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

Pelvic Floor Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400540
• Other study ID #: AU-NBA-20171221
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: June 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 1, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• willing to participate in the study

Exclusion Criteria:

• pregnancy

• previous abdominal surgeries

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness

Intervention

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.

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 (2)

Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28. — View Citation

Bø K, Sherburn M, Allen T. Transabdominal ultrasound measurement of pelvic floor muscle activity when activated directly or via a transversus abdominis muscle contraction. Neurourol Urodyn. 2003;22(6):582-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary bladder displacement in millimeters during first verbal instruction	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	up to 6 months
Primary	urinary bladder displacement in millimeters during second verbal instruction	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	up to 6 months
Primary	urinary bladder displacement in millimeters during third verbal instruction	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	up to 6 months
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	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	questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form	scale range 0-21 points. higher values represent worse outcome	baseline
Secondary	BMI	measured in kg/m^2 and calculated from the reported values of weight and height	baseline