NCT01057550已完成3 期
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Abertawe Bro Morgannwg University NHS Trust2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2001年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- success rate at improving symptom of stress urinary incontinence
研究概览
简要总结
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.
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
- Double (Investigator, 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
- 是
入选标准
- •Women requiring surgery for SUI following failed conservative treatment
排除标准
- •Under 18 years of age
- •Previous surgery for SUI
- •Evidence of neurological disease
- •Pelvic Organ Prolapse (POP) greater than Grade 2
- •Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment
结局指标
主要结局
success rate at improving symptom of stress urinary incontinence
时间窗: 1 year
次要结局
- completely dry rates(1 year)
- quality of life scores(1 year)
- intra & post-operative complications(1 year)
- re-operation rates(1 year)
- hospital stay(5 days)
- operative time(hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months AfterPelvic Organ ProlapseUrinary Stress IncontinenceNCT00308009Ullevaal University Hospital194
已完成
不适用
Pelvital Stress Urinary Incontinence Training Device: P-SUITIncontinenceNCT02954042Pelvital USA, Inc.120
招募中
不适用
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.Stress Incontinence FemaleUrinary IncontinenceUrinary Incontinence,StressPainPain AcuteNCT06369922University of Rochester100
已完成
不适用
Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive BladderUrinary IncontinencePain, AcuteOveractive BladderNCT05330117University of Rochester100
已完成
不适用
Tension Free Vaginal Tape (TVT) Versus the Miniarc SlingUrodynamic Stress IncontinenceNCT00843908Medway NHS Foundation Trust70