What you should know
About the study
This study is an early feasibility clinical study conducted by Cosm Medical to evaluate a novel pessary design. The purpose of this study is to further assess device performance, fit, and participant experience to support pelvic health care.
Participation in this study is voluntary. Individuals who meet eligibility criteria and choose to participate will be subject to assessments conducted at scheduled visits.
Participants will receive compensation for their time and participation.
What participation involves
Study Visits
Location
Downtown Toronto
Number of visits
Up to four in-person visits and up to three phone follow-ups
Visit duration
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Visit 1 — up to 3 hours
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Visit 2–3 — up to 2 hours each
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Phone follow-up — ~15 minutes
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Visit 4 — up to 1 hour
Study Timeline
Approximately one year
Full study procedures and visit details will be explained during the screening and informed consent process.
Examination
Participants will undergo a vaginal examination and pessary fitting. Study assessments include participant questionnaires and clinician evaluations related to device fit and performance.
Some participants may require additional fitting visits if an appropriate device fit is not achieved at the initial visit.
Trial Period
Participants who are successfully fitted will use the pessary at home for up to one month, with a follow-up study visit afterward.
Who may be eligible
Cosm is currently seeking individuals who meet the following criteria:
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Over 18 years of age
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Assigned female at birth
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Affected by pelvic organ prolapse
You may not be eligible if you meet the following exclusion criteria:
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Pregnant at the time of recruitment
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Planning pregnancy in the next 6 months
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Patients with pelvic organ prolapse who are less than 6 weeks postpartum
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Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary (for patients who currently use a standard pessary)
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Ongoing treatment of recurrent urinary tract or vaginal infections
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Patients who have neurologic condition causing loss of sensation at the pelvic floor
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Restricted mobility that prevents them from ambulating to assess the comfort level of a pessary
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Inability to communicate with the person acquiring consent, performing pessary fitting, and obtaining ultrasound
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Vaginal erosions, ulcerations, lacerations, bleeding, or urinary/acute genital tract infections at time of fitting
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Unable/unwilling to provide informed consent
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Known silicone allergy
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Active pelvic, vaginal infections, or urinary tract infections
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Please note that final eligibility will be determined after initial contact with the team.
How to participate
If you are interested in contributing to clinical research in pelvic health and would like to learn whether this study may be right for you, please contact us by clicking the "Get in touch" button below.
An authorized member of the clinical trial team will connect with you for a confidential screening session to:
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Review initial eligibility criteria
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Provide additional details about the study
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Answer any questions regarding participation