CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled / 92 target
Drug / intervention
Face to face intervention group +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05443074
NCT05443074N/ACompletedHigh Momentum (2.4/mo)Completion was 9mo ago

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

University of Sao Paulo·interventional·Posted Jul 5, 2022·Updated Jun 24, 2026

In Brief

A clinical study evaluating Face to face intervention group, Remote intervention group, and 1 other intervention for Urinary Incontinence. Completed, enrolled 92 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 5, 2022
Enrollment StartApr 12, 2023
Primary CompletionSep 22, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.0 years ago

Arms & Interventions

Face to face intervention groupactive_comparator

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

Other: Face to face intervention group
Remote intervention groupexperimental

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

Other: Remote intervention group
Control groupactive_comparator

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

Interventions

Face to face intervention groupother

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).

Remote intervention groupother

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.

Control groupother

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.