Use Of Collagenase Clostridium Histolyticum Research Articles

(400) Geographic Disparity in Collagenase Clostridium Histolyticum Utilization: A National Population-Based Analysis

Abstract Introduction In 2013, the Food and Drug Administration approved the use of intralesional collagenase clostridium histolyticum for the treatment of Peyronie’s Disease. Objective To describe geographic utilization patterns of collagenase clostridium histolyticum. Methods The Medicare Provider Utilization and Payment Database was queried for all collagenase clostridium histolyticum injections (Current Procedural Terminology code 54200) performed between 2013 and 2020. The United States Census Bureau estimates for state population by male sex for 2020 were used to calculate the number of injections per male capita. Linear regression was performed with statistical significance set to 95% confidence intervals. Results Twenty-two states accounted for a total of 8,576 injections performed on 1,887 men. Five states (Georgia, California, Florida, North Carolina, and Delaware) represented over 50% of the injections per million male capita (figure). There were 28 states with zero injections recorded in the database. The number of injections per year increased from 263 in 2013 to 1,388 in 2020 (y=141.43x + 435.57, R2=0.71, p=0.008). All 8,576 injections were performed in urban vs. rural areas. Urologists and advanced practice providers (APPs) performed 8,309 (97%) and 267 (3%) of these procedures, respectively. The average reimbursement was $80.19 (SD $3.87) for urologists and $67.96 (SD $3.33) for APPs. Conclusions In this national population-based database, there was geographic disparity in the use of collagenase clostridium histolyticum for Peyronie’s Disease. Utilization increased fivefold from 2013 to 2020 and was limited to urban centers and less than half the states. APP’s performed a minority of injections. Disclosure No.

Outcomes of collagenase Clostridium histolyticum in men with ventral curvatures: an updated series.

The efficacy and safety of collagenase Clostridium histolyticum (CCH) have been demonstrated in the treatment of men with Peyronie's disease (PD); however, the pivotal clinical trials excluded men with ventral penile curvature. The study sought to evaluate outcomes of CCH treatment in men with ventral curvatures secondary to PD. Men with PD treated with CCH were identified from a prospective database. Patients received up to 4 series of CCH injections using a progressively modified protocol over time. Results were compared between those with baseline ventral vs nonventral penile curvatures. Changes in penile curvature, Peyronie's Disease Questionnaire scores, International Index of Erectile Function scores, nonstandardized assessments, and adverse events. A total of 560 men with PD (85 ventral curvature, 475 nonventral curvature) were included in the analysis. Baseline median curvature was 60.0° (interquartile range, 48.8°-75.0°) in the ventral cohort and 65.0° (interquartile range, 45.0°-80.0°) in the nonventral cohort. Median change from baseline penile curvature was -25.0° in the ventral cohort vs -24.0° in the nonventral cohort (P = .08, between-group comparison), which corresponded to curvature reductions of 44.7% and 33.6%, respectively (P = .03). In the subset of patients who completed CCH treatment (ie, received 8 injections or discontinued early because of patient satisfaction with curvature reduction), median change from baseline was -35.0° in the ventral cohort vs -25.0° in the nonventral cohort (P < .05); median percent improvement was 48.3% and 37.5%, respectively (P = .11). Median change from baseline in Peyronie's Disease Questionnaire and International Index of Erectile Function domain scores and adverse events were similar between cohorts, with the exception of possibly higher hematoma rates in the nonventral group (50% vs 37%; P = .05). No urethral injuries were sustained in either cohort. Data support the use of CCH for the treatment of ventral as well as nonventral penile curvatures in men with PD. Study strengths are the inclusion of a general clinical population of men with PD, the prospective design, and the relatively large series of men with ventral curvature. Limitations include the single-center and observational nature of the study. CCH was safe and effective in the treatment of both ventral and nonventral penile curvatures in men with PD.

Expanded Utilization of Intralesional Therapies for Treatment of Peyronie's Disease.

