Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CB21 Pharma Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD-based therapy | Experimental | Participants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CANNEFF® SUP rectal suppositories | Device | CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alleviating Chronic Non-bacterial Prostatitis Symptoms | 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. | 30 days |
| Alleviating Chronic Pelvic Pain Symptoms | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score Evaluation | 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. | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Only biological male identity.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Hospital Olomouc, Czech Republic | Olomouc | 779 00 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9187685 | Background | Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0. | |
| 1279218 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Erectile Function Evaluation | 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. | 30 days |
| Safety Profile Evaluation | Adverse events reported were monitored after 30 d of intervention. | 30 days |
| 10411041 | Background | 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. |
| 11176483 | Background | 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. |
| D052801 |
| Male Urogenital Diseases |