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

• ClinicalTrials.gov Identifier: NCT01948713
• Recruitment Status: Completed
• First Posted: September 24, 2013
• Last Update Posted: April 6, 2017
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Other: Strengthening of pelvic floor muscles.; Other: Strengthening of hip muscles.	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial
• Actual Study Start Date: January 7, 2013
• Actual Primary Completion Date: September 18, 2014
• Actual Study Completion Date: January 8, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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)

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Brazil

University of Sao Paulo General Hospital

Sao Paulo, Brazil, 05403000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

• Principal Investigator: Simone A. Marques, researcher; University of Sao Paulo

More Information

• Responsible Party: University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT01948713
• Other Study ID Numbers: SimoneM
• First Posted: September 24, 2013
• Last Update Posted: April 6, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders