Intra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- efficacy as measured by global response assessment "GRA"
研究概览
简要总结
A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .
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
- None
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
- •Patients with a diagnosis of interstitial cystitis/ Bladder painful Syndrome for more than 3 months will be enrolled
排除标准
- •Patients with Anemia, blood disorders, history of pelvic irradiation, pelvic malignancy, and active urinary tract infection unless treated, vesical stone, gynecological disorders e.g. uterine fibroid and neurological disorders will be excluded. Patients less than 18 years old will not be allowed to participate.
研究组 & 干预措施
intravesical instillation
Intravesical instillation of platelet enriched plasma every week for 6 weeks
干预措施: platelet enriched plasma (Biological)
submucosal injection
submucosal injectionof platelet enriched plasma
干预措施: platelet enriched plasma (Biological)
结局指标
主要结局
efficacy as measured by global response assessment "GRA"
时间窗: 3 month for each case. Expected time about 18-24 months for whole study period
It will be measured by global response assessment as main tool. Other measurable outcomes including visual analogue scale for pain, Interstitial Cystitis Symptom Index (4 questions) and Problem Index (4 questions) (ICSI/ICPI). These measures will be collected after each session during period of administration of treatment then at 3 months after end of treatment
次要结局
- safety : rate of complication and grade of complications graded by Dindo-Clavien classification(3 month for each case. Expected time about 18-24 months for whole study period)
- incidence of urinary tract infection and gynecological infection among this group(3 month for each case. Expected time about 18-24 months for whole study period)
研究者
Ahmed Sobhy Elhefnawy
principle investigator
Mansoura University