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

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A Correction to this article was published on 17 April 2021

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Abstract

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.

Methods

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).

Results

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).

Conclusions

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.

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Authors and Affiliations

  1. Department of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy

    Andrea Cocci, Fabrizio Di Maida, Gianmartin Cito, Andrea Romano & Andrea Minervini

  2. Urology Section, Department of Surgery, University of Catania, Catania, Italy

    Giorgio Ivan Russo & Marina Di Mauro

  3. Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy

    Paolo Capogrosso & Andrea Salonia

  4. Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy

    Lotti Francesco

  5. Department of Urology, University of Trieste, Trieste, Italy

    Michele Rizzo

  6. Urology Clinic, A.O.U. Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy

    Marco Falcone

  7. Psychosexuologist, Como, Italy

    Gaia Polloni

  8. Department of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

    Juan Ignacio Martinez-Salamanca & Esaù Fernández-Pascual

  9. Andrology Center, Villa Donatello Hospital, Florence, Italy

    Nicola Mondaini

Authors
  1. Andrea Cocci
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  2. Fabrizio Di Maida
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  3. Giorgio Ivan Russo
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  10. Marco Falcone
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  11. Andrea Romano
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  15. Andrea Minervini
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  16. Nicola Mondaini
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Corresponding author

Correspondence to Fabrizio Di Maida.

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Funding

No sources of funding were received for the conduct of this study or the preparation of this article.

Conflict of interest

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 and Nicola Mondaini have no conflicts of interest that are directly relevant to the content of this study.

Ethics approval

The study was approved by the Donatello Private Hospital Committee (MED-2019-VD) and conducted in accordance with Good Clinical Practice Guidelines and the principles of the Declaration of Helsinki.

Informed consent

All patients provided written informed consent to participate in the study.

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Cocci, A., Di Maida, F., Russo, G.I. et al. Efficacy of Collagenase Clostridium histolyticum (Xiapex®) in Patients with the Acute Phase of Peyronie’s Disease. Clin Drug Investig 40, 583–588 (2020). https://doi.org/10.1007/s40261-020-00916-4

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  • DOI: https://doi.org/10.1007/s40261-020-00916-4

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