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临床试验/NCT02130713
NCT02130713已完成4 期

Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
210
试验地点
1
主要终点
Meares-Stamey evaluation

研究概览

简要总结

Background - bacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition but also a psychological distress. Commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the European Urology guidelines. This approach, although recommended, may not be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.

Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study. All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively antibiotic alone and an association of antibiotic plus supplement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 54 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • patients affected by chronic bacterial prostatitis
  • positivity to the Meares-Stamey test
  • symptoms duration > 3 months (dysuria, pelvic pain and/or discomfort)

排除标准

  • positivity to Chlamydia trachomatis, Ureaplasma urealiticum, Mycoplasma, Neisseria gonorrhoeae, herpes simplex viruses (HSV 1/2) and human papillomavirus (HPV)
  • age less than 18 years
  • history of neurological disease, urinary stones or cancer
  • allergy to fluoroquinolones
  • refusal to sign the informed consent
  • incomplete follow-up time.

研究组 & 干预措施

Group A, antibiotics

Active Comparator

Prulifloxacin 600 mg

干预措施: Third generation fluoroquinolone (Drug)

Group B, antibiotics plus nutraceuticals

Active Comparator

Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg

干预措施: Nutritional supplement + third generation fluoroquinolone (Dietary Supplement)

结局指标

主要结局

Meares-Stamey evaluation

时间窗: up to 6 months

The Meares-Stamey test, also known as 4-glass test, is the standard method of assessing inflammation and presence of bacteria in the lower urinary tract of men presenting CBP. The test has been performed on each patient before and after the therapy. The Meares-Stamey evaluation allows the collection of four samples: first voided urine (VB1) that represents urethra, mid-stream urine (VB2) that represents bladder, expressed prostatic secretion (EPS) and post-prostatic massage urine (VB3) that represent the prostate. It is considered positive when we have urophathogen colony-forming units (CFU)/mL ≥103.

次要结局

  • NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)(up to 6 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ettore De Berardinis

Professor

University of Roma La Sapienza

研究点 (1)

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