The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Landon Trost - One of the best experts on this subject based on the ideXlab platform.

  • Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis
    Sexual medicine, 2021
    Co-Authors: Landon Trost, Huan Huang, Xu Han, Chakkarin Burudpakdee
    Abstract:

    Abstract Introduction Treatments for Peyronie's disease (PD) include surgical management and Collagenase Clostridium Histolyticum (CCH). Aims To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts. Methods Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts. Main outcome measures The main outcome measures of this study were treatment patterns, penile complications, and analgesic use. Results In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with Conclusion CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery. L Trost, H Huang, X Han, et al. Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis. Sex Med 2021;XX:XXX–XXX.

  • safety and efficacy of Collagenase Clostridium Histolyticum in the treatment of acute phase peyronie s disease a multi institutional analysis
    Urology, 2020
    Co-Authors: Hoang Minh Tue Nguyen, Landon Trost, Matthew Ziegelmann, Martin K Gelbard, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Ayad Yousif, Wayne J.g. Hellstrom
    Abstract:

    Objective To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of Collagenase Clostridium Histolyticum (CCH) in the treatment of acute phase PD. Methods Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. Results A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. Conclusion This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

  • the influence of indentation deformity on outcomes with intralesional Collagenase Clostridium Histolyticum monotherapy for peyronie s disease
    Urology, 2020
    Co-Authors: Matthew Ziegelmann, Landon Trost, Daniel Heslop, M Houlihan, Petar Bajic, S Helo, Tobias S. Köhler
    Abstract:

    Abstract Objective To identify patient-specific factors associated with patient-reported improvements in functional outcomes after intralesional Collagenase Clostridium Histolyticum (CCH) for Peyronie's Disease (PD). Methods We retrospectively explored our prospectively maintained CCH registry. We sought to identify patient-specific factors that prevented the need for surgical straightening and/or improved ability to engage in penetrative intercourse. Results Eighty-six patients underwent CCH monotherapy and had objective follow-up data available. Mean PD symptom duration was 25 months (SD 44) and baseline curvature was 65o (SD 24). Prominent indentation/hourglass deformities (defined as girth discrepancy >10%) were present in 40 patients (47%). Mean objective curve improvement was 19o (SD 20), and 60% achieved improvement ≥15o. Greater baseline curvature was associated with greater absolute improvements in curvature, although there was no association between baseline curvature and relative (%) improvement. Three of 40 patients (8%) with indentation achieved girth improvement. Patients with baseline indentation/hourglass were less likely to report that CCH prevented the need for surgery (35% vs 64%, P = .018). Patients with curve improvement Conclusion Baseline indentation/hourglass deformity and curve improvement

  • comparative cost effectiveness of surgery Collagenase Clostridium Histolyticum and penile traction therapy in men with peyronie s disease in an era of effective clinical treatment
    The Journal of Sexual Medicine, 2019
    Co-Authors: Kevin Wymer, Tobias S. Köhler, Landon Trost
    Abstract:

