Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
研究概览
简要总结
The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostatitis like symptoms for at least three months
排除标准
- •significant post-voidal residual volume
- •Meares and Stamey test suggestive for bacterial infection
- •neoplasms,
- •urinary stones,
- •antibiotic therapy in the previous three months,
- •irritable bowel syndrome,
- •previous radiotherapic or chemiotherapic treatment,
- •urethral stenosis,
- •neurogenic bladder
- •previous prostatic surgery
研究组 & 干预措施
Patients with prostatitis-like symptoms
Cohort of patients with CP/CPPS (abacterial prostatitis)
干预措施: Proxelan (Drug)
结局指标
主要结局
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
时间窗: 30 days
Evaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms.
次要结局
未报告次要终点
研究者
Prof. Riccardo Bartoletti
Professor
University of Pisa