OBJECTIVES: To examine the efficacy of intralesional collagenase clostridium histolyticum (CCH) in defined subgroups of subjects with Peyronie's disease (PD).
SUBJECTS AND METHODS: The efficacy of CCH compared with placebo from baseline to week 52 was examined in subgroups of subjects from the Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II, defined by: severity of penile curvature deformity at baseline (30°-60° [n=492] and 61°-90° [n=120]); PD duration (1 to ≤ 2 [n=201], >2 to ≤ 4 [n=212], and >4 years [n=199]); degree of plaque calcification (no calcification [n=447], noncontiguous stippling [n=103], and contiguous calcification that did not interfere with the injection [n=62]); and baseline erectile function (International Index of Erectile Function [IIEF] 1-5 [n=22], 6-16 [n=106], and ≥17 [n=480]).
RESULTS: Reductions in penile curvature deformity and PD symptom bother were observed in all subgroups. Penile curvature deformity reductions were significantly greater for CCH vs placebo for: baseline penile curvature 30°-60° and 61°-90°; disease duration >2 to ≤ 4 years and >4 years; no calcification; and IIEF ≥17 (high IIEF erectile function) (P < .05 for all). PD symptom bother reductions were significantly greater in the CCH group for: penile curvature 30°-60°; disease duration >4 years; no calcification; and IIEF 1-5 (no sexual activity) and ≥17 (P < .05 for all).
CONCLUSIONS: In this analysis, the clinical efficacy of CCH treatment for reducing penile curvature deformity and PD symptom bother was demonstrated across subgroups. In the IMPRESS I and II studies overall, AEs were typically mild or moderate, although treatment-related serious AEs, including corporal rupture or penile hematoma, occurred. Future studies could be considered to directly assess the efficacy and safety of CCH treatment in defined subgroups of PD patients, with the goal of identifying predictors of optimal treatment success.
Written by:
Lipshultz LI, Goldstein I, Seftel AD, Kaufman GJ, Smith TM, Tursi JP, Burnett AL. Are you the author?
Scott Department of Urology, Baylor College of Medicine, Houston, TX.
Reference: BJU Int. 2015 Feb 24. Epub ahead of print.
doi: 10.1111/bju.13096
PubMed Abstract
PMID: 25711400