Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms

Clinica Urologica Molinette - Città della Saliute e della Scienza

Status and phase: Completed; Phase 4

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis (CP); Chronic Prostatitis/ Pelvic Pain Syndrome

Treatments: Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT07013890

CET n. 530/2021

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

FICOXPEA®

Experimental group

Description:

FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg 1. capsule containing all these compounds is administered every day for 30 days

Treatment:

Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium