Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

NCT06804083 | Completed Phase 4

• 1 other identifier: CET n. 00054/2019
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic prostatitis; chronic pelvic pain syndrome; PROSTYM®; bovine colostrum; LUTS; pain

Outcome Measures

Primary Outcomes (1)

• Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline

  improvement of CP symptoms

  6 months

Secondary Outcomes (3)

• Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline

  6 months

• Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline

  6 months

• Total Number of Adverse Events

  6 months

Study Arms (1)

PROSTYM®

EXPERIMENTAL

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.

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

Interventions

oral combination of colostrum and Serenoa repens extracts (PROSTYM®) 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). Drug administration (1 capsule per day) for 6 months.

Also known as: PROSTYM®

PROSTYM®

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients (with a prostate)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Urologica Molinette - Città della Saliute e della Scienza: lead
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator

Study Sites (1)

Molinette Hospital

Torino, Torino, 10126, Italy

Location

Related Publications (4)

• Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brahler E, Weidner W. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study. Eur Urol. 2009 Sep;56(3):544-51. doi: 10.1016/j.eururo.2009.05.046. Epub 2009 Jun 3.

  PMID: 19524353 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.

  PMID: 10411041 BACKGROUND

• Cai T, Luciani LG, Caola I, Mondaini N, Malossini G, Lanzafame P, Mazzoli S, Bartoletti R. Effects of pollen extract in association with vitamins (DEPROX 500(R)) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study. Urologia. 2013 Apr 24;80 Suppl 22:5-10. doi: 10.5301/RU.2013.10597. Epub 2013 Jan 16.

  PMID: 23334883 BACKGROUND

• Sibona M, Destefanis P, Agnello M, Lillaz B, Giuliano M, Cai T, Gontero P. The association of Boswellia resin extract and propolis derived polyphenols can improve quality of life in patients affected by prostatitis-like symptoms. Arch Ital Urol Androl. 2020 Jan 14;91(4):251-255. doi: 10.4081/aiua.2019.4.251.

  PMID: 31937091 BACKGROUND

MeSH Terms

Conditions

Prostatitis; Pain

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist, MD

Model Details: prospective, observational, single-arm study

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 31, 2025
• Study Start: March 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)