3D Translabial Ultrasound for Pessary Size Estimation

Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: 3D translabial ultrasound

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Recruiting
      • Western University
      • Contact: Yvonne Leong; Phone Number: 5196858223; Email: yvonne.leong@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Cosm Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 113264; 6086 (ReDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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