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Published in: Trials 1/2020

01-12-2020 | Stress Incontinence | Study protocol

The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial

Authors: Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini, Rodrigo Aquino Castro

Published in: Trials | Issue 1/2020

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Abstract

Background

Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinence (SUI), the awareness phase of PFMT cannot be omitted. The purpose of this study is to evaluate whether vaginal palpation together with verbal instructions about PFMs and body awareness techniques helps women with SUI learn how to correctly contract the PFMs and improve their functions.

Methods

This single-centre, double-blind randomized controlled trial with two intervention groups was designed following the standard protocol items for randomized interventional trials (SPIRIT). The results will be reported in a manner consistent with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Patients with SUI (n = 172) will be recruited. The experimental group will receive verbal instructions about PFM function and body awareness techniques together with vaginal palpation; the control group will receive similar protocol without vaginal palpation. The primary outcome includes the number of fast-twitch muscle fibres assessed by vaginal palpation and visual observation. Secondary outcomes include power and muscular endurance that will be assessed by visual observation and vaginal palpation (Oxford scale), the use of accessory muscles during the voluntary contraction of PFMs, and the self-efficacy and the expectations for the results using the self-efficacy scale of pelvic floor exercises.

Discussion

This study will determine whether vaginal palpation can help women with SUI to correctly perform PFM contractions and improve their functions.

Trial registration

ClinicalTrials.gov NCT 03325543. Registered on 30 November 2017. Study protocol version 1; 30 November 2020. Prospectively registered.
Appendix
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Metadata
Title
The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial
Authors
Letícia de Azevedo Ferreira
Fátima Faní Fitz
Márcia Maria Gimenez
Mayanni Magda Pereira Matias
Maria Augusta Tezelli Bortolini
Rodrigo Aquino Castro
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04624-4

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