NCT00860912已完成不适用
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery
研究概览
简要总结
The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.
详细描述
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient is equal or greater than 18 years old
- •Meets follow-up evaluation time frame
- •Understands the nature of the procedure and has provided written informed consent
- •Is scheduled to undergo vaginal pelvic reconstructive surgery
- •Has > 2nd degree midline cystocele
排除标准
- •Presence of severe mucosal ulceration
- •Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
- •Allergy to bovine material
- •Severe mucosal atrophy
- •Shortened vaginal length as determined by Investigator
- •Pregnant or intends to become pregnant during study
- •Has a UTI
- •Has vault prolapse < 2nd degree cystocele
结局指标
主要结局
To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery
时间窗: 2 years
prolapse degree on pelvic exam
次要结局
- To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery(2 years)
研究者
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