Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01948713
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE September 24, 2013
Last Update Posted Date April 6, 2017
Actual Study Start Date  ICMJE January 7, 2013
Actual Primary Completion Date September 18, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
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. ]
number of episodes of urinary leakage per week
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
  • 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. ]
    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. ]
    Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
Official Title  ICMJE Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial
Brief Summary 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.
Detailed Description the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group 1
    Strengthening of pelvic floor muscles.
    Intervention: Other: Strengthening of pelvic floor muscles.
  • Experimental: Group 2
    Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
    Interventions:
    • Other: Strengthening of pelvic floor muscles.
    • Other: Strengthening of hip muscles.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2013)
40
Actual Study Completion Date  ICMJE January 8, 2015
Actual Primary Completion Date September 18, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01948713
Other Study ID Numbers  ICMJE SimoneM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Sao Paulo General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Sao Paulo General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simone A. Marques, researcher University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP