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Completed

NCT Number: NCT03325543

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

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.

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Key information

Conditions

Urinary Incontinence Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Letícia de Azevedo Ferreira

São Paulo, 04042005, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with predominance of SUI symptoms and ≥ 2 g leakage measured by pad test and without capability to contract the PFM properly

Exclusion criteria

  • Not included if they were younger than 18 years old, had chronic degenerative diseases, pelvic organ prolapse greater than stage I by POP-Q, neurologic or psychiatric diseases, ability to contract PFMs, had previous pelvic floor re-education programs and/or pelvic floor surgeries

Treatment and study plan

Visual observation

Other

Verbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction

Vaginal palpation (bidigital touch)

Other

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

Primary outcomes

  1. Number of fast muscle fibres

    Time frame: After 4 weeks of supervised treatment

    Vaginal palpation (fast and with full force contraction, 1 second each)

Secondary outcomes

  1. PFM function

    Time frame: After 4 weeks of supervised treatment

    Vaginal palpation

  2. Occurrence of associated contractions

    Time frame: After 4 weeks of supervised treatment

    Contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM

  3. Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises

    Time frame: Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.

    The scale is composed of 17 questions in the visual analogue scale format with responses ranging from 0 (not confident) to 100 (most confident). Thirteen questions refer to self-efficacy and four questions to expectation of results. The final result is obtained by averaging the items, which ranges from 0 to 100, where higher values are equivalent to more beneficial action of self-efficacy / expected result of the training of the PFM.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Oct 30, 2017
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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