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Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Face to face intervention group
Remote intervention group
Control group
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

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who are not able to contract their PFM (≤ 2 of Modified Oxford Scale);
  • Cognitive ability, hearing and visual acuity preserved (through 10-point cognitive screener and Snellen test, respectively);
  • Non-neurogenic UI;
  • No history of neurological disorders;
  • No symptoms of a vaginal or urinary tract infection;
  • Pelvic organ prolapse ≤2 (according to the Baden and Walker scale);
  • Who have not already been instructed on how to perform PFM contraction or who is not already performing PFM training;
  • No suspected or confirmed pregnancy.

Exclusion Criteria:

  • Who have intolerance to physical examination, or latex allergy;
  • Who withdraws from participating in the study.

Sites / Locations

  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Face to face intervention group

Remote intervention group

Control group

Arm Description

This group will be composed of participants who will receive face to face physiotherapy instruction session.

This group will be composed of participants who will receive real time remote physiotherapy instruction session.

This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study.

Outcomes

Primary Outcome Measures

Change in contraction capacity
The Modified Oxford Scale will be used to assess change in the capacity to perform a PFM contraction through vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Change in self-perception of the PFM
The Modified Oxford Scale will be used to assess change in the participants' self-perception of their contraction after vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.

Secondary Outcome Measures

Self-report of UI symptoms
Reports of UI symptoms will be evaluated through the International Consultation on Incontinence Questionnaire - Short Form. Participants who report having had no urinary leakage in the last four weeks will be considered continents. The International Consultation on Incontinence Questionnaire score can range from 0 (when there is no report of urinary leakage, with no impact on quality of life) to 21 (highest in UI severity and maximum impact on quality of life).
Assessment of the usefulness of teaching resources
The usefulness of teaching resources will be evaluated by the numerical visual scale and by a questionnaire developed by the researchers. In the post-intervention evaluation of face to face intervention group and remote intervention group, the numerical visual scale and the questionnaire will be presented to the participants and then they will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction/usefulness of the resources. Scores closer to 0 correspond to no satisfaction with the resources used in the instruction session about pelvic floor and scores closer to 10 correspond to satisfaction with the resources used.
Satisfaction with the orientations
Satisfaction with the instructions received during the session will be evaluated by the numerical visual scale. In the post-intervention evaluation, face to face intervention group and remote intervention group will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction with the guidelines given in the session. Scores closer to 0 correspond to no satisfaction with the instruction received during session about pelvic floor and scores closer to 10 correspond to satisfaction with the instruction received during session about pelvic floor.
System usability assessment
The usability of the system used to carry out the remote intervention group session will be evaluated through the systems usability scale. The system usability assessment score can range from 0 (the lower the score, the greater the usability problems of the system used) to 100 (the higher the score, the lower the usability problems of the system used).

Full Information

First Posted
May 24, 2022
Last Updated
May 22, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05443074
Brief Title
Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence
Official Title
Efficacy of a Face-to-face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in the Pelvic Floor Muscle Capacity of Incontinent Women: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Face to face intervention group
Arm Type
Active Comparator
Arm Description
This group will be composed of participants who will receive face to face physiotherapy instruction session.
Arm Title
Remote intervention group
Arm Type
Experimental
Arm Description
This group will be composed of participants who will receive real time remote physiotherapy instruction session.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study.
Intervention Type
Other
Intervention Name(s)
Face to face intervention group
Intervention Description
Participants of this group will participate in a one 15 minutes face to face session where they will receive information about anatomy, functions and dysfunctions of the pelvic floor. During the session, some teaching materials will be used (an anatomical model, prototype simulator of the functions of the PFM, posters, videos and images), in order to facilitate the learning of women about how to contract their PFM and how to avoid urinary loss by contracting their muscles. At the end of the session, the participants will have time to ask their questions and will receive a home booklet reinforcing the information given during the session including instructions for them to perform a PFM contraction during daily live situations that generate an increased intra-abdominal pressure, such as coughing, sneezing, weight lifting and other activities, as well as strategies to inhibit urge urinary incontinence (UI).
Intervention Type
Other
Intervention Name(s)
Remote intervention group
Intervention Description
Participants of this group will be referred to a room with a computer (inside the rehabilitation center) to participate in a one 15 minutes real time remote session, where they will receive information about anatomy, functions and dysfunctions of the pelvic floor. During the session, some teaching materials will be used (an anatomical model, prototype simulator of the functions of the PFM, posters, videos and images), in order to facilitate the learning of women about how to contract their PFM and how to avoid urinary loss by contracting their muscles. At the end of the session, the participants will have time to ask their questions and will receive a home booklet reinforcing the information given during the session including instructions for them to perform a PFM contraction during daily live situations that generate an increased intra-abdominal pressure, such as coughing, sneezing, weight lifting and other activities, as well as strategies to inhibit urge UI.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Participants of this group will be assessed in the same time points of the participants of the two other groups. They will not receive any intervention or information about pelvic floor anatomy, functions and dysfunctions of the pelvic floor, however after the last assessment (20 days after) for ethical reasons they will receive the same intervention.
Primary Outcome Measure Information:
Title
Change in contraction capacity
Description
The Modified Oxford Scale will be used to assess change in the capacity to perform a PFM contraction through vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Time Frame
At baseline, immediately after intervention and 20 days after the intervention.
Title
Change in self-perception of the PFM
Description
The Modified Oxford Scale will be used to assess change in the participants' self-perception of their contraction after vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Time Frame
At baseline, immediately after intervention and 20 days after the intervention.
Secondary Outcome Measure Information:
Title
Self-report of UI symptoms
Description
Reports of UI symptoms will be evaluated through the International Consultation on Incontinence Questionnaire - Short Form. Participants who report having had no urinary leakage in the last four weeks will be considered continents. The International Consultation on Incontinence Questionnaire score can range from 0 (when there is no report of urinary leakage, with no impact on quality of life) to 21 (highest in UI severity and maximum impact on quality of life).
Time Frame
At baseline and 20 days after the intervention.
Title
Assessment of the usefulness of teaching resources
Description
The usefulness of teaching resources will be evaluated by the numerical visual scale and by a questionnaire developed by the researchers. In the post-intervention evaluation of face to face intervention group and remote intervention group, the numerical visual scale and the questionnaire will be presented to the participants and then they will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction/usefulness of the resources. Scores closer to 0 correspond to no satisfaction with the resources used in the instruction session about pelvic floor and scores closer to 10 correspond to satisfaction with the resources used.
Time Frame
Immediately after intervention
Title
Satisfaction with the orientations
Description
Satisfaction with the instructions received during the session will be evaluated by the numerical visual scale. In the post-intervention evaluation, face to face intervention group and remote intervention group will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction with the guidelines given in the session. Scores closer to 0 correspond to no satisfaction with the instruction received during session about pelvic floor and scores closer to 10 correspond to satisfaction with the instruction received during session about pelvic floor.
Time Frame
Immediately after intervention
Title
System usability assessment
Description
The usability of the system used to carry out the remote intervention group session will be evaluated through the systems usability scale. The system usability assessment score can range from 0 (the lower the score, the greater the usability problems of the system used) to 100 (the higher the score, the lower the usability problems of the system used).
Time Frame
Immediately after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who are not able to contract their PFM (≤ 2 of Modified Oxford Scale); Cognitive ability, hearing and visual acuity preserved (through 10-point cognitive screener and Snellen test, respectively); Non-neurogenic UI; No history of neurological disorders; No symptoms of a vaginal or urinary tract infection; Pelvic organ prolapse ≤2 (according to the Baden and Walker scale); Who have not already been instructed on how to perform PFM contraction or who is not already performing PFM training; No suspected or confirmed pregnancy. Exclusion Criteria: Who have intolerance to physical examination, or latex allergy; Who withdraws from participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline C Pena
Phone
+5519995017000
Email
carolinecpena@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristine H Jorge
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14026956
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristine H Jorge
Email
cristine@fmrp.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence

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