CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms (Urol-CBD)

Palacky University

Status: Completed

Conditions: Prostatitis

Treatments: Device: CANNEFF® SUP rectal suppositories

Study type: Interventional

Funder types: Other

Identifiers

NCT06968910

176/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

CBD-based therapy

Experimental group

Description:

Participants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days.

Treatment:

Device: CANNEFF® SUP rectal suppositories