A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- changes in POP-Q score at different time nodes
研究概览
简要总结
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.
详细描述
Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥30 years old;
- •pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life
- •Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery
- •The patient agrees to conduct the study and can be followed up on time.
排除标准
- •Those who cannot tolerate surgery and anesthesia
- •Those who need to remove the uterus
- •Those who have removed the uterus
- •Those who cannot be followed up on time.
结局指标
主要结局
changes in POP-Q score at different time nodes
时间窗: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Gynecological examination
次要结局
- PFDI-20 score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
- ICIQ-SF score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
- PISQ-12 score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
- UDI-6 scores at different time nodes UDI-6(pre-operation and post-operation(at 1month, 3 month, 6 month and a year))
- Postoperative urinary incontinence assessment(post-operation(at 1month, 3 month, 6 month and a year))
- OABss score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
- PFIQ-7 score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
- I-QoL score at different time nodes(post-operation(at 1month, 3 month, 6 month and a year))
研究者
Sun Xiuli
Chief Gynecology Physician
Peking University People's Hospital