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Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

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)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • willing to participate in the study

Exclusion Criteria:

  • none

Sites / Locations

  • Ariel University, Department of Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

verbal instruction

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." ""squeeze the anus" "shorten the penis" "elevate the scrotum"

Outcomes

Primary Outcome Measures

urinary bladder displacement in millimeters during verbal instructions
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2018
Last Updated
September 24, 2018
Sponsor
University of Haifa
Collaborators
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT03507660
Brief Title
Verbal Instruction for Contraction Pelvic Floor Muscles Among Males
Official Title
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
August 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 compare the effectiveness of different verbal instruction on pelvic floor muscle contraction among males. Pelvic floor contraction will be measured via ultrasound.
Detailed Description
This study will examine pelvic floor muscle contraction following six different verbal instructions among males. 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. All participants will be given six 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
Single Group Assignment
Model Description
all participants will receive the same six verbal instruction given in a random order.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verbal instruction
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." ""squeeze the anus" "shorten the penis" "elevate the scrotum"
Intervention Type
Other
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 verbal instructions
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
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
BMI
Description
measured in kg/m^2 and calculated from the reported values of weight and height
Time Frame
baseline
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
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
this research will include male population only
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: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PHd
Organizational Affiliation
University of Haifa
Official's Role
Study Director
Facility Information:
Facility Name
Ariel University, Department of Physical Therapy
City
Ariel
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
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 Access Criteria
according to journal policy
Citations:
PubMed Identifier
26642347
Citation
Stafford RE, Coughlin G, Lutton NJ, Hodges PW. Validity of Estimation of Pelvic Floor Muscle Activity from Transperineal Ultrasound Imaging in Men. PLoS One. 2015 Dec 7;10(12):e0144342. doi: 10.1371/journal.pone.0144342. eCollection 2015.
Results Reference
result

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Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

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