Sildenafil orodispersible film in the treatment of erectile dysfunction after radical prostatectomy: A single-centre open-label uncontrolled trial

Abstract

Phosphodiesterase-5 inhibitors are the first-line therapy for erectile dysfunction (ED) after radical prostatectomy (RP). This single-centre open-label uncontrolled study evaluated the efficacy and safety of the new sildenafil orodispersible film (ODF) in ED treatment after RP. Sildenafil 100 mg ODF was administered twice a week for 3 months to patients under 75 years of age, with a Framingham cardiovascular risk score < 20% and a pre-operative International Index of Erectile Function (IIEF)-5 score ≥ 17, who had undergone open RP between 2016 and 2018. Erectile function was assessed pre-operatively, post-operatively and after treatment through the IIEF-5 score, the Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3; adverse events (AE) were also investigated after 3 months. A total of 65 patients with a median (25th-75th percentile) post-operative IIEF-5 score of 8 (7–9) were treated. Nine (13.8%) patients reported AE of mild/moderate grade and discontinued treatment. A significant IIEF-5 score median (25th-75th percentile) increase of 10 (0–12) was found after treatment in the other 56 patients (p <.001). Sildenafil 100 mg ODF was effective in ED after RP in terms of improved IIEF-5 score and improved SEP-Q2 and SEP-Q3 in 67.9% of patients. It could represent a valid alternative for those patients with low compliance to tablet intake.