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Clinical Trials/NCT01948713
NCT01948713CompletedNot Applicable

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

University of Sao Paulo General Hospital1 site in 1 country43 target enrollmentStarted: January 7, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
Change in frequence of urinary incontinence

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Group 1

Experimental

Strengthening of pelvic floor muscles.

Intervention: Strengthening of pelvic floor muscles. (Other)

Group 2

Experimental

Strengthening of pelvic floor muscles associated with strengthening of hip muscles.

Intervention: Strengthening of pelvic floor muscles. (Other)

Group 2

Experimental

Strengthening of pelvic floor muscles associated with strengthening of hip muscles.

Intervention: Strengthening of hip muscles. (Other)

Outcomes

Primary Outcomes

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

  • Change in quality of life(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.)
  • Change in strength of pelvic floor muscles(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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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