NCT02272361已完成不适用
Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up
University Hospital, Lille12 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 12
- 主要终点
- PFDI-20 score
研究概览
简要总结
The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.
The secondary objectives of this study are the following:
- to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
- to overall quality of life assessment and expectations of patients.
- to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
- to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
- •Written informed consent
- •insured under the French social security system
排除标准
- •Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
- •Participation in another trial
研究组 & 干预措施
laparoscopic sacrocolpopexy
Other
laparoscopic sacrocolpopexy
干预措施: laparoscopic sacrocolpopexy (Other)
vaginal mesh surgery
Other
vaginal mesh surgery
干预措施: vaginal mesh surgery (Other)
结局指标
主要结局
PFDI-20 score
时间窗: 4 years
The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse
次要结局
未报告次要终点
研究者
研究点 (12)
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