Efficacy and safety of intracavernosal incobotulinumtoxinA (Xeomin) as add-on therapy to sildenafil for the treatment of erectile dysfunction insufficiently responsive to phosphodiesterase type 5 inhibitors
Abstract
BACKGROUND
Studies suggest intracavernosal botulinum toxin A (BTX/A) could improve difficult-to-treat erectile dysfunction (ED) ie with an insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is).
AIM
To investigate efficacy and safety of intracavernosal injection (ICI) of BTX/A combined with sildenafil 100 mg on demand in patients with ED and insufficient response to PDE5-Is.
METHODS
Double-blind, placebo-controlled, multicenter, randomized phase 2 trial to investigate the efficacy and safety of bilateral 0.5 ml ICIs of incobotulinumtoxinA 50 U or placebo, both combined with sildenafil 100 mg on demand in men with ED and insufficient response to sildenafil 100 mg on demand. The inclusion criteria were International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 50% of attempts at sexual intercourse unsuccessful during a 4-week open-label run-in phase with sildenafil 100 mg on demand.
OUTCOMES
Mean change in IIEF-EF score and the proportion of "Yes" responses to Sexual Encounter Profile (SEP)-Q2 (ability to penetrate) and SEP-Q3 (ability to maintain an erection for successful intercourse) at 3 months.
RESULTS
Out of 226 patients screened, 165 patients were randomized (mean age: 60.1 years, mean IIEF-EF on sildenafil 100 mg: 11.1). Intention-to-treat (ITT) analysis showed no significant improvement in IIEF-EF score with incobotulinumtoxinA 100 U combined with sildenafil 100 mg at 3 months. IncobotulinumtoxinA 100 U improved penetration…
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. Reported size: 226 participants or records.
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