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Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

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ClinicalTrials.gov Identifier: NCT03507660
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Ariel University
Information provided by (Responsible Party):
Gali Dar, University of Haifa

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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Weakness Other: verbal instruction Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: all participants will receive the same six verbal instruction given in a random order.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Arm Intervention/treatment
Experimental: verbal instruction

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

  1. "squeeze the pelvic floor muscles".
  2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"
  3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."
  4. ""squeeze the anus"
  5. "shorten the penis"
  6. "elevate the scrotum"
Other: verbal instruction
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.
Other Name: diagnostic ultrasound assesment




Primary Outcome Measures :
  1. urinary bladder displacement in millimeters during verbal instructions [ Time Frame: up to 6 months ]
    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool


Secondary Outcome Measures :
  1. demographic self reported questionnaire regarding height [ Time Frame: baseline ]
    height in meters

  2. demographic self reported questionnaire regarding weight [ Time Frame: baseline ]
    weight in kilograms

  3. self reported questionnaire regarding physical activity [ Time Frame: baseline ]
    number of practice per week

  4. BMI [ Time Frame: baseline ]
    measured in kg/m^2 and calculated from the reported values of weight and height

  5. pelvic floor muscles endurance of contraction in seconds [ Time Frame: up to 6 months ]
    time of muscle contraction will be measured during the last contraction in each instruction

  6. questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form [ Time Frame: baseline ]
    scale range 0-21 points. higher values represent worse outcome



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   this research will include male population only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • willing to participate in the study

Exclusion Criteria:


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): NCT03507660


Contacts
Contact: Noa Ben-Ami, PhD 972-54-4989778 djba@bezeqint.net
Contact: Gali Dar, PhD 972-5-662054 galidar@yahoo.com

Locations
Israel
Ariel University, Department of Physical Therapy Recruiting
Ariel, Israel
Contact: Noa Ben-Ami, PhD    972-54-4989778    djba@bezeqint.net   
Sponsors and Collaborators
University of Haifa
Ariel University
Investigators
Study Director: Gali Dar, PHd University of Haifa

Publications of Results:
Responsible Party: Gali Dar, senior lecturer, University of Haifa
ClinicalTrials.gov Identifier: NCT03507660     History of Changes
Other Study ID Numbers: AU-NBA-20180315
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
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.
Access Criteria: according to journal policy
URL: http://

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

Keywords provided by Gali Dar, University of Haifa:
verbal instruction, pelvic diaphragm, muscle contraction

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms