Bovine Colostrum Efficacy 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 (CP); Chronic Prostatitis with Chronic Pelvic Pain Syndrome; Chronic Prostatitis/ Pelvic Pain Syndrome

Treatments: Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06804083

CET n. 00054/2019

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 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.

Enrollment: 42 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 ≥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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

PROSTYM®

Experimental group

Description:

It is a phytotherapic drug. 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). All these components are included in one capsule. The drug is administered for 6 months in a 1 cp/die dosage.

Treatment:

Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)