Chronic Prostatitis (CP), Chronic Prostatitis/ Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
Chronic prostatitis, chronic pelvic pain syndrome, PROSTYM®, bovine colostrum, LUTS, pain
Brief summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition. The aim of this study was to investigate the role of an oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in the treatment of CP/CPPS patients. The main questions the present study aims to answer are: * Does PROSTYM® enhance quality of life of CPP/CPPS patients? * Does it help reducing pain symptoms of CPP/CPPS patients? Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy. Participants will: * Take PROSTYM® every day for 6 months; * Visit the clinic for follow-up visits at 3 and 6 months; * Answer validated questionnaires and declare potential adverse events at follow-up visits.
Interventions
DRUGoral combination of colostrum and Serenoa repens extracts (PROSTYM®)
The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). Drug administration (1 capsule per day) for 6 months.
Sponsors
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Clinica Urologica Molinette - Città della Saliute e della Scienza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, observational, single-arm study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult male patients (aged \>18 years) * clinical affection by CP/CPPS with symptoms that persisted for ≥6 months; * CPSI pain domain score ≥5 points; * negative Meares and Stamey test score.
Exclusion criteria
* patients with prevalent BPH symptoms (CPSI pain domain \<5), acute prostatitis, chronic bacterial prostatitis (positive Meares and Stamey test), prostate or bladder cancer, urethral stenosis or neurological bladder; * no other drug or supplement specific to chronic prostatitis in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline | 6 months | improvement of CP symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline | 6 months | improvement of CP pain symptoms |
| Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline | 6 months | improvement of CP QoL |
| Total Number of Adverse Events | 6 months | number and type, so safety analysis |
Countries
Italy
Outcome results
None listed