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Completed

NCT Number: NCT01871337

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

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Key information

Conditions

Urinary Incontinence; Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Sclerosis Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Hospital, Jerusalem, Israel

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paula method

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.

Other names: Circular muscle exercises

Primary outcomes

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

    Time frame: two years

Secondary outcomes

  1. quality of life, sexual function and mobility

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

A Clinical Trial for the Efficacy of Paula Method ( Circular Muscle Exercise) in Women With Multiple Sclerosis Who Suffer From Urinary Incontinence

Acronym: UI-MS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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