Chronic Prostatitis (CP), Chronic Prostatitis/ Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
Chronic prostatitis, chronic pelvic pain syndrome, LUTS, pain, phycocyanin, palmitoylethanolamide, FICOXPEA®, phytotherapy
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 association of phycocyanin (PC) and palmitoylethanolamide (PEA) and selenium (FICOXPEA®) in male patients affected by CP/CPPS. The main questions the present study aims to answer are: * Does FICOXPEA® enhance quality of life of CPP/CPPS patients? * Does it help reducing pain symptoms of CPP/CPPS patients? Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy. Participants will: * Take FICOXPEA® once a day for 30 days; * Visit the clinic for follow-up visits at 1 and 3 months; * Answer validated questionnaires and declare potential adverse events at follow-up visits.
Interventions
DRUGFICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium
FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg
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, multicentric, 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 ≥ 3 months; * PSA values of 4 to 10 ng/ml (at least 2 determinations) * patients must have completed diagnostic work-up, such as multiparametric prostate MRI (evidence level 1a according to EAU guidelines) with or without subsequent prostate biopsy (according to the diagnostic flow-chart depicted by EAU international guidelines).
Exclusion criteria
* patients with previous diagnosis of prostate cancer * patients who underwent previous low urinary tract surgery * patients who underwent previous intravescical chemotherapy * patients with acute bacterial prostatitis * diagnostic work-up for prostate cancer not completed * patients having antibiotic therapy or specific chronic prostatis treatment (phytotherapy included) or benign prostatic iperplasia treatment (e.g. alpha litics) at the time of the recruitment or finished less than a month before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistically significant change of CPSI total score compared to baseline | 1 month and 3 months | Improvement of CP symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Statistically significant change of CPSI pain domain score compared to baseline | 1 month and 3 months | improvement of CP pain symptoms |
| Statistically significant change of CPSI QoL domain score compared to baseline | 1 month and 3 months | Improvement of CP QoL |
| Statistically significant change of total PSA | 1 month and 3 months | Decrease of chronic altered PSA values |
| n° of any adverse events | 1 month and 3 months | number and type, so safety analysis |
Countries
Italy
Outcome results
None listed