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

• Published in: International Urogynecology Journal Vol. 32; no. 4; pp. 937 - 944
• Main Authors: Anglim, Breffini, Zhao, Zi Ying, Lovatsis, Danny, McDermott, Colleen D.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01-04-2021; Springer Nature B.V
• Subjects: Clinical trials; Clinics; Estrogens; Gynecology; Medicine; Medicine & Public Health; Original Article; Patient satisfaction; Pelvic organ prolapse; Questionnaires; Surgery; Urinary retention; Urology; Vagina; Pelvic organ prolapse; Complications; Pessary; Satisfaction
• ISSN: 0937-3462; 1433-3023
• DOI: 10.1007/s00192-020-04489-w

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.