Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Stress incontinence
研究概览
简要总结
- To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence.
- Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.
详细描述
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.
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 (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
- •Bulge of paries anterior vaginas stage III-IV
- •Uterine prolapse stage II-II
- •Without symptoms of stress urinary incontinence
- •Screening tests of occult stress urinary incontinence(OSUI) should be positive
- •≥55 years old.
排除标准
- •Pregnancy
- •Illegible to follow up after surgery
- •Previous surgery for stress urinary incontinence
- •Unfinished data collection before surgery
研究组 & 干预措施
No TVT-O
Improved reconstruction pelvic surgery
干预措施: Improved reconstruction pelvic surgery (Procedure)
Combined surgery group
Improved reconstruction pelvic surgery TVT-O procedure
干预措施: TVT-O (Procedure)
Combined surgery group
Improved reconstruction pelvic surgery TVT-O procedure
干预措施: Improved reconstruction pelvic surgery (Procedure)
结局指标
主要结局
Stress incontinence
时间窗: 3 months to 2 years post-operation
Urine loss from physical activity such as coughing, sneezing or laughing.
次要结局
- Immediate and short-term complications(Intraoperative and 2 years post-opeartion)
- Overall urinary tract function(3 months, 12 months and 2 years post-operation)