Brigham Young University, Department of Physiology and Developmental Biology, Provo, UT 84602, United States.
Male Fertility and Peyronie's Clinic, Orem, UT 84057, United States.
J Sex Med. 2024 Jan 30;21(2):169-174. doi: 10.1093/jsxmed/qdad167.
The efficacy and safety of collagenase Clostridium histolyticum (CCH) have been demonstrated in the treatment of men with Peyronie's disease (PD); however, the pivotal clinical trials excluded men with ventral penile curvature.
The study sought to evaluate outcomes of CCH treatment in men with ventral curvatures secondary to PD.
Men with PD treated with CCH were identified from a prospective database. Patients received up to 4 series of CCH injections using a progressively modified protocol over time. Results were compared between those with baseline ventral vs nonventral penile curvatures.
Changes in penile curvature, Peyronie's Disease Questionnaire scores, International Index of Erectile Function scores, nonstandardized assessments, and adverse events.
A total of 560 men with PD (85 ventral curvature, 475 nonventral curvature) were included in the analysis. Baseline median curvature was 60.0° (interquartile range, 48.8°-75.0°) in the ventral cohort and 65.0° (interquartile range, 45.0°-80.0°) in the nonventral cohort. Median change from baseline penile curvature was -25.0° in the ventral cohort vs -24.0° in the nonventral cohort (P = .08, between-group comparison), which corresponded to curvature reductions of 44.7% and 33.6%, respectively (P = .03). In the subset of patients who completed CCH treatment (ie, received 8 injections or discontinued early because of patient satisfaction with curvature reduction), median change from baseline was -35.0° in the ventral cohort vs -25.0° in the nonventral cohort (P < .05); median percent improvement was 48.3% and 37.5%, respectively (P = .11). Median change from baseline in Peyronie's Disease Questionnaire and International Index of Erectile Function domain scores and adverse events were similar between cohorts, with the exception of possibly higher hematoma rates in the nonventral group (50% vs 37%; P = .05). No urethral injuries were sustained in either cohort.
Data support the use of CCH for the treatment of ventral as well as nonventral penile curvatures in men with PD.
Study strengths are the inclusion of a general clinical population of men with PD, the prospective design, and the relatively large series of men with ventral curvature. Limitations include the single-center and observational nature of the study.
CCH was safe and effective in the treatment of both ventral and nonventral penile curvatures in men with PD.
已经证明胶原酶 C. histolyticum(CCH)在治疗患有 Peyronie 病(PD)的男性中的疗效和安全性;然而,关键性临床试验排除了患有腹侧阴茎弯曲的男性。
本研究旨在评估 CCH 治疗 PD 引起的腹侧弯曲男性的治疗结果。
从前瞻性数据库中确定接受 CCH 治疗的 PD 男性患者。患者接受了最多 4 系列的 CCH 注射,使用逐渐修改的方案随时间进行。比较了基线时腹侧与非腹侧阴茎弯曲的结果。
阴茎弯曲度、Peyronie 病问卷评分、国际勃起功能指数评分、非标准化评估和不良事件的变化。
共纳入 560 名 PD 男性(85 名腹侧弯曲,475 名非腹侧弯曲)进行分析。腹侧队列的基线中位数弯曲度为 60.0°(四分位距,48.8°-75.0°),非腹侧队列为 65.0°(四分位距,45.0°-80.0°)。腹侧队列与非腹侧队列相比,从基线阴茎弯曲度的中位数变化为-25.0°(P=.08,组间比较),分别对应 44.7%和 33.6%的曲率减小(P=.03)。在完成 CCH 治疗的患者亚组中(即接受 8 次注射或因患者对曲率减小的满意度而提前停药),腹侧队列从基线的中位数变化为-35.0°,非腹侧队列为-25.0°(P<.05);中位数百分比改善分别为 48.3%和 37.5%(P=.11)。队列之间的佩罗尼病问卷和国际勃起功能指数域评分和不良事件的中位数变化相似,除了非腹侧组血肿发生率可能较高(50%比 37%;P=.05)外。两个队列均未发生尿道损伤。
数据支持将 CCH 用于治疗 PD 男性的腹侧和非腹侧阴茎弯曲。
研究的优势在于纳入了一般临床人群的 PD 男性,前瞻性设计和相对较大的腹侧弯曲男性系列。局限性包括研究的单中心和观察性质。
CCH 治疗 PD 男性的腹侧和非腹侧阴茎弯曲是安全有效的。