NCT01644214

Extended Pessary Interval for Care (EPIC Study)

Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are commonly used in conservative treatment. Despite their prevalence, there is no literature to guide the management of pessaries. Our objective is to determine whether patients managed with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if there is any difference in complications rates between the two groups. Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 6 month follow-up intervals and that there will be no difference in complication rates between the two follow-up groups. Method: The investigators will conduct a prospective randomized control trial comparing patient satisfaction and complication rates between patients with pessaries randomized to either 3 or 6 month follow-up intervals over 1 year.

Conditions

• Pelvic Organ Prolapse
• Pessary

Interventions

Type	Name	Description
OTHER	6 month follow up for pessary check in the clinic setting	The standard of care is considered to be pessary checks every 3 months, therefore those that are checked every 6 months will be considered to be in the intervention group.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-11-01
• Completion: 2020-03-01
• First posted: 2012-07-19
• Last updated: 2019-12-04

Locations

1 site across 1 country: Canada