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

Launched by AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITA · Dec 12, 2023

Keywords

ClinConnect Summary

The ProSeRePEA Trial is studying a new treatment for men with benign prostatic hyperplasia (BPH), a condition that can cause urinary problems like difficulty urinating or a weak stream. This trial is looking at a supplement called PEAPROSTIL 600, which combines two ingredients, Serenoa Repens and PEA. Researchers want to see if this supplement can help improve urinary symptoms, either on its own or when used with a medication called Tamsulosin, which is commonly prescribed for BPH.

To be eligible for this trial, participants must be male, at least 40 years old, and have specific urinary symptoms that are not too severe. They also need to have a prostate size within a certain limit and be able to understand and agree to participate in the study. Throughout the trial, participants will be monitored for any side effects or reactions to the treatment. If you or someone you know is struggling with BPH and meets these criteria, this study might be an opportunity to explore a potential new treatment option.

Gender

MALE

Eligibility 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