Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

Pelvic Floor Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507660
• Other study ID #: AU-NBA-20180315
• Status: Completed
• Phase: N/A
• 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
• 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:

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness

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