Factors for Vaginal Epithelium-Related Adverse Events in Pessary Users: A Secondary Analysis of a Randomized Controlled Trial

INTRODUCTION AND HYPOTHESIS: Pessary use is a first-line treatment for pelvic organ prolapse (POP). However, complications such as ulcerations, excessive discharge and so on, often compromise treatment adherence, and their risk factors remain poorly characterized. This study is aimed at identifying associated factors for vaginal epithelium-related adverse events (VERAEs) in pessary users. METHODS: This was a secondary analysis of a randomized controlled trial, including postmenopausal women with symptomatic POP ≥ stage 2 and successfully fitted with ring pessaries with support. VERAEs were defined as vaginal epithelial abnormalities (erythema, abrasion or erosion/ulceration), vaginal bleeding, or excessive discharge. Participants with and without VERAEs were compared and a multivariable logistic regression model was performed to identify independent factors. RESULTS: Of 411 women with ≥ 1 follow-up, 119 (29.0%) developed VERAEs. In multivariable regression analysis, longer time since menopause (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.07), higher education (undergraduate or higher vs elementary: OR 3.07, 95% CI 1.37-7.03), and advanced prolapse stage (stage 3 vs 2: OR 2.75, 95% CI 1.40-5.74; stage 4 vs 2: OR 3.19, 95% CI 1.20-8.67) were independent risk factors. Protective factors included higher vaginal parity (OR 0.72, 95% CI 0.52-0.98), active sexual life (OR 0.43, 95% CI 0.24-0.76), and continuous estrogen use (≥ 12 months vs none: OR 0.46, 95% CI 0.26-0.77). CONCLUSIONS: Prolonged postmenopausal status, higher education, and severe prolapse increased the risk of VERAEs, whereas increased vaginal parity, active sexual life, and estrogen use are protective factors.