Comparison of the Efficacy of Two Kinesiotherapy Protocols for Stress Urinary Incontinence in Women

This study is currently recruiting participants.
Verified September 2013 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01948713
First received: June 5, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Other: Strengthening of pelvic floor muscles.
Other: Strengthening of hip muscles.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Two Kinesiotherapy Protocols for Stress Urinary Incontinence in Women: Randomized Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Change in frequence of urinary incontinence [ Time Frame: At the first session of physical therapy and after 12 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 12 weeks. ] [ Designated as safety issue: No ]
    number of episodes of urinary leakage per week


Secondary Outcome Measures:
  • Change in strength of pelvic floor muscles [ Time Frame: At the first session of physical therapy and after 12 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 12 weeks. ] [ Designated as safety issue: No ]
    The strength of pelvic floor muscles will be assessed qualitatively by the functional evaluation of pelvic floor and quantitatively by perineometer.

  • Change in quality of life [ Time Frame: At the first session of physical therapy and after 12 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 12 weeks. ] [ Designated as safety issue: No ]
    Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Strengthening of pelvic floor muscles.
Other: Strengthening of pelvic floor muscles.
Kegel exercises kinesiotherapy
Experimental: Group 2
Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
Other: Strengthening of pelvic floor muscles.
Kegel exercises kinesiotherapy
Other: Strengthening of hip muscles.
Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with 50 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948713

Contacts
Contact: Simone A Marques, researcher 55-11-99670-2123 simone.am_marques@hotmail.com

Locations
Brazil
University of Sao Paulo General Hospital Recruiting
Sao Paulo, Brazil, 05403000
Contact: Nanci Valeis    55-11- 3061-7672    nanci.valeis@hcnet.usp.br   
Principal Investigator: Simone A Marques, researcher         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Simone A. Marques, researcher Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01948713     History of Changes
Other Study ID Numbers: SimoneM
Study First Received: June 5, 2013
Last Updated: September 18, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014