Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
研究概览
简要总结
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.
Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 more than 18
- •Vaginal vault prolapse of grade 2 or more (POP-Q system)
- •Symptomatic prolapse
排除标准
- •Patient unable to read French language
- •Cystocele without vaginal vault prolapse
- •Vaginal vault prolapse of grade 1
- •Associated rectal prolapse
- •Rectal inflammatory disease (Crohn, RCH).
结局指标
主要结局
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
次要结局
- - Anatomical cure rate on vaginal vault support
- - Peri-operative morbidity
- - Patient satisfaction
- - Quality of life
- - Post-operative sexuality