A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 13
- 主要终点
- Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
研究概览
简要总结
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
详细描述
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
- •patient has agreed to undergo implantation of TVM (prolift) or fascial plication
- •patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
- •patient is willing to complete quality of life questionnaires at 6 and 12 months
排除标准
- •patient is or wants to become pregnant
- •patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
- •patient has current urinary tract or vaginal infections
- •patient has a blood coagulation disorder
- •patient has a compromised immune system or any other condition that would compromise healing
- •patient has renal insufficiency and/or upper urinary tract obstruction
- •patient is unwilling or unable to return for evaluation
- •patient has had previous irradiation
- •patient has any malignancy
- •patient has large ovarian cysts of large myoma
结局指标
主要结局
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
时间窗: 12 months
Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
次要结局
- Bulge Symptoms(12 months)
- Mesh Exposure at 12 Months(12 months)
- "Patient Global Impression of Improvement" (PGI-I) at 12 Months(at 12 months)
研究者
Mariella Withagen
Principal Investigator
Radboud University Medical Center