Avanafil 200 mg vs Sildenafil 100 mg post nerve sparing robotic prostatectomy: a multicentric prospective randomized trial
Della Camera , PA1; Bencini, G1; Tasso, G1; Cito, G1; Morselli, S1; Cocci, A1; Ruffo, A2; Del Fabbro, D3; Carini, M1; Gacci, M1; Serni, S1; Natali, A1
1: Aouc ,Florence, Italy; 2: Santa Maria delle Grazie Hospital, Naples,Italy; 3: ''Tor Vergata''Hospital, Rome,Italy
Objectives: 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.
Material and Method: 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.
Result: 114 patients were randomized for each group. The median age was 65 years (± 6) for both groups and there were no statistically significant differences such as Ecog, CCI, comorbidity (diabetes mellitus, hypertension) and number of weekly reports. The preoperative mean IIEF 15 was 23 and 22 for S group and A group respectively. In the third month after surgery there was no statistical difference in terms of IIEF 15 with mean score of 18,4 for S group, 17,1 for S group(p=0,144), Qol(p=0,504),Sep3, Gaq1, Gaq2. Sep q2 and adverse events showed a statistically significant difference between two groups 87.5% vs 62.5%, 20% vs 8.3% for S Group vs A group respectively (p <0.05).
Conclusion: Compared with sildenafil, avanafil showed equal effectiveness in improving sexual function with less incidence of adverse events. However, sildenafil therapy appears to be better in allowing completion of sexual intercourse
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