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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03507660
Other study ID # AU-NBA-20180315
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date August 1, 2018

Study information

Verified date September 2018
Source University of Haifa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- willing to participate in the study

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Israel Ariel University, Department of Physical Therapy Ariel

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa Ariel University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary urinary bladder displacement in millimeters during verbal instructions bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool up to 6 months
Secondary demographic self reported questionnaire regarding height height in meters baseline
Secondary demographic self reported questionnaire regarding weight weight in kilograms baseline
Secondary self reported questionnaire regarding physical activity number of practice per week baseline
Secondary BMI measured in kg/m^2 and calculated from the reported values of weight and height baseline
Secondary pelvic floor muscles endurance of contraction in seconds time of muscle contraction will be measured during the last contraction in each instruction up to 6 months
Secondary questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form scale range 0-21 points. higher values represent worse outcome baseline
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