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Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917615
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Haifa

Tracking Information
First Submitted Date  ICMJE April 14, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE April 8, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2019)
  • direction of urinary bladder displacement during contraction [ Time Frame: baseline ]
    upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
  • urinary bladder displacement in millimeters [ Time Frame: baseline ]
    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2019)
pelvic floor muscles endurance of contraction in seconds [ Time Frame: baseline ]
time of muscle contraction will be measured during the last contraction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Official Title  ICMJE Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Brief Summary The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Detailed Description

Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.

The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2 groups according to the year of physiotherapy school.
Masking: Single (Participant)
Masking Description:
Participants will not know the aim of study
Primary Purpose: Screening
Condition  ICMJE Pelvic Floor Muscle Weakness
Intervention  ICMJE Other: pelvic floor contraction
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
Study Arms  ICMJE
  • Experimental: after "women health" course
    The participants will be instructed to contract the pelvic floor muscle
    Intervention: Other: pelvic floor contraction
  • Active Comparator: before "women health" course
    The participants will be instructed to contract the pelvic floor muscle
    Intervention: Other: pelvic floor contraction
Publications * Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2019)
40
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy students
  • willing to participate in the study

Exclusion Criteria:

  • has been treated before for pelvic floor rehabilitation
  • active urinary tract infection
  • pregnancy
  • previous abdominal surgeries
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917615
Other Study ID Numbers  ICMJE 123/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Time Frame: one year
Responsible Party University of Haifa
Study Sponsor  ICMJE University of Haifa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gali Dar, PhD University of Haifa
PRS Account University of Haifa
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP