- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507660
Verbal Instruction for Contraction Pelvic Floor Muscles Among Males
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ariel, Israel
- Ariel University, Department of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- willing to participate in the study
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: verbal instruction
The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urinary bladder displacement in millimeters during verbal instructions
Time Frame: up to 6 months
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bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
demographic self reported questionnaire regarding height
Time Frame: baseline
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height in meters
|
baseline
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demographic self reported questionnaire regarding weight
Time Frame: baseline
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weight in kilograms
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baseline
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self reported questionnaire regarding physical activity
Time Frame: baseline
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number of practice per week
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baseline
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BMI
Time Frame: baseline
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measured in kg/m^2 and calculated from the reported values of weight and height
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baseline
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pelvic floor muscles endurance of contraction in seconds
Time Frame: up to 6 months
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time of muscle contraction will be measured during the last contraction in each instruction
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up to 6 months
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questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
Time Frame: baseline
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scale range 0-21 points.
higher values represent worse outcome
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baseline
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-NBA-20180315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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