3D Translabial Ultrasound for Pessary Size Estimation
Primary Purpose
Pelvic Organ Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3D translabial ultrasound
Sponsored by
About this trial
This is an interventional other trial for Pelvic Organ Prolapse
Eligibility Criteria
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
Sites / Locations
- Western UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D translabial ultrasound
Arm Description
3D translabial ultrasound with concurrent vaginal manometry
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03955744
First Posted
May 6, 2019
Last Updated
November 4, 2020
Sponsor
Western University, Canada
Collaborators
Cosm Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03955744
Brief Title
3D Translabial Ultrasound for Pessary Size Estimation
Official Title
Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
Collaborators
Cosm Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D translabial ultrasound
Arm Type
Experimental
Arm Description
3D translabial ultrasound with concurrent vaginal manometry
Intervention Type
Other
Intervention Name(s)
3D translabial ultrasound
Intervention Description
All patients will undergo 3D translabial ultrasound with vaginal manometry
Primary Outcome Measure Information:
Title
3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
Description
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.
Time Frame
1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).
Secondary Outcome Measure Information:
Title
Survey
Description
Participants will be asked to fill out a short survey about their experience with the pessaries they already use and the ultrasound examination process
Time Frame
5 minutes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Leong
Phone
5196858223
Email
yvonne.leong@lhsc.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D Translabial Ultrasound for Pessary Size Estimation
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