Benign Prostate Hypertrophy(BPH)FINALNCT07665749
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 of Benign Prostate Hypertrophy(BPH), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Prostate or bladder cancer
- History of neurogenic bladder
- Urinary tract abnormalities (including urethral strictures)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: 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).
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.
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Keywords
- BPH, LUTS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 - AB+Serenoa repens | PATIENTS TREATED WITH AB+Serenoa repens | |
| GROUP 2 - AB+antimuscarinics | PATIENTS TREATED WITH AB+antimuscarinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: AT 6 MONTHS FOLLOW UP
Secondary outcomes (1)
SIDE EFFECTS
Frequency of side effects in the two treatment categories
Measured: AT 6 MONTHS FOLLOW UP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2026
- Study completion1 Nov 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Boeri, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665749
- Sponsor's protocol ID
- 6876
- Acronym
- FINAL
- Status last verified
- Nov 2026
- First submitted
- 18 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07665749
- Acronym / sponsor ID
- FINAL / 6876
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Keywords
- BPH, LUTS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Nov 2026 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 - AB+Serenoa repens | – | –PATIENTS TREATED WITH AB+Serenoa repens |
| GROUP 2 - AB+antimuscarinics | – | –PATIENTS TREATED WITH AB+antimuscarinics |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Prostate or bladder cancer
- History of neurogenic bladder
- Urinary tract abnormalities (including urethral strictures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
SIDE EFFECTS
Time frame: AT 6 MONTHS FOLLOW UP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIFFERENCE IN IPSS (time frame: AT 6 MONTHS FOLLOW UP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.