Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- Objective Stress Urinary Incontinence
研究概览
简要总结
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
详细描述
Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.
In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.
However, to date the success and complications of these two procedures have not been compared or studied.
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
- 是
入选标准
- •Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
排除标准
- •Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
研究组 & 干预措施
Monarc
Placement of a transobturator monarc sling for stress urinary incontinence
干预措施: Monarc (Device)
Mini-arc
Placement of a single incision mini-arc sling for stress urinary incontinence
干预措施: Mini-arc (Device)
结局指标
主要结局
Objective Stress Urinary Incontinence
时间窗: 1 year
The primary outcome was presence of leakage during cough stress test(CST) on examination
次要结局
- Quality of Life Questionnaire ICIQ(1 year)
- Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence(1 year)
- Quality of Life Questionnaire IIQ-7(1 year)
- Quality of Life Questionnaire UDI-6(1 year)
- Number of Participants Who Completed Self- Assessment of Cure(1 year)
研究者
Cecilia Calvo
coordinator
The Cleveland Clinic