NCT03955744

3D Translabial Ultrasound for Pessary Size Estimation

Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.

Detailed 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 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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	3D translabial ultrasound	All patients will undergo 3D translabial ultrasound with vaginal manometry

Timeline

• Start date: 2019-12-18
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2019-05-20
• Last updated: 2024-05-02

Locations

1 site across 1 country: Canada