100 Avanafil 200 mg vs Sildenafil 100 mg post nerve sparing robotic prostatectomy: a multicentric prospective randomized trial
Abstract
Nowadays, Phosphodiesterase type 5 inhibitors are considered to be the first line therapy for erectile dysfunction secondary to nerve sparing radical prostatectomy,each of them with its own pharmacokinetic features and profiles of efficacy and safety. We evaluated the efficacy and safety of avanafil 200 mg three times a week compared to the same sildenafil 100 mg therapy. We enrolled 301 candidates for nerve sparing robot assisted prostatectomy from January 2016 to July 2017 with following preoperative criteria: Charlson Comorbidity Index (CCI) ≤1, ECOG performance status ≤1, International index of erectile function (IIEF) 15> 17, EHS> 2, positive response to Sexual Encounter Profile(Sep) q2 and Sepq3, Quality of Life <3 and finally one sexual intercourse por week. Only 220 were eligible for the study. Patients were randomized into two groups: avanafil 200 mg group (A group) and 100 mg sildenafil group (S Group).After removal of the bladder catheter at the tenth postoperative day, they started rehabilitation therapy three times a week for three months. At the third months, the validated measures of erectile function (IIEF 15, SEPq2-q3, Ehs) and Qol, Gaq1-2 were administered and we evaluated the number of weekly sexual intercourse. Randomization was performed by each center with Randomizer Research and statistical analysis was performed using Chi-Square and Wilcoxon-Mann-Whitney tests, as appropiated. All analyses were performed with MedCalc Statistical Software version 15.8.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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