Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

Not Applicable

Completed

• Conditions: Pelvic Floor Muscle Weakness
• Interventions: Other: verbal instruction

• Registration Number: NCT03507660
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-25
• Study Start: 2018-05-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-08-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

• willing to participate in the study

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
verbal instruction	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"

Primary Outcome Measures

Name	Time	Method
urinary bladder displacement in millimeters during verbal instructions	up to 6 months	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

Secondary Outcome Measures

Name	Time	Method
demographic self reported questionnaire regarding height	baseline	height in meters
demographic self reported questionnaire regarding weight	baseline	weight in kilograms
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form	baseline	scale range 0-21 points. higher values represent worse outcome
self reported questionnaire regarding physical activity	baseline	number of practice per week
BMI	baseline	measured in kg/m\^2 and calculated from the reported values of weight and height
pelvic floor muscles endurance of contraction in seconds	up to 6 months	time of muscle contraction will be measured during the last contraction in each instruction

Trial Locations

Locations (1)

Ariel University, Department of Physical Therapy; 🇮🇱 Ariel, Israel