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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948713
• Other study ID #: SimoneM
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: April 4, 2017
• Start date: January 7, 2013
• Est. completion date: January 8, 2015

Study information

• Verified date: March 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 8, 2015
• Est. primary completion date: September 18, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• 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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.