Prostatitis
Conditions
Keywords
prostatitis, chronic pelvic pain, cannabidiol and hyaluronic acid, rectal delivery
Brief summary
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.
Detailed description
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.
Interventions
DEVICECANNEFF® SUP rectal suppositories
CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients
Sponsors
CB21 Pharma Ltd.
Palacky University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alleviating Chronic Non-bacterial Prostatitis Symptoms | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score Evaluation | 30 days | Secondary outcome measures included the International Prostate Symptom Score (IPSS). The IPSS evaluates lower urinary tract symptoms (both storage and voiding). A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. The index was assessed at baseline and again on Day 30. |
| Erectile Function Evaluation | 30 days | The five-item International Index of Erectile Function (IIEF-5) was evaluated, whereas the IIEF-5 provides a brief assessment of erectile function (higher scores indicating better function). Interpretation: score 22-25 - No erectile dysfunction, 17-21 - Mild erectile dysfunction, 12-16 - Mild to moderate erectile dysfunction, 8-11 - Moderate erectile, 5-7 - Severe erectile dysfunction. The index was assessed at baseline and again on Day 30. |
| Safety Profile Evaluation | 30 days | Adverse events reported were monitored after 30 d of intervention. |
Countries
Czechia
Outcome results
None listed