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.
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.
This study will determine whether vaginal palpation can help women with SUI to correctly perform PFM contractions and improve their functions.
ClinicalTrials.gov NCT03325543 . Registered on 30 November 2017. Study protocol version 1; 30 November 2020. Prospectively registered.
Trials. 2020 Jul 31*** epublish ***
Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini, Rodrigo Aquino Castro
Department of Gynaecology, Federal University of Sao Paulo (UNIFESP), Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil. ., Department of Gynaecology, Federal University of Sao Paulo (UNIFESP), Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.