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Completed

NCT Number: NCT03507660

Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ariel University, Department of Physical Therapy

Ariel, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • willing to participate in the study

Exclusion criteria

  • none

Treatment and study plan

verbal instruction

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ariel University

Registry information

Official study title

What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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