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Collagenase Clostridium histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach

Published on Jun 1, 2015in The Journal of Sexual Medicine3.649
· DOI :10.1111/jsm.12904
Martin K. Gelbard16
Estimated H-index: 16
,
Larisa Chagan1
Estimated H-index: 1
,
James P. Tursi13
Estimated H-index: 13
Abstract
Abstract Introduction The conception of collagenase Clostridium histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD. Aim To review the origins, clinical research history, and ultimately FDA approval of collagenase as PD treatment. Methods A PubMed search using (Peyronie's or Peyronie) AND collagenase, and limited to clinical research studies, returned nine papers that were examined in the current review. Results Collagenase as a PD treatment arose in response to a lack of effective nonsurgical treatments and the incomplete understanding of underlying PD etiology. Awareness of dense collagen in PD scarring and parallel initial exploration of collagenase to treat herniated lumbar discs coincided with and inspired laboratory-based investigation of collagenase effects on excised PD plaque tissue. The foundational conceptual work and the critical development of purified injectable collagenase allowed the pursuit of clinical studies. Progression of clinical studies into large-scale robust trials culminated in two important outcomes: development of the first validated, PD-specific measure of psychosexual function, the Peyronie's Disease Questionnaire, and the first FDA-approved treatment for PD. Conclusions Collagenase therapy began as an attempt to modify the structure of PD-related tunica albuginea scarring, despite the lack of a fundamental understanding of the scar's origin. If we wish to advance PD treatment beyond this first effective step, the future needs to bring us full circle to the starting point: We need a greater understanding of the control of collagen deposition and wound healing in men with PD. Gelbard MK, Chagan L, and Tursi JP. Collagenase Clostridium histolyticum for the treatment of Peyronie's disease: The development of this novel pharmacologic approach. J Sex Med 2015;12:1481–1489.
  • References (43)
  • Citations (11)
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#2Ravi MavuduruH-Index: 3
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#1Martin K. Gelbard (UCLA: University of California, Los Angeles)H-Index: 16
#2Irwin Goldstein (UCSD: University of California, San Diego)H-Index: 77
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Purpose: IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II examined the clinical efficacy and safety of collagenase Clostridium histolyticum intralesional injections in subjects with Peyronie disease. Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo controlled studies included the percent change in the penile curvature abnormality and the change in the Peyronie disease questionnaire symptom bother score from baseline to ...
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#1Wayne J.G. Hellstrom (Tulane University)H-Index: 63
#2R. G. FeldmanH-Index: 35
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Purpose: We validated the Peyronie's Disease Questionnaire (http://www.auxilium.com/PDQ), a 15-question self-reported survey that measures the impact and severity of Peyronie's disease symptoms in 3 domains, including 1) psychological and physical symptoms, 2) penile pain and 3) symptom bother.Materials and Methods: We used baseline data from 2 phase 3 clinical trials (334 and 345 patients, respectively) of collagenase clostridium histolyticum treatment for Peyronie's disease associated penile c...
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#1Martin K. GelbardH-Index: 16
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Purpose: Collagenase Clostridium histolyticum is an investigational nonsurgical treatment for Peyronie disease. In this phase 2b, double-blind, randomized, placebo controlled study we determined the safety and efficacy of collagenase C. histolyticum and assessed a patient reported outcome questionnaire.Materials and Methods: A total of 147 subjects were randomized into 4 groups to receive collagenase C. histolyticum or placebo (3:1) with or without penile plaque modeling (1:1). Per treatment cyc...
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#1Susan Emeigh HartH-Index: 1
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#1Shaunak S. Desai (Stanford University)H-Index: 4
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ABSTRACT Introduction The field of Peyronie's disease is evolving and there is need for a state-of-the-art information in this area. Aim To develop an evidence-based state-of-the-art consensus report on the management of Peyronie's disease. Methods To provide state-of-the-art knowledge regarding the prevalence, etiology, medical and surgical management of Peyronie's Disease, representing the opinion of leading experts developed in a consensus process over a 2-year period. Main Outcome Measures E...
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#1Nestor F. Gonzalez-Cadavid (UCLA: University of California, Los Angeles)H-Index: 59
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Abstract Introduction and objective Surgery is the treatment of choice for patients with Peyronie's disease presenting difficulty in penetration or erectile dysfunction without adequate response to therapy. Several techniques have been described, and urologists must be aware of their possible complications and sequelae in order to offer the patient the best possible alternative. Patients and methods Three complex cases of patients with Peyronie's disease are presented. The first case exposes a c...
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#1Steven A. Mills (UCLA: University of California, Los Angeles)H-Index: 2
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