3D Translabial Ultrasound for Pessary Size Estimation

• Sponsor: Western University, Canada (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03955744
• Collaborator: Cosm Medical Corporation (Other)
• Enrollment: 35
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.4
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: 3D translabial ultrasound	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
• Actual Study Start Date: Dec 18, 2019
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D translabial ultrasound 3D translabial ultrasound with concurrent vaginal manometry	Other: 3D translabial ultrasound; All patients will undergo 3D translabial ultrasound with vaginal manometry

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western University	London	Ontario	Canada	N6A 3K7

Sponsors and Collaborators

• Western University, Canada
• Cosm Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Western University, Canada
• ClinicalTrials.gov Identifier: NCT03955744
• Other Study ID Numbers: 113264; 6086
• First Posted: May 20, 2019
• Last Update Posted: Nov 5, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Nov 5, 2020