    Abstract Background Traditionally, surgery has been considered the gold standard treatment for Peyronie’s disease (PD). Less-invasive alternatives, such as Collagenase Clostridium Histolyticum (CCH) and traction therapy, have been proposed and proven effective. Aim To compare cost-effectiveness of management options for PD. Methods A Markov analytic model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX (RXPTT), vs CCH vs surgery. Outcomes were derived from single-institution, prospective data of 63 men treated with RXPTT, 115 with CCH, and 23 with plication or incision and grafting. Costs were based on 2017 Medicare reimbursement and utility values from the literature. Main Outcome Measures Model outcomes included complications for each treatment arm, as well as the probability of success, which was defined as ≥20% improvement in curvature. Univariable and multivariable sensitivity analyses were performed to test the robustness of the model. Results Overall success rates were 96% (surgery), 66% (CCH), and 48% (RXPTT). At 10 years after treatment, RXPTT was the most cost-effective, with mean costs per patient of $883 (RXPTT), $11,419 (surgery), and $33,628 (CCH). CCH and surgery both resulted in a gain of quality adjusted life years (QALYs) relative to RXPTT (9.44 and 9.36 vs 9.27, respectively). Sensitivity analysis demonstrated greater cost-effectiveness for surgery if lower (≤46%) rates of postoperative erectile dysfunction or length loss (≤3%). CCH became more cost-effective at lower costs (≤$16,726) or higher success rates (≥76%). On multivariable sensitivity analysis at a willingness to pay threshold of $100,000/QALY, the most cost-effective strategy was RXPTT in 49%, surgery in 48%, and CCH in 3% of simulations. At a willingness to treat threshold of $150,000/QALY, the most cost-effective treatment option was RXPTT in 33%, surgery in 55%, and CCH in 12% of simulations. Clinical Implications In an era of value-based care, this model can guide cost-effective treatment selection on the basis of provider, patient, and payer characteristics. Strengths & Limitations The current study represents the first cost-effectiveness comparison of treatment modalities for PD and is strengthened by prospective data collection, large CCH and traction sample sizes, and robust sensitivity analyses. Consistent with cost-effective models, the model is limited by assumptions and may not apply to all scenarios. Conclusions RXPTT represents a more cost-effective method for achieving ≥20% curvature improvement compared with surgery or CCH. Depending on treatment goals, rate of surgical complications, and willingness to pay threshold, surgery and CCH may become more cost-effective in select scenarios. Wymer K, Kohler T, Trost L. Comparative Cost-effectiveness of Surgery, Collagenase Clostridium Histolyticum, and Penile Traction Therapy in Men with Peyronie’s Disease in an Era of Effective Clinical Treatment. J Sex Med 2019;16:1421–1432.

  • efficacy of combined Collagenase Clostridium Histolyticum and restorex penile traction therapy in men with peyronie s disease
    The Journal of Sexual Medicine, 2019
    Co-Authors: Manaf Alom, Kiran Lata Sharma, Amir Toussi, Tobias S. Köhler, Landon Trost
    Abstract:

    Abstract Background Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie’s disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. Aim To assess the safety and efficacy of treatment with the RestoreX device plus Collagenase Clostridium Histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. Methods A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). Outcomes Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. Results Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups. Clinical Implications Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. Strengths & Limitations Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. Conclusion The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium Histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease. J Sex Med 2019;16:891–900.

Wayne J.g. Hellstrom - One of the best experts on this subject based on the ideXlab platform.

  • review of intralesional Collagenase Clostridium Histolyticum injection therapy and related combination therapies in the treatment of peyronie s disease an update
    Sexual medicine reviews, 2021
    Co-Authors: Caleb Natale, David M Mclellan, Ayad Yousif, Wayne J.g. Hellstrom
    Abstract:

    Abstract Introduction Collagenase Clostridium Histolyticum (CCH) is an injectable agent used to treat Peyronie's disease (PD) by enzymatically degrading the interstitial collagen in plaques. CCH has been administered via multiple treatment protocols, in combination therapies, to patients with varying curvatures and in both the acute and stable phases of this condition. Objectives To review the current literature and provide an update on CCH as an injectable therapy for PD, as a singular therapy or in conjunction with combination therapies, and its associated complications. We provide a brief background of PD treatments, evaluate CCH efficacy in penile curvature reduction and subjective improvement in a variety of protocols, and compare combination therapies (penile traction, sildenafil), plaque location, and efficacy in both acute and stable diseases. Methods We performed a systematic review of the existing PubMed literature pertaining to CCH injection therapy in the treatment of PD and compared the effectiveness to different treatment modalities. Results CCH is a safe and effective injectable agent for all curvature directions in both acute and stable PD. It can be used in conjunction with multiple penile modeling techniques, in combination with sildenafil, and following a shortened administration protocol. Moderate to severe treatment-related adverse events occur at a rate of 9% and are typically managed conservatively. Conclusion Intralesional injections of CCH are FDA approved as a nonsurgical treatment for men with PD. The IMPRESS trials were instrumental in demonstrating the efficacy and safety of CCH and provided a standard protocol for administration. Additional studies are required to optimize treatment protocols and use in combination therapies. Further investigation of patients with ventral curvatures, hourglass deformities, and those in acute phase is needed. Natale C, McLellan D, Yousif A, et al. Review of Intralesional Collagenase Clostridium Histolyticum Injection Therapy and Related Combination Therapies in the Treatment of Peyronie's Disease (an Update). Sex Med 2020;XX:XXX–XXX.

