Purpose: The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy and safety of collagenase clostridium histolyticum (CCH) intralesional injections in subjects with Peyronie's disease (PD). Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo-controlled studies included percent change in penile curvature deformity and change in Peyronie's Disease Questionnaire PD symptom bother score from baseline to 52 weeks.
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Materials and Methods: The IMPRESS I (N=417) and II (N=415) studies examined CCH intralesional injections through a maximum of 4 treatment cycles, each separated by 6 weeks. Subjects received up to 8 injections of 0.58 mg CCH, 2 injections per cycle separated by approximately 24-72 hours, with the second injection in each followed 24-72 hours later by penile plaque modeling. Subjects were stratified by degree of penile curvature at baseline (30-60° versus 61-90°) and randomized to CCH or placebo (2:1 in favor of CCH).
Results: From a post-hoc meta-analysis of IMPRESS I and II data, CCH-treated subjects showed a mean 34% improvement in penile curvature deformity, a mean -17.0±14.8° change per subject, compared with a mean 18.2% improvement in placebo-treated subjects, a mean -9.3±13.6° change per subject (p<0.0001). Mean change in PD symptom bother score was significantly improved in CCH-treated (-2.8±3.8) versus placebo (-1.8±3.5, p=0.0037) subjects. Three corporal rupture serious adverse events occurred and were all surgically repaired.
Conclusions: The IMPRESS I and II studies support the clinical efficacy and safety of CCH treatment for both the physical and psychological aspects of PD.
Written by:
Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd Are you the author?
Urology Associates Medical Group, Burbank, CA, USA. Electronic address: .
Reference: J Urol. 2013 Jan 30 (Epub ahead of print)
doi: 10.1016/j.juro.2013.01.087
PubMed Abstract
PMID: 23376148
