PURPOSE:Patients undergoingpenile surgery often have postoperative erections that can be painful and may interfere with wound healing. In retrospective studies ketoconazole has been shown to decrease the number and pain of postoperative erections. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of ketoconazole in the prevention of postoperative erections. MATERIALS AND METHODS:Patients undergoing penile reconstructive surgery were randomized to receive ketoconazole (400 mg 3 times a day) or placebo starting 2 days before surgery and continuing for 7 days after surgery. We recorded the number and characteristics of each erection on a standardized log. Liver function tests were drawn before and after surgery. RESULTS: Of the 40 patients enrolled 20 were randomized to the ketoconazole group and 20 to placebo. In the ketoconazole group 81.25% reported postoperative erections compared to 83% in the placebo group. Of those patients who had postoperative erections 85% in the ketoconazole group reported painful erections compared to 80% in the placebo group. These differences were not statistically significant (p >0.99). In the ketoconazole group 3 patients (15.8%) withdrew early because of nausea and 1 in the ketoconazole group had a transient increase in liver function tests. CONCLUSIONS: To our knowledge this is the only prospective, double-blind, placebo controlled study to evaluate the use of ketoconazole in the prevention of postoperative erections. While prior retrospective reports showed promise for this medication, our study suggests that ketoconazole is not effective in preventing postoperative erections.
RCT Entities:
PURPOSE:Patients undergoing penile surgery often have postoperative erections that can be painful and may interfere with wound healing. In retrospective studies ketoconazole has been shown to decrease the number and pain of postoperative erections. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of ketoconazole in the prevention of postoperative erections. MATERIALS AND METHODS:Patients undergoing penile reconstructive surgery were randomized to receive ketoconazole (400 mg 3 times a day) or placebo starting 2 days before surgery and continuing for 7 days after surgery. We recorded the number and characteristics of each erection on a standardized log. Liver function tests were drawn before and after surgery. RESULTS: Of the 40 patients enrolled 20 were randomized to the ketoconazole group and 20 to placebo. In the ketoconazole group 81.25% reported postoperative erections compared to 83% in the placebo group. Of those patients who had postoperative erections 85% in the ketoconazole group reported painful erections compared to 80% in the placebo group. These differences were not statistically significant (p >0.99). In the ketoconazole group 3 patients (15.8%) withdrew early because of nausea and 1 in the ketoconazole group had a transient increase in liver function tests. CONCLUSIONS: To our knowledge this is the only prospective, double-blind, placebo controlled study to evaluate the use of ketoconazole in the prevention of postoperative erections. While prior retrospective reports showed promise for this medication, our study suggests that ketoconazole is not effective in preventing postoperative erections.