Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

Prolapse Clinical Trial

Official title:

Evaluation of 3D Ultrasound Vaginal Manometry for Estimating the Optimal Pessary Size for Patients With Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099121
• Other study ID #: 6086
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 1, 2023

Study information

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

Clinical Trial Summary

Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. Currently, pessaries are fit through trial and error after manual examination, the accuracy of which depends on the physician's expertise level.

The objective of this study is to evaluate the feasibility of using 3D translabial ultrasound imaging of the vagina at various distension volumes to predict the pessary size for successful fit. Ultrasound images will be obtained using commercially available 3D ultrasound probes (Philips, Netherlands), as well as a commercially available 2D ultrasound probe (Philips, Netherlands), which is linearly scanned to capture a 3D volume. The linear scanning will be performed by attaching the 2D probe to a motorized hand-held scanner, which is used to tilt and move the probe to acquire images. Please note that the hand-held scanner does not come in contact with the patient. To distend the vagina, a sterile bag is inserted in the vagina and gradually filled with water using a commercially available urodynamic system (Laborie, Canada) until the vaginal capacity is reached, without causing any discomfort to the patient. This image acquisition technique, previously reported in the literature, is referred to as 3D ultrasound vaginal manometry in this study.

To achieve the objective of this project, 35 pelvic organ prolapse patients, who (i) are current pessary users, (ii) can perform self-care of the pessary, and (iii) can provide informed consent, will be invited to participate in the study. Patients will be asked to remove their pessary prior to ultrasound imaging. Then, 3D ultrasound vaginal manometry will be performed, using the technique described above. Ultrasound images will be analyzed once data acquisition is completed. The size of the pessary estimated from ultrasound images will be compared with the actual pessary size used by the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 1, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Current pessary users (> 6 months) who have no pessary related complication, including discomfort, repeated 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 2 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, (including hysterectomy)

• Using pessaries other than ring, incontinence dish, donut, Shaatz, Marland, or Gellhorn.

• 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

• Prolapse

Intervention

Device:
• Ultrasound Imaging
3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Cosm Medical Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEASIBILITY: The predicted pessary size	The predicted pessary size in cubic mm will be compared with the actual size of the pessary used by the patient	Up to 3 months following data collection
Primary	FEASIBILITY: The predicted pessary shape	The predicted pessary shape will be compared with the actual shape of the pessary used by the patient by calculating the DICE coefficient.	Up to 3 months following data collection