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

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.

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms; Urinary Incontinence; Urination Disorders; Urinary Incontinence, Stress
• Intervention / Treatment: Other: Verbal instruction and Vaginal palpation

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 EMG activity of the PFMs, gluteus maximus, hip adductor, and the group formed by the abdominal transverse (TrA) and internal oblique (IO) muscles during rest and maximal voluntary contractions (MVCs). The secondary outcome measure will be the PFM function (vaginal palpation and visual observation), posture assessment (software SAPO), and self-efficacy scale for practising PFM exercises.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Letícia Ferreira; Phone Number: 55 11 994001829; Email: leticia_azfe@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04042005
    • Letícia de Azevedo Ferreira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; 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.	Other: Verbal instruction and Vaginal palpation; The experimental group will receive verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques and vaginal palpation to learn the correct PFMs contraction. The control group will receive only verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques.; Other Names: Verbal instruction
ACTIVE_COMPARATOR: Control Group; The control group will receive only verbal instructions about the anatomy and function of the PFM, and to perform the contraction of the PFMs.	Other: Verbal instruction and Vaginal palpation; The experimental group will receive verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques and vaginal palpation to learn the correct PFMs contraction. The control group will receive only verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques.; Other Names: Verbal instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography (EMG)	EMG activity muscles during rest and maximal voluntary contractions (MVCs)	After 4 weeks of supervised treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFM function	Vaginal palpation	After 4 weeks of supervised treatment
Posture assessment	Software SAPO	After 4 weeks of supervised treatment
Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises	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.	Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Letícia A Ferreira, Federal University of São Paulo

Publications and helpful links

General Publications

• de Azevedo Ferreira L, Fitz FF, Gimenez MM, Matias MMP, Bortolini MAT, Castro RA. 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. Trials. 2020 Jul 31;21(1):693. doi: 10.1186/s13063-020-04624-4.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2017
• Primary Completion (ANTICIPATED): October 27, 2018
• Study Completion (ANTICIPATED): October 27, 2018

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Urinary Incontinence, Stress; Pelvic Floor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urological Manifestations; Elimination Disorders; Urinary Incontinence; Lower Urinary Tract Symptoms; Enuresis; Urinary Incontinence, Stress; Urination Disorders
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No