Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
研究概览
简要总结
The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.
详细描述
A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue > 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years old and no improvement with conservative management
排除标准
- •Prior anti incontinence surgery
结局指标
主要结局
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
时间窗: 1 month
Urinary retention will be considered the need for bladder catheterization or post-voiding residue\> 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.
次要结局
- To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.(1 month)