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NCT Number: NCT01948713

Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence

INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology causes physical discomfort and impacts the quality of life in a negative manner. Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can be applied with focus on strengthening the pelvic floor muscles or on muscular synergism. OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in association with the strengthening of the muscles of the hip in the treatment of stress urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims at assessing objectively the strength of the pelvic floor, the improvement in the number of episodes of loss and impact on quality of life. The study will accept up to 40 women, who will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic floor muscles with Kegel exercises associated with the strengthening of muscles of the hip). The two groups will be evaluated at the beginning and at the end of treatment.

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Key information

About this study

the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with 30 to 70 years of age;
  • Clinical diagnosis of stress urinary incontinence;
  • Urodynamic study.

Exclusion criteria

  • Stress urinary incontinence with sphincter deficiency;
  • Urinary urgence;
  • Mixed urinary incontinence;
  • Pregnant women;
  • Neurological or muscular disease that interfere with continence;
  • Urinary infection;
  • Genital prolapse;
  • Gynecological surgery for urinary incontinence in the last year;
  • Hormone replacement therapy;
  • Strength 0 in functional evaluation of the pelvic floor muscles.

Treatment and study plan

Strengthening of pelvic floor muscles.

Other

Kegel exercises kinesiotherapy

Strengthening of hip muscles.

Other

Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles

Primary outcomes

  1. Change in frequence of urinary incontinence

    Time frame: At the first session of physical therapy and after 10 weeks of physical therapy treatment a voiding diary will be applied, and every session a follow up diary will be used. The physiotherapy treatment will be held twice a week for 10 weeks.

    number of episodes of urinary leakage per week

Secondary outcomes

  1. Change in strength of pelvic floor muscles

    Time frame: At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.

    The strength of pelvic floor muscles will be assessed qualitatively by the functional evaluation of pelvic floor and quantitatively by perineometer.

  2. Change in quality of life

    Time frame: At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.

    Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 24, 2013
Registry last updated
Apr 6, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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