Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic P… (NCT07665749) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Lower Urinary Tract Symptoms
50 participantsStarted 2026-06-01
Plain-language summary
The study aims to investigate, through the International Prostatic Symptoms Score (IPSS) questionnaire, the non-inferiority of the therapy with the alpha-blockers+Serenoa repens combination compared to the alpha-blockers+antimuscarinic combination on storage lower urinary tract syndrome (LUTS) in patients with moderate-severe symptomatic benign prostatic hyperplasia (BPH).
Who can participate
Age range
40 Years – 80 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:
* Age 40-80 inclusive
* Male
* With moderate-to-severe LUTS from BPH according to IPSS score
* Placed on AB+Serenoa repens or AB+antimuscarinics for 6 months
Exclusion Criteria:
* Prostate or bladder cancer
* History of neurogenic bladder
* Urinary tract abnormalities (including urethral strictures)
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
DIFFERENCE IN IPSS
Timeframe: AT 6 MONTHS FOLLOW UP
Trial details
NCT IDNCT07665749
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico