Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparison of the cure rates between the mini sling and classical transobturator tapes
研究概览
简要总结
- OBJECTIVE:
To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment. 2. METHODS:
This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years
- •Clinical and urodynamic diagnosis of stress urinary incontinence
- •Absence of associated neurological diseases
- •No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)
排除标准
- •urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
- •Coagulopathies
- •Pregnancy
- •History of sensitivity to foreign body
- •Acute Urinary Tract Infection
- •Sequelae of high exposure to ionizing radiation
- •Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
- •anesthetic contraindication to the procedure
- •Vulvovaginitis: presence of vaginal discharge with laboratory proven infection
结局指标
主要结局
Comparison of the cure rates between the mini sling and classical transobturator tapes
时间窗: Up to one year
Percentage of patients who are regarded as cured or improved based on the following criteria: * Negative Cough Stress test 1 year after surgery * Pad Test \< 2 g 1 year after surgery
次要结局
- Number of participants with adverse events(0, 1, 6 and 12 months after surgery)
研究者
Emerson Oliveira
Phd
Faculdade de Medicina do ABC