source: org_study_id