Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatments strengthening of pelvic floor muscles., strengthening of hip muscles.
Sponsor University of Sao Paulo General Hospital
Start date January 2013
End date July 2014
Trial size 40 participants
Trial identifier NCT01948713, SimoneM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Strengthening of pelvic floor muscles.
strengthening of pelvic floor muscles.
Kegel exercises kinesiotherapy
(Experimental)
Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
strengthening of pelvic floor muscles.
Kegel exercises kinesiotherapy
strengthening of hip muscles.
Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
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.

Eligibility Criteria

Female participants from 30 years up to 70 years old.

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.

Additional Information

Official title Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial
Principal investigator Simone A. Marques, researcher
Description the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.