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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
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

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

First Posted
May 6, 2019
Last Updated
November 4, 2020
Sponsor
Western University, Canada
Collaborators
Cosm Medical Corporation
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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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