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CompletedNCT07665749FINALUpdated Nov 6, 2026

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

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

Updated Nov 6, 2026Now CompletedFirst site in Italy+2 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Ages
40 Years to 80 Years
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Benign Prostate Hypertrophy(BPH)

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Keywords

  • BPH
  • LUTS
03

In context

Prostatic Hyperplasia

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 →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Prostate or bladder cancer
  • History of neurogenic bladder
  • Urinary tract abnormalities (including urethral strictures)
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • GROUP 1 - AB+Serenoa repens

    PATIENTS TREATED WITH AB+Serenoa repens

  • GROUP 2 - AB+antimuscarinics

    PATIENTS TREATED WITH AB+antimuscarinics

06

What researchers measure

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

07

Study locations

1 site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2026 to primary completion in Jun 2026, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 24, 2026
StartActual
Jun 1, 2026
Primary completionActual
Jun 30, 2026
CompletionActual
Nov 1, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Nov 6, 2026
Sites
1 site added — first site in Italy
Show site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · Milan, Italy
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Not yet recruiting→Completed
    1 site added — first site in Italy
    Show site
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · Milan, Italy
    + 3 other changes: verification date, date precision and contact details

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 ↗

09

Registry details

Key details

Study ID
NCT07665749
Responsible party
Luca Boeri (MD, PHD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Jun 24, 2026
Start date
Jun 1, 2026
Primary completion
Jun 30, 2026
Completion
Nov 1, 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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