In this narrative review we explore additional indications for which intralesional collagenase Clostridium histolyticum (CCH) injection therapy may be used, in addition to those utilized in the IMPRESS trials. The goal is to provide updated assessment of available intralesional therapies and justify whether to expand clinical indications based on advancements over the last decade. Patients receiving CCH in the acute phase of PD have shown significant improvement in penile curvature - which may be even more significant than reported due to progressive curvature over the longitudinal course of injection therapy. Across studies, patients with ventral plaques achieved the greatest curvature improvement (~30°) compared to PD patients with dorsal or lateral plaques. Patients with curvature > 90° have been minimally documented. However, the concept of patients with higher degree of curvature achieving more significant degrees of improvement prevails across studies. Studies including PD patients with volume loss deformities or indentation(s) focus on curvature improvement and do not gauge improvement in these girth loss or indentation features specifically. PD patients with calcification may benefit from CCH, however, critical analysis of included study designs and results compared to placebo do not lend for strong support of CCH in PD at this time. Based on the most recent research, the use of CCH in the acute phase of PD and patients with ventral penile plaques may be effective and safe. The limited available research on the efficacy of CCH on calcified plaque(s) and curvature greater than 90° is promising, however, more research is needed to ensure safety and success in this patient cohort. Finally, the current literature continues to show the use of CCH is not effective in PD patients with volume loss, indentation, or hourglass deformity. When expanding the use of CCH to patients not originally included in the IMPRESS trials, providers must prioritize minimizing chances of potential injury to urethral tissue. Finally, further investigation is required to determine whether CCH has utility for curvature greater than 90° or calcified plaques, although the limited available literature is promising.

(164) Real-World Practice in Peyronie’s Disease Management: Results from a National Survey of Urologists

Abstract Introduction There are many treatment options for men with Peyronie's disease, some which have been shown in randomized controlled trials to be more effective than placebo in reducing curvature and plaque size and others which do not have strong evidence of efficacy for use. It is unclear which of the many Peyronie's disease treatment choices are preferred by practicing urologists. Objective To survey practicing urologists on their preferred methods for diagnosing and treating Peyronie's disease. Methods A 34-item survey was distributed via REDCap to urologists in all American Urological Association (AUA) sections. Questions elicited demographic information as well as practices in diagnosis and treatment of Peyronie’s disease. Comparisons were made with Pearson’s chi-squared test. Results A total of 145 respondents completed the survey, of whom 19% were fellowship trained in andrology/sexual medicine, 36% practiced in an academic setting, and 50% had at least 20 years in practice. Only 60% of respondents reporting performing in-office curvature assessment prior to commencing intralesional injection or surgical treatment, with higher prevalence in andrology/sexual medicine fellowship-trained vs. non-fellowship trained urologists (85% vs. 54%, p=0.003). The most popular treatment modalities were collagenase clostridium histolyticum (CCH) (61% of respondents), phosphodiesterase-5 (PDE-5) inhibitors (54%), and penile traction (53%). Twenty-one percent of respondents reported currently using a treatment that is explicitly discouraged by the AUA guidelines (extracorporeal shockwave therapy for curvature, L-carnitine, omega-3 fatty acids, procarbazine, tamoxifen, or vitamin E). Conclusions We found reported use of a variety of Peyronie's disease treatments, despite poor evidence of efficacy for several of these therapies. PDE-5 inhibitors, penile traction, and CCH were among the most popular non-surgical treatments, with a significant proportion of urologists reporting “off-label” use of CCH. Efforts are needed to identify optimal regimens for Peyronie's disease treatment and to better educate urologists on the up-to-date evidence and guidelines in Peyronie's disease management. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman Health

New Considerations in the Use of Collagenase Clostridium Histolyticum for the Treatment of Cellulite.

New Considerations in the Use of Collagenase Clostridium Histolyticum for the Treatment of Cellulite.

Peyronie's Disease - Outcomes of collagenase clostridium histolyticum injection: A systematic review

