Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strengthening of pelvic floor muscles.
Strengthening of hip muscles.
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- University of Sao Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Strengthening of pelvic floor muscles.
Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
Outcomes
Primary Outcome Measures
Change in frequence of urinary incontinence
number of episodes of urinary leakage per week
Secondary Outcome Measures
Change in strength of pelvic floor muscles
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
Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)
Full Information
NCT ID
NCT01948713
First Posted
June 5, 2013
Last Updated
April 4, 2017
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01948713
Brief Title
Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
Official Title
Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
September 18, 2014 (Actual)
Study Completion Date
January 8, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Strengthening of pelvic floor muscles.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
Intervention Type
Other
Intervention Name(s)
Strengthening of pelvic floor muscles.
Intervention Description
Kegel exercises kinesiotherapy
Intervention Type
Other
Intervention Name(s)
Strengthening of hip muscles.
Intervention Description
Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles
Primary Outcome Measure Information:
Title
Change in frequence of urinary incontinence
Description
number of episodes of urinary leakage per week
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.
Secondary Outcome Measure Information:
Title
Change in strength of pelvic floor muscles
Description
The strength of pelvic floor muscles will be assessed qualitatively by the functional evaluation of pelvic floor and quantitatively by perineometer.
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.
Title
Change in quality of life
Description
Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone A. Marques, researcher
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
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