Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Lower Urinary Tract Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Benign Prostate Hypertrophy(BPH). Basic parameters: 40 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- DIFFERENCE IN IPSS [Time frame: AT 6 MONTHS FOLLOW UP]
Secondary outcome measures (1)
- SIDE EFFECTS [Time frame: AT 6 MONTHS FOLLOW UP]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07665749 · 6876