The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Stress urinary incontinence symptoms
研究概览
简要总结
Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.
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
- Double (Participant, Investigator)
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
- •Adult women with stress urinary incontinence
排除标准
- •pregnancy,
- •history of active malignant pathology,
- •mental disorders making them unable to give consent,
- •undiagnosed abnormal uterine bleeding,
- •genitourinary fistula,
- •anti-incontinence surgery,
- •pelvic organ prolapse stage > 2 according to POP-Q system
结局指标
主要结局
Stress urinary incontinence symptoms
时间窗: 6-12 months
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) Number of items: 12 Question items: Nocturia,Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis Completion time: 4-5 minutes Scoring: 0-16 filling symptoms subscale 0-12 voiding symptoms subscale 0-20 incontinence symptoms subscale 0-48 where all subscale scores are added. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient Higher scores indicate greater impact of individual symptoms for the patient.
次要结局
- Patient Global Impression of Improvement(6-12 months)
- Assessment of urine loss (1-hr pad test)(6-12 months)
- Impact of urinary incontinence on the quality of life(6-12 months)
- Level of discomfort during injections (VAS score)(6-12 months)
研究者
Themos Grigoriadis
Associate Professor of Gynecology
National and Kapodistrian University of Athens