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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.
International Urogynecology Journal
|August 14, 2020
Summary
Pelvic organ prolapse pessary management shows high patient satisfaction and low complications. A randomized trial comparing follow-up intervals was not feasible due to recruitment challenges.
Area of Science:
- Urogynecology
- Pelvic Floor Disorders
- Medical Device Research
Background:
- Pelvic organ prolapse (POP) is a common condition affecting women's quality of life.
- Pessaries are widely used for POP management, but optimal follow-up intervals require further study.
- Existing research lacks robust comparisons of different pessary maintenance schedules.
Purpose of the Study:
- To evaluate study design flaws and limited outcomes of a randomized trial.
- To compare patient satisfaction and complication rates between different pessary follow-up intervals (3-month vs. 6-month).
- To assess the feasibility of conducting a randomized trial on pessary follow-up frequency.
Main Methods:
- A randomized clinical trial was conducted at two tertiary pessary clinics.
- Patients were randomized to 3-month or 6-month follow-up intervals for 12 months.
- Patient-reported symptoms, satisfaction, and clinical outcomes were recorded.
Main Results:
- The study failed to reach its target sample size, recruiting only 20 out of 56 patients over two years.
- High overall patient satisfaction with pessary use was observed, with no significant difference between follow-up groups.
- Pessary complications occurred in low numbers in both groups.
Conclusions:
- Pessary use is associated with high patient satisfaction and low complication rates, irrespective of follow-up interval.
- A randomized trial comparing different follow-up intervals for pessary management is not feasible.
- Pessary follow-up should ideally be guided by patient symptoms and preferences.
