Efficacy of Tadalafil vs Tamsulosin as monotherapy for lower urinary tract symptoms secondary to Benign Prostatic Hyperplasia: A Randomized Single Centre Study

Dr Sai Vijay Boya0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Patients with Lower Urinary Tract Symptoms for at least or more than 6 months at screening
•2.Patients with a total International Prostate Symptom Score (IPSS) greater than or equal to 13.
•3.Patients who agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
•4.Patients who have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed. Subjects reporting use of BPH, overactive bladder, or ED therapy underwent a 4-week treatment-free washout period.

•1.Prostate-specific antigen (PSA) >10.0 ng/ml (if Ã¢â?°Â¥4.0 to Ã¢â?°Â¤10.0 ng/ml, malignancy has to be ruled out)
•2.Post void residual (PVR) volume Ã¢â?°Â¥300 ml at screening.
•3.Subjects with the use of finasteride or dutasteride within the recent 3 or 6 months respectively.
•4.Recent lower urinary tract instrumentation (within 30 days)
•5.Subjects with history of urinary retention or lower urinary tract stones within the last 6 months.
•6.Subjects with history of urethral and/or proven bladder neck obstruction secondary to reasons other than BPH.
•7.Patients with the diagnosis or features suggestive of neurogenic bladder.
•8.Creatinine clearance < 30 ml/min.
•9.Severe hepatic impairment.
•10.Cardiovascular conditions with the risk of hypotension and the patients who require or are on current nitrate therapy.

发起方

Dr Sai Vijay Boya