INTRODUCTION: Several treatment regimens for rehabilitation of erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) are currently discussed. The optimal and most cost-effective therapy is still not found yet. AIM: To evaluate the effect of vardenafil, a PDE5 inhibitor, dose escalation on recovery of EF after unilateral nsRP. METHODS:Thirty-six sexually active patients received a unilateral nsRP. All patients completed an International Index of Erectile Function-5 items (IIEF-5) questionnaire concerning EF preoperatively. Group 1 (N = 12 patients) received vardenafil 5 mg/day vs. group 2 (N = 12) who received vardenafil 10 mg/day at night beginning the day of catheter removal. A control of 12 patients underwentfollow-up without PDE5 inhibitors. MAIN OUTCOME MEASURE: The IIEF-5 was the primary end point. IIEF-5 questionnaires were completed at baseline, 3, 6, and 12 months after nsRP. RESULTS: In group 1 (5 mg/day vardenafil) the IIEF-5 score decreased from a preoperative 22.4 mean score to 4.2 at 3 months, 8.9 at 6 months, and 13.4 mean score at 12 months after nsRP vs. preoperative 22.8, 4.1 at 3 months, 7.9 at 6 months, and 12.8 mean score at 12 months in group 2 (10 mg/day vardenafil). In the control group the preoperative IIEF-5 mean score of 21.9 decreased to 3.8 at 3 months, 6.1 at 6 months, and 8.9 at 12 months. Statistical evaluation showed significant difference in IIEF-5 score and time to recovery of EF between groups 1 and 3 and between groups 2 and 3 (P < 0.01). No statistical differences were found between groups 1 and 2. CONCLUSIONS: Daily low-dose vardenafil lead to significant improvement of recovery of EF. In this study doubling the dosage did not improve the recovery of EF further.
RCT Entities:
INTRODUCTION: Several treatment regimens for rehabilitation of erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) are currently discussed. The optimal and most cost-effective therapy is still not found yet. AIM: To evaluate the effect of vardenafil, a PDE5 inhibitor, dose escalation on recovery of EF after unilateral nsRP. METHODS: Thirty-six sexually active patients received a unilateral nsRP. All patients completed an International Index of Erectile Function-5 items (IIEF-5) questionnaire concerning EF preoperatively. Group 1 (N = 12 patients) received vardenafil 5 mg/day vs. group 2 (N = 12) who received vardenafil 10 mg/day at night beginning the day of catheter removal. A control of 12 patients underwent follow-up without PDE5 inhibitors. MAIN OUTCOME MEASURE: The IIEF-5 was the primary end point. IIEF-5 questionnaires were completed at baseline, 3, 6, and 12 months after nsRP. RESULTS: In group 1 (5 mg/day vardenafil) the IIEF-5 score decreased from a preoperative 22.4 mean score to 4.2 at 3 months, 8.9 at 6 months, and 13.4 mean score at 12 months after nsRP vs. preoperative 22.8, 4.1 at 3 months, 7.9 at 6 months, and 12.8 mean score at 12 months in group 2 (10 mg/day vardenafil). In the control group the preoperative IIEF-5 mean score of 21.9 decreased to 3.8 at 3 months, 6.1 at 6 months, and 8.9 at 12 months. Statistical evaluation showed significant difference in IIEF-5 score and time to recovery of EF between groups 1 and 3 and between groups 2 and 3 (P < 0.01). No statistical differences were found between groups 1 and 2. CONCLUSIONS: Daily low-dose vardenafil lead to significant improvement of recovery of EF. In this study doubling the dosage did not improve the recovery of EF further.
Authors: Yiannis A Philippou; Jae Hung Jung; Martin J Steggall; Stephen T O'Driscoll; Caitlin J Bakker; Joshua A Bodie; Philipp Dahm Journal: Cochrane Database Syst Rev Date: 2018-10-23