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

NCT ID: NCT03400540

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-06-01

Brief 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.

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.

Conditions

Pelvic Floor Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

1. "squeeze the pelvic floor muscles"

2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"

3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."

4. "contract all of the above together"

Group Type: EXPERIMENTAL

verbal instruction

Intervention Type: DIAGNOSTIC_TEST

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.

Group B

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

1. "squeeze the pelvic floor muscles"

2. "squeeze the anus"

3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."

4. "contract all of the above together"

Group Type: EXPERIMENTAL

verbal instruction

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

diagnostic ultrasound assesment

Eligibility Criteria

Inclusion Criteria

• willing to participate in the study

Exclusion Criteria

• pregnancy
• previous abdominal surgeries

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ariel University

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Gali Dar

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gali Dar, PHd

Role: STUDY_DIRECTOR

University of Haifa

Noa Ben-Ami, PhD

Role: STUDY_DIRECTOR

Ariel University

Locations

Ariel University, Department of Physical Therapy

Ariel, , Israel

Countries

Israel

References

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.

Reference Type: RESULT

PMID: 12951667 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26215905 (View on PubMed)

Other Identifiers

AU-NBA-20171221

Identifier Type: -

Identifier Source: org_study_id