ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03325543
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Lower Urinary Tract Symptoms Other: Verbal instruction and Vaginal palpation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation? Protocol of a Randomized Controlled Clinical Trial
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : October 27, 2018
Estimated Study Completion Date : October 27, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Verbal instruction




Primary Outcome Measures :
  1. Electromyography (EMG) [ Time Frame: After 4 weeks of supervised treatment ]
    EMG activity muscles during rest and maximal voluntary contractions (MVCs)


Secondary Outcome Measures :
  1. PFM function [ Time Frame: After 4 weeks of supervised treatment ]
    Vaginal palpation

  2. Posture assessment [ Time Frame: After 4 weeks of supervised treatment ]
    Software SAPO

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325543


Contacts
Contact: Letícia Ferreira 55 11 994001829 leticia_azfe@hotmail.com

Locations
Brazil
Letícia de Azevedo Ferreira
São Paulo, Brazil, 04042005
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Letícia A Ferreira Federal University of São Paulo

Responsible Party: Letícia de Azevedo Ferreira, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03325543     History of Changes
Other Study ID Numbers: 1
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Letícia de Azevedo Ferreira, Federal University of São Paulo:
Urinary Incontinence, Stress
Pelvic Floor
Exercise

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Lower Urinary Tract Symptoms
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders