Self-reported Clinical Meaningfulness Early in the Treatment Course Predicts Objective Outcomes in Men Undergoing Collagenase Clostridium histolyticum Injections for Peyronie Disease.

OBJECTIVE

To compare perceived meaningfulness early in the course of collagenase Clostridium histolyticum (CCH) with final outcomes to evaluate its use as a predictor of efficacy.

MATERIALS AND

METHODS

A registry of patients undergoing CCH from March 2014 to September 2016 was maintained. Patients were recommended to complete 4 injection cycles. After each cycle, patients completed a questionnaire that included, "If you stopped at this point, would you consider this a meaningful improvement for you?" Curve assessments were performed before and at therapy completion. Analyses were performed to compare objective curve changes and reported meaningfulness.

RESULTS

Complete information was available on 52 patients, including 79% who reported meaningful results. Median improvement (interquartile range) was 25 degrees (15;35) in the meaningful (+) group compared with 5 degrees (0;15) in the meaningful (-) group (P = .0007). When stratified by perception early during therapy, patients who found the second series meaningful experienced a greater final curve improvement (P = .005). More than 50% of patients with curvature improvements of ≥10 degrees or ≥10% found the therapy meaningful. Among men with ≤5-degree improvement after 2 series, 83% (5/6) experienced further curve improvements (median 20 degrees). Interestingly, 50% of patients with improvement ≤10 degrees reported meaningfulness, including 40% without objective improvement.

CONCLUSION

Objective curve outcomes can be stratified by early subjective clinical meaningfulness with CCH, and the majority of patients with ≥10-degree or ≥10% curve improvement found CCH meaningful. Men failing to achieve objective curve benefits after 2 series experience further curve improvements in the majority of cases.