A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
研究概览
简要总结
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of 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
- Single
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Urinary incontinence symptoms
- •Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- •Age of at least 21 years
- •Desires surgical correction of stress urinary incontinence
排除标准
- •Post-void residual volume >100cc
- •Detrusor overactivity on preoperative multichannel urodynamic testing
- •History of previous synthetic, biologic or fascial sub-urethral sling
- •Desires future childbearing
- •Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurativa
- •History of bleeding diathesis or current anti-coagulation therapy
- •Inguinal lymphadenopathy or inguinal/vulvar mass
- •Current genitourinary fistula or urethral diverticulum
- •Reversible cause of incontinence (i.e. drug effect)
- •Contraindication to surgery
结局指标
主要结局
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
时间窗: 12 months
次要结局
- Complications
- Postoperative pain(2 weeks, 6 weeks)
- HRQOL(6 months, 12 months, 18 months, 24 months)
- Sexual function(12 months, 24 months)
- Global improvement in bladder function(6 months, 12 months, 18 months, 24 months)
- Development of anterior vaginal prolapse(12 months, 24 months)