A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Objective/subjective symptoms improvements
研究概览
简要总结
Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.
详细描述
Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.
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
- •Predominant or 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
- •Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
- •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
- Quality of life(12 months)
- Failure rate(12 months)
- Recurrence rate(12 months)
- Sexual function(12 months)
- Intra-operative complication rate(one day)
- Postoperative complications rate(12 months)
研究者
Stefano Palomba
Associate Professor
University Magna Graecia