Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Lower Urinary Tract Symptoms

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-80
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: GROUP 1 - AB+Serenoa repens
Group B: GROUP 2 - AB+antimuscarinics

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

SIDE EFFECTS

Frequency of side effects in the two treatment categories

Time frame
AT 6 MONTHS FOLLOW UP

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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