The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- objective assessment of SUI through cough stress test
概览
简要总结
this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence
详细描述
stress urinary incontinence classified in urodynamic study according to Valsalva leak point pressure to intrinsic sphincteric muscle weakness best treated by PRP periurethral injection and VLPP is less than or equal 60cmH2O and MUCP less than 20cmH2O(21 ) patients enrolled in this group , while hypermobile urethra identified by VLPP is high more than 90cmh2O best treated by trans obturator tape(21) patients recruited in this group , mode of preparation of PRP is by withdrawing 15 ml blood and placed in falcon tube with ACD ( acid citrate dextrose) added centrifuged first at 800 RPM and then the supernatant removed and re-centrifuged again at 3500 RPM and then injected periurethral by 5cc syringe with 30G needle after applying 2% lidocaine ,patient assessed at one and three month objectively by cough stress test and subjectively by ICIQ questionnaire and presence of any adverse effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stress urinary incontinence identified by urodynamic study
- •patient agreement to undergo surgical treatment
排除标准
- •previous GUS operation
- •evidence of detrusor overactivity urinary system
- •presence of pelvic organ prolapse
- •malignancies of genitourinary system
- •history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .
研究组 & 干预措施
patients complaining of stress urinary incontinence based on urodynamic study
GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT
干预措施: Platelet Rich Plasma (Procedure)
patients complaining of stress urinary incontinence based on urodynamic study
GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT
干预措施: Mid urethral sling ( trans obturator tape) (Procedure)
结局指标
主要结局
objective assessment of SUI through cough stress test
时间窗: after one and three months
次要结局
未报告次要终点