NCT01384084已完成3 期
URINARY INCONTINENCE AND URO-GENITAL PROLAPSE: A RANDOMIZED TRIAL OF PELVIC ORGAN PROLAPSE REPAIR PLUS MINI-SLING VERSUS PELVIC ORGAN PROLAPSE REPAIR ALONE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- urinary incontinence
研究概览
简要总结
The investigators have performed colposacropexy in women with uterovaginal prolapse for many years with satisfactory results.
This study was designed to compare whether, in the treatment of patients with uro-genital prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure such as mini-sling is associated with a reduction of post-operative urinary incontinence (correction of pre-existent urinary incontinence and prevention of masked urinary incontinence).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients affected by III-IV grade urogenital urogenital prolapsed and urinary incontinence
- •Candidates for pelvic organ prolapsed repair using sacropexy
- •Prospectively randomized, using a predetermined computer-generated randomization code (4 blocks), to sacropexy plus anti-incontinence procedure (mini-sling) or sacropexy alone
排除标准
- •fertile patients
- •contraindication to major surgery
- •uterine cancer
结局指标
主要结局
urinary incontinence
时间窗: 12 months
long-term relief of symptoms with anatomic correction of prolapse and subjective/objective correction of urinary incontinence
次要结局
- peri and post-operative complications(1 month)
研究者
Luigi Mearini
senior assistant
University Of Perugia
研究点 (2)
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