NCT05443074

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
OTHER	Face to face intervention group	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).
OTHER	Remote intervention group	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.
OTHER	Control group	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.

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-07-05
• Last updated: 2023-05-23

Locations

1 site across 1 country: Brazil