3D Translabial Ultrasound for Pessary Size Estimation

Western University, Canada

Status

Terminated

Conditions

Pelvic Organ Prolapse

Treatments

Other: 3D translabial ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03955744

6086 (Other Identifier)

113264

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

are current pessary users (> 6 months) who have no pessary related complication, including discomfort, 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 two days before the ultrasound examination date

Exclusion criteria

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 (excluding hysterectomy)
using pessaries other than ring, incontinence dish, donut, Shaatz
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