Effect of open prostatectomy versus transurethral prostatectomy on clinical and laboratory findings in patients with benign prostatic hyperplasia: a randomized clinical trial

Objectives: To assess open prostatectomy versus transurethral prostatectomy on clinical and laboratory findings in patients with benign prostatic hyperplasia. Design: a randomized clinical trial. Setting and conduct: The eligible patients with benign prostatic hyperplasia who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial. Inclusion criteria: (a) having benign prostatic hyperplasia; (b) indication of prostatectomy. Exclusion criteria: (a) prostate greater than 100 gr or lower than 40 gr; (b) history of previous prostatic or urethral surgery; (c) having bladder stone. Intervention group: Prostate resection through transurethral prostatectomy. Control group: Prostate resection through open surgery prostatectomy. Primary outcome: (a) assessing the urine flow before and one month after intervention using uroflowmetry; (b) assessing incontinency before and one month after intervention by taking history; (c) assessing number of nocturia before and one month after intervention by taking history; (d) assessing impotency before and one month after intervention by taking history. Secondary outcome: (a) assessing prostatic specific antigen before and one month after intervention through laboratory test. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of groups of six. Blinding: Not possible.

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences