search
Back to results

What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?

Primary Purpose

Pelvic Floor Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
verbal instruction
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring verbal instruction, pelvic diaphragm, muscle contraction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • willing to participate in the study

Exclusion Criteria:

  • pregnancy
  • previous abdominal surgeries

Sites / Locations

  • Ariel University, Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles" "squeeze and lift the pelvic floor muscles as if stopping the flow of urine" "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." "contract all of the above together"

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles" "squeeze the anus" "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." "contract all of the above together"

Outcomes

Primary Outcome Measures

urinary bladder displacement in millimeters during first verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
urinary bladder displacement in millimeters during second verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
urinary bladder displacement in millimeters during third verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

Secondary Outcome Measures

pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction in each instruction
demographic self reported questionnaire regarding height
height in meters
demographic self reported questionnaire regarding weight
weight in kilograms
self reported questionnaire regarding physical activity
number of practice per week
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
scale range 0-21 points. higher values represent worse outcome
BMI
measured in kg/m^2 and calculated from the reported values of weight and height

Full Information

First Posted
December 29, 2017
Last Updated
June 4, 2018
Sponsor
University of Haifa
Collaborators
Ariel University
search

1. Study Identification

Unique Protocol Identification Number
NCT03400540
Brief Title
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Official Title
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Ariel University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound.
Detailed Description
This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment. A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort. The participants will be divided into 2 groups randomly. Both groups will be given three different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound. To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness
Keywords
verbal instruction, pelvic diaphragm, muscle contraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles" "squeeze and lift the pelvic floor muscles as if stopping the flow of urine" "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." "contract all of the above together"
Arm Title
Group B
Arm Type
Experimental
Arm Description
The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles" "squeeze the anus" "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor." "contract all of the above together"
Intervention Type
Diagnostic Test
Intervention Name(s)
verbal instruction
Other Intervention Name(s)
diagnostic ultrasound assesment
Intervention Description
Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
Primary Outcome Measure Information:
Title
urinary bladder displacement in millimeters during first verbal instruction
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
up to 6 months
Title
urinary bladder displacement in millimeters during second verbal instruction
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
up to 6 months
Title
urinary bladder displacement in millimeters during third verbal instruction
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
pelvic floor muscles endurance of contraction in seconds
Description
time of muscle contraction will be measured during the last contraction in each instruction
Time Frame
up to 6 months
Title
demographic self reported questionnaire regarding height
Description
height in meters
Time Frame
baseline
Title
demographic self reported questionnaire regarding weight
Description
weight in kilograms
Time Frame
baseline
Title
self reported questionnaire regarding physical activity
Description
number of practice per week
Time Frame
baseline
Title
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
Description
scale range 0-21 points. higher values represent worse outcome
Time Frame
baseline
Title
BMI
Description
measured in kg/m^2 and calculated from the reported values of weight and height
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: willing to participate in the study Exclusion Criteria: pregnancy previous abdominal surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PHd
Organizational Affiliation
University of Haifa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noa Ben-Ami, PhD
Organizational Affiliation
Ariel University
Official's Role
Study Director
Facility Information:
Facility Name
Ariel University, Department of Physical Therapy
City
Ariel
ZIP/Postal Code
40700
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
IPD Sharing Time Frame
following completion of data collection
IPD Sharing Access Criteria
according to journal policy
Citations:
PubMed Identifier
12951667
Citation
Bo K, Sherburn M, Allen T. Transabdominal ultrasound measurement of pelvic floor muscle activity when activated directly or via a transversus abdominis muscle contraction. Neurourol Urodyn. 2003;22(6):582-8. doi: 10.1002/nau.10139.
Results Reference
result
PubMed Identifier
26215905
Citation
Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.
Results Reference
result

Learn more about this trial

What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?

We'll reach out to this number within 24 hrs