Status:
COMPLETED
Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
Cosm Medical Corp.
Conditions:
Prolapse
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to ...
Eligibility Criteria
Inclusion
- Current pessary users (\> 6 months) who have no pessary related complication, including discomfort, repeated vaginal bleeding, and pessary extrusion
- Are able to provide informed consent
- Can perform self-care, i.e. removing and inserting the pessary themselves
- Are willing to remove their pessary 2 days before the ultrasound examination date.
Exclusion
- Inability to give informed consent
- Inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
- History of pelvic radiation or surgery, (including hysterectomy)
- Using pessaries other than ring, incontinence dish, donut, Shaatz, Marland, or Gellhorn.
- Inability to perform the Valsalva maneuver or pelvic floor contraction
- Restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit.
- Lack of sensation at the pelvic floor.
- Being pregnant at the time of the examination.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04099121
Start Date
February 1 2020
End Date
November 1 2023
Last Update
April 30 2024
Active Locations (1)
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1
Victoria Hospital
London, Ontario, Canada, N6A 5W9