The Clinical Safety and Efficacy of Ketoconazole in the Prevention of Postoperative Erection: A Systematic Review

Abstract

Objective: To identify and assess the available literature in evaluating the efficacy and safety of ketoconazole in preventing postoperative erection among patients who underwent penile or urethral reconstructive surgery.

Methods: From the period of 1990 to September 2016, the investigators assessed Cochrane Central Register of Controlled Trials, EMBASE, HERDIN, and PubMed for studies evaluating the efficacy and safety of ketoconazole in preventing post operative erection among patients who underwent penile or urethral reconstructive surgery. Review authors selected articles for inclusion, extracted data and assessed trial quality.

Results: One randomized controlled study and 2 retrospective studies were included in the review. Three studies for a total of 83 patients ages 13-72 comprised the evidence for this review. All trials investigated the efficacy and safety of ketoconazole in the prevention of post operative erection. In both retrospective studies, ketoconazole had significant prevention of erection in however both of these studies were non-RCTs. In the randomized control study by DeCastro et.al., ketoconazole had no significant difference in the prevention of post operative erection against placebo. Sixteen out of 19 patients (84%) taking ketoconazole had episodes of erection and 15 out of 18 patients in the placebo group (83%) had episodes of erection. Common side effects include nausea (9 - 21%) and elevated liver enzymes (0 - 5.3%). Other reported adverse events include feet swelling, pruritus, frequent urination and headache, Present in only 1 out of the 31 patients (3.2%) in the study of DeCastro. All these adverse events were not statistically significant.

Conclusion: This review demonstrated that the use of Ketoconazole in the prevention of postoperative erection remains inconclusive. Further prospective randomized controlled trials with testosterone assay will help determine the appropriate dose and its efficacy in the prevention of postoperative erections. Ketoconazole is relatively safe if target testosterone levels are achieved using the 400mg/ tab TID dosing.