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Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04099121
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : April 6, 2020
Cosm Medical Corp.
Information provided by (Responsible Party):
Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Prolapse Device: Ultrasound Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pelvic organ prolapse only occurs in females.
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04099121

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Contact: Yvonne Leong, MD 519-685-8223

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Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Yvonne Leong, MD   
Sponsors and Collaborators
Western University, Canada
Cosm Medical Corp.
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Responsible Party: Western University, Canada Identifier: NCT04099121    
Other Study ID Numbers: 6086
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be de-identified, and only the aggregate results will be used for publication. Patient information will not be made public or shared with researchers outside of the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical