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

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ClinicalTrials.gov Identifier: NCT04159467
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Pauliana Carolina de Souza Mendes, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Obesity Strength; Pelvic Floor Other: Pelvic Floor Muscle Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : July 29, 2022
Estimated Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine


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)
Experimental group will receive supervised pelvic floor muscle training additionally to a low calorie diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The 4 sets will be performed in 3 different positions (lying, sitting and standing). Twice a month (once every 15 days), they will receive a supervised session using the same protocol described above except for the position that will be only sitting and standing. In addition, they will be instructed to perform the "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).




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Participants' adherence to the PFMT protocol [ Time Frame: Women will be evaluated at baseline and right after 12 weeks ]
    Will be assessed using an exercise diary and the complier average causal effects (CACE) method

  2. PFM function [ Time Frame: Women will be evaluated at baseline ]
    the modified Oxford grading scale- MOS (digital vaginal palpation)

  3. participants self-perception of their PFM function [ Time Frame: Women will be evaluated at baseline ]
    women´s self-perception of their PFM function according to the MOS categories

  4. Satisfaction with treatment [ Time Frame: only after 12 weeks from the baseline assessment ]
    Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction

  5. Subjective satisfaction with treatment [ Time Frame: only after 12 weeks from the baseline assessment ]
    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 ?

  6. Identification of barriers for the treatment [ Time Frame: only after 12 weeks from the baseline assessment ]
    Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Women who do not wish to continue participating in the research
  • Who become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159467


Contacts
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Contact: Pauliana CS Mendes +55 16 99364-9581 doutorapaulianasouza@outlook.com
Contact: Cristine HJ Ferreira +55 16 99621-7919 cristine@fmrp.usp.br

Locations
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Brazil
Pauliana Carolina de Souza Mendes Recruiting
Franca, SP, Brazil, 14408060
Contact: Pauliana Mendes    16993649581    doutorapaulianasouza@outlook.com   
Sponsors and Collaborators
University of Sao Paulo
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Responsible Party: Pauliana Carolina de Souza Mendes, Physiotherapist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04159467    
Other Study ID Numbers: 16379919.5.0000.5440
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pauliana Carolina de Souza Mendes, University of Sao Paulo:
Urinary Incontinence
Obesity
Diet
Pelvic floor muscles training
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Signs and Symptoms
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders