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临床试验/NCT05295420
NCT05295420已完成不适用

The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月1日最近更新:
适应症

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
urinary incontinence severity by PRP treatment

研究概览

简要总结

Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.

Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

详细描述

Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation.

Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.

Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion.

Hence, there is a need for alternative efficacious, outpatient SUI treatments. Platelet-derived therapies are a growing trend across multiple medical and surgical specialties. Evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines.

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
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patient with mild to moderate SUI

排除标准

  • Under anti-platelet agent treatment
  • Platelet dysfunction syndrome
  • Critical thrombocytopenia
  • Acute and chronic infections
  • Anti-coagulation therapy
  • History of malignancy

结局指标

主要结局

urinary incontinence severity by PRP treatment

时间窗: From baseline to 3 months after the PRP treatment day.

Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,

次要结局

  • Patients can control voiding on stress(From baseline to first month and continued to 3 months after the treatment day)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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