3D Translabial Ultrasound for Pessary Size Estimation

NCT03955744 | Terminated

• 2 other identifiers: 1132646086
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survey

  5 minutes

Study Arms (1)

3D translabial ultrasound

EXPERIMENTAL

3D translabial ultrasound with concurrent vaginal manometry

Other: 3D translabial ultrasound

Interventions

3D translabial ultrasound OTHER

All patients will undergo 3D translabial ultrasound with vaginal manometry

3D translabial ultrasound

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• Cosm Medical Corporation: collaborator

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 20, 2019
• Study Start: December 18, 2019
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)