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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Muscle Weakness
• Intervention / Treatment: Diagnostic test: verbal instruction

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel, 40700
    • Ariel University, Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• willing to participate in the study

Exclusion Criteria:

• pregnancy
• previous abdominal surgeries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles"; "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"; "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."; "contract all of the above together"	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.; Other Names: diagnostic ultrasound assesment
Experimental: Group B; The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences: "squeeze the pelvic floor muscles"; "squeeze the anus"; "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."; "contract all of the above together"	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.; Other Names: diagnostic ultrasound assesment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic self reported questionnaire regarding height	height in meters	baseline
demographic self reported questionnaire regarding weight	weight in kilograms	baseline
self reported questionnaire regarding physical activity	number of practice per week	baseline
BMI	measured in kg/m^2 and calculated from the reported values of weight and height	baseline
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
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form	scale range 0-21 points. higher values represent worse outcome	baseline

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Ariel University
• Investigators: Study Director: Noa Ben-Ami, PhD, Ariel University

Publications and helpful links

General Publications

• Bo 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. doi: 10.1002/nau.10139.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): May 23, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: verbal instruction, pelvic diaphragm, muscle contraction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: AU-NBA-20171221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
• IPD Sharing Time Frame: following completion of data collection
• IPD Sharing Access Criteria: according to journal policy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No