A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
研究概览
简要总结
Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS.
详细描述
Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.
Objective
To compare TVT with CS as primary treatment for stress incontinence (SUI).
Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.
Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.
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
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
- •Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
- •Cystocele over grade I
- •Previous hysterectomy
- •Body mass index (BMI) of 40 or more
- •Uncontrolled diabetes
- •Neurological disease
- •Recurrent urinary tract infections
- •Genital atrophy precluding vaginal surgery
- •Known bleeding diathesis or current anticoagulant therapy
排除标准
- 未提供
结局指标
主要结局
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
次要结局
- Criteria were established to include patients in one of three groups: cure, improved and treatment failure