Collagenase Clostridium histolyticum (CCH) is a bacterial enzyme commercialized as Xiaflex (Endo Pharmaceuticals, Dublin, Ireland), and is the only intralesional injectable medication that has ever been approved by Food and Drug Administration in the U.S to treat PD patients.6 CCH has the potential to decompose collagen types I and II which are the principal components of a PD plaque.7 Both the American Urological Association and the European Association of Urology PD guidelines recommend intralesional CCH in PD men with dorsal or lateral curvature between 30-90 degrees.8,9
CCH has become a standard treatment for PD patients. Several studies have demonstrated its efficacy in PD patients.7,10 There are very few reports defining predictors of penile curvature improvement after CCH treatment, as well as there is a lack of information about the rate of success based on the baseline penile curvature. This study aims to define factors predicting improvement in penile curvature in men with PD treated with CCH.
We retrospectively collected the data of patients with PD treated with CCH up to 8 injections divided into four cycles. Per protocol, penile curvature was assessed at baseline, and after the second and ford CCH cycle. If after cycle 2, curvature demonstrated no improvement, or penile curvature was significantly improved and the patient was happy, no further treatment was recommended. However, if penile curvature was significantly improved and the patient remained dissatisfied, 4 cycles were completed. Three categories of response were evaluated: improvement (≥10 degrees or ≥20%, either one happens), unchanged (±10 degrees or ±20%) or worsened (≥10 degrees or ≥20%, either one happens). Logistic regression analyses were performed to evaluate predictive factors associated with penile curvature improvements.
114 patients underwent CCH treatment. At baseline, mean curvature was 47 degrees, 65% had dorsal curvature, 53% mid-shaft location, and 15% calcification. After CCH treatment, the mean final curvature was 40 degrees. 44% improved the curvature, 39% had no change while 17% worsened after CCH treatment. Of men who had penile curvature improvement with CCH treatment, the mean curvature decreasing in degrees, and the percentage was 22 degrees and 41%, respectively. Men with baseline curvature ≤ 30, 31-59, and ≥ 60 degrees, the percentage curvature improvement was 29%, 43%, and 60%, respectively. Baseline curvature was the only significant predictor of penile curvature improvement after CCH (OR 1.33, 95% CI = 1.1, 1.7).
The most important contribution of this study is that baseline penile curvature is the most important predictive factor, and this is the first report describing proportions of penile curvature improvement with CCH treatment based on baseline curvature.
Written by: Jose M. Flores, MD, MHA, Sexual & Reproductive Medicine, Department of Surgery, Urology, Memorial Sloan Kettering Cancer Center, New York, NY
- Mulhall JP, Schiff J, Guhring P. An analysis of the natural history of Peyronie's disease. J Urol. 2006;175: 2115-8; discussion 18.
- Smith JF, Walsh TJ, Conti SL, Turek P, Lue T. Risk factors for emotional and relationship problems in Peyronie's disease. J Sex Med. 2008;5: 2179-84.
- Serefoglu EC, Smith TM, Kaufman GJ, Liu G, Yafi FA, Hellstrom WJG. Factors Associated With Erectile Dysfunction and the Peyronie's Disease Questionnaire in Patients With Peyronie Disease. Urology. 2017;107: 155-60.
- Chung E, Ralph D, Kagioglu A, et al. Evidence-Based Management Guidelines on Peyronie's Disease. J Sex Med. 2016;13: 905-23.
- Walsh TJ, Hotaling JM, Lue TF, Smith JF. How curved is too curved? The severity of penile deformity may predict sexual disability among men with Peyronie's disease. Int J Impot Res. 2013;25: 109-12.
- Goldstein I, Lipshultz LI, McLane M, et al. Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease. J Urol. 2020;203: 1191-97.
- Ziegelmann MJ, Bajic P, Levine LA. Peyronie's disease: Contemporary evaluation and management. Int J Urol. 2020;27: 504-16.
- Nehra A AR, Culkin DJ, Faraday MM, Lawrence S, Heidelbaugh JJ, et al. . AUA Guideline Peyronie's. AUA clin Guidel. 2015: 1-41.
- Salonia A, Bettocchi C, Boeri L, et al. European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction. Eur Urol. 2021;80: 333-57.
- Garcia-Gomez B, Garcia-Rojo E, Alonso-Isa M, et al. Treatment of peyronie's disease with combination of clostridium histolyticum collagenase and penile traction therapy: a prospective, multicenter, single-arm study. Int J Impot Res. 2020.