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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Face to face intervention group
* Other: Remote intervention group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face to face intervention group<br>This group will be composed of participants who will receive face to face physiotherapy instruction session. | Other: Face to face intervention group<br>* 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).<br>|
| Experimental: Remote intervention group<br>This group will be composed of participants who will receive real time remote physiotherapy instruction session. | Other: Remote intervention group<br>* 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.<br>|
| Active Comparator: Control group<br>This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study. | Other: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, immediately after intervention and 20 days after the intervention. | 
| 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. | At baseline, immediately after intervention and 20 days after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | At baseline and 20 days after the intervention. | 
| 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. | Immediately after intervention | 
| 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. | Immediately after intervention | 
| 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). | Immediately after intervention |