Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

NCT ID: NCT03507660

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-08-01

Brief 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.

Detailed 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.

Conditions

Pelvic Floor Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

verbal instruction

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. ""squeeze the anus"

5. "shorten the penis"

6. "elevate the scrotum"

Group Type: EXPERIMENTAL

verbal instruction

Intervention Type: OTHER

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: OTHER

Other Intervention Names

diagnostic ultrasound assesment

Eligibility Criteria

Inclusion Criteria

• willing to participate in the study

Exclusion Criteria

• none

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

Sponsors

Ariel University

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Gali Dar

senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gali Dar, PHd

Role: STUDY_DIRECTOR

University of Haifa

Locations

Ariel University, Department of Physical Therapy

Ariel, , Israel

Countries

Israel

References

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.

Reference Type: RESULT

PMID: 26642347 (View on PubMed)

Other Identifiers

AU-NBA-20180315

Identifier Type: -

Identifier Source: org_study_id