Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
研究概览
简要总结
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
详细描述
eligibility criteria was : female stress 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants were randomly allocated to a single-incision mini-sling or a transobturator midurethral tape by a simple randomization procedure using a random number generator computer program. Randomization was performed at the moment of inclusion by a nurse blinded to women's histories. Group assign- ment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years
排除标准
- •postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication
结局指标
主要结局
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
时间窗: one year
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
次要结局
未报告次要终点
研究者
Ana Livia Garcia Pascom
M.D.
Federal University of São Paulo