Clinical trial NCT06968910: CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms
Official title: Cannabidiol-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms - Single-arm Open-label Pilot Clinical Trial With Intrarectal Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatitis
Keywords: prostatitis
chronic pelvic pain
cannabidiol and hyaluronic acid
rectal delivery
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: CB21 Pharma Ltd.
First posted: 2025-05-13
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alleviating Chronic Non-bacterial Prostatitis Symptoms
timeFrame: 30 days
measure: Alleviating Chronic Pelvic Pain Symptoms
timeFrame: 30 days
Secondary outcomes:
measure: International Prostate Symptom Score Evaluation
timeFrame: 30 days
measure: Erectile Function Evaluation
timeFrame: 30 days
measure: Safety Profile Evaluation
timeFrame: 30 days
Other outcomes:
Locations:
city: Olomouc
country: Czech Republic
facility: Department of Urology, University Hospital Olomouc, Czech Republic
Study officials:
References:
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citation: Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
citation: Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x.
citation: Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001 Mar;165(3):842-5.