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

NCT05443074 | Completed DMC

• 1 other identifier: 52672521.0.0000.5440
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Self-report of UI symptoms

  At baseline and 20 days after the intervention.

• Assessment of the usefulness of teaching resources

  Immediately after intervention

• Satisfaction with the orientations

  Immediately after intervention

• System usability assessment

  Immediately after intervention

Study Arms (3)

Face to face intervention group

ACTIVE 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 group

EXPERIMENTAL

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

Other: Remote intervention group

Control group

ACTIVE 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 group OTHER

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).

Face to face intervention group

Remote intervention group OTHER

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.

Remote intervention group

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14026956, Brazil

Location

Related Publications (23)

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  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cristine H Jorge

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: July 5, 2022
• Study Start: April 12, 2023
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)