AIMS: Obstructive pelvic arterial lesions are highly prevalent in patients with erectile dysfunction and commonly located in penile artery segments. In this first-in-man study, we intended to assess the safety and feasibility of balloon angioplasty for isolated penile artery stenoses in patients with erectile dysfunction. METHODS AND RESULTS: Twenty-five patients with erectile dysfunction and isolated penile artery stenoses (unilateral stenosis ≥70% or bilateral stenoses ≥50%) identified by pelvic computed tomographic angiography were enrolled. A total of 20 patients (mean age 61 years [range, 48-79 years]) underwent balloon angioplasty. Three patients had bilateral penile artery stenoses. Procedural success was achieved in all 23 penile arteries, with an average balloon size of 1.6 mm (range, 1.00-2.25 mm). The average International Index for Erectile Function-5 (IIEF-5) score improved from 10.0±5.2 at baseline to 15.2±6.7 (p<0.001) at one month and 15.2±6.3 (p<0.001) at six months. Clinical success (change in the IIEF-5 score ≥4 or normalisation of erectile function [IIEF-5 ≥22]) was achieved in 15 (75%), 13 (65%), and 12 (60%) patients at one, three, and six months, respectively. There were no adverse events through follow-up. CONCLUSIONS: For the first time we demonstrated that penile artery angioplasty is safe and can achieve clinically significant improvement in erectile function in 60% of patients with erectile dysfunction and isolated penile artery stenoses.
AIMS: Obstructive pelvic arterial lesions are highly prevalent in patients with erectile dysfunction and commonly located in penile artery segments. In this first-in-man study, we intended to assess the safety and feasibility of balloon angioplasty for isolated penile artery stenoses in patients with erectile dysfunction. METHODS AND RESULTS: Twenty-five patients with erectile dysfunction and isolated penile artery stenoses (unilateral stenosis ≥70% or bilateral stenoses ≥50%) identified by pelvic computed tomographic angiography were enrolled. A total of 20 patients (mean age 61 years [range, 48-79 years]) underwent balloon angioplasty. Three patients had bilateral penile artery stenoses. Procedural success was achieved in all 23 penile arteries, with an average balloon size of 1.6 mm (range, 1.00-2.25 mm). The average International Index for Erectile Function-5 (IIEF-5) score improved from 10.0±5.2 at baseline to 15.2±6.7 (p<0.001) at one month and 15.2±6.3 (p<0.001) at six months. Clinical success (change in the IIEF-5 score ≥4 or normalisation of erectile function [IIEF-5 ≥22]) was achieved in 15 (75%), 13 (65%), and 12 (60%) patients at one, three, and six months, respectively. There were no adverse events through follow-up. CONCLUSIONS: For the first time we demonstrated that penile artery angioplasty is safe and can achieve clinically significant improvement in erectile function in 60% of patients with erectile dysfunction and isolated penile artery stenoses.