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

NCT03400540 | Completed

• 1 other identifier: AU-NBA-20171221
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Weakness

Keywords

verbal instruction, pelvic diaphragm, muscle contraction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• pelvic floor muscles endurance of contraction in seconds

  up to 6 months

• demographic self reported questionnaire regarding height

  baseline

• demographic self reported questionnaire regarding weight

  baseline

• self reported questionnaire regarding physical activity

  baseline

• questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form

  baseline

Study Arms (2)

Group A

EXPERIMENTAL

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"

Diagnostic Test: verbal instruction

Group B

EXPERIMENTAL

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"

Diagnostic Test: verbal instruction

Interventions

verbal instruction 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.

Also known as: diagnostic ultrasound assesment

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• willing to participate in the study

You may not qualify if:

• pregnancy
• previous abdominal surgeries

Sponsors & Collaborators

• University of Haifa: lead
• Ariel University: collaborator

Study Sites (1)

Ariel University, Department of Physical Therapy

Ariel, 40700, Israel

Location

Related Publications (2)

• 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.

  PMID: 12951667 RESULT

• 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.

  PMID: 26215905 RESULT

Study Officials

• Gali Dar, PHd

  University of Haifa

  STUDY DIRECTOR

• Noa Ben-Ami, PhD

  Ariel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 17, 2018
• Study Start: January 22, 2018
• Primary Completion: May 23, 2018
• Study Completion: June 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: following completion of data collection
• Access Criteria: according to journal policy

Locations

IL (1)