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

NCT07665749 | Not Yet Recruiting

• 1 other identifier: 6876
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Benign Prostate Hypertrophy(BPH)

Keywords

BPH; LUTS

Outcome Measures

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.

  AT 6 MONTHS FOLLOW UP

Secondary Outcomes (1)

• SIDE EFFECTS

  AT 6 MONTHS FOLLOW UP

Study Arms (2)

GROUP 1 - AB+Serenoa repens

PATIENTS TREATED WITH AB+Serenoa repens

GROUP 2 - AB+antimuscarinics

PATIENTS TREATED WITH AB+antimuscarinics

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Prostate or bladder cancer
• History of neurogenic bladder
• Urinary tract abnormalities (including urethral strictures)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

LUCA BOERI, MD, PHD

CONTACT

+390255034501; LUCA.BOERI@POLICLINICO.MI.IT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 1, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06