Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
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|ClinicalTrials.gov Identifier: NCT04099121|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : April 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prolapse||Device: Ultrasound Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 3D Ultrasound Vaginal Manometry for Estimating the Optimal Pessary Size for Patients With Pelvic Organ Prolapse|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
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.
Device: Ultrasound Imaging
3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.
- FEASIBILITY: The predicted pessary size [ Time Frame: Up to 3 months following data collection ]The predicted pessary size in cubic mm will be compared with the actual size of the pessary used by the patient
- FEASIBILITY: The predicted pessary shape [ Time Frame: Up to 3 months following data collection ]The predicted pessary shape will be compared with the actual shape of the pessary used by the patient by calculating the DICE coefficient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099121
|Contact: Yvonne Leong, MDfirstname.lastname@example.org|
|London, Ontario, Canada, N6A 5W9|
|Contact: Yvonne Leong, MD Yvonne.Leong@lhsc.on.ca|