NCT00527696终止3 期
Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Objective cure as defined by the cough test at one year from surgery
研究概览
简要总结
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.
排除标准
- •Women with predominantly symptoms of urge urinary incontinence
- •Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
- •Detrusor overactivity on cystometrogram at urodynamic testing
- •Previous surgery for incontinence
- •Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
- •Voiding dysfunction with postvoid residual >100 cc
结局指标
主要结局
Objective cure as defined by the cough test at one year from surgery
时间窗: one year
次要结局
未报告次要终点
研究者
Ken Maslow
Assistant professor
University of Manitoba
研究点 (2)
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