A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 50
- 主要终点
- Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
研究概览
简要总结
The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with benign prostate hypertrophy requiring surgical treatment
- •Age up to 80 years
- •Documented, dated, written Informed Consent
- •Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery
排除标准
- •Any unstable medical, psychiatric, or substance abuse disorder
- •History of previous prostatectomy
- •Patients suspect of prostate cancer
- •Hereditary degenerative retinal disorder
- •History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment
- •Any cardiovascular condition
- •History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- •Uncontrolled atrial fibrillation/flutter at screening
- •Severe chronic or acute liver disease
- •Chronic hematological disease which may lead to priapism
- •Bleeding disorder
- •Significant active peptic ulceration
- •Resting hypotension
- •History of positive test for Hepatitis B surface antigen or Hepatitis C
- •Symptomatic postural hypotension within 6 months of Visit 1
- •Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well
- •Subjects who are taking nitrates or nitric oxide donors
- •Subjects who are taking androgens or anti-androgens
- •Subjects who are taking potent inhibitors of cytochrome P4503A4
- •Subjects who have received any investigational drug within 30 days of Visit 1
- •Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
- •Use of inhibitors of 5-alpha reductase after ablation of prostate
- •Subjects with serum creatinine clearance <30.0 mL/min
- •Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >3 times the upper limit of normal
- •Subjects with known hypersensitivity to Vardenafil
- •Subjects who are illiterate or unable to understand subject diaries
- •Subjects who would be non-compliant with the study visit schedule
研究组 & 干预措施
Vardenafil (Levitra, BAY38-9456)
One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
干预措施: Vardenafil (Levitra, BAY38-9456) (Drug)
Placebo
One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
干预措施: Placebo (Drug)
结局指标
主要结局
Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
时间窗: baseline and up to 3 months after surgery
Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.
次要结局
- Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)(baseline and up to 3 months after surgery)
- Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)(baseline and up to 3 months after surgery)
- Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)(baseline and up to 3 months after surgery)
- Duration of Surgery(on the day of surgery, without any further allowable time window)