Alessio Miceli1, José-Luis Dueñas-Diez2,3. 1. Department of Surgery, Obstetrics & Gynaecology Area, School of Medicine, Seville University, Sevilla, Spain. alessiomiceli@libero.it. 2. Department of Surgery, Obstetrics & Gynaecology Area, School of Medicine, Seville University, Sevilla, Spain. 3. Department of Obstetrics and Gynaecology, Hospital Universitario Virgen Macarena, Sevilla, Spain.
Abstract
INTRODUCTION AND HYPOTHESIS: This study aimed to evaluate the efficacy of the ring pessary compared with surgery as a primary treatment for advanced pelvic organ prolapse (POP) in non-hysterectomized, postmenopausal women. Our starting hypothesis was that the pessary is as effective as and less risky than surgery. METHODS: This study was a prospective observational study, which recruited 171 women with symptomatic advanced POP in a tertiary hospital for 30 months. They were treated according their preference with either surgery [77/171 (45.0%)] or vaginal ring pessary without support [94/171 (55.0%)]. The primary outcomes included the discontinuation of pessary use and the incidence of recurrent prolapse throughout the study. Secondary outcomes included complications categorized according to Clavien-Dindo classification. Descriptive statistics were used for demographic data. The mean and standard deviation were calculated for continuous variables, and continuity correction tests, Mann-Whitney U tests, and Fisher's exact tests were used for categorical variables. RESULTS: There was successful use of a pessary in 84.4% (76/90) of cases, and 89.6% (69/77) of patients did not have prolapse recurrence in the surgical group (>POP-Q 2). In the pessary group, the adverse event rate was 31.6%, and all were Clavien-Dindo grade I. Thirty patients [30/77 (39.0%)] had complications in the surgery group: 14.3% were Clavien-Dindo grade I (11/77), 10.4% were grade II (8/77), and 14.3% were grade III (11/77). CONCLUSIONS: The pessary is effective and has mild adverse events in non-hysterectomized, postmenopausal women with advanced POP.
INTRODUCTION AND HYPOTHESIS: This study aimed to evaluate the efficacy of the ring pessary compared with surgery as a primary treatment for advanced pelvic organ prolapse (POP) in non-hysterectomized, postmenopausal women. Our starting hypothesis was that the pessary is as effective as and less risky than surgery. METHODS: This study was a prospective observational study, which recruited 171 women with symptomatic advanced POP in a tertiary hospital for 30 months. They were treated according their preference with either surgery [77/171 (45.0%)] or vaginal ring pessary without support [94/171 (55.0%)]. The primary outcomes included the discontinuation of pessary use and the incidence of recurrent prolapse throughout the study. Secondary outcomes included complications categorized according to Clavien-Dindo classification. Descriptive statistics were used for demographic data. The mean and standard deviation were calculated for continuous variables, and continuity correction tests, Mann-Whitney U tests, and Fisher's exact tests were used for categorical variables. RESULTS: There was successful use of a pessary in 84.4% (76/90) of cases, and 89.6% (69/77) of patients did not have prolapse recurrence in the surgical group (>POP-Q 2). In the pessary group, the adverse event rate was 31.6%, and all were Clavien-Dindo grade I. Thirty patients [30/77 (39.0%)] had complications in the surgery group: 14.3% were Clavien-Dindo grade I (11/77), 10.4% were grade II (8/77), and 14.3% were grade III (11/77). CONCLUSIONS: The pessary is effective and has mild adverse events in non-hysterectomized, postmenopausal women with advanced POP.
Entities:
Keywords:
Advanced pelvic organ prolapse; Adverse events; Efficacy; Ring pessary without support; Vaginal hysterectomy
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