Extended Pessary Interval for Care (EPIC Study) (EPIC)
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|ClinicalTrials.gov Identifier: NCT01644214|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2012
Last Update Posted : December 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse Pessary||Other: 6 month follow up for pessary check in the clinic setting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||March 2020|
No Intervention: Pessary Check at 3 months
Patients seen at 3 month intervals for pessary check-ups is the most common interval check in our clinic so this arm is considered the control group.
Experimental: 6 month Pessary Check
Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.
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.
- Patient satisfaction [ Time Frame: At 6 months from study enrollment ]To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.
- Patient satisfaction [ Time Frame: At 12 months from study enrollment ]To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.
- Pessary associated complications [ Time Frame: Checked at all follow-up visits (3 and 6 months, depending on study group) ]To determine if there is a difference in complication rates associated with indwelling pessaries between those that are seen at 6 week intervals and those that are seen at 12 week intervals, over a one year time period.
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 ClinicalTrials.gov identifier (NCT number): NCT01644214
|Women's College Hospital/Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1Z5|
|Principal Investigator:||Colleen D McDermott, MD, FRCSC||St. Michael's Hospital, Women's College Hospital, University of Toronto|