Status:
UNKNOWN
Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Conditions:
Benign Prostatic Hyperplasia
Urinary Obstruction
Eligibility:
MALE
40+ years
Phase:
NA
Brief 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 ...
Detailed Description
Study design Single-center 3-arm randomized prospective clinical trial. * Arm 1: PEAPROSTIL 600 + Tamsulosin 0.4 mg * Arm 2: PEAPROSTIL 600 * Arm 3: Tamsulosin 0.4 mg At the time of study enrollmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06181175
Start Date
October 1 2021
End Date
April 30 2025
Last Update
December 26 2023
Active Locations (1)
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1
Michele Billia
Novara, Italy, 28100