  • safety and efficacy of Collagenase Clostridium Histolyticum in the treatment of acute phase peyronie s disease a multi institutional analysis
    Urology, 2020
    Co-Authors: Hoang Minh Tue Nguyen, Landon Trost, Matthew Ziegelmann, Martin K Gelbard, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Ayad Yousif, Wayne J.g. Hellstrom
    Abstract:

    Objective To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of Collagenase Clostridium Histolyticum (CCH) in the treatment of acute phase PD. Methods Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. Results A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. Conclusion This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

  • intralesional Collagenase Clostridium Histolyticum causes meaningful improvement in men with peyronie s disease results of a multi institutional analysis
    The Journal of Urology, 2019
    Co-Authors: Wayne J.g. Hellstrom, Landon Trost, Matthew Ziegelmann, Laith Alzweri, Hoang Minh Tue Nguyen, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Martin K Gelbard
    Abstract:

    Purpose:In a multi-institutional setting we studied the efficacy and safety outcomes at multiple high volume centers where Collagenase Clostridium Histolyticum is used to treat Peyronie's disease.M...

  • successful treatment of residual curvature in peyronie disease in men previously treated with intralesional Collagenase Clostridium Histolyticum
    Urology, 2017
    Co-Authors: Kenneth J Delay, Faysal A Yafi, Hoang Minh Tue Nguyen, Jonathan Zurawin, Linley Diao, Russell P Libby, Wayne J.g. Hellstrom
    Abstract:

    Objective To determine the success and feasibility of surgically correcting residual curvature after intralesional Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie disease (PD). Methods We performed a retrospective analysis of patients who had intralesional CCH treatment for PD and who subsequently underwent penile plication (PP), plaque incision and grafting (PIG), or inflatable penile prosthesis (IPP) placement. Results Ten men who underwent PP, PIG, or IPP for the treatment of residual curvature after intralesional CCH were identified. Six patients underwent PP; 1 patient underwent PIG; and 3 patients underwent IPP with ancillary straightening maneuvers. The mean time from the last CCH injection to surgical correction was 150.9 days, or 5 months. The mean pre-CCH curvature was 67 degrees and the mean post-CCH curvature was 51 degrees. Eight of 10 patients had no residual curvature after surgical treatment. The mean postprocedure curvature was 4.5 degrees. The mean operative time was 72.1 minutes. The mean estimated blood loss was 20 mL. Increased fibrosis with increased surgical difficulty was noted in 3 (all  Conclusion The surgical treatment of PD after intralesional CCH is safe and effective. If surgery is considered, this should be performed at least 6 months after the last CCH injection, given the potential for an increased inflammatory reaction in this area.

  • safety and efficacy of Collagenase Clostridium Histolyticum in the treatment of acute phase peyronie s disease
    The Journal of Sexual Medicine, 2017
    Co-Authors: Hoang Minh Tue Nguyen, James Anaissie, Faysal A Yafi, Kenneth J Delay, Suresh C Sikka, Wayne J.g. Hellstrom
    Abstract:

    Abstract Background Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of Collagenase Clostridium Histolyticum (CCH) in the treatment of acute phase PD. Aim To examine the efficacy and safety of CCH in the treatment of acute-phase PD. Methods We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events. Outcomes Parameters of efficacy and safety were compared between acute- and stable-phase PD. Results A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P  = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P  = .778). Clinical Implications CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD. Strengths and Limitations This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting. Conclusions Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD. Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and Efficacy of Collagenase Clostridium Histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225.

James P Tursi - One of the best experts on this subject based on the ideXlab platform.

  • treatment of recurrent dupuytren contracture in joints previously effectively treated with Collagenase Clostridium Histolyticum
    Journal of Hand Surgery (European Volume), 2017
    Co-Authors: Brian J Bear, James P Tursi, Gregory J Kaufman, Thomas F D Kaplan, Clayton A. Peimer, Ted M Smith
    Abstract:

    Purpose Collagenase Clostridium Histolyticum (CCH) is approved for the treatment of adults with Dupuytren contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH. Methods Patients participating in a long-term follow-up study who had contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint contracture, range of motion, and the percentage of joints that achieved contracture of 5° or less at day 30 after the last injection. Results The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported. Conclusions At a short-term follow-up of 1 year, recurrent contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH. Type of study/level of evidence Therapeutic IV.

  • RESEARCH ARTICLE Open Access Multiple concurrent Collagenase Clostridium Histolyticum injections to dupuytren’s cords: an
    2016
    Co-Authors: Stephen Coleman, James P Tursi, Nigel Jones, Greg Kaufman, David Gilpin, Brian Cohen
    Abstract:

    Background: Dupuytren’s contracture (DC) is a progressive fibroproliferative disorder characterized by development of nodules and collagen cords within the palmar fascia of the hand. Collagenase Clostridium Histolyticum (CCH) is currently approved in adults with DC for the nonsurgical treatment of a single palpable cord during a 30-day treatment cycle. This open-label pilot study was designed to examine the safety, efficacy, and multiple-dose pharmacokinetics of injecting two cords (affected joints) with multiple doses of CCH concurrently into the same hand in subjects with DC and multiple contractures. Methods: Twelve subjects with DC were enrolled, each with ≥3 contractures caused by palpable cords. Efficacy assessments were taken 30 days after treatment and adverse events (AEs) were recorded throughout. In the first treatment period, all subjects were injected with a single dose of CCH (0.58 mg) into a single cord. The same subjects entered a second treatment period 30 days later, where two different cords (affected joints) were injected concurrently on the same hand. A finger extension procedure was performed 24 hours after each administration of CCH to disrupt the enzymatically weakened cord. Results: For metacarpophalangeal (MP) joints, mean contracture reduction per joint treated was 29.0 ± 20.7 degrees following single injection vs 30.3 ± 10.9 degrees per treated joint following multiple injections. For proxima

  • analysis of the clinical safety of intralesional injection of Collagenase Clostridium Histolyticum cch for adults with peyronie s disease pd
    BJUI, 2015
    Co-Authors: Culley C Carson, James P Tursi, Gregory J Kaufman, Hossein Sadeghinejad, Ted M Smith, Kimberly Gilbert, Stanton C Honig
    Abstract:

    Objective To examine the safety of intralesional injection of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies. Patients and Methods Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH. Adverse events (AEs), including treatment-emergent AEs, treatment-related AEs, and serious AEs (SAEs), were characterised. Potential immunogenicity-related AEs were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, AEs, and reported terms possibly associated with immunological or hypersensitivity events. Results Overall, 85.8% of 1 044 pooled patients reported at least one treatment-related AE. The most frequently reported (≥25.0% of patients) treatment-related AEs included penile haematoma (82.7% had the verbatim ‘penile bruising’), penile pain, and penile swelling. Most patients (75.2%) had mild- or moderate-severity treatment-related AEs, and 14.2% had no treatment-related AEs. Nine patients (0.9%) had treatment-related SAEs: five with penile haematoma and four with corporal rupture. There was no association between AEs and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred. Conclusions This pooled safety analysis shows that although non-serious and serious treatment-related AEs can occur after CCH treatment for PD, most were non-serious and the SAEs were manageable. Providers should be prepared to manage possible SAEs.

  • the efficacy and safety of concurrent Collagenase Clostridium Histolyticum injections for 2 dupuytren contractures in the same hand a prospective multicenter study
    Journal of Hand Surgery (European Volume), 2015
    Co-Authors: Glenn R Gaston, James P Tursi, Gregory J Kaufman, Stephen Coleman, Brian M Cohen, Soren Larsen, Gary M Pess, Brian Dean, Lawrence C Hurst
    Abstract:

    Purpose To evaluate efficacy and safety of concurrent administration of 2 Collagenase Clostridium Histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs). Methods Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized. Results The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension. Conclusions Collagenase Clostridium Histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment. Type of study/level of evidence Therapeutic III.

