ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial.
Int Urogynecol J
; 32(6): 1571-1578, 2021 Jun.
Article
em En
| MEDLINE
| ID: mdl-33501563
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Descarga Vaginal
/
Prolapso de Órgão Pélvico
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
Idioma:
En
Revista:
Int Urogynecol J
Assunto da revista:
GINECOLOGIA
/
UROLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Reino Unido