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

Primary Purpose

Urinary Incontinence, Obesity, Strength; Pelvic Floor

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Obesity, Diet, Pelvic floor muscles training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Pauliana Carolina de Souza MendesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1- diet therapy (control)

Grupo 2 - low calorie diet + PFMT (experimental)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Participants' adherence to the PFMT protocol
Will be assessed using an exercise diary and the complier average causal effects (CACE) method
PFM function
the modified Oxford grading scale- MOS (digital vaginal palpation)
participants self-perception of their PFM function
women´s self-perception of their PFM function according to the MOS categories
Satisfaction with treatment
Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction
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 ?
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?

Full Information

First Posted
October 21, 2019
Last Updated
October 3, 2022
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04159467
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
August 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Obesity, Strength; Pelvic Floor
Keywords
Urinary Incontinence, Obesity, Diet, Pelvic floor muscles training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1- diet therapy (control)
Arm Type
Active Comparator
Arm 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.
Arm Title
Grupo 2 - low calorie diet + PFMT (experimental)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
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 Measure Information:
Title
Self report of urinary incontinence by women
Description
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.
Time Frame
Women will be evaluated at baseline
Title
Severity and impact of Urinary incontinence in women´s quality of life
Description
the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score
Time Frame
Women will be evaluated at baseline
Secondary Outcome Measure Information:
Title
Participants' adherence to the PFMT protocol
Description
Will be assessed using an exercise diary and the complier average causal effects (CACE) method
Time Frame
Women will be evaluated at baseline and right after 12 weeks
Title
PFM function
Description
the modified Oxford grading scale- MOS (digital vaginal palpation)
Time Frame
Women will be evaluated at baseline
Title
participants self-perception of their PFM function
Description
women´s self-perception of their PFM function according to the MOS categories
Time Frame
Women will be evaluated at baseline
Title
Satisfaction with treatment
Description
Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction
Time Frame
only after 12 weeks from the baseline assessment
Title
Subjective satisfaction with treatment
Description
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 ?
Time Frame
only after 12 weeks from the baseline assessment
Title
Identification of barriers for the treatment
Description
Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?
Time Frame
only after 12 weeks from the baseline assessment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauliana CS Mendes
Phone
+55 16 99364-9581
Email
doutorapaulianasouza@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cristine HJ Ferreira
Phone
+55 16 99621-7919
Email
cristine@fmrp.usp.br
Facility Information:
Facility Name
Pauliana Carolina de Souza Mendes
City
Franca
State/Province
SP
ZIP/Postal Code
14408060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauliana Mendes
Phone
16993649581
Email
doutorapaulianasouza@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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