NCT07366762已完成3 期
Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
研究概览
简要总结
compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with primary symptoms of SUI confirmed by patient's medical history and clinical examination, including a focused incontinence evaluation
- •Age range of 30-75 years
- •Females unfit for surgery
- •Females with SUI recurrence after previous surgical procedure by suburethal sling
- •Females refusing surgical interventions
排除标准
- •Residual urine volume exceeding 100 cc after excretion
- •Evidence of detrusor over-activity on the urodynamic test
- •Active urinary tract or vaginal infection
- •Malignancies of the genitourinary system
- •Patients with genitourinary fistula or urethral diverticulum
研究组 & 干预措施
group one who had received PRP injections
Active Comparator
干预措施: Platelet Rich Plasma (Biological)
group two who had received i-PRF injections
Active Comparator
干预措施: Platelet rich fibrin (Biological)
结局指标
主要结局
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
时间窗: baseline and three and six months follow up
次要结局
- changes in the severity of SUI using 10 point visual analogue scale(baseline and three and six months follow up)
研究者
Marwa Reda Mohamed Gebril
obstetrics and gynecology resident
Kafrelsheikh University
研究点 (1)
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