Institute of Urology, University College London Hospitals, London, UK.
Institute of Urology, University College London Hospitals, London, UK; Andrology Department, Cairo University Hospital, Cairo, Egypt.
J Sex Med. 2017 Nov;14(11):1430-1437. doi: 10.1016/j.jsxm.2017.08.015. Epub 2017 Sep 30.
Collagenase Clostridium histolyticum (CCH) is indicated for the treatment of penile curvature in adult men with Peyronie's disease (PD) with palpable plaque and curvature deformity of at least 30° at the start of therapy.
To evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD.
Adult men with PD and penile curvature of at least 30° were randomly assigned to receive CCH 0.58 mg plus vacuum therapy alone (n = 15) or with penile plaque modeling (n = 15). Patients received no more than four treatment cycles (cycle = ∼6-week duration), each consisting of two intralesional injections of CCH administered 24 to 72 hours apart. Vacuum therapy was applied twice daily from 14 days after the second injection of each cycle until the following cycle. Modeling was performed 24 to 72 hours after the second injection of each cycle.
The primary end point was change in penile curvature from baseline to week 36; additional end points included changes in Peyronie's Disease Questionnaire (PDQ) domain scores, composite response (≥20% decrease in penile curvature and decrease in PDQ bother score ≥ 1 point), and global response (small but important, moderate, or much improvement in the Global Assessment of PD).
At week 36, improvement in penile curvature from baseline was similar in the two groups (mean change from baseline = -23.7° [SD = 10.9] for CCH + vacuum + modeling and -23.3° [SD = 7.2] for CCH + vacuum; between-group difference = -0.3°, 95% CI = -7.3 to 6.6). Improvements in most PDQ domains, including bother, were observed from baseline to week 36 in the two groups. Most patients were composite (66.7% and 84.6% with CCH + vacuum + modeling and CCH + vacuum, respectively) and global (86.7% and 92.3%, respectively) responders. The most common adverse events were penile contusion, penile swelling, and penile pain.
Vacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms.
This was a pilot study with a small sample and limited follow-up duration.
CCH and vacuum-pump therapy (alone or combined with modeling) could be an appropriate consideration for men with PD and warrants further investigation. Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med 2017;14:1430-1437.
胶原酶溶组织梭菌（CCH）被批准用于治疗患有 Peyronie 病（PD）的成年男性的阴茎弯曲，这些男性在开始治疗时有可触及的斑块和至少 30°的弯曲畸形。
评估 CCH 联合真空抽吸治疗联合或不联合阴茎成型术治疗 PD 的疗效和安全性。
患有 PD 且阴茎弯曲至少 30°的成年男性被随机分配接受 CCH 0.58mg 联合单独的真空治疗（n=15）或联合阴茎斑块成型术（n=15）。患者最多接受四个治疗周期（每个周期约 6 周），每个周期包括两次间隔 24 至 72 小时的 CCH 皮内注射。从每个周期第二次注射后 14 天开始，每天两次应用真空治疗，直到下一个周期。模型在每个周期第二次注射后 24 至 72 小时进行。
主要终点是从基线到第 36 周时阴茎弯曲的变化；其他终点包括 Peyronie's 疾病问卷（PDQ）域评分的变化、综合反应（阴茎弯曲至少减少 20%和 PDQ 烦恼评分至少减少 1 分）和全球反应（PD 的全球评估有较小但重要、中度或明显改善）。
CCH 和真空抽吸治疗（单独或联合成型）可能是 PD 男性的一种合适选择，值得进一步研究。
这是一项样本量小、随访时间有限的初步研究。
