scholarly journals Prospective, Randomized, Double-Blind, Vehicle Controlled, Multicenter Phase IIb Clinical Trial of the Pore Forming Protein PRX302 for Targeted Treatment of Symptomatic Benign Prostatic Hyperplasia

2013 ◽  
Vol 189 (4) ◽  
pp. 1421-1426 ◽  
Author(s):  
Mostafa M. Elhilali ◽  
Peter Pommerville ◽  
Richard C. Yocum ◽  
Rosemina Merchant ◽  
Claus G. Roehrborn ◽  
...  
Author(s):  
S. T. CAHYO ARIWICAKSONO ◽  
ROBERTUS B PRASETYO ◽  
NINDRA PRASADJA ◽  
NUGROHO B. UTOMO

Objective: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate associated with aging. BPH can cause lower urinary tract syndrome (LUTS). Medical therapy for patients with moderate and severe LUTS symptoms comprises a-1 adrenergic receptor antagonists. This study aimed to determine whether there are differences in the international prostate symptom score (IPSS) and maximal flow rate (Qmax) of patients with BPH receiving either silodosin or tamsulosin over 12 w. Methods: This study was a double-blind randomized clinical trial. Subjects were 50 men aged ³ 50 y diagnosed with BPH with an IPSS ³ 8 at the Gatot Soebroto Indonesian Army Hospital. The participants received either silodosin or tamsulosin. Their IPSS and Qmax were assessed at the initial assessment and after 4, 8, and 12 w of treatment. Results: The initial median IPSS was 15 in the tamsulosin group and 17 in the silodosin group (P = 0.808). After 12 w of therapy, the median IPSS decreased to 9 in the tamsulosin group and 10 in the silodosin group (P = 0.186). The initial median Qmax was 10.1 ml/s in the tamsulosin group and 10.9 ml/s in the silodosin group (P = 0.290). After 12 w of therapy, the median Qmax increased to 12.1 ml/s in the tamsulosin group and 11.9 ml/s in the silodosin group (P = 0.969). Although the differences between groups were not significant, the initial and 12-week IPSS and Qmax values differed significantly within each group. Conclusion: There were no significant between-group differences in the IPSS or Qmax after 12 w of therapy. However, both silodosin and tamsulosin produced significant differences between initial and 12-week assessments of IPSS and Qmax.


2018 ◽  
Vol 85 (2) ◽  
pp. 51-54
Author(s):  
Hamidreza Baghani Aval ◽  
Zeinab Ameli ◽  
Mojtaba Ameli

Introduction: Acute urinary retention is one of the most significant complications of benign prostatic hyperplasia. Until now, standard treatments include catheterization and use of α-blockers. Tadalafil has been recently seen to also play a role in the treatment of urinary symptoms caused by benign prostatic hyperplasia. The aim of this study was to survey the addition of tadalafil to tamsulosin in the treatment of acute urinary retention in patients with benign prostatic hyperplasia. Materials and Methods: This is a randomized, double-blind placebo-controlled clinical trial. In all, 80 patients with benign prostatic hyperplasia–related acute urinary retention referred to the emergency department of the hospital were divided into two groups of 40 each and randomly assigned to receive either 0.4 mg tamsulosin plus placebo or 0.4 mg tamsulosin plus 10 mg tadalafil daily for 7 days. At the same first visit, the catheter was removed and the ability to void in 24 h and 1 week later was assessed in each group. Results: The differences in age, urine retention volume, history of drug use, lower urinary tract symptoms, and previous acute urinary retention were not significant between the two groups ( p = 0.619, 0.149, 0.501, 0.284, and 0.371, respectively). After catheter removal, 23 (57.5%) patients in the placebo group and 26 (65%) in the tadalafil group voided successfully at 24 h ( p = 0.491). After 1 week, 29 (72.5%) patients taking placebo and 26 (65%) taking tadalafil could void, yet indicating no significant difference ( p = 0.469). Conclusion: Addition of tadalafil to α-blockers has no significant advantage in improving benign prostatic hyperplasia–related acute urinary retention versus tamsulosin alone.


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