Comparison of Collagenase <i>Clostridium histolyticum</i> to Surgery for the Management of Peyronie's Disease: A Randomized Trial.

Abstract

Since Food and Drug Administration approval of collagenase <i>Clostridium histolyticum</i> for Peyronie's disease, there has been significant debate regarding its role and comparable efficacy to surgery. A randomized, controlled trial was performed of Peyronie's disease men treated with either collagenase <i>C histolyticum</i> + RestoreX penile traction therapy + sildenafil or penile surgery + RestoreX penile traction therapy + sildenafil, with 3-month data presented. Primary objectives were overall satisfaction, subjective changes in erectile function, penile sensation, penile length, and changes in the International Index of Erectile Function-Erectile Function Domain score. Secondary outcomes included objective changes in length, curve, adverse events, and other standardized and nonstandardized questionnaires. A total of 40 men were enrolled, with 38 (collagenase <i>C histolyticum</i> group = 19, surgery group = 19) completing treatment and having 3-month data available. All demographic and clinicopathological variables were similar between groups. Following treatment, 50% of men in the collagenase <i>C histolyticum</i> group reported being very satisfied (vs 21% in the surgery group, <i>P</i> = .08) and noted better subjective erectile function (100% vs 68%, <i>P</i> = .03) and penile length (88% vs 16%, <i>P</i> < .0001), lesser impacts on penile sensation (75% vs 11% no change, <i>P</i> < .001), and similar International Index of Erectile Function-Erectile Function Domain changes (+1.5 vs +2.5, <i>P</i> = .91). Objectively, men in the surgery group had greater curve improvements (84% vs 54%, <i>P</i> < .01) and higher rates of adverse events (50 vs 13 events, <i>P</i> < .001) but decreased penile length (-0.5 cm vs +1.0 cm, <i>P</i> < .01). At 3 months posttreatment, collagenase <i>C histolyticum</i> + RestoreX penile traction therapy + sildenafil results in lesser curve improvements but greater penile length and fewer adverse events, including impacts on subjective erectile function and sensation, than men treated with surgery.