Corporal rupture and collagenase clostridium histolyticum: a population based study
Collagenase clostridium histolyticum (CCH) was approved for treatment of Peyronie's disease (PD) in 2014. While results from clinical trials showed significant improvement in penile curvature and symptoms, adverse events were reported in 84.2% of patients, compared to 36.3% with placebo. The most concerning of these, corporal rupture, occurred in 0.54% of CCH patients (all treated operatively). Subsequent studies report that 34% of urologists administering CCH have encountered a corporal rupture and in one series 4.9% of patients treated with CCH developed the complication. In the later study, 20% of cases were managed non-operatively. In this study, we use a national insurance claims database to evaluate rates of corporal rupture over time and relation to penile injections in PD patients.
We extracted data on PD diagnosis (ICD-9 607.95 and ICD-10 N48.6), corporal rupture (ICD-9 959.13 and ICD-10 S39.840A), CCH use (J0775), penile injections (CPT 54200), and corporal rupture repair from 2004 to 2016 using the Optum insurance claims database (covers 6 to 7 million males annually). We analyzed data for rates of corporal rupture and repair by year, number of ruptures after CCH injections, and number of ruptures after non-CCH penile injections. Analyses were conducted using SAS (version 9.3).
Annual rates of corporal rupture (1.72% - 2.98%) and corporal rupture repair (0.69% - 1.64%) were stable over the study period. Of men with PD, 845 received CCH injections and 2783 received injections with other agents. In the CCH group, 5 corporal ruptures occurred (0.59%) and none were repaired. Ruptures occurred at a median of 86 days after injection (range 40-206) and after a median of 5 injections (range 3-13). In the other agents group, 11 corporal ruptures occurred (0.40%) and 1 was repaired. Ruptures occurred at a median of 105 days after injection (range 5-3531) and after a median of 4 injections (range 1-13).
Our rate of corporal rupture after CCH use is similar to clinical trials of the drug. However, the rate of rupture in the other agents group was similar to this as well. Moreover, the overall rate of corporal rupture did not increase after introduction of CCH in 2014. Timing of ruptures in relation to time of penile injection was similar between the two groups. The management of corporal rupture after injection therapy was non-operative in >90% of cases. Further research is needed to better characterize the risk of corporal rupture related to penile injections as well as its management.