Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeReP… (NCT06181175) | Clinical Trial Compass
UnknownNot Applicable
Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
Italy250 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire
Timeframe: 1 year
2
Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire
Timeframe: 1 year
Trial details
NCT IDNCT06181175
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita