Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- After one month of first session, the rate of Improvement of the stress urinary incontinence increased .
研究概览
简要总结
Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI .
This study add the effect both HIFU and PRP together in treating SUI.
详细描述
What is stress urinary incontinence (SUI)? Stress urinary incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. With mild SUI, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. If your SUI is more severe, you may also leak with less forceful activities like standing up, walking or bending over. Urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes SUI is a very common bladder problem for women. Key SUI statics About half of women age 65 and above find that they sometimes leak urine. How can SUI Affect life? Many people find that SUI gets in the way of daily and social activities. It can affect family and sexual relationships. Some people even begin to feel isolated and hopeless because of it The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this.
PRP is extremely rich in growth factors and cytokines which regulate tissue reconstruction, PRP is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject PRP under urethra to restore bulbourethral ligment .
HIFU is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women complain of SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (American Urological Association 2017).
- •Positive cough test when filled urinary bladder.
- •Women chose non-invasive management rather than surgical management. • • Among the 20 patients enrolled, the average age was 30-60 years old.
- •Urodynamic study proven the diagnosis.
排除标准
- •Patient of previous operation or radiation
- •Uncontrolled diabetes Neuromuscular disorder
- •Uncontrolled psychiatric diseases
- •Pregnancy
- •Lactation
- •Active carcinoma
- •Cystocele.
- •Antiplatelet drug intake less than 7 days before and after procedure. - bleeding disorder.
- •Patients cannot deal with Questionnaires.
研究组 & 干预措施
Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval.
Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.
干预措施: PRP injection (Device)
Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU.
Procedure: 3 cycles of vaginal HIFU together with 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals
干预措施: Hifu procedure and PRP injection (Device)
结局指标
主要结局
After one month of first session, the rate of Improvement of the stress urinary incontinence increased .
时间窗: One month after first session
Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.
次要结局
- one month after complete three sessions ,the rate of Improvement of the urinary incontinence increased.(One month after complete three sessions)
研究者
Dina Mohamed Ahmed Srour
Doctor
Ain Shams Maternity Hospital
