NCT03325543

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

Completed NA Last updated 30 July 2025

What this trial tests

NA trial testing Visual observation in Urinary Incontinence in 176 participants. Completed in 31 July 2023.

Timeline

20 December 2017

Primary endpoint
27 November 2022

31 July 2023

Quick facts

Lead sponsor	Federal University of São Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	176
Start date	20 December 2017
Primary completion	27 November 2022
Estimated completion	31 July 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Visual observation
• Vaginal palpation (bidigital touch)

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →
• Urinary Incontinence, Stress — all drugs for Urinary Incontinence, Stress →
• Urination Disorders — all drugs for Urination Disorders →
• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →

Sponsor

Federal University of São Paulo

Who can join

Adults 18 to 80, female only, with Urinary Incontinence or Urinary Incontinence, Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.
   Fernandes ACN, Jorge CH, Weatherall M, Ribeiro IV, et al · · 2025 · cited 6× · PMID 40066950 · DOI 10.1002/14651858.cd009252.pub2
2. 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.
   de Azevedo Ferreira L, Fitz FF, Gimenez MM, Matias MMP, et al · · 2020 · cited 2× · PMID 32736576 · DOI 10.1186/s13063-020-04624-4