ABSTRACT Introduction Peyronie's Disease (PD) is a condition characterized by abnormal and excessive wound repair causing fibrous plaquing of the tunica albuginea. Intralesional (IL) therapies are for patients who prefer to avoid surgical intervention and associated adverse complications. Currently, among available IL injection therapies (Collagenase Clostridium histolyticum (CCh) (Xiaflex, Endo Pharmaceuticals, Dublin, Ireland), verapamil, IFN-a-2b, OnabotulinumtoxinA (Botox) (AbbVie, Chicago, Illinois), Hyaluronic acid). The only FDA approved intralesional treatment option is CCh, which recently expanded its indications for atypical PD. Objective This study aims to review recent literature pertaining to CCh and other intralesional therapies in treatment of PD. Methods A systematic search of literature using exclusively PubMed was performed. There were no specific inclusion or exclusion criteria, however a preference was placed on recent and high impact articles. The review represents many types of studies including randomized control trials, meta-analyses, as well as phase 2 and 3 clinical trials. The use of CCh was compared to other IL therapies and evaluated for efficacy. This included Lastly, CCh use in atypical Peyronie's Disease was assessed for rate of success and complication. Results Recent literature supports the notion that CCh is the most superior IL treatment for typical and atypical PD patients. The capstone CCh study was the IMPRESS trial that showed a 34% reduction in curvature with a mean -17.0 ± 14.8 angle reduction with IL CCh, while men in the placebo saw an average 18.2% decrease in penile bend with a mean -9.3 ± 13.6 degree of change per person (p&amp;lt;0.0001). A shortened protocol for IL CCh treatment offered a 31.4% reduction in curvature while decreasing cost and office visits, potentially increasing patient compliance. Lastly, the literature shows CCh is used most commonly in atypical cases with about 64.8% of patients being treated with CCh – this is probably because of the high efficacy and superb safety profile that it offers. The most serious complications associated with CCh including urethral injury, corporal rupture and penile fracture are rare in all types of PD. Conclusion Since the approval of CCh by the FDA in 2013, it has been a staple in the treatment of PD, and here we report the continued success and superiority of this therapy. CCh is an effective, minimally invasive therapeutic option in most PD populations, however recent changes have made CCh unavailable for commercial use out of the United States, thus impacting many patients who have previous benefited from it. Disclosure Work supported by industry: no.

The Effect of Collagenase Clostridium Histolyticum Injection on the Treatment Patterns of Peyronie's Disease: An Analysis of Large Health Care System Over 15-year Period

ABSTRACT Introduction Penile plication or excision with grafting has traditionally been the only effective treatment for stable Peyronie's disease (PD) without concurrent erectile dysfunction. Intralesional collagenase clostridium histolyticum (CCH) was approved by the U.S. Food and Drug Administration(FDA) in 2013 for patients with stable disease with curvature between 30 and 90°. The effect of CCH injection therapy on the diagnosis and treatment patterns of PD is unknown. Objective We studied the effect of FDA approval of CCH on the management of PD in a population-based analysis. We analyzed the effect of the advent of CCH on rates of prescribing of oral treatments, including vitamin E, colchicine, and pentoxifylline along with surgical intervention. We also studied the effect of injection therapy on the rate of new diagnosis of PD in a population-based analysis. Methods The Kaiser Permanente Southern California database, which provides comprehensive data on all Kaiser Permanente patients in 15 medical centers in the Southern California region was reviewed. Patients undergoing a penile prosthetic surgery for concurrent erectile dysfunction were excluded. PD patients were identified using ICD-9 code and ICD-10 code. Injection therapy was determined using CPT codes, as well as the use of CCH based on the pharmacy database. Surgical therapy (either penile plication or excision with grafting) was identified using CPT codes. The use of oral medication treatment (e.g., vitamin E, colchicine, and pentoxifylline) was ascertained using both the outpatient and inpatient pharmacy database. Main Outcome Measure This study first presented the annual incident rates of PD from 2004 to 2020 among Kaiser members ages 18 or older, and, among eligible PD patients, the annual rates of receiving CCH injection therapy, surgical therapy, and oral medication treatment. Descriptive statistics and multivariable logistic regression modeling were used to assess factors influencing the choice of intralesional injection vs surgical therapy. Results From 2004 to 2020, 11,706 patients presented for PD management (average incident rate, 52.8 per 100,000 eligible members). Median age was 58 years and 54.5% were Caucasian. Over the study period, the incident rate (per 1,000 eligible patients) of surgical management declined on average by 0.37 each year (p &amp;lt; 0.001) while there was an increase of 0.43 for injection therapy (p &amp;lt; 0.001). Following the FDA's approval of CCH in 2013, the average incident rate (per 1,000 eligible patients) for surgical therapy in 2014-2020 declined by 2.8 (p &amp;lt; 0.001) compared to that in 2004-2013, whereas it significantly increased by 5.1 (p &amp;lt; 0.001) for injection therapy. Average rates of prescribing of oral colchicine and vitamin E significantly decreased from 2016-2020 compared to 2004-2015 (p&amp;lt;0.001), while average rates of prescribing pentoxifylline significantly increased (p&amp;lt;0.001). Patients presenting in the post-CCH era were approximately two times significantly more likely to receive injection therapy (OR: 2.08; P &amp;lt; 0.001 CI: 1.47 to 2.94). On multivariable modeling, patients more likely to receive injection therapy as primary treatment for PD were ages 45-54 (OR: 2.77; P = 0.002; CI: 1.34 to 5.73). Conclusions Since the Introduction: of CCH, there has been a significant change in the management pattern for PD (decrease in surgical therapy, and increase in intralesional injections). Since the recent publication of AUA Guidelines on PD in 2015, there has been a significant decrease in non-evidence supported oral medication prescriptions. Disclosure No

The Effect of Anticoagulation on the Treatment of Dupuytren Contracture with Collagenase.

