Cannabidiol-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms - Single-arm Open-label Pilot Clinical Trial With Intrarectal Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Alleviating Chronic Non-bacterial Prostatitis Symptoms
研究概览
简要总结
Efficacy and safety of the medical device rectal CANNEFF® SUP suppositories containing two active ingredients cannabidiol (CBD) and hyaluronic acid (HA) in alleviating non-bacterial prostatitis symptoms and improving quality of life in men will be evaluated.
详细描述
Chronic non-bacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS) is the third most common urogenital diagnosis in men, following benign prostatic hyperplasia and prostate cancer, with an estimated prevalence reaching 8.2%. Clinically, CP/CPPS often presents with persistent pelvic pain, lower urinary tract symptoms (LUTS), and sexual dysfunction, all of which can substantially diminish quality of life. Psychological comorbidities, including anxiety, stress, and depression, further amplify the burden on patients. Despite its considerable socioeconomic impact, no definitive treatment consensus exists for CP/CPPS. This study assessed the effects of rectal administration of cannabidiol (CBD)-based therapy in men with CP/CPPS. A single-arm, open-label pilot trial on men with CP/CPPS (NIH Chronic Prostatitis Symptom Index [NIH-CPSI] >10, pain subscore ≥4). The participants self-administered rectal CANNEFF® suppositories containing CBD (100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients, nightly for 30 days. Outcome measures included changes in NIH-CPSI total score, International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5). Safety and tolerability were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •men aged 18-50 years
- •reported pelvic pain for ≥3 months in the past 6 months
- •reported the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score >10 with a pain subscore ≥4
- •clinically and laboratory diagnosed CP/CPPS
排除标准
- •confirmed genitourinary infections (e.g., Escherichia coli, Enterococcus faecalis, Chlamydia spp.)
- •recent antibiotic use (within 6 months)
- •cannabis use
- •alpha-blockers or phytotherapeutics in the preceding 4 weeks
- •no history of pelvic trauma, surgery or radiotherapy, neurogenic bladder, post-void residual >50 mL, or psychiatric disorders affecting compliance
结局指标
主要结局
Alleviating Chronic Non-bacterial Prostatitis Symptoms
时间窗: 30 days
The primary outcome was the change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score between baseline (Day 0) and Day 30. The NIH-CPSI has a total score range from 0 to 43, and it includes three subscales addressing pain (score range 0-21), urinary symptoms (score range 0-10), and quality of life (QOL) (score range 0-12). Higher score means a worse outcome.
Alleviating Chronic Pelvic Pain Symptoms
时间窗: 30 days
The changes in the NIH-CPSI pain subscore (score range 0-21) were evaluated to capture the specific impact on pelvic pain. Higher score means a worse outcome.
次要结局
- International Prostate Symptom Score Evaluation(30 days)
- Erectile Function Evaluation(30 days)
- Safety Profile Evaluation(30 days)
研究者
Jan Vacek
Olomouc University Hospital
Palacky University