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

Sponsor
University of Haifa (Other)
Overall Status
Completed
CT.gov ID
NCT03400540
Collaborator
Ariel University (Other)
56
Enrollment
1
Location
2
Arms
4.3
Actual Duration (Months)
13.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: verbal instruction
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Actual Study Start Date :
Jan 22, 2018
Actual Primary Completion Date :
May 23, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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"

Diagnostic Test: 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 Names:
  • diagnostic ultrasound assesment

    		•
    Experimental: Group B

    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"

    Diagnostic Test: 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 Names:
  • diagnostic ultrasound assesment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. urinary bladder displacement in millimeters during first verbal instruction [up to 6 months]

      bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    2. urinary bladder displacement in millimeters during second verbal instruction [up to 6 months]

      bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    3. urinary bladder displacement in millimeters during third verbal instruction [up to 6 months]

      bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    Secondary Outcome Measures

    1. pelvic floor muscles endurance of contraction in seconds [up to 6 months]

      time of muscle contraction will be measured during the last contraction in each instruction

    2. demographic self reported questionnaire regarding height [baseline]

      height in meters

    3. demographic self reported questionnaire regarding weight [baseline]

      weight in kilograms

    4. self reported questionnaire regarding physical activity [baseline]

      number of practice per week

    5. questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form [baseline]

      scale range 0-21 points. higher values represent worse outcome

    6. BMI [baseline]

      measured in kg/m^2 and calculated from the reported values of weight and height

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • willing to participate in the study
    Exclusion Criteria:

    • pregnancy

    • previous abdominal surgeries

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ariel University, Department of Physical Therapy Ariel Israel 40700

    Sponsors and Collaborators

    • University of Haifa
    • Ariel University

    Investigators

    • Study Director: Gali Dar, PHd, University of Haifa
    • Study Director: Noa Ben-Ami, PhD, Ariel University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gali Dar, principal investigator, University of Haifa
    ClinicalTrials.gov Identifier:
    NCT03400540
    Other Study ID Numbers:
    • AU-NBA-20171221
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gali Dar, principal investigator, University of Haifa
    verbal instruction, pelvic diaphragm, muscle contraction
    Additional relevant MeSH terms:
    Muscle Weakness

    Study Results

    No Results Posted as of Jun 6, 2018