Clinical trial NCT04159467: Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Obesity
Strength; Pelvic Floor
Keywords: Urinary Incontinence
Obesity
Diet
Pelvic floor muscles training
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Women
* 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.

Primary outcomes:
measure: Self report of urinary incontinence by women
timeFrame: Women will be evaluated at baseline
measure: Severity and impact of Urinary incontinence in women´s quality of life
timeFrame: Women will be evaluated at baseline
Secondary outcomes:
measure: Participants' adherence to the PFMT protocol
timeFrame: Women will be evaluated at baseline and right after 12 weeks
measure: PFM function
timeFrame: Women will be evaluated at baseline
measure: participants self-perception of their PFM function
timeFrame: Women will be evaluated at baseline
measure: Satisfaction with treatment
timeFrame: only after 12 weeks from the baseline assessment
measure: Subjective satisfaction with treatment
timeFrame: only after 12 weeks from the baseline assessment
measure: Identification of barriers for the treatment
timeFrame: only after 12 weeks from the baseline assessment
Other outcomes:
Locations:
city: Franca
country: Brazil
facility: Pauliana Carolina de Souza Mendes
state: SP
Study officials:
References: