Effectiveness and Safety of an Association of Phycocyanin and Palmitoylethanolamide in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Observational Multicentric Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Statistically significant change of CPSI total score compared to baseline
研究概览
简要总结
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.
The aim of this study was to investigate the role of an association of phycocyanin (PC) and palmitoylethanolamide (PEA) and selenium (FICOXPEA®) in male patients affected by CP/CPPS.
The main questions the present study aims to answer are:
- Does FICOXPEA® enhance quality of life of CPP/CPPS patients?
- Does it help reducing pain symptoms of CPP/CPPS patients?
Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
- Take FICOXPEA® once a day for 30 days;
- Visit the clinic for follow-up visits at 1 and 3 months;
- Answer validated questionnaires and declare potential adverse events at follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •adult male patients (aged >18 years)
- •clinical affection by CP/CPPS with symptoms that persisted for ≥ 3 months;
- •PSA values of 4 to 10 ng/ml (at least 2 determinations)
- •patients must have completed diagnostic work-up, such as multiparametric prostate MRI (evidence level 1a according to EAU guidelines) with or without subsequent prostate biopsy (according to the diagnostic flow-chart depicted by EAU international guidelines).
排除标准
- •patients with previous diagnosis of prostate cancer
- •patients who underwent previous low urinary tract surgery
- •patients who underwent previous intravescical chemotherapy
- •patients with acute bacterial prostatitis
- •diagnostic work-up for prostate cancer not completed
- •patients having antibiotic therapy or specific chronic prostatis treatment (phytotherapy included) or benign prostatic iperplasia treatment (e.g. alpha litics) at the time of the recruitment or finished less than a month before
研究组 & 干预措施
FICOXPEA®
FICOXPEA® is a phytoterapic compound made of:
- phycocyanin (spirulina platensis extract) 250 mg
- palmitoylethanolamide 200 mg
- L-selenometionine 11 mg
- capsule containing all these compounds is administered every day for 30 days
干预措施: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium (Drug)
结局指标
主要结局
Statistically significant change of CPSI total score compared to baseline
时间窗: 1 month and 3 months
Improvement of CP symptoms
次要结局
- Statistically significant change of CPSI pain domain score compared to baseline(1 month and 3 months)
- n° of any adverse events(1 month and 3 months)
- Statistically significant change of CPSI QoL domain score compared to baseline(1 month and 3 months)
- Statistically significant change of total PSA(1 month and 3 months)
研究者
Mattia Sibona
Urologist, MD
Clinica Urologica Molinette - Città della Saliute e della Scienza