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
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Floor Muscle Weakness||Other: verbal instruction||Not Applicable|
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)|
|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|
Experimental: verbal instruction
The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:
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
- 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
- demographic self reported questionnaire regarding height [ Time Frame: baseline ]height in meters
- demographic self reported questionnaire regarding weight [ Time Frame: baseline ]weight in kilograms
- self reported questionnaire regarding physical activity [ Time Frame: baseline ]number of practice per week
- BMI [ Time Frame: baseline ]measured in kg/m^2 and calculated from the reported values of weight and height
- 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
- 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
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
|Contact: Noa Ben-Ami, PhDfirstname.lastname@example.org|
|Contact: Gali Dar, PhDemail@example.com|
|Ariel University, Department of Physical Therapy||Recruiting|
|Contact: Noa Ben-Ami, PhD 972-54-4989778 firstname.lastname@example.org|
|Study Director:||Gali Dar, PHd||University of Haifa|