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

June 24, 2026 updated by: Luca Boeri, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Mixed Lower Urinary Tract Symptoms: Results of a Cross-sectional Clinical Study

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).

Study Overview

Status

Not yet recruiting

Conditions

Benign Prostate Hypertrophy(BPH)

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: LUCA BOERI, MD, PHD
Phone Number: +390255034501
Email: LUCA.BOERI@POLICLINICO.MI.IT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study 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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
GROUP 1 - AB+Serenoa repens PATIENTS TREATED WITH AB+Serenoa repens
GROUP 2 - AB+antimuscarinics PATIENTS TREATED WITH AB+antimuscarinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DIFFERENCE IN IPSS Time Frame: AT 6 MONTHS FOLLOW UP	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.	AT 6 MONTHS FOLLOW UP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SIDE EFFECTS Time Frame: AT 6 MONTHS FOLLOW UP	Frequency of side effects in the two treatment categories	AT 6 MONTHS FOLLOW UP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria