Miceli Alessio, Dueñas-Diez José-Luis
Department of Surgery, Obstetrics & Gynaecology Area, School of Medicine, Seville University, Sevilla, Spain.
Department of Obstetrics and Gynaecology, Hospital Universitario Virgen Macarena, Sevilla, Spain.
Int Urogynecol J. 2019 Dec;30(12):2161-2169. doi: 10.1007/s00192-019-03919-8. Epub 2019 Mar 12.
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.
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.
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).
The pessary is effective and has mild adverse events in non-hysterectomized, postmenopausal women with advanced POP.
本研究旨在评估对于未行子宫切除术的绝经后女性,环形子宫托与手术作为晚期盆腔器官脱垂(POP)的初始治疗方法的疗效。我们最初的假设是子宫托与手术疗效相当且风险更低。
本研究为前瞻性观察性研究,在一家三级医院招募了171例有症状的晚期POP女性患者,为期30个月。她们根据自身偏好接受手术治疗[77/171(45.0%)]或无支撑阴道环形子宫托治疗[94/171(55.0%)]。主要结局包括在整个研究过程中子宫托使用的终止情况以及复发脱垂的发生率。次要结局包括根据Clavien-Dindo分类法分类的并发症。描述性统计用于人口统计学数据。连续变量计算均值和标准差,分类变量使用连续性校正检验、Mann-Whitney U检验和Fisher精确检验。
子宫托组84.4%(76/90)的病例成功使用了子宫托,手术组89.6%(69/77)的患者未出现脱垂复发(>POP-Q 2)。在子宫托组,不良事件发生率为31.6%,均为Clavien-Dindo I级。手术组有30例患者[30/77(39.0%)]出现并发症:14.3%为Clavien-Dindo I级(11/77),10.4%为II级(8/77),14.3%为III级(11/77)。
对于未行子宫切除术的绝经后晚期POP女性,子宫托有效且不良事件轻微。