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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Urinary Incontinence; Strength; Pelvic Floor
• Intervention / Treatment: Other: Pelvic Floor Muscle Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauliana CS Mendes; Phone Number: +55 16 99364-9581; Email: doutorapaulianasouza@outlook.com
• Study Contact Backup: Name: Cristine HJ Ferreira; Phone Number: +55 16 99621-7919; Email: cristine@fmrp.usp.br

Study Locations

• Brazil
  • SP
    • Franca, SP, Brazil, 14408060
      • Recruiting
      • Pauliana Carolina de Souza Mendes
      • Contact: Pauliana Mendes; Phone Number: 16993649581; Email: doutorapaulianasouza@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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).
Experimental: 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.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self report of urinary incontinence by women	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.	Women will be evaluated at baseline
Severity and impact of Urinary incontinence in women´s quality of life	the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score	Women will be evaluated at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' adherence to the PFMT protocol	Will be assessed using an exercise diary and the complier average causal effects (CACE) method	Women will be evaluated at baseline and right after 12 weeks
PFM function	the modified Oxford grading scale- MOS (digital vaginal palpation)	Women will be evaluated at baseline
participants self-perception of their PFM function	women´s self-perception of their PFM function according to the MOS categories	Women will be evaluated at baseline
Satisfaction with treatment	Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction	only after 12 weeks from the baseline assessment
Subjective satisfaction with treatment	Women will answer the following questions: are you satisfied with the treatment you received for UI? would you do this treatment again ? would you recomend this treatment ? to other people, would you chase another treatment ?	only after 12 weeks from the baseline assessment
Identification of barriers for the treatment	Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?	only after 12 weeks from the baseline assessment

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Anticipated): August 26, 2023
• Study Completion (Anticipated): December 26, 2023

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Diet; Urinary Incontinence; Pelvic floor muscles training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 16379919.5.0000.5440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No