Green Benjamin, Flores Ashley, Warner Jacob, Kohler Tobias, Helo Sevann, Trost Landon
Male Fertility and Peyronie's Clinic, Orem, Utah.
CURE PD, Orem, Utah.
J Urol. 2023 Nov;210(5):791-802. doi: 10.1097/JU.0000000000003634. Epub 2023 Oct 9.
Since Food and Drug Administration approval of collagenase 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 + 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 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 group reported being very satisfied (vs 21% in the surgery group, = .08) and noted better subjective erectile function (100% vs 68%, = .03) and penile length (88% vs 16%, < .0001), lesser impacts on penile sensation (75% vs 11% no change, < .001), and similar International Index of Erectile Function-Erectile Function Domain changes (+1.5 vs +2.5, = .91). Objectively, men in the surgery group had greater curve improvements (84% vs 54%, < .01) and higher rates of adverse events (50 vs 13 events, < .001) but decreased penile length (-0.5 cm vs +1.0 cm, < .01).
At 3 months posttreatment, collagenase + 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.
自美国食品药品监督管理局批准胶原酶用于佩罗尼氏病以来，关于其作用以及与手术相比的疗效一直存在重大争议。
对佩罗尼氏病患者进行了一项随机对照试验，患者分别接受胶原酶+RestoreX阴茎牵引疗法+西地那非或阴茎手术+RestoreX阴茎牵引疗法+西地那非治疗，并给出了3个月的数据。主要目标包括总体满意度、勃起功能、阴茎感觉、阴茎长度的主观变化以及勃起功能国际指数-勃起功能领域评分的变化。次要结果包括长度、弯曲度的客观变化、不良事件以及其他标准化和非标准化问卷。
共招募了40名男性，其中38名（胶原酶组=19名，手术组=19名）完成治疗并提供了3个月的数据。两组之间所有人口统计学和临床病理变量均相似。治疗后，胶原酶组50%的男性报告非常满意（手术组为21%，P = 0.08），并指出主观勃起功能更好（100%对68%，P = 0.03），阴茎长度增加（88%对16%，P < 0.0001），对阴茎感觉的影响较小（75%对11%无变化，P < 0.001），勃起功能国际指数-勃起功能领域变化相似（+1.5对+2.5，P = 0.91）。客观上，手术组男性的弯曲度改善更大（84%对54%，P < 0.01），不良事件发生率更高（50起对13起，P < 0.001），但阴茎长度缩短（-0.5厘米对+1.0厘米，P < 0.01）。
治疗后3个月，与接受手术治疗的男性相比，胶原酶+RestoreX阴茎牵引疗法+西地那非导致弯曲度改善较小，但阴茎长度增加且不良事件较少，包括对主观勃起功能和感觉的影响。
