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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01871337
First received: June 4, 2013
Last updated: February 26, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention
Urinary Incontinence;
Multiple Sclerosis
Behavioral: Paula method

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial for the Efficacy of Paula Method ( Circular Muscle Exercise) in Women With Multiple Sclerosis Who Suffer From Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life, sexual function and mobility [ Time Frame: two years ] [ Designated as safety issue: No ]
    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;


Estimated Enrollment: 34
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other Name: Circular muscle exercises

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871337

Contacts
Contact: Adi Vaknin, Dr. 972-2-6776939 adembinsky@yahoo.com
Contact: Michal Liebergall, PhD 972-26777144 michall2@hadassah.org.il

Locations
Israel
Hadassah University Hospital Not yet recruiting
Jerusalem, Israel, 91120
Contact: Michal Liebergall, PhD    972-2-6777144    michall2@hadassah.org.il   
Principal Investigator: Adi Vaknin, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Adi Vaknin, MD Hadassah University Hospital
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01871337     History of Changes
Other Study ID Numbers: UI_MS_HMO
Study First Received: June 4, 2013
Last Updated: February 26, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Multiple Sclerosis
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014