A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Cure rate
研究概览
简要总结
The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).
To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.
详细描述
Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .
All eligible patients 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
- •Genuine stress urinary incontinence by self report, examination and test
- •Urethral hypermobility
- •Eligible for all three 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
Cure rate
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