Efficacy of collagenaseClostridium histolyticumin men with congenital penile curvature

Abstract

Background Collagenase Clostridium histolyticum (CCH) has been proven effective in multiple subpopulations of PD men; however, no studies have evaluated its role with congenital penile curvature (CPC). Aim To evaluate the safety and efficacy of CCH in men with CPC. Methods A prospective registry was queried of men undergoing CCH injections at our institution. Beginning in 2016, CCH was administered to CPC men using a similar protocol to PD. A comparative analysis was performed between cohorts to evaluate the safety and efficacy of therapy. Outcomes Objective measures included penile length and curvature, while subjective outcomes included standardized (International Index of Erectile Function and Peyronie’s Disease Questionnaire) and non-standardized assessments. Curvature outcomes were categorized as follows: 1 – included all men, with the most recent assessment considered final, and 2 – only men who had completed eight CCH injections or stopped early due to satisfaction. Results From 2014 to Oct 2021, a total of 453 men (408 PD, 45 CPC) underwent one or more CCH injections. In comparing cohorts, CPC men were younger (33 vs 58 years, p<0.0001), had lesser baseline curvatures (52.5 vs 65°, p<0.01), more ventral curves (25.7 vs 9.2%, p<0.01), and longer penile lengths (12.5 vs 12.0 cm, p=0.04). Following treatment, both cohorts experienced similar curvature improvements. Specifically, PD men experienced 20-25° or 33-35% improvements depending on definition compared to 25-30° or 40-50% in CPC men (all p-values >0.05). CPC and PD men also demonstrated similar changes on standardized questionnaires, with the exception of the Psychological and Physical subdomain, which was more improved in CPC men (-11 vs -4, p<0.01). Baseline curvature was positively correlated with greater absolute (degree) and relative (percent) improvements. Adverse events were similar between groups after controlling for confounders. Clinical Implications CCH may be safely and effectively administered in men with CPC. These data provide the first evidence for the efficacy of a non-surgical therapeutic option in this cohort. Strengths and Limitations Strengths – large, prospective series with standardized assessments; Limitations - non-randomized study, short-term follow-up, and lack of standardized method to differentiate CPC from PD. Conclusions CCH may be safely and effectively administered to men with CPC, with similar success rates compared to PD. Increasing curvature was associated with greater absolute (degree) and relative (percent) improvements, supporting the role for CCH in men with mild, moderate, or severe curvatures. External validation is warranted prior to routine implementation.

Comparison of Collagenase Clostridium histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial

“…Primary outcomes included differences between groups based on (1) overall satisfaction with treatment, (2) subjective changes in erectile function, (3) subjective changes in penile sensation, (4) subjective changes in penile length, and (5) change in the International Index of Erectile Function (IIEF) Erectile Function Domain (EFD) score. Secondary outcomes were also compared between groups and included (1) changes in length/curve, (2) need for future CCH or surgery, (3) hospitalizations/emergency room visits, (4) remaining IIEF domains, (5) Peyronie's Disease Questionnaire (PDQ) domains, (6) Beck Depression Inventory (BDI), (7) subjective satisfaction with length and curve, (8) subjective changes to indentations/ hourglass deformities, (9) Sexual Encounter Profile (SEP)-2 and -3, and (10) the Patient Global Impression of Improvement (PGI-I) questionnaire.…”

“…[2][3][4] In addition to technique modifications, the clinical utilization of CCH expanded beyond initial indications to include men with ventral curvatures, all degrees of calcification, and in those with congenital curves. [5][6][7] With the availability of effective conservative treatment options, there has been increasing debate as to optimal management protocols for PD. Specifically, there is increasing interest to directly compare CCH D RxPTT to surgery D RxPTT to determine relative efficacies, differential side effects, long-term durability, and overall patient satisfaction.…”

“…2-4 In addition to technique modifications, the clinical utilization of CCH expanded beyond initial indications to include men with ventral curvatures, all degrees of calcification, and in those with congenital curves. 5-7…”