  • Collagenase Clostridium Histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach.
    The journal of sexual medicine, 2015
    Co-Authors: Martin K Gelbard, Larisa Chagan, James P Tursi
    Abstract:

    Abstract Introduction The conception of Collagenase Clostridium Histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD. Aim To review the origins, clinical research history, and ultimately FDA approval of Collagenase as PD treatment. Methods A PubMed search using (Peyronie's or Peyronie) AND Collagenase, and limited to clinical research studies, returned nine papers that were examined in the current review. Results Collagenase as a PD treatment arose in response to a lack of effective nonsurgical treatments and the incomplete understanding of underlying PD etiology. Awareness of dense collagen in PD scarring and parallel initial exploration of Collagenase to treat herniated lumbar discs coincided with and inspired laboratory-based investigation of Collagenase effects on excised PD plaque tissue. The foundational conceptual work and the critical development of purified injectable Collagenase allowed the pursuit of clinical studies. Progression of clinical studies into large-scale robust trials culminated in two important outcomes: development of the first validated, PD-specific measure of psychosexual function, the Peyronie's Disease Questionnaire, and the first FDA-approved treatment for PD. Conclusions Collagenase therapy began as an attempt to modify the structure of PD-related tunica albuginea scarring, despite the lack of a fundamental understanding of the scar's origin. If we wish to advance PD treatment beyond this first effective step, the future needs to bring us full circle to the starting point: We need a greater understanding of the control of collagen deposition and wound healing in men with PD. Gelbard MK, Chagan L, and Tursi JP. Collagenase Clostridium Histolyticum for the treatment of Peyronie's disease: The development of this novel pharmacologic approach. J Sex Med 2015;12:1481–1489.

Martin K Gelbard - One of the best experts on this subject based on the ideXlab platform.

  • long term curvature deformity characterization in men previously treated with Collagenase Clostridium Histolyticum for peyronie s disease subgrouped by penile plaque calcification
    Urology, 2020
    Co-Authors: Irwin Goldstein, Michael Mclane, Qinfang Xiang, Henry R Wolfe, Martin K Gelbard
    Abstract:

    ABSTRACT OBJECTIVE : To examine the long-term (5-year) efficacy and safety of Collagenase Clostridium Histolyticum (CCH) therapy in men with Peyronie's disease (PD) and varying degrees of plaque calcification. METHODS : CCH-treated adult men from the 12-month IMPRESS I/II or 9-month open-label studies were eligible. Degree of plaque calcification (no calcification, noncontiguous stippled calcification, or calcification that did not interfere with CCH injection) were determined by penile x-ray or ultrasound. Penile curvature deformity and Peyronie's Disease Questionnaire (PDQ) responses were assessed annually for up to 5 years, with ≥6 months between consecutive visits. RESULTS : For no calcification group, from baseline to last (Reference) visit during the prior studies (n=160), mean penile curvature improved by 20.9±16.3 degrees (39.3%) with CCH. Similar improvements with CCH from baseline to Reference were observed in stippled calcification (n=27; improvement of 24.1±20.2 degrees [42.7%]) and calcification (n=27; improvement of 21.7±14.8 degrees [43.3%]) subgroups. At Year 5 follow-up in no calcification group (n=119), an additional 10.0% improvement in mean penile curvature versus Reference (4.3 degrees) occurred. Penile curvature improvements seen at Reference in stippled calcification and calcification groups were maintained through Year 5. Additional numeric improvements in 3 PDQ domains were observed at Year 5 visit versus baseline scores. No long-term safety issues were identified. CONCLUSIONS : This first report of long-term (5-year) CCH clinical trial outcomes in a population with penile plaque calcification demonstrates that nonsurgical intralesional CCH therapy is an appropriate PD treatment in men with penile plaque calcification that is stippled or does not impede CCH injection.

  • long term curvature deformity characterization in men previously treated with Collagenase Clostridium Histolyticum for peyronie s disease subgrouped by penile plaque calcification
    Urology, 2020
    Co-Authors: Irwin Goldstein, Michael Mclane, Qinfang Xiang, Henry R Wolfe, Martin K Gelbard
    Abstract:

    Abstract Objective To examine the long-term (5-year) efficacy and safety of Collagenase Clostridium Histolyticum (CCH) therapy in men with Peyronie's disease and varying degrees of plaque calcification. Materials and Methods CCH-treated adult men from the 12-month Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I/II or 9-month open-label studies were eligible. Degree of plaque calcification (no calcification, noncontiguous stippled calcification, or calcification that did not interfere with CCH injection) was determined by penile x-ray or ultrasound. Penile curvature deformity and Peyronie's Disease Questionnaire responses were assessed annually for up to 5 years, with ≥6 months between consecutive visits. Results For no calcification group, from baseline to last (Reference) visit during the prior studies (n = 160), mean penile curvature improved by 20.9° ± 16.3° (39.3%) with CCH. Similar improvements with CCH from baseline to Reference were observed in stippled calcification (n = 27; improvement of 24.1° ± 20.2° [42.7%]) and calcification (n = 27; improvement of 21.7° ± 14.8° [43.3%]) subgroups. At Year 5 follow-up in no calcification group (n = 119), an additional 10.0% improvement in mean penile curvature vs Reference (4.3°) occurred. Penile curvature improvements seen at Reference in stippled calcification and calcification groups were maintained through Year 5. Additional numeric improvements in 3 Peyronie's Disease Questionnaire domains were observed at Year 5 visit vs baseline scores. No long-term safety issues were identified. Conclusion This first report of long-term (5-year) CCH clinical trial outcomes in a population with penile plaque calcification demonstrates that nonsurgical intralesional CCH therapy is an appropriate Peyronie's disease treatment in men with penile plaque calcification that is stippled or does not impede CCH injection.

  • safety and efficacy of Collagenase Clostridium Histolyticum in the treatment of acute phase peyronie s disease a multi institutional analysis
    Urology, 2020
    Co-Authors: Hoang Minh Tue Nguyen, Landon Trost, Matthew Ziegelmann, Martin K Gelbard, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Ayad Yousif, Wayne J.g. Hellstrom
    Abstract:

    Objective To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of Collagenase Clostridium Histolyticum (CCH) in the treatment of acute phase PD. Methods Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. Results A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. Conclusion This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

  • sixty years in the making Collagenase Clostridium Histolyticum from benchtop to fda approval and beyond
    World Journal of Urology, 2020
    Co-Authors: Steven A Mills, Martin K Gelbard
    Abstract:

    The introduction of Collagenase Clostridium Histolyticum (CCH) as the first and only FDA-approved non-surgical treatment for Peyronie’s disease (PD) has been an important step in its management. Our aim is to provide an overview of the historical origins of CCH and its development through FDA approval and beyond for the treatment of PD. A PubMed search using the terms Peyronie OR Peyronie’s AND Collagenase and limited to clinical research studies resulted in 24 articles that were examined for the current review. PD is a connective tissue disorder of the penile tunica albuginea involving fibrotic penile plaques that cause abnormal curvature and, in many cases, erectile pain. Although the exact mechanism and underlying pathophysiology are not well characterized, the known lability of these plaques to exogenous bacterial Collagenase combined with a lack of effective medical therapies led to the development of CCH as an evidence-based treatment of PD. The initial discovery of Collagenase was followed by in vitro studies on PD plaque tissue and following the phase 3 IMPRESS trial culminated in FDA approval of CCH in 2013. Future directions in CCH therapy include improved patient selection, use in acute phase PD, adjuvant and combination therapies, and novel delivery mechanisms. CCH provides an effective non-surgical treatment option for men with PD. We have traced the development of CCH in the treatment of PD from the earliest in vitro investigations to comprehensive multi-study meta-analyses confirming its highly rated efficacy when compared to other historical non-surgical remedies.

  • Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase Clostridium Histolyticum for Peyronie’s Disease
    The Journal of urology, 2020
    Co-Authors: Irwin Goldstein, Larry I Lipshultz, Michael Mclane, Qinfang Xiang, Genzhou Liu, Saji Vijayan, Martin K Gelbard
    Abstract:

    Purpose:We assessed the long-term safety and immunogenicity profile of Collagenase Clostridium Histolyticum and characterized penile curvature deformity over time in patients previously treated for...

