CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CBD-based therapy

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

Group Type EXPERIMENTAL

CANNEFF® SUP rectal suppositories

Intervention Type DEVICE

CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients

Interventions

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CANNEFF® SUP rectal suppositories

CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No