Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
研究概览
简要总结
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
详细描述
This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female.
- •Subject is at least 18 years of age.
- •Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
- •Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
- •Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
- •Subject is willing to provide written informed consent.
- •Subject is willing and able to comply with follow-up regimen.
排除标准
- •Subject is pregnant or intends to become pregnant in the future.
- •Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
- •Subject has undergone any previous repair for pelvic organ prolapse.
- •Subject has undergone a hysterectomy.
- •Subject lacks competency of the English language.
研究组 & 干预措施
Restorelle Smartmesh
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
干预措施: Restorelle Smartmesh (Device)
结局指标
主要结局
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
时间窗: Within first two years after surgical procedure
Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.
次要结局
未报告次要终点
研究者
Salil Khandwala
Medical Director
Michigan Institution of Women's Health PC