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| ID | Type | Description | Link |
|---|---|---|---|
| 6086 | Other Identifier | ReDA |
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Sponsor terminated study as there had been sufficient data collected from the recruited patients to characterize vaginal contraction biomechanics
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| Name | Class |
|---|---|
| Cosm Medical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D translabial ultrasound | Experimental | 3D translabial ultrasound with concurrent vaginal manometry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D translabial ultrasound | Other | All patients will undergo 3D translabial ultrasound with vaginal manometry |
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| Measure | Description | Time Frame |
|---|---|---|
| 3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse | 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. | 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant). |
| Measure | Description | Time Frame |
|---|---|---|
| Survey | Participants will be asked to fill out a short survey about their experience with the pessaries they already use and the ultrasound examination process | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University | London | Ontario | N6A 3K7 | Canada |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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