A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Subjective cure rate (compared to results of TVT)
研究概览
简要总结
The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.
Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.
Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.
详细描述
Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).
During the study, the clinical outcomes, and the adverse experience 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 incontinence
排除标准
- •pregnancy
- •<12 months postpartum
- •systemic disease and/or drugs known to affect bladder function
- •current chemotherapy or radiation therapy
- •urethral diverticulum
- •augmentation cytoplasty
- •artificial sphincter
- •genital prolapse equal to or more than second degree
- •history of severe abdominopelvic infections
- •detrusor instability and/or intrinsic sphincter dysfunction
- •other gynecologic pathologies
结局指标
主要结局
Subjective cure rate (compared to results of TVT)
次要结局
- Objective cure rate
- Intraoperative complication rate(one day)
- Blood loss
- Postoperative complication rate(thirty days)
- Long-term complication rate(twelve months)
- Postoperative pain
- Patients' satisfaction
- Sexual function
- Quality of life
- Recurrence rate
- Feasibility (degree of surgical difficulty in non-trained surgeons)
- Learning curve (change in operative time, intra- and post-operative complications over the time