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.
The journal of sexual medicine. 2018 May [Epub]
Andrea Cocci, Giorgio Ivan Russo, Andrea Salonia, Gianmartin Cito, Federica Regis, Gaia Polloni, Gianluca Giubilei, Giovanni Cacciamani, Marco Capece, Marco Falcone, Isabella Greco, Massimiliano Timpano, Andrea Minervini, Mauro Gacci, Tommaso Cai, Giulio Garaffa, Bruno Giammusso, Davide Arcaniolo, Vincenzo Mirone, Nicola Mondaini
Department of Urology, Careggi Hospital, University of Florence, Florence, Italy. Electronic address: ., Department of Urology, University of Catania, Catania, Italy., Department of Urology, San Raffaele Hospital, Milano, Italy., Department of Urology, Careggi Hospital, University of Florence, Florence, Italy., Psycho-sexology, Como, Italy., Leonardo Clinic, Florence, Italy., Department of Urology, University of Verona, Verona, Italy., Department of Urology, University of Naples, Naples, Italy., Department of Urology, Molinette Hospital, University of Turin, Turin, Italy., Department of Urology, University of Trento, Trento, Italy., Institute of Urology, University College of London, London, United Kingdom., Department of Urology, Santa Maria Annunciata Hospital, Florence, Italy.