Pelvic Organ Prolapse
Conditions
Brief 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.
Interventions
OTHER3D translabial ultrasound
All patients will undergo 3D translabial ultrasound with vaginal manometry
Sponsors
Cosm Medical Corporation
Western University, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse | 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant). | 3D ultrasound images of the vaginal canal and the pelvic floor will be obtained using various ultrasound probes. Pressure and volume measurements (i.e. manometry) will be obtained using a urodynamic system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey | 5 minutes | Participants will be asked to fill out a short survey about their experience with the pessaries they already use and the ultrasound examination process |
Countries
Canada
Outcome results
None listed