Brearton, K

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH), few studies have been able to identify variables which predict curve improvements, with baseline extent of curvature most highly correlated. In addition to extent of baseline curvature, our team has previously identified curve direction and plaque calcification as additional predictive variables. We therefore sought to create an integrated predictive model which incorporated several factors to better estimate anticipated outcomes. Objective To report outcomes of a novel scoring system designed to better predict outcomes of men undergoing CCH injections for Peyronie’s disease (PD). Methods A prospective database has been maintained of men undergoing CCH injections for PD. Data were reviewed to identify variables predictive of curve improvements in men with isolated curvature as well as among those with key characteristics, including indentations, hourglass deformities, penile tapering, and calcification. A predictive model was subsequently developed to improve correlations between disease factors and subsequent CCH outcomes. The final model (CLINiC Score) assigned points as follows: +1 point for every 10 degrees of curvature (C for Curvature), +5 points for penile narrowing >25% (IN for INdent), +3 points for narrowing 0-25%, -4 points for pure lateral curvatures (L for Lateral), and -2 points for plaque calcification (C for Calcification). Patients were assigned scores based on the CLINiC model, and results were correlated with final curve outcomes. Results A total of 476 PD men were included in the current analysis. Baseline variables for the cohort included a mean age of 55.6 yrs (SD 10.9), PD duration 31.9 months (SD 61.4), composite curvature 64.6 degrees (SD 23.9), 47% with indentations, 42% with hourglass deformity, and 17% with calcification. The mean CLINiC score for the cohort was 6.9 (SD 3.4). For the overall cohort, the use of the CLINiC score increased the correlation coefficient from 0.35 to 0.46 (r-squared 0.13 vs 0.21), with a predictive linear formula of 2.1 - 3.2 * CLINiC score. The difference was more pronounced among a subset cohort of men who had pure lateral curvatures, plaque calcification, or narrowing deformity. In comparing the CLINiC predictive model to baseline curve alone, the correlation coefficient increased to 0.54 (r-squared 0.29, p<0.0001) compared to 0.38 (r-squared 0.15, p<0.001). The linear equation to predict curve improvement outcomes using the CLINiC score was 2.2 - 3.5 * total CLINiC score. Conclusions Use of a novel scoring system (CLINiC) improves upon baseline curvature alone to predict post-CCH curve improvements, with the difference more pronounced among men with pure lateral curvatures, plaque calcification, and/or narrowing deformities. External validation is warranted. Disclosure No

ABSTRACT Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie's Disease (PD), several investigators have reported outcomes of CCH, with improvements ranging from approximately 15-30%. More recently, we reported improved results (49% mean improvement) when CCH was combined with RestoreX penile traction therapy (RxPTT). Since then, we have made additional modifications to create a more aggressive injection / traction protocol to further optimize outcomes. Objective To report outcomes of a more aggressive CCH injection / traction protocol in men with PD. Methods A prospective database has been maintained of all individuals undergoing CCH injections since 2014. Our CCH injection protocol has evolved from the one described in the IMPRESS trials to a more aggressive use of injections and manual and mechanical traction. Currently, the protocol consists of injecting 0.9 mg of CCH in 0.7 ml of saline into approximately 15-20 sites around the point of maximal curvature (pharmacologically-induced erection performed with the first injection of each series). Injections are only performed on subsequent days (not 2-3 days apart), and very aggressive (i.e. 10-15 lbs of force) modeling is performed with the 2nd injection. Patients are counseled to begin RestoreX traction at 24-48 hours after the 2nd injection for 30-60 minutes daily, and to continue aggressive manual modeling for at least the first week post injection. Penile wraps are applied for 5 days post injection. A descriptive analysis was subsequently performed to review outcomes. Results A total of 320 men underwent at least 1 series of CCH and had baseline and follow-up curve assessment data available. Mean age was 55.8 (SD 10.4), with a mean PD duration of 27.8 months (SD 53) and a median baseline composite curvature of 64 degrees (IQR 45-80). Curvature improvements (most recent minus baseline) improved over time, correlating with increased injection experience and implementation of more aggressive traction protocols: 2014-2020 (20 degrees, 29% improvement) vs 2020-mid 2021 (27.8 degrees, 50%, p<0.001). When men were stratified by those who either completed 8 injections or indicated that they were satisfied with outcomes (n=147), median results were more pronounced: 2014-2017 (29% improvement), 2018 (38%), 2019 (47%), 2020-mid 2021 (59%), p<0.01. Conclusions Progressive implementation of a more aggressive CCH injection protocol has resulted in improved curvature outcomes. Given the specialized nature of technique modifications described, these results would argue for a center-of-excellence model for CCH administration to achieve optimal outcomes. Disclosure Work supported by industry: no.