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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urination Disorders
• Interventions: Other: Verbal instruction and Vaginal palpation

• Registration Number: NCT03325543
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-30
• Study Start: 2017-12-20
• Primary Completion: 2022-11-27
• Study Completion: 2023-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Verbal instruction and Vaginal palpation	The treatment program is based on the motor learning concepts of PFMs. The steps of learning a correct muscle contraction will be separate into four levels: 1. Understand 2. Search 3. Find 4. Learn. Feedback from the PF is mandatory. The intervention program will last four weeks, and will contain four outpatient consultations (1 session per week) lasting 60 minutes each session.
Control Group	Verbal instruction and Vaginal palpation	The control group will receive only verbal instructions about the anatomy and function of the PFM, and to perform the contraction of the PFMs.

Primary Outcome Measures

Name	Time	Method
Number of fast muscle fibres	After 4 weeks of supervised treatment	Vaginal palpation (fast and with full force contraction, 1 second each)

Secondary Outcome Measures

Name	Time	Method
PFM function	After 4 weeks of supervised treatment	Vaginal palpation
Occurrence of associated contractions	After 4 weeks of supervised treatment	Contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM
Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises	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.

Trial Locations

Locations (1)

Letícia de Azevedo Ferreira; 🇧🇷 São Paulo, Brazil