NCT03917615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 14, 2019

Last Update Submit

July 29, 2019

Conditions

Keywords

pelvic diaphragm, Physiotherapy students, education

Outcome Measures

Primary Outcomes (2)

  • direction of urinary bladder displacement during contraction

    upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

    baseline

  • urinary bladder displacement in millimeters

    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    baseline

Secondary Outcomes (1)

  • pelvic floor muscles endurance of contraction in seconds

    baseline

Study Arms (2)

after "women health" course

EXPERIMENTAL

The participants will be instructed to contract the pelvic floor muscle

Other: pelvic floor contraction

before "women health" course

ACTIVE COMPARATOR

The participants will be instructed to contract the pelvic floor muscle

Other: pelvic floor contraction

Interventions

Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function

after "women health" coursebefore "women health" course

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy students
  • willing to participate in the study

You may not qualify if:

  • has been treated before for pelvic floor rehabilitation
  • active urinary tract infection
  • pregnancy
  • previous abdominal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University, Department of PHysical Therapy

Haifa, Israel

Location

Related Publications (1)

  • 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.

Study Officials

  • Gali Dar, PhD

    University of Haifa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know the aim of study
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 2 groups according to the year of physiotherapy school.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 17, 2019

Study Start

April 8, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results

Shared Documents
STUDY PROTOCOL
Time Frame
one year

Locations