There have been no formal studies of the use of collagenase clostridium histolyticum (Xiaflex; Endo Pharmaceuticals, Malvern, Pa.) in the anticoagulated patient. Previous study on its use excluded patients receiving anticoagulation therapy. This study reviewed the effects of anticoagulation use in patients undergoing collagenase clostridium histolyticum injection and cord rupture to determine safety and efficacy. The authors retrospectively reviewed patients receiving collagenase clostridium histolyticum injections for Dupuytren contracture between 2010 and 2017. Outcomes included type of anticoagulation, skin tear, tendon rupture, lymphadenopathy, sensory abnormality, hematoma, and bleeding. A total of 388 injections were performed in 197 patients. The average clinical follow-up was 311 days. Fifty-two percent of patients (n = 201) were anticoagulated. The vast majority were taking aspirin (acetylsalicylic acid) (n = 182), followed by warfarin (n = 27), clopidogrel (n = 9), apixaban (n = 8), rivaroxaban (n = 4), and dabigatran (n = 2). There were 42 skin tears, 21 in the anticoagulated group. One tendon rupture occurred in the anticoagulated group (acetylsalicylic acid) and none occurred in the nonanticoagulated group (p = 0.34). No patients experienced sensory abnormalities, a hematoma requiring intervention, or uncontrollable bleeding. Anticoagulation is commonly encountered by hand surgeons treating Dupuytren contracture. There is no significant difference in complications in the anticoagulated patient versus the nonanticoagulated patient. It is safe to perform collagenase clostridium histolyticum injections for Dupuytren contracture in the anticoagulated patient, regardless of the type of anticoagulation. Therapeutic, III.

Current role of the collagenase Clostridium histolyticum in Dupuytren's disease treatment.

Collagenase Clostridium histolyticum (CCH) is a recent treatment for Dupuytren disease, which is a fibroproliferative disorder that leads to progressive, persistent digital flexion contracture that interferes with basic daily activities. While CCH has changed the treatment of this hand disorder, numerous concerns have to be analyzed. Our purpose is to assess the current status of this medical treatment. Literary review based on a manual search on PubMed, Web of Science, and Google Academic. Pharmacoeconomic analyses support the use of CCH, but long-term studies showing that it should be favored over conventional surgery or other treatments are lacking. Treatment decisions, therefore, must be guided by current data, which include a 5-year recurrence rate of 47%. Complications following CCH treatment are also a controversial topic, as rates of over 90% have been reported, although most of the complications are mild and self-limiting. A definition and classification of CCH-related complications is sorely needed. If we exclude adverse effects that could be considered inherent to the mechanisms of action of CCH, then the complication rate would be similar to rates reported for other techniques. Although CCH is becoming an increasingly popular treatment for Dupuytren disease, the potential applications of this modality, are much higher than currently believed, for more disorders characterized by excessive fibrosis. Currently, the administration of this treatment is promising although long-term studies are necessary to see the real role that this drug can play in both Dupuytren's disease and other fibrotic disorders.

Management of Peyronie's disease with collagenase Clostridium histolyticum in the acute phase.

Peyronie's disease (PD) can affect men of all ages and is associated with penile pain as well as curvature and erectile dysfunction. Treatment modalities for PD include conservative, less invasive and surgical treatments. Choice of treatment depends on the disease's phase. Injection of collagenase Clostridium histolyticum (CCH) is only the Food and Drug Administration approved treatment for the management of the chronic phase of the disease. Only a few limited studies have evaluated its potential benefits during the acute phase. To evaluate the current evidence on the use of injectable CCH during the acute or active phase of PD. We performed a PubMed database search for articles published between 2015 and 2018 that investigated the use of CCH for the management of the acute phase of PD. Search keywords included "Peyronie's disease", "collagenase Clostridium histolyticum", and "acute phase". Changes in penile curvature after treatment with injectable CCH. Mean curvature decrease ranged between 15.8° and 22.6° corresponding to 27.4-37.4% decrease from baseline after 2.5-4 cycles, corresponding to 5-8 injections, of CCH treatment in patients during the acute phase of PD. Intralesional CCH injection therapy during the acute phase of PD can be both safe and effective and clinically significant improvements in penile curvature may be achieved. Larger multi-institutional studies are, however, still needed to confirm these results and validate this additional indication for CCH.

PMS118 - QUALITY OF LIFE OF DUPUYTREN’S DISEASE PATIENTS TREATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM: A PROSPECTIVE COHORT STUDY

Dupuytren’s disease (DD) is a connective tissue disorder leading to contractures. The use of Collagenase Clostridium histolyticum (CCH) as a potential minimally-invasive, non-surgical option to treat DD has been approved. The goal was to assess the quality of life of patients with DD and treated with CCH in Valencian Community Hospitals. Patients aged 18 years and over, with DD and active extension deficit (AED) ≥20° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, with a palpable cord and having been treated or going to be treated with CCH were included in this prospective observational multicenter study. Change in hand function were assessed combining physical measures (i.e, goniometry) and QuickDASH questionnaires at 30 days post injection visit. We performed a logistic regression to describe the improvement of QuickDASH (10% increment vs baseline) adjusted by demographic variables and functional variables. Overall, 48 patients (51 joints) received one CCH injection, and 46 patients (49 joints) completed the study. Patients had 66 years, 84% men, 75% of patients without DD family story and 82% naïve. QuickDASH score decreased from 26.80 (21.71) to 17.92 (18.05) (p<0.01). AED score decreased from 27.49 (22.15) to 0.82 (3.44) for MCP, and 29.53 (25.63) to 6.14 (11.80) for PIP. The best logistic model included (level of studies categorized [OR: 0.11 (CI95% 0.02 to 0.56)], change in the mobility of the extension of the PIP and the MCP joint [OR: 1.01 (CI95% 0.95 to 1.07) and OR: 0.96 (CI95% 0.90 to 1.03)], and implicated finger [OR: 0.16 with CI95% (0.02 to 1.05)]. Treatment with CCH for DD is an effective treatment in the short term and able to increase quality of life. The educational level seems to work as an independent predictor of the surgical improvement of quality of life improvement.

697 General urologists' attitudes towards the use of collagenase clostridium histolyticum (Xiapex) in Peyronie's Disease

Peyronie's disease (PD) is commonly treated by general urologists, rather than sexual medicine specialists. Recently, Collagenase Clostridium Histolyticum (Xiapex) has been added to armamentarium of PD interventions. This study outlines the general urologists' attitudes towards Xiapex and their practice patterns. A web survey was conducted among 220 general urologists. The survey included questions about general urologists' experience, their PD patients' volume and considerations in choosing the right treatment for the right patient, with an emphasis on their attitudes towards the use of Xiapex. Sixty responses were returned (27.3% response rate). Most responders (60%) had more than 20 years of experience. Eighty-seven percent had seen less than 10 PD patients in the preceding 3 months. Penile curvature angle was commonly assessed by self-photography only (85%). It was assessed at the erect state in-clinic only by 13%. When treatment for stable PD was indicated, 36% offered surgical treatment only and 39% offered either surgery or Xiapex injections. When the chosen treatment was Xiapex injections, 70% of the urologists couldn't perform it themselves and had to refer the patient to another urologist. The leading consideration (70% of responders) in selection of Xiapex as the preferred treatment was patients' inclination. Additional considerations were difficulty in penetration (52%) and curvature angle (48%). The predicted success rate and the existence of calcified plaques (known to decrease the success rate) were considered only by 2% of general urologists. The leading considerations in patient selection for Xiapex were realistic expectations (65%), willingness to adhere to the treatment protocol (58%) and curvature angle (48%), but not treatment adequacy or the predicted success rate.

211 Ultrasound predictive factors for efficacy and safety of the use of Collagenase Clostridium Histolyticum (CCH) in the treatment of Peyronie's disease (PD): Impact of patient's selection

The use of CCH has become a therapeutic option in the non-surgical management of PD. The discordance in the efficacy of CCH among patients prompted us to look for ultrasound and clinical findings that may allow us to select the best candidates for this therapy. Between June 2014 and September 2017, we evaluated and treated 87 patients with stable PD curvature. Collection of clinical data (PDQ, IIEF-5, degree of curvature) and a Doppler-US of the penis by a dedicated radiologist was performed to every patient. Several data were obtained (size and thickness of plaque, septal involvement, embedding of dorsal arteries, subglandar involvement, plaque calcification among others). Our protocol consisted of 3-month cycles with two CCH injections for the first 2 weeks, following by modeling the next week, and two months of "Triple Therapy" - tadalafil 2.5/5mg daily, pentoxifylline 400mg twice a day and 4-6 hours of penile traction therapy. The cohort mean age was 51.6 years (SD 9.5) with a mean curvature of 47.9º (SD 15.3), 67.8% of them with dorsal curvature and 33.2% dorso-lateral.

921 - Ultrasound predictive factors for efficacy and safety of the use of Collagenase Clostridium Histolyticum (CCH) in the treatment of Peyronie’s disease (PD): Impact on patient’s selection

921 - Ultrasound predictive factors for efficacy and safety of the use of Collagenase Clostridium Histolyticum (CCH) in the treatment of Peyronie’s disease (PD): Impact on patient’s selection

Collagenase Clostridium Histolyticum in the Treatment of Urologic Disease: Current and Future Impact.

Peyronie's disease (PD) is a connective tissue disorder resulting in the abnormal accumulation of type I to III collagen, fibrin, and disorganized elastic fibers in the tunica albuginea of the penis. Many medical and non-pharmacologic modalities have been used in the treatment of PD; however, these approaches have proved largely ineffective, with surgery being the only definitive treatment. Intralesional injection of collagenase Clostridium histolyticum (CCH) has recently become the gold standard for minimally invasive treatment of PD, and studies have suggested the role of CCH could expand to the treatment of other urologic conditions such as urethral stricture disease. To provide an update on available data on the use of CCH in the treatment of PD and other urologic conditions. Comprehensive review of recent clinical trials and invivo studies that examined the safety and efficacy of CCH in urologic disease. Assessing the efficacy of CCH in the management of PD as determined by improvement in the severity of penile fibrosis, curvature deformity, and pain. Several well-designed clinical trials have demonstrated the efficacy and tolerability of CCH in the treatment of PD. CCH has demonstrated significant decreases in penile curvature and plaque consistency and improvements in patient satisfaction. Treatment durability and long-term adverse effects are still being assessed; however, outcomes of PD management with CCH continue to replicate the results obtained during the IMPRESS clinical trials. Preliminary studies support the premise that CCH can modify disease progression in patients with acute-phase PD. Furthermore, one invivo study showed that CCH also could be applied to urethral stricture disease without serious adverse complications. CCH continues to be the mainstay for non-surgical management of stable-phase PD. However, its role in the treatment of acute-phase PD, PD with ventral plaques, and urethral stricture disease could expand in the coming years. Gabrielson AT, Spitz JT, Hellstrom WJG. Collagenase Clostridium Histolyticum in the Treatment of Urologic Disease: Current and Future Impact. Sex Med Rev 2018;6:143-156.

HP-09-003 Clinical outcomes of the use of Collagenase Clostridium Histolyticum (CCH) for peyronie's disease (PD)

HP-09-003 Clinical outcomes of the use of Collagenase Clostridium Histolyticum (CCH) for peyronie's disease (PD)

Collagenase Clostridium histolyticum in the treatment of Peyronie's disease: patient selection and perspectives.

The safety and efficacy of the use of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie’s disease has been confirmed over the past several years. However, identification of the ideal patient population for use of this treatment is not well established. Multiple studies have attempted to delineate various patient-specific factors that may predict response to treatment with CCH, with the intent of enhancing patient selection. To date, these include baseline curvature severity, duration of disease, disease phase at presentation, plaque calcification, baseline erectile function, plaque size, age, comorbid diabetes, previous penile trauma, responsiveness to first treatment cycle, baseline penile shortening or pain, prior treatment with intralesional injection, compliance with plaque modeling, and atypical curvature. In addition, other studies have sought to explore various aspects of treatment with CCH that may affect patient perspective of treatment. They have focused on patient-reported outcomes, female partner considerations, cost of treatment, and potential confounders of patient satisfaction. This review provides a summary and analysis of currently available literature on topics of patient selection and perspectives in regard to treatment of Peyronie’s disease with CCH.

