Prospective Observational Pessary registry for AI Training (POP-AI)

Summary

Do you have concerns about pelvic floor disorders?
Are you looking for a pessary to treat your pelvic floor symptoms?

Researchers want to study the application of Artificial Intelligence
(AI) prediction models to estimate pessary shape, size, and fitting
success.

This an observational study where you will be asked to try commercially available pessaries and fill out questionnaires about your experience. We are collecting physical measurements to estimate the probability that a patient will continue pessary treatment for at least 12 months, the probability that a given pessary type/size will be successful, and the risks for any pessary complications. The development of a successful prediction model may help improve pessary fittings and patient experience in the future.

What does participating involve?
- Pessary care clinic visits with no change to your quality of care
- Filling out confidential questionnaires during the initial
visit and follow-up visits (5-10 minutes)
- Participation in this study lasts 1 year, with a minimum of 3 visits
(1 Pessary fitting Visit and 2 Follow Up Visits at 2-4 weeks and
12 months after the intial fitting visit to the Women’s Health Ambulatory Center, at Foothills
Medical Center.

Please contact the given number/email address to get in touch.

Contact information: 403-944-1636

Eligibility

Currently recruiting participants: Yes

Eligible ages: 18 to 110

Inclusion criteria:

You can enter this study if you are-

1. Patients with vaginal anatomy
2. At least 18 years old at time of screening
3. Diagnosed of POP and/or SUI
4. Electing to undergo conservative treatment with pessaries
5. Not being treated with a pessary for at least 7 days prior to the first visit

Exclusion criteria:

You CAN NOT enter the study if you-

1. Cannot give consent before participating in the study

Participate

Fill out the following form if you want to participate in this research

Method of contact

Collection of personal information
Your personal information is collected under the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If you have any questions about the collection or use of this information, please visit our Access to Information page.

Additional information

Contact information

Dr. Shunaha Kim-Fine

Principal investigator:

Shunaha Kim-Fine

Clinical trial:

No

REB-ID:

REB22-1543