Efficacy of Collagenase Clostridium histolyticum (Xiapex®) in Patients with the Acute Phase of Peyronie's Disease.

BACKGROUND AND OBJECTIVE: Plaque formation ordinarily takes place in the acute phase of Peyronie's disease. There is no unanimous consent regarding the management of the acute phase of Peyronie's disease.  The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenase Clostridium histolyticum in patients with the active phase of Peyronie's disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse.

Sexually active men aged older than 18 years with the acute phase of Peyronie's disease were enrolled. All patients received treatment with a single intralesional injection of collagenase Clostridium histolyticum. The primary outcome of the study was the change in penile curvature after treatment while secondary outcomes were the change in sexual function (International Index of Erectile Function [IIEF-5]) and in the Peyronie Disease Questionnaire (PDQ) and its sub-scores, PDQ-PS (psychological symptoms), PDQ-PP (penile pain) and PDQ-BD (bother disease).

Overall, 74 patients were enrolled. Mean penile curvature at baseline was 41.1° ± 12.2°. The mean changes before and at the 3-month evaluation in terms of penile curvature, Visual Analog Scale score at rest, and Visual Analog Scale score during intercourse were - 19.3 ± 8.4 (p < 0.0001), - 0.8 ± 1.1 (p < 0.0001) and - 3.8 ± 0.9 (p < 0.0001) with the benefit persisting also after 6 months. Moreover, improvements of mean IIEF-5 score (1.1 ± 0.9, p = 0.03; 0.9 ± 0.5, p = 0.02), PDQ-PS (- 2.7 ± 2.2; - 2.5 ± 2.0, p = 0.01), PDQ-PP (- 1.2 ± 1.6; - 1.1 ± 1.2, p = 0.02) and PDQ-BD (- 3.8 ± 3.4; - 3.5 ± 3.1, p = 0.001) were observed 3 and 6 months after the end of treatment, respectively. At the multivariable regression analysis, the time since disease onset (modelled with non-linear terms) and baseline curvature were independently associated with the degree of curvature improvement (coefficient: 0.30; 95% confidence interval 0.16-0.44) after a single intralesional injection (all p < 0.03).

Although intralesional therapy with collagenase Clostridium histolyticum is not yet indicated for the acute phase of Peyronie's disease, these preliminary results suggest the effectiveness of this minimally invasive option by improving penile curvature and IIEF-5 and PDQ scores.

Clinical drug investigation. 2020 Apr 27 [Epub ahead of print]

Andrea Cocci, Fabrizio Di Maida, Giorgio Ivan Russo, Paolo Capogrosso, Lotti Francesco, Michele Rizzo, Marina Di Mauro, Andrea Salonia, Gianmartin Cito, Marco Falcone, Andrea Romano, Gaia Polloni, Juan Ignacio Martinez-Salamanca, Esaù Fernández-Pascual, Andrea Minervini, Nicola Mondaini

Department of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy., Department of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy. ., Urology Section, Department of Surgery, University of Catania, Catania, Italy., Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy., Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy., Department of Urology, University of Trieste, Trieste, Italy., Urology Clinic, A.O.U. Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy., Psychosexuologist, Como, Italy., Department of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain., Andrology Center, Villa Donatello Hospital, Florence, Italy.

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