Experience in the use of collagenase clostridium histolyticum in the management of Peyronie's disease: current data and future prospects.
Level 5 - mechanism / opinion, no new human data
Narrative review of trial data and regulatory approval without a systematic review methodology reported.
PubMed 25276229 · doi:10.1177/1756287214537331
What was done
The authors conducted a review synthesizing clinical trial evidence and regulatory data regarding the efficacy and safety of injectable collagenase clostridium histolyticum (Xiaflex) for the nonsurgical management of Peyronie's disease in men with palpable plaque and penile curvature of 30° or greater.
What was found
Clinical trials of collagenase clostridium histolyticum demonstrated mean improvements in penile curvature ranging from 29% to 34%, along with improvements in disease-related bother scores. Adverse events were predominantly mild or moderate in severity, and 79% resolved spontaneously without requiring clinical intervention.
Why it matters
This review contextualizes the clinical trial data that supported FDA approval of the first nonsurgical injectable enzymatic treatment for Peyronie's disease.
Limits
The abstract describes a narrative review without detailing search methodology, study inclusion criteria, or total participant numbers. Long-term durability and safety beyond initial trial periods were not established and require larger extended follow-up studies.
Cited by
- supports Peyronie's disease is a condition characterized by fibrous scar tissue or damage inside the penis that causes penile curvature.