A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Objective/subjective symptoms improvements
研究概览
简要总结
The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.
详细描述
Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterior defect, in patients of arm 1 will be associated TOT, whereas in patients of arm 2 will be associated TVT.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cystocele
- •Genuine stress urinary incontinence by self report, examination and test
- •Urethral hypermobility
- •Eligible for both surgical procedures
- •Ambulatory
排除标准
- •Pregnancy
- •<12 months post-partum
- •Systemic disease and/or drugs known to affect bladder function
- •Current chemotherapy or radiation therapy
- •Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
- •Recent pelvic surgery
- •Previous pelvic or anti-incontinence surgery
- •History of severe abdominopelvic infections
- •Known extensive abdominopelvic adhesions
- •Detrusor instability and/or intrinsic sphincter dysfunction
- •Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
结局指标
主要结局
Objective/subjective symptoms improvements
时间窗: 12 months
次要结局
- Intra-operative complication rate(one day)
- Postoperative complications rate(12 months)
- Failure rate(12 months)
- Recurrence rate(12 months)
- Quality of life(12 months)
- Sexual function(12 months)
研究者
Stefano Palomba
Associate Professor
University Magna Graecia