Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.
Department of Urology, University of Catania, Catania, Italy.
J Sex Med. 2018 May;15(5):716-721. doi: 10.1016/j.jsxm.2018.03.084.
Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD).
To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners' bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center.
All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections.
International Index of Erectile Function (IIEF)-15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment.
Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF-15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF-total and all domains significantly improved after treatment (all P < .01). A PC mean change of 19.07 (P = .00) was measured. At the univariate linear regression analysis, IIEF-15, IIEF-erectile function, IIEF-sexual desire, and IIEF-intercourse satisfaction were positively associated with FSFI (all P ≤ .03); conversely, PDQ-penile pain, PDQ-symptom bother, and post-treament penile curvature (P ≤ .04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02-0.11; P = .004). Global satisfaction after treatment was 89.6% (121/135).
This modified CCH treatment protocol could improve both patients' and partner's sexual function.
This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account.
The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients' and partners' sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716-721.
胶原酶溶组织梭菌（CCH；Xiapex）注射是治疗勃起功能障碍的唯一许可的医学治疗方法。
使用改良的治疗方案评估稳定型勃起功能障碍患者接受 CCH 注射的疗效和安全性，并评估在单一三级转诊中心接受治疗的白种欧洲活跃异性恋男性大队列中伴侣的改善情况。
所有 135 名入组患者均接受了全面评估，包括病史采集、体格检查和药物诱导人工勃起试验（阴茎海绵体内注射），以评估基线时和治疗完成后的阴茎弯曲度（PC）程度。有钙化斑块和/或腹侧弯曲的患者被排除在外。所有患者均接受改良的治疗方案，即在最大弯曲点处每隔 4 周进行 3 次 0.9mg 的 CCH 腔内注射。每次注射后，患者被指示遵循严格的常规，在注射间隔期间每天进行阴茎伸展。
总体而言，135 名患者完成了研究方案。治疗前，18 名（13.33%）伴侣表现出一定程度的性功能障碍。基线时的国际勃起功能指数问卷-15 （IIEF-15） 、总体勃起功能障碍问卷（PD） 、PD 问卷（PDQ）和女性性功能指数（FSFI）问卷的中位数分别为 59.0、35.0 和 23.0。总体而言，治疗后 IIEF-总评分和所有领域均显著改善（均 P <.01）。测量到 PC 的平均变化为 19.07（P=.00）。在单变量线性回归分析中，IIEF-15、IIEF-勃起功能、IIEF-性欲和 IIEF-性交满意度与 FSFI 呈正相关（均 P ≤.03）；相反，PDQ-阴茎疼痛、PDQ-症状困扰和治疗后阴茎弯曲（P ≤.04）与 FSFI 评分降低相关。此外，PC 的中位数变化与 FSFI 的中位数变化显著相关（r=0.25；95%CI 0.02-0.11；P=.004）。治疗后总体满意度为 89.6%（121/135）。
这种改良的 CCH 治疗方案可以改善患者和伴侣的性功能。
这是一项开放标签、单臂临床研究，没有安慰剂。仅包括稳定关系中的异性恋夫妇。此外，没有对女性性功能困扰进行真正的评估，也没有考虑患者和女性伴侣的长期性功能。
对于稳定的勃起功能障碍，改良的 CCH 注射治疗方案对稳定性关系中的异性恋夫妇的患者和伴侣的性功能具有积极影响。Cocci A、Russo GI、Salonia A 等。胶原酶溶组织梭菌注射治疗勃起功能障碍后患者及其伴侣性功能改善的预测因素：多中心单臂研究结果。性医学杂志 2018；15：716-721。
