ISRCTN73316039已完成3 期
Serenoa repens, lycopene and selenium vs. phosphodiesterase type 5 inhibitor (PDE5 inhibitor) for the treatment of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH): the Sprite study
Konpharma SR0 个研究点目标入组 600 人开始时间: 2015年5月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29569389
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Age between 50 and 75
- •2. Digital rectal examination negative for prostate cancer
- •3. Prostate specific antigen (PSA) <4ng/ml
- •4. IPSS =12
- •5. PVR <100 ml
- •6. Peak flow between 4 and 15ml/s
排除标准
- •1. Prostate cancer, previous bladder cancer, diabetes mellitus, neurogenic disorders, severe liver
- •disease, history of orthostatic hypotension or syncope, symptomatic urinary tract infection.
- •2. Antiandrogens, antidepressants (neuroleptics, anticholinergics) therapy, recent treatment with an
- •a blocker (within 1 month) or phytotherapy including saw palmetto extract (within 3 months),
- •previous medical therapy with 5ARI, PDE-5i or surgical treatment for LUTS/BPH.
- •3. Patients with catheter or with an episode of acute retention of urine in the last 3 months
研究者
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