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

Primary Purpose

Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Verbal instruction and Vaginal palpation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Stress, Pelvic Floor, Exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Letícia de Azevedo Ferreira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

The control group will receive only verbal instructions about the anatomy and function of the PFM, and to perform the contraction of the PFMs.

Outcomes

Primary Outcome Measures

Electromyography (EMG)
EMG activity muscles during rest and maximal voluntary contractions (MVCs)

Secondary Outcome Measures

PFM function
Vaginal palpation
Posture assessment
Software SAPO
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.

Full Information

First Posted
October 16, 2017
Last Updated
November 30, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03325543
Brief Title
Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
October 27, 2018 (Anticipated)
Study Completion Date
October 27, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Lower Urinary Tract Symptoms
Keywords
Urinary Incontinence, Stress, Pelvic Floor, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Verbal instruction and Vaginal palpation
Other Intervention Name(s)
Verbal instruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyography (EMG)
Description
EMG activity muscles during rest and maximal voluntary contractions (MVCs)
Time Frame
After 4 weeks of supervised treatment
Secondary Outcome Measure Information:
Title
PFM function
Description
Vaginal palpation
Time Frame
After 4 weeks of supervised treatment
Title
Posture assessment
Description
Software SAPO
Time Frame
After 4 weeks of supervised treatment
Title
Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises
Description
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.
Time Frame
Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Letícia Ferreira
Phone
55 11 994001829
Email
leticia_azfe@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Letícia A Ferreira
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Letícia de Azevedo Ferreira
City
São Paulo
ZIP/Postal Code
04042005
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32736576
Citation
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.
Results Reference
derived

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

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