3D Translabial Ultrasound for Pessary Size Estimation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pelvic Organ Prolapse
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
Description
Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized co...
Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.
Tracking Information
- NCT #
- NCT03955744
- Collaborators
- Cosm Medical Corporation
- Investigators
- Not Provided
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