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

Tracking Information

• First Submitted Date: June 5, 2013
• First Posted Date: September 24, 2013
• Last Update Posted Date: April 6, 2017
• Actual Study Start Date: January 7, 2013
• Actual Primary Completion Date: September 18, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2017)

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

Original Primary Outcome Measures (submitted: September 18, 2013)

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. ]

number of episodes of urinary leakage per week

Current Secondary Outcome Measures (submitted: April 4, 2017)

• 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.
• 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)

Original Secondary Outcome Measures (submitted: September 18, 2013)

• 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. ]
  The strength of pelvic floor muscles will be assessed qualitatively by the functional evaluation of pelvic floor and quantitatively by perineometer.
• 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. ]
  Questionnaires: International Consultation on Incontinence Questionnaire (ICIQ); King´s Health Questionnaire (KHQ)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stress Urinary Incontinence

Intervention

• 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

Study Arms

• Experimental: Group 1
  Strengthening of pelvic floor muscles.
  Intervention: Other: Strengthening of pelvic floor muscles.
• Experimental: Group 2
  Strengthening of pelvic floor muscles associated with strengthening of hip muscles.
  Interventions:

  • Other: Strengthening of pelvic floor muscles.
  • Other: Strengthening of hip muscles.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 4, 2017): 43
• Original Estimated Enrollment (submitted: September 18, 2013): 40
• Actual Study Completion Date: January 8, 2015
• Actual Primary Completion Date: September 18, 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01948713
• Other Study ID Numbers: SimoneM
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Sao Paulo General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Sao Paulo General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Sao Paulo General Hospital
• Verification Date: March 2017