Clinical trial NCT01948713: Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
Official title: Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 43
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Change in frequence of urinary incontinence
timeFrame: 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 outcomes:
measure: Change in strength of pelvic floor muscles
timeFrame: 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.
measure: Change in quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo
name: Simone A. Marques, researcher
role: PRINCIPAL_INVESTIGATOR
References: