Clinical trial NCT03507660: Verbal Instruction for Contraction Pelvic Floor Muscles Among Males
Official title: What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Keywords: verbal instruction, pelvic diaphragm, muscle contraction
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ariel University
First posted: 2018-04-25
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants will receive the same six verbal instruction given in a random order.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* willing to participate in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: urinary bladder displacement in millimeters during verbal instructions
timeFrame: up to 6 months
Secondary outcomes:
measure: demographic self reported questionnaire regarding height
timeFrame: baseline
measure: demographic self reported questionnaire regarding weight
timeFrame: baseline
measure: self reported questionnaire regarding physical activity
timeFrame: baseline
measure: BMI
timeFrame: baseline
measure: pelvic floor muscles endurance of contraction in seconds
timeFrame: up to 6 months
measure: questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
timeFrame: baseline
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University, Department of Physical Therapy
Study officials:
affiliation: University of Haifa
name: Gali Dar, PHd
role: STUDY_DIRECTOR
References:
citation: 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.