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

NCT ID: NCT04159467

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2023-12-26

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.

Conditions

Urinary Incontinence; Obesity; Strength; Pelvic Floor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1- diet therapy (control)

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.

Group Type: ACTIVE_COMPARATOR

Pelvic Floor Muscle Training

Intervention Type: OTHER

4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).

Grupo 2 - low calorie diet + PFMT (experimental)

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.

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type: OTHER

4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).

Interventions

Pelvic Floor Muscle Training

4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Pauliana Carolina de Souza Mendes

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pauliana Carolina de Souza Mendes

Franca, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Pauliana CS Mendes

Role: CONTACT

doutorapaulianasouza@outlook.com

+55 16 99364-9581

Cristine HJ Ferreira

Role: CONTACT

cristine@fmrp.usp.br

+55 16 99621-7919

Facility Contacts

Pauliana Mendes

Role: primary

doutorapaulianasouza@outlook.com

16993649581

References

Mendes PCS, Fretta TB, Camargo MFC, Driusso P, Homsi Jorge C. Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial. Trials. 2023 Jun 5;24(1):376. doi: 10.1186/s13063-023-07347-4.

Reference Type: DERIVED

PMID: 37277833 (View on PubMed)

Other Identifiers

16379919.5.0000.5440

Identifier Type: -

Identifier Source: org_study_id