Penile augmentation with injection of paraffin is a common practice in South East Asia. Penile paraffinoma occurring due to injection of liquid paraffin to enhance the size of the penis is an uncommon condition. Normally, this procedure is carried out by nonmedical personnel, without the prior knowledge or consultation of any urologist. The occurrence of such a deforming procedure is not commonly known to the medical profession in Malaysia.

AIMTo evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 (PDE-5) inhibitor, in men of Asian ethnicity with erectile dysfunction (ED).

METHODSIn this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil (10 mg) or placebo (4:1 ratio) for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question (GAQ) on erection improvement.

RESULTSLeast-squares mean baseline IIEF-EF domain scores (vardenafil 14.6, placebo 13.4) were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo (22.4 vs. 14.3; P<0.001). Vardenafil was associated with significant improvements from baseline in least squares (LS) mean success rates for SEP-2 (vardenafil 82.2 vs. placebo 43.6; P<0.001) and SEP-3 (vardenafil 66.1 vs. placebo 24.0; P<0.001). Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient.

CONCLUSIONVardenafil (10 mg) is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.

Adult ; Aged ; Double-Blind Method ; Erectile Dysfunction ; drug therapy ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Prospective Studies ; Sulfones ; adverse effects ; therapeutic use ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride