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Clinical Trials/NCT04159467
NCT04159467
Recruiting
Not Applicable

Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial

University of Sao Paulo1 site in 1 country20 target enrollmentSeptember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University of Sao Paulo
Enrollment
20
Locations
1
Primary Endpoint
Self report of urinary incontinence by women
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. The study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their PFM function, and satisfaction with treatment.

Detailed Description

According to the World Health Organization (WHO), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. In addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (PFM) disorders and urinary incontinence (UI) is the most prevalent one. Conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (PFMT) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.

Registry
clinicaltrials.gov
Start Date
September 28, 2022
End Date
December 26, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pauliana Carolina de Souza Mendes

Physiotherapist

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service
  • Over 18 years old
  • With body mass index greater than 30kg / m2
  • Who have reported urinary incontinence in the last four weeks
  • Who have the ability to contract the pelvic floor muscles
  • No report of neurological disease, no cognitive impairment
  • That are not pregnant.

Exclusion Criteria

  • Women who do not wish to continue participating in the research.

Outcomes

Primary Outcomes

Self report of urinary incontinence by women

Time Frame: Women will be evaluated at baseline

Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.

Severity and impact of Urinary incontinence in women´s quality of life

Time Frame: Women will be evaluated at baseline

the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score

Secondary Outcomes

  • participants self-perception of their PFM function(Women will be evaluated at baseline)
  • Satisfaction with treatment(only after 12 weeks from the baseline assessment)
  • Participants' adherence to the PFMT protocol(Women will be evaluated at baseline and right after 12 weeks)
  • PFM function(Women will be evaluated at baseline)
  • Identification of barriers for the treatment(only after 12 weeks from the baseline assessment)
  • Subjective satisfaction with treatment(only after 12 weeks from the baseline assessment)

Study Sites (1)

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