Quality of Life After Conservative and Surgical Treatment of Pelvic Organ
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- symptom change assessed by German Pelvic Floor Questionnaire (GPFQ)
研究概览
简要总结
This is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment Options (conservative and surgical therapy of Pelvic Organ Prolapse) but the knowledge gained of the data will help to develop treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pelvic Organ Prolapse (POP)
排除标准
- •< 18 years
- •Patients unable to understand an informed consent
- •Patients unwilling to participate
- •emergency operations
- •pregnancy
- •Overactive Bladder without descensus
- •Stool incontinence without POP
结局指标
主要结局
symptom change assessed by German Pelvic Floor Questionnaire (GPFQ)
时间窗: before therapy and up to 5 years post-therapy
Change in the symptom scores assessed by the German Pelvic Floor Questionnaire (GPFQ) by at least 1.0 points 6 months post-therapy. The GPFQ does contain the domains bladder function, bowel function, prolapse and sexual symptoms. In each domain a total of 10 points may be reached. The maximum symptom score for the entire questionnaire are 40 points. The minimal symptom score is 0 points. The minimal important difference (MID) for patients with Pelvic Organ Prolapse (POP) is 1.0 points. A decrease of the symptom score by at least 1 point reflects a meaningful improvement.
次要结局
未报告次要终点