The Clinical Efficacy of Pelvic Organ Prolapse Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- the objective recurrent rate
研究概览
简要总结
One thousand patients with stage>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.
详细描述
Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patients with stage>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.
排除标准
- •The patients with POP who have not undergone surgery are excluded.
研究组 & 干预措施
the efficacy
transvaginal synthetic mesh
干预措施: transvaginal synthetic mesh (Device)
the rate of the LUTS
We use Tolterodine to improve patients' LUTS
干预措施: Tolterodine (Drug)
结局指标
主要结局
the objective recurrent rate
时间窗: one year after surgery
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
次要结局
- the quality of life questionnaires(one year after surgery)
- the rate of the lower urinary tract symptoms(one year after surgery)