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The extended pessary interval for care (EPIC) study: a failed randomized clinical trial
Breffini Anglim1, Zi Ying Zhao2, Danny Lovatsis1
1Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, 8-815, 700 University Ave., Mount Sinai Hospital, Toronto, Ontario, Canada.
Introduction And Hypothesis:
To describe study design flaws and limited outcomes of a randomized trial that intended to compare satisfaction and complication rates between patients managing their pelvic organ prolapse with a pessary at different maintenance intervals.
Methods:
A randomized clinical trial was conducted at two tertiary pessary clinics. After a successful fitting, patients were randomly allocated to follow-up at 3-month or 6-month intervals and followed for 12 months. Symptoms, complications, and pelvic examination characteristics were recorded at each visit. At 6 and 12 months, patient satisfaction with the pessary was also recorded. Sample size calculation was based on the minimal relevant difference in Pessary Satisfaction score (created for this study). With a power of 0.8 and an alpha of 0.05, the minimum number of patients required in each group was 28.
Results:
We were unable to reach our sample size as most patients did not meet inclusion criteria. After 2 years we were only able to recruit 20/56 patients, with 9 patients in the 3-month group and 11 patients in the 6-month group. Additionally, seven patients dropped out of the study. Overall satisfaction was high and similar between groups at 6- and 12-month follow-up visits. Pessary complications were noted in both groups but in low numbers.
Conclusions:
Pessary use is associated with high patient satisfaction and low complication rates, regardless of the follow-up interval. The recruitment failure demonstrated that a randomized trial is not feasible for this research question. Optimally, pessary follow-up should be based on patient symptoms and scheduling preference.
