Department of Surgery, Obstetrics & Gynecology Area, Faculty of Medicine, University of Seville, Seville, Spain.
Instituto Valenciano de Infertilidad, IVIRMA-Seville, Seville, Spain.
Int Urogynecol J. 2020 Dec;31(12):2521-2528. doi: 10.1007/s00192-020-04240-5. Epub 2020 Feb 15.
The study was aimed at evaluating the safety and efficacy of ring pessaries without support under continuous use without periodic removal or replacement for the treatment of advanced pelvic organ prolapse (POP) in women for 2 consecutive years.
This study was a prospective observational study. A total of 123 women were recruited in a tertiary hospital from January 2013 to January 2016. The primary objective was the percentage of patients maintaining the use of the pessary after 24 months. The secondary objectives were the reasons for discontinuation and the adverse events in patients with successful fittings.
A total of 115 patients (93.5%) had a successful fitting. Four patients died of non-pessary-related causes during the study and, one patient dropped out the follow-up so that finally, 110 patients were included in the efficacy analysis. Pessary use was maintained by 91.8% of the women at the end of the study. The adverse events rate was low (27.0%). The two main factors of interruption in the pessary use were: age (OR 0.93; 95% CI 0.87-0.99) and history of urinary urge incontinence (OR 0.33; 95% CI 0.11-0.96]).
A high success rate and low adverse events rate were achieved in patients with advanced-stage POP with continuous pessary use for 24 months, indicating that a ring pessary could also be used without periodic removal for at least the first 2 years. This practice could reduce the number of control visits.
本研究旨在评估连续使用无支撑环形子宫托治疗晚期盆腔器官脱垂（POP）女性，无需定期取出或更换，在 2 年内的安全性和疗效。
本研究为前瞻性观察性研究。2013 年 1 月至 2016 年 1 月，我们在一家三级医院招募了 123 名女性。主要目的是评估 24 个月后仍继续使用子宫托的患者比例。次要目的是成功适配患者中停止使用的原因和不良事件。
共有 115 名患者（93.5%）适配成功。4 名患者在研究期间死于非子宫托相关原因，1 名患者退出随访，最终有 110 名患者纳入疗效分析。研究结束时，91.8%的女性仍在使用子宫托。不良事件发生率较低（27.0%）。中断使用子宫托的两个主要因素是：年龄（OR 0.93；95%CI 0.87-0.99）和急迫性尿失禁史（OR 0.33；95%CI 0.11-0.96）。
晚期 POP 患者连续使用子宫托 24 个月，成功率高，不良事件发生率低，表明环形子宫托在至少前 2 年内无需定期取出，这种方法可减少就诊次数。