Collagenase Clostridium Histolyticum in the Treatment of Peyronie's Disease: Review of a Minimally Invasive Treatment Option.

Peyronie's disease (PD) is an inflammatory disorder characterized by an abnormal collagen deposition in the tunica albuginea of the penis, leading to fibrous and non-compliant plaques that can impede normal erection. Although pharmacological treatments are available, only intralesional injection therapy and surgical reconstruction have demonstrated tangible clinical efficacy in the management of this condition. Intralesional injection of collagenase clostridium histolyticum (CCH) has come to the forefront of minimally invasive treatment of PD. In this review, the authors provide an update on the safety, efficacy, and indications for CCH. The efficacy of CCH will be assessed on the basis of improvement in the severity of penile fibrosis, curvature, and pain. Numerous well-designed clinical trials and post-approval studies involving more than 1,500 patients have consistently demonstrated the efficacy and tolerability of CCH in the treatment of PD. CCH significantly decreases penile curvature and plaque consistency, as well as improves quality of life. Post-approval studies continue to demonstrate the efficacy of CCH despite broader inclusion criteria for treatment, such as the case with acute phase disease and atypical plaque deformities (i.e., ventral plaques, hourglass narrowing). CCH continues to be the gold standard for non-surgical management of stable phase PD, in the absence of strong evidence supporting oral therapy agents and ongoing evaluation of extracorporeal shockwave therapy. However, recent studies are beginning to provide precedent for the use of CCH in the management of acute phase and atypical PD.

The Impact of Collagenase Clostridium histolyticum Introduction on Dupuytren Treatment Patterns in the United States

The U.S. Food and Drug Administration approved the use of collagenase Clostridium histolyticum (CCH) in the United States in February 2010. This study addresses the impact of that approval on the number of Dupuytren contracture (DC) encounters and treatment patterns in the United States. Using the Intercontinental Marketing Services Health Office-Based Medical Claims database, we identified the monthly number of DC encounters and DC procedures between January 2007 and December 2013. Collagenase Clostridium histolyticum usage data from March 2010 to December 2013 was derived from the U.S. CCH manufacturer's data warehouse. Using the combined data, the yearly increasing trends in DC encounters and treatment volume were compared before and after the introduction of CCH. Time trends in the relative procedure frequencies were then examined. Finally, the presence of seasonal variation was tested for in each treatment type. Dupuytren contracture encounters increased on average by 19,015 per year between 2007 and 2009, whereas between 2011 and 2013, DC encounters increased on average by 34,940 per year. In terms of absolute procedure counts, the surgery trend line began decreasing in 2010 with the release of CCH. Meanwhile, CCH continuously increased between 2010 and 2013, and needle aponeurotomy (NA) remained relatively stable. By the year 2013, minimally invasive techniques (NA and CCH) comprised 39% of all treatment, compared with only 14% in 2007. Lastly, there was a statistically significant seasonal increase in the number of surgical procedures during the wintertime but no seasonal variation in NA or CCH. After the introduction of CCH, the number of Dupuytren encounters increased at a greater annual rate. The introduction and growth of CCH coincided with a decrease in surgery. The number of NA procedures remained steady throughout the study period. The number of open surgery cases followed a predictable seasonal variation with more procedures during the winter months, but this seasonal variation was not seen with less invasive techniques. Economic/Decision Analysis II.

Collagenase clostridium histolyticum in Dupuytren's contracture: a systematic review.

In the last few years, the use of collagenase clostridium histolyticum for management of Dupuytren's contracture has increased. The procedure of enzymatic fasciectomy has become popular because it is non-invasive, safe and fast to perform. A systematic search was performed on Medline (PubMed), Web of Science and Scopus databases using the combined keywords 'Dupuytren collagenase' and 'Dupuytren clostridium histolyticum'. Forty-three studies were identified. The quality of the studies was assessed using the Coleman Methodological Score. The use of collagenase clostridium histolyticum provides better outcomes in patients with mild-moderate joint contracture, with lower complications and side effects than open fasciectomy. Manipulation can be performed 2-7 days after the injection. The use of collagenase is cost-effective. Most of the studies did not report patient-related outcomes. The role of dynamic splint has to be investigated with randomized clinical trials. The shorter recovery time and the low incidence of serious or major adverse effects are the main advantages of this new technology. There is a need to perform studies with longer follow-up because the recurrence rate seems to increase with time. Further investigations are necessary to assess whether it is safe and effective to inject two or more cords at the same time.