The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
Bacterial prostatitis (BP) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions. It affects young and older men bimodally and significantly impacts quality of life (QoL). Treatment typically involves antibiotics, but a multimodal approach with additional nutraceuticals may enhance outcomes. This work aims to assess the efficacy of Butirprost® in association with fluoroquinolones in patients with Chronic Bacterial Prostatitis (CBP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patient aged between 18 and 50 years
- •symptoms consistent with CBP
- •positive Mears-Stamey test
排除标准
- •patients younger than 18 years
- •history of neurological disease, urinary stones or cancer
- •allergy to fluoroquinolones or any components of Butirprost®
- •post-void residual > 50 mL
- •Use of alpha-blockers or 5-alpha-reductase inhibitors (5-ARI)
- •previous prostatic surgery, antibiotic treatment within four weeks prior to the study
- •refusal to provide informed consent and incomplete follow-up data
- •Patients testing positive for certain pathogens like Chlamydia trachomatis (Ct), Ureaplasma urealyticum, Neisseria gon-orrhoeae, herpes simplex virus types 1 and 2 (HSV-1/2), and human papillomavirus (HPV)
研究组 & 干预措施
Butirprost and antibiotic
The treatment schedule was based on fluoroquinolone (levofloxacin, 1 tablet 500 mg daily for 4 weeks) plus 1 tablet of Butirprost® daily for 4 weeks
干预措施: Sodium Hyaluronate (Drug)
Butirprost and antibiotic
The treatment schedule was based on fluoroquinolone (levofloxacin, 1 tablet 500 mg daily for 4 weeks) plus 1 tablet of Butirprost® daily for 4 weeks
干预措施: Levofloxacin 500mg (Drug)
Antibiotic
the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)
干预措施: Levofloxacin 500mg (Drug)
结局指标
主要结局
Change in pain
时间窗: 30 days
Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) and its pain subset at 15- and 30 days (lower scores mean better outcomes).
Change in urinary symptoms
时间窗: 30 days
Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) and its urinary subset at 15- and 30 days (lower scores mean better outcomes).
Change in Quality of Life (QoL)
时间窗: 30 days
Assessing the International Prostatic Symptoms Score (0-35) and its subsets at 15- and 30 days (lower scores mean better outcomes).
次要结局
未报告次要终点
研究者
Benito Fabio Mirto
Principal Investigator
Federico II University