Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

NCT03507660 | Completed

• 1 other identifier: AU-NBA-20180315
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Weakness

Keywords

verbal instruction, pelvic diaphragm, muscle contraction

Outcome Measures

Primary Outcomes (1)

• urinary bladder displacement in millimeters during verbal instructions

  bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

  up to 6 months

Secondary Outcomes (6)

• demographic self reported questionnaire regarding height

  baseline

• demographic self reported questionnaire regarding weight

  baseline

• self reported questionnaire regarding physical activity

  baseline

• BMI

  baseline

• pelvic floor muscles endurance of contraction in seconds

  up to 6 months

Study Arms (1)

verbal instruction

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. ""squeeze the anus" 5. "shorten the penis" 6. "elevate the scrotum"

Other: verbal instruction

Interventions

verbal instruction 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.

Also known as: diagnostic ultrasound assesment

verbal instruction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: this research will include male population only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• willing to participate in the study

You may not qualify if:

• none

Sponsors & Collaborators

• University of Haifa: lead
• Ariel University: collaborator

Study Sites (1)

Ariel University, Department of Physical Therapy

Ariel, Israel

Location

Related Publications (1)

• 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.

  PMID: 26642347 RESULT

Study Officials

• Gali Dar, PHd

  University of Haifa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior lecturer

Model Details: all participants will receive the same six verbal instruction given in a random order.

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: April 25, 2018
• Study Start: May 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
• Access Criteria: according to journal policy

Locations

IL (1)