Suelene Costa de Albuquerque Coelho1, Paulo Cesar Giraldo1, Luiz Gustavo Oliveira Brito1, Cássia Raquel Teatin Juliato2,3. 1. Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil. 2. Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil. cassia.raquel@gmail.com. 3. Division of Gynecology-Rua Alexander Fleming, 101-Cidade Universitária - Campinas, Campinas, 13083-881, Brazil. cassia.raquel@gmail.com.
Abstract
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.
RCT Entities:
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.