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

CompletedNot a drug-phase studyMS (type not specified)NCT01871337

What it found

No results found

We found no results in the registry or in papers.

This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Paula method

What it measured

Main measures

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

    two years

    Bladder, bowel and sexual function

Other measures (1)

  • quality of life, sexual function and mobility

    two years

    Disability progressionWalking and mobilityBladder, bowel and sexual functionQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Feb 2014

    2. Main results due

      Sept 2015

    3. Finished

      Sept 2015

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