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Sildenafil orodispersible film in the treatment of erectile dysfunction after radical prostatectomy: A single‐centre open‐label uncontrolled trial
Author(s) -
Pavone Carlo,
Abrate Alberto,
Agiato Sonia,
Billeci Sandro,
Tulone Gabriele,
Vella Marco,
Serretta Vincenzo,
Simonato Alchiede
Publication year - 2020
Publication title -
andrologia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.633
H-Index - 59
eISSN - 1439-0272
pISSN - 0303-4569
DOI - 10.1111/and.13705
Subject(s) - medicine , erectile dysfunction , sildenafil , prostatectomy , cgmp specific phosphodiesterase type 5 , urology , adverse effect , erectile function , surgery , prostate cancer , cancer
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.