Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet

U

University of Sao Paulo

Status

Enrolling

Conditions

Obesity
Urinary Incontinence
Strength; Pelvic Floor

Treatments

Other: Pelvic Floor Muscle Training

Study type

Interventional

Funder types

Other

Identifiers

NCT04159467
16379919.5.0000.5440

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Group 1- diet therapy (control)
Active Comparator group
Description:
Control group undergoing a low calorie diet will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and after 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study.
Treatment:
Other: Pelvic Floor Muscle Training
Grupo 2 - low calorie diet + PFMT (experimental)
Experimental group
Description:
The experimental group will receive supervised pelvic floor muscle training in addition to a hypocaloric diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary contractions of the pelvic floor muscles. The 4 sets will be performed in 2 different positions (sitting and standing). Once a month, they will receive a supervised in-person session using the same protocol described above, in the other weeks of the month will receive a session supervised by telephysiotherapy once a week. In addition to supervised sessions, women will be encouraged to perform the protocol three more days a week. In addition, they will be instructed to perform "the knack" maneuver.
Treatment:
Other: Pelvic Floor Muscle Training

Trial contacts and locations

0

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Central trial contact

Cristine HJ Ferreira; Pauliana CS Mendes

Data sourced from clinicaltrials.gov

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