An observational study in Benign Prostate Hypertrophy(BPH), sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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).
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in adult men. LUTS/BPH can be very bothersome and impair the quality of life (QoL) of affected men and their partners. Furthermore, LUTS also negatively impact patients' work productivity, being a major cause of absence from work and medical appointments. The prevalence of LUTS/BPH increases with age, making them increasingly common conditions in the Western world.
Standard medical treatments for patients with LUTS/BPH include alpha-blockers (ABs), 5-alpha-reductase inhibitors (5ARIs), phosphodiesterase type 5 inhibitors, and antimuscarinics. Serenoa repens (HESr) supplements are also recommended as a therapeutic option in international LUTS guidelines. In particular, Serenoa repens has been shown to have anti-inflammatory, anti-apoptotic, and muscle relaxant effects that can counteract the effects of BPH. Historically, ABs have been used as first-line therapy for voiding LUTS, while antimuscarinics are effective for irritative LUTS. However, most patients often present with mixed LUTS and therefore require combination therapy. Recent studies have shown that the combination of AB + Serenoa was non-inferior to therapy with AB + 5ARI in improving LUTS, producing fewer side effects. In particular, Serenoa was also seen to be effective in improving irritative symptoms. However, no studies have compared therapy with AB + Serenoa to AB + antimuscarinics in patients with mixed LUTS due to BPH.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 50 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.
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The study population consists of men affected by moderate-severe BPH (assessed using the IPSS questionnaire) with mixed symptoms, treated with AB + Serenoa repens or AB + antimuscarinics in the period from January 2020 to October 2025, with follow-up until March 2025.
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Exclusion Criteria:
PATIENTS TREATED WITH AB+Serenoa repens
PATIENTS TREATED WITH AB+antimuscarinics
DIFFERENCE IN IPSS
Difference in International Prostatic Symptoms Score (IPSS) at follow-up between the two treatment groups. IPSS min value 0 - max value 35, where: * 0-7 refers to mild symtomps; * 8-19 refers to moderate symtomps; * 20-35 refers to severe symtomps. Non-inferiority will be defined as a difference of up to 1 point in the International Prostatic Symptoms Score (IPSS) between the two groups at follow-up.
Time frame: AT 6 MONTHS FOLLOW UP
SIDE EFFECTS
Frequency of side effects in the two treatment categories
Time frame: AT 6 MONTHS FOLLOW UP
Ran from Jun 2026 to primary completion in Jun 2026, 0 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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