ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial.

Introduction And Hypothesis: To evaluate the complications of new users' vaginal pessaries (VP), with and without the use of vaginal estrogen after a 6-month follow-up.

Methods: A parallel, single-blinded, randomized, controlled trial. Symptomatic postmenopausal women (n = 98) with pelvic organ prolapse (POP) (stage 3/4) were recruited from August 2018 to October 2019. Patients were randomized into the local estrogen group (promestriene 3 × for a week) and the control group (no estrogen). They were evaluated for their vaginal symptoms at the baseline, after 3 months, and after 6 months, and a physical examination and vaginal sampling for microbiological analysis were done. Data were analyzed according to an intention-to-treat analysis (ITT). A 5% significance level was established for statistical analysis.

Results: Twenty women discontinued treatment (20.4%), mainly due to pessary extrusion (n = 15) and 5 for other reasons (lost to follow-up, pain, and surgery). Baseline characteristics were not statistically different between the estrogen and control groups. Regarding the presence of complications, the presence of erosion was 10% in the control group, but there was no significant difference between the groups (p = 0.175) after 6 months. Bacterial vaginosis (BV) was more prevalent in the control group, according to the Nugent (p = 0.007) and Amsel (p = 0.014) criteria. Urinary urgency and increased urinary frequency were significantly improved in the estrogen group after 6 months.

Conclusion: There was no evident benefit related to complications such as ulcerations, itching, and vaginal discharge/odor from the use of vaginal estrogen in POP women using pessaries.