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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Strengthening of pelvic floor muscles.; Other: Strengthening of hip muscles.

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • University of Sao Paulo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequence of urinary incontinence	number of episodes of urinary leakage per week	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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 quality of life	Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)	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.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Simone A. Marques, researcher, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2013
• Primary Completion (Actual): September 18, 2014
• Study Completion (Actual): January 8, 2015

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SimoneM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO