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ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial.
Int Urogynecol J. 2021 Jun; 32(6):1571-1578.IU

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil. cassia.raquel@gmail.com. Division of Gynecology-Rua Alexander Fleming, 101-Cidade Universitária - Campinas, Campinas, 13083-881, Brazil. cassia.raquel@gmail.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

33501563

Citation

de Albuquerque Coelho, Suelene Costa, et al. "ESTROgen Use for Complications in Women Treating Pelvic Organ Prolapse With Vaginal PESSaries (ESTRO-PESS)-a Randomized Clinical Trial." International Urogynecology Journal, vol. 32, no. 6, 2021, pp. 1571-1578.
de Albuquerque Coelho SC, Giraldo PC, Brito LGO, et al. ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial. Int Urogynecol J. 2021;32(6):1571-1578.
de Albuquerque Coelho, S. C., Giraldo, P. C., Brito, L. G. O., & Juliato, C. R. T. (2021). ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial. International Urogynecology Journal, 32(6), 1571-1578. https://doi.org/10.1007/s00192-020-04654-1
de Albuquerque Coelho SC, et al. ESTROgen Use for Complications in Women Treating Pelvic Organ Prolapse With Vaginal PESSaries (ESTRO-PESS)-a Randomized Clinical Trial. Int Urogynecol J. 2021;32(6):1571-1578. PubMed PMID: 33501563.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - ESTROgen use for complications in women treating pelvic organ prolapse with vaginal PESSaries (ESTRO-PESS)-a randomized clinical trial. AU - de Albuquerque Coelho,Suelene Costa, AU - Giraldo,Paulo Cesar, AU - Brito,Luiz Gustavo Oliveira, AU - Juliato,Cássia Raquel Teatin, Y1 - 2021/01/26/ PY - 2020/10/26/received PY - 2020/12/10/accepted PY - 2021/1/28/pubmed PY - 2021/7/6/medline PY - 2021/1/27/entrez KW - Adverse effects KW - Estrogen KW - Pelvic organ prolapse KW - Pessary KW - Randomized, controlled trial SP - 1571 EP - 1578 JF - International urogynecology journal JO - Int Urogynecol J VL - 32 IS - 6 N2 - 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. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/33501563/ESTROgen_use_for_complications_in_women_treating_pelvic_organ_prolapse_with_vaginal_PESSaries__ESTRO_PESS__a_randomized_clinical_trial_ DB - PRIME DP - Unbound Medicine ER -