Double-blind, Placebo-controlled Study on Men With Lower Urinary Tract Symptoms to Assess Changes in Pressure Flow Study and in Molecular Profile of Prostatic Tissue After 12 Weeks Treatment With Tadalafil.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Improvement of LUTS/BPH symptoms
研究概览
简要总结
At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated.
Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
- •treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
- •being capable of giving informed consent.
排除标准
- •participation in another clinical study;
- •known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value >10 ng/mL;
- •suspected lack of the participant's compliance;
- •known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
- •nown neurogenic bladder (i.e. Parkinson's disease);
- •suspected or proven urinary infections;
- •presence of bladder stone.
研究组 & 干预措施
Tadalafil
43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to tadalafil 5 mg - 1 film-coated tablet orally once daily for 12 weeks.
干预措施: Tadalafil (Drug)
Placebo
43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Improvement of LUTS/BPH symptoms
时间窗: 12 weeks
BPH-associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI). BPH-associated LUTS will be assessed by using International Prostate Symptom Score (IPSS).
次要结局
- Variation in genic expression of prostatic inflammation markers(12 weeks)
- Change in prostate inhomogeneity and in the number of prostatic macrocalcifications(12 weeks)
- Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate)(12 weeks)
- Variation in seminal plasma IL-8 (interleukin-8) levels(12 weeks)
- Volumetric change of the prostate(12 weeks)
- Improvement in metabolic profile(12 weeks)
- Improvement in erectile function(12 weeks)
- Improvement of pressure flow study (PFS) parameters(12 weeks)
研究者
Mario Maggi
Full Professor of Endocrinology
University of Florence