NCT03325543

Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?

Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation? Protocol of a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The pelvic floor muscle training (PFMT) is a conservative treatment, currently considered as first line for women with stress urinary incontinence (SUI). However, in practice, about 30 to 50% of women are unable to perform the correct contraction of the pelvic floor muscles (PFMs). When requested to perform the muscle contraction, the contraction of the gluteal muscles, hip adductors, or abdominal muscles is observed initially, rather of contraction of the levator anus muscle. Some factors make it difficult to perform the contraction of the PFM, such as its location on the pelvic floor, and its small size, followed by a lack of knowledge of the pelvic region, as well as its functions. Associated with these factors is the use of the muscles adjacent to the PFM, as previously mentioned. In order for women to benefit from a PFMT program for the treatment of SUI, the awareness phase of PFM can't be omitted, since the literature is unanimous in stating that pelvic exercises improve the recruitment capacity of the musculature, its tone and reflex coordination during the effort activities.

Detailed description

Research Questions: The objectives of this study is to test the hypothesis that the provision of verbal instructions about the anatomy and function of PFMs associated with the use of body techniques awareness and vaginal palpation helps in learning the correct contraction and improves the function of the PFMs. Design: A single-centered, double-blind (investigator and outcome assessor) randomised controlled trial with two physiotherapy intervention groups. Measurements: The primary outcome measure will be the number of fast muscle fibres, as determined by the number of effective contractions (fast and with full force contraction, 1 second each) out of ten contractions performed. The secondary outcome measure will be the PFM function (vaginal palpation and visual observation), the occurrence of associated contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM , and self-efficacy scale for practising PFM exercises.

Conditions

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urination Disorders
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
OTHER	Visual observation	Verbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction
OTHER	Vaginal palpation (bidigital touch)	The physiotherapist touched the patients' perineal region (vulva, tendinous centre of the perineum and external region of the anal canal) with a spatula and asked them to identify the pointed region; and with the digital palpation, the physiotherapist touched the tendinous centre of the perineum, pressing it in the cranial direction, and instructed the patients to contract the pelvic floor muscle

Timeline

• Start date: 2017-12-20
• Primary completion: 2022-11-27
• Completion: 2023-07-31
• First posted: 2017-10-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: Brazil