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

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ClinicalTrials.gov Identifier: NCT03325543
Recruitment Status : Unknown
Verified November 2017 by Letícia de Azevedo Ferreira, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Letícia de Azevedo Ferreira, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE October 16, 2017
First Posted Date  ICMJE October 30, 2017
Last Update Posted Date December 4, 2017
Estimated Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date October 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Electromyography (EMG) [ Time Frame: After 4 weeks of supervised treatment ]
EMG activity muscles during rest and maximal voluntary contractions (MVCs)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03325543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • PFM function [ Time Frame: After 4 weeks of supervised treatment ]
    Vaginal palpation
  • Posture assessment [ Time Frame: After 4 weeks of supervised treatment ]
    Software SAPO
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?
Official Title  ICMJE Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation? Protocol of a Randomized Controlled Clinical Trial
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Incontinence
  • Urinary Incontinence, Stress
  • Urination Disorders
  • Lower Urinary Tract Symptoms
Intervention  ICMJE 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 Name: Verbal instruction
Study Arms  ICMJE
  • 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.
    Intervention: Other: Verbal instruction and Vaginal palpation
  • 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.
    Intervention: Other: Verbal instruction and Vaginal palpation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 27, 2018
Estimated Primary Completion Date October 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03325543
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Letícia de Azevedo Ferreira, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Letícia A Ferreira Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP