The extended pessary interval for care (EPIC) study: a failed randomized clinical trial.

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.