Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- continence rates at three years after surgery
研究概览
简要总结
The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.
详细描述
Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis.
Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.
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
- Single (Investigator)
入排标准
- 年龄范围
- 31 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Stress urinary incontinence
- •Mix urinary incontinence
- •Previous failed anti-incontinence surgery
- •Previous gynecologic surgery
排除标准
- •Urodynamical detrusor overactivity or impaired bladder activity
- •Prolaps of pelvic organ
- •Urge incontinence
- •Neurogenic bladder
- •Bladder outlet obstruction
- •Urinary fistula, Pregnancy
- •Active urinary or vaginal enfection
- •Contraindication to anesthesia
- •> 100ml PVR urine volume
结局指标
主要结局
continence rates at three years after surgery
时间窗: three years after surgery
Ultrapromesh® with its superior biomechanical characteristics and with its high success rates,low vaginal and urethral extrusion and denovo urgency rates determined in clinical studies,can be reliably and effectively used in sling surgery.
次要结局
- urethral erosion at three years after surgery(three years after surgery)
- vaginal erosion at three years after surgery(three years after surgery)
- Denovo urgency at three years after surgery(three years after surgery)
- urine retantion at three years after surgery(three years after surgery)
- sutur granuloma at three years after surgery(three years after surgery)