Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial

• Status: Recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to evaluate the efficacy of the supplement PEAPROSTIL 600 (FARMITALIA®) composed of Serenoa Repens combined with PEA in single or combined therapy with alpha-blocker in the reduction of voiding symptoms in benign prostatic hyperplasia (BPH) patients at low risk of progression to obstructing conditioning that need for surgical therapy. Any adverse events, intolerance, allergic reactions, complications related to the products used will be recorded throughout the study period.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• male with age> 40 years

• baseline International Prostate Symptoms Score between 8 and 14

• prostate volume ≤ 60 cc assessed by transrectal ultrasound (TRUS)

• maximum flow (Qmax at uroflowmetry) ≤ 15 ml / sec

• post voiding residue on extemporaneous ultrasound ≤ 120 ml

• Signature of informed consent for participation in the study

• ability to understand the conditions of the study and to participate in the study throughout its duration.

Exclusion Criteria:

• urinary incontinence

• overactive bladder

• neurological bladder

• malignancies in progress and which have undergone treatment in the previous 6 months

• local or systemic infections (urinary tract infection, osteomyelitis, sepsis, etc.)

• kidney failure

• macrohematuria

• bladder stones