Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

NCT ID: NCT04099121

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-11-01

Brief 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.

Conditions

Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with Pelvic Organ Prolapse

Patients who meet the inclusion criteria will be recruited. Ultrasound images of the pelvic floor and vaginal cavity will be analyzed to predict pessary size and type. This will be compared against the pessary size and type being used already by the patient.

Group Type: OTHER

Ultrasound Imaging

Intervention Type: DEVICE

3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.

Interventions

Ultrasound Imaging

3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cosm Medical Corp.

UNKNOWN

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Victoria Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

6086

Identifier Type: -

Identifier Source: org_study_id