Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS) (UI-MS)
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.
|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|
- Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire [ Time Frame: two years ] [ Designated as safety issue: No ]
- 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;
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01871337
|Contact: Adi Vaknin, Dr.||firstname.lastname@example.org|
|Contact: Michal Liebergall, PhDemail@example.com|
|Contact: Adi Vaknin, M.D. 972-2-6776639 firstname.lastname@example.org|
|Contact: Michal Liebergall, PhD 972-50-7874206 email@example.com|
|Hadassah University Hospital||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Michal Liebergall, PhD 972-2-6777144 firstname.lastname@example.org|
|Principal Investigator: Adi Vaknin, MD|
|Principal Investigator:||Adi Vaknin, MD||Hadassah University Hospital|