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临床试验/NCT07665749
NCT07665749尚未招募不适用

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

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico0 个研究点目标入组 50 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
DIFFERENCE IN IPSS

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 40-80 inclusive
  • With moderate-to-severe LUTS from BPH according to IPSS score
  • Placed on AB+Serenoa repens or AB+antimuscarinics for 6 months

排除标准

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

研究组 & 干预措施

GROUP 1 - AB+Serenoa repens

PATIENTS TREATED WITH AB+Serenoa repens

GROUP 2 - AB+antimuscarinics

PATIENTS TREATED WITH AB+antimuscarinics

结局指标

主要结局

DIFFERENCE IN IPSS

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Boeri

MD, PHD

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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