3D Translabial Ultrasound for Pessary Size Estimation

Pelvic Organ Prolapse Clinical Trial

Official title:

Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03955744
• Other study ID #: 113264
• Secondary ID: 6086
• Status: Terminated
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: November 17, 2023

Study information

• Verified date: May 2024
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• 3D translabial ultrasound
All patients will undergo 3D translabial ultrasound with vaginal manometry

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Cosm Medical Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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