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.

Clinical Experience With Penile Traction Therapy Among Men Undergoing Collagenase Clostridium histolyticum for Peyronie Disease.

OBJECTIVE: To evaluate the outcomes in men undergoing collagenase Clostridium histolyticum (CCH) with concurrent penile traction therapy (PTT) for the treatment of Peyronie disease (PD). MATERIALS AND METHODS: We identified patients treated with CCH between March 2014 and July 2016. Patients were recommended to perform modeling and PTT between injection series. A final curve assessment was performed after patients completed CCH. A prospective database was maintained, including patient-reported frequency and duration of PTT. Statistical analysis was performed to evaluate outcomes based on use and duration of PTT. RESULTS: A total of 51 patients completed CCH and had complete objective data available for analysis. Mean (standard deviation [SD]) baseline curvature was 66.7 (25.0) degrees, and mean (SD) improvement post CCH was 20.9 (17.3) degrees (P < .0001). Thirty-five (69%) men reported daily PTT for a mean (SD) of 9.8 (6.3) hours per week. No significant difference was identified in the degree of curve improvement based on frequency or duration of PTT (P = .40). Similarly, no associations between PTT and functional outcomes including intercourse restoration and surgery prevention were identified. Stretched penile length increased nonsignificantly by a mean (SD) of +0.4 (1.5) cm in the PTT group, compared with -0.35 (1.5) in the non-PTT group (P = .21). CONCLUSION: The current series represents a "true-to-life" experience, wherein utilization patterns, attrition, and compliance issues are relevant factors impacting efficacy. PTT use with the Andropenis declined in both frequency and duration with subsequent injection series, and there was no significant difference in curve improvement or stretched penile length with a mean 10 hours of weekly concurrent PTT.

Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease.

PURPOSE: Collagenase clostridium histolyticum is approved for the treatment of Peyronie's disease. To date, no post-release study to our knowledge has evaluated patient perceived outcomes and satisfaction. Therefore, we evaluated patient perceived experience with collagenase clostridium histolyticum injection for Peyronie's disease in a clinical practice. MATERIALS AND METHODS: From March 2014 to July 2015, 69 patients underwent 1 to 4 series of collagenase clostridium histolyticum injections for Peyronie's disease at our institution. Objective changes in penile curvature as well as patient reported functional outcomes and patient perceived curvature improvements were evaluated. RESULTS: By the time of analysis 31 patients (45%) had completed 4 trials, 47 (68%) completed 3 trials and 59 (86%) completed 2 trials. Patient reported improvements (percentage) in curvature increased with each series (trial 1-14%, trial 2-28%, trial 3-30% and trial 4-37%, p <0.05). Among those completing therapy 57% reported that collagenase clostridium histolyticum injections negated a need for surgery and 52% reported restoration of penetration. Overall 81% of men perceived collagenase clostridium histolyticum treatment as meaningful and 88% reported subjective improvements after 4 series of injections. Objective measures demonstrated a mean 23-degree curvature improvement (38%, p <0.0001). Seven patients (10%) experienced penile hematomas and no patients experienced tunical rupture. CONCLUSIONS: Collagenase clostridium histolyticum reduced the need for surgery and restored penetration in the majority of patients completing 4 series of injections. It also significantly reduced the degree of objectively measured penile curvature. Subjective improvements in curvature increased with each series of collagenase clostridium histolyticum injections as well and the majority of patients considered the therapy worthwhile.