Coolen Anne-Lotte W M, Troost Stephanie, Mol Ben Willem J, Roovers Jan- Paul W R, Bongers Marlies Y
Department of Gynecology and Obstetics, Máxima Medical Centre, De Run 4600, 5500 MB, Veldhoven, The Netherlands.
Department of Gynaecology and Obstetrics, The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, 5000, Australia.
Int Urogynecol J. 2018 Jan;29(1):99-107. doi: 10.1007/s00192-017-3372-x. Epub 2017 Jun 9.
The objective of this study was to compare the functional outcomes after pessary treatment and after prolapse surgery as primary treatments for pelvic organ prolapse (POP).
This was a prospective cohort study performed in a Dutch teaching hospital in women with symptomatic POP of stage II or higher requiring treatment. Patients were treated according to their preference with a pessary or prolapse surgery. The primary endpoint was disease-specific quality of life at 12 months follow-up according to the prolapse domain of the Urogenital Distress Inventory (UDI) questionnaire. Secondary outcomes included adverse events and additional interventions. To show a difference of ten points in the primary outcome, we needed to randomize 80 women (power 80%, α 0.05, taking 10% attrition into account).
We included 113 women (74 in the pessary group, 39 in the surgery group). After 12 months, the median prolapse domain score was 0 (10th to 90th percentile 0-33) in the pessary group and 0 (10th to 90th percentile 0-0) in the surgery group (p < 0.01). Differences in other domain scores were not statistically significant. In the pessary group, 28% (21/74) of the women had a surgical intervention versus 3% (1/39) reoperations in the surgery group (p = 0.01).
In women with POP of stage II or higher undergoing surgery, prolapse symptoms were less severe than in those who were treated with a pessary, but 72% of women who were treated with a pessary did not opt for surgery.
Dutch trial register NTR2856.
本研究的目的是比较子宫托治疗和脱垂手术作为盆腔器官脱垂（POP）主要治疗方法后的功能结局。
这是一项在荷兰一家教学医院对有症状的Ⅱ期或更高分期的POP且需要治疗的女性进行的前瞻性队列研究。患者根据自身偏好接受子宫托或脱垂手术治疗。主要终点是根据泌尿生殖系统困扰量表（UDI）问卷的脱垂领域，在随访12个月时特定疾病的生活质量。次要结局包括不良事件和额外干预措施。为了在主要结局中显示出10分的差异，我们需要随机分配80名女性（检验效能80%，α 0.05，考虑10%的损耗率）。
我们纳入了113名女性（子宫托组74名，手术组39名）。12个月后，子宫托组脱垂领域评分中位数为0（第10至90百分位数为0 - 33），手术组为0（第10至90百分位数为0 - 0）（p < 0.01）。其他领域评分的差异无统计学意义。子宫托组中，28%（21/74）的女性接受了手术干预，而手术组再次手术的比例为3%（1/39）（p = 0.01）。
在接受手术治疗的Ⅱ期或更高分期的POP女性中，脱垂症状比接受子宫托治疗的女性轻，但72%接受子宫托治疗的女性未选择手术。
荷兰试验注册编号NTR2856。
