An interventional study of verbal instruction in Pelvic Floor Muscle Weakness, sponsored by University of Haifa. Completed at 1 site in Israel. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University of Haifa · Not applicable, Interventional, and Treatment
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.
This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. 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.
The participants will be divided into 2 groups randomly. Both groups will be given three 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.
Exclusion Criteria:
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
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
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
urinary bladder displacement in millimeters during first verbal instruction
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time frame: 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
Time frame: 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
Time frame: up to 6 months
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction in each instruction
Time frame: up to 6 months
demographic self reported questionnaire regarding height
height in meters
Time frame: baseline
demographic self reported questionnaire regarding weight
weight in kilograms
Time frame: baseline
self reported questionnaire regarding physical activity
number of practice per week
Time frame: baseline
questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
scale range 0-21 points. higher values represent worse outcome
Time frame: baseline
BMI
measured in kg/m\^2 and calculated from the reported values of weight and height
Time frame: baseline
Plan to share: Yes — the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.
Supporting information: Study protocol, Csr
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Haifa