NCT00379314Unknown3 期
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Objective cure rate by stress test and pad weighing test
研究概览
简要总结
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •history of stress incontinence
- •indications for surgical treatment
- •positive cough stress test
- •urgency score < 7
排除标准
- •prior incontinence surgery
- •need of concomitant surgery
- •post void residual urine volume < 100 ml
- •urinary tract anomalies
- •urinary tract infection
- •more than 3 urinary tract infection within last year
- •more than grade 2 urogenital prolapse
- •Body mass index > 35
- •Radiotherapy of the pelvic region
- •active malignancy
- •hemophilia
- •anticoagulant treatment
- •neurological disorder or other disease which affects bladder function
- •anticholinergic treatment
- •use of duloxetine
- •do not understand the purpose of the trial
- •immobility
结局指标
主要结局
Objective cure rate by stress test and pad weighing test
Complications
次要结局
- Quality of life questionnaires
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-upUrinary Incontinence,StressUrinary Incontinence, UrgeNCT04240613Turku University Hospital106
已完成
不适用
Randomised trial of tension-free vaginal tape and transobturator tape as treatment for urinary stress incontinence in womerodynamic stress incontinenceUrological and Genital DiseasesOther disorders of urinary systemISRCTN34377436niversity Hospitals of Leicester NHS Trust (UK)200
已完成
不适用
Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.Female Stress Urinary IncontinenceNCT01699425Hospital Universitari Vall d'Hebron Research Institute60
已完成
不适用
Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinencerodynamic Stress Incontinence (USI)Urological and Genital DiseasesUrodynamic Stress Incontinence (USI)ISRCTN71562338Countess of Chester NHS Foundation Trust (UK)320
终止
不适用
A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary IncontinenceStress Urinary IncontinenceNCT00642109David Scheiner160