About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prostate or bladder cancer
History of neurogenic bladder
Urinary tract abnormalities (including urethral strictures)
Trial population
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.
Trial design
Other
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
SIDE EFFECTS
Frequency of side effects in the two treatment categories
Locations
Sponsors and contacts
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