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  • safety and efficacy of Collagenase Clostridium Histolyticum in the treatment of acute phase peyronie s disease a multi institutional analysis
    Urology, 2020
    Co-Authors: Hoang Minh Tue Nguyen, Landon Trost, Matthew Ziegelmann, Martin K Gelbard, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Ayad Yousif, Wayne J.g. Hellstrom
    Abstract:

    Objective To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of Collagenase Clostridium Histolyticum (CCH) in the treatment of acute phase PD. Methods Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. Results A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. Conclusion This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

  • characteristics of men with peyronie s disease and Collagenase Clostridium Histolyticum treatment failure predictors of surgical intervention and outcomes
    The Journal of Sexual Medicine, 2020
    Co-Authors: Petar Bajic, Matthew Ziegelmann, Adam Wiggins, Laurence A Levine
    Abstract:

    Abstract Background A subset of patients with Peyronie's disease (PD) treated with Collagenase Clostridium Histolyticum (CCH) experience persistent bother and some require surgery. Aim We characterize patients experiencing persistent bother after CCH treatment and identify associations and predictors of surgical intervention/outcomes. Methods We retrospectively identified patients with PD from October 2014 to October 2019 and identified those presenting with persistent bother after CCH treatment by other urologists. Intracavernosal injection and penile Doppler ultrasonography were performed, and subsequent interventions/outcomes were recorded. Baseline characteristics were compared with Student t-test and chi-square test. Predictors of surgical intervention and complications were assessed using multivariable logistic regression. Outcomes The primary outcome was surgery after CCH treatment. Secondary outcomes included worsened erectile function, sensory deficits, and penile length change. Results Of 573, 67 (11.7%) patients with PD had undergone prior CCH treatment with median 6 injections (range 2–24). Mean post-CCH PD Questionnaire bother score was 10.1 (SD: 3.1), and total International Index of Erectile Function-5 was 15.3 (SD: 8.7). Mean PD duration was 27.8 (SD: 35.7) months, with a mean composite curvature (MCC) of 69.0° (SD: 33.8) measured after injection. Of 67, 44 (65.7%) patients had MCC >60°. Of 67, 52 (77.6%) patients had indent, narrowing, or hourglass and 26 (38.8%) had hinge effect (buckling of the erect penis with axial pressure) on examination. Calcification was identified in 26 of 67 (38.8%) patients, with grade 3 calcifications comprising 6 of 23 (26.1%) patients. Of 67, 33 (49.3%) patients underwent surgery, with 20 (60.1%) undergoing partial plaque excision and grafting with/without tunica albuginea plication, 6 (18.2%) undergoing tunica albuginea plication alone, and 7 (21.2%) undergoing penile prosthesis with plaque incision and grafting. Surgical patients had greater mean curvature (82.6 vs 55.4, P = .001) and were more likely to have hinge (54.5% vs 20.6%, P = .005). On multivariable analysis, MCC ≥60° predicted patient’s decision for surgery (odds ratio: 2.99, P  Clinical Implications Patients presenting with persistent bother after CCH treatment often have narrowing and calcifications (despite calcifications being a contraindication to CCH treatment), and those who have hinge or severe curvature are more likely to undergo surgery with low rates of complications. Strengths/Limitations This study's generalizability is limited by selection bias, but useful data are provided for patient counseling. Conclusion Patients with persistent bother after CCH treatment had high rates of indentation/narrowing, plaque calcifications, and MCC >60° at completion of CCH treatment. Surgical intervention is more common with hinge and is safe and feasible in these patients, with low rates of complications. These findings suggest possible negative prognostic factors for CCH treatment, which merit further investigation. Bajic P, Wiggins AB, Ziegelmann MJ, et al. Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes. J Sex Med 2020;17:1005–1011.

  • the influence of indentation deformity on outcomes with intralesional Collagenase Clostridium Histolyticum monotherapy for peyronie s disease
    Urology, 2020
    Co-Authors: Matthew Ziegelmann, Landon Trost, Daniel Heslop, M Houlihan, Petar Bajic, S Helo, Tobias S. Köhler
    Abstract:

    Abstract Objective To identify patient-specific factors associated with patient-reported improvements in functional outcomes after intralesional Collagenase Clostridium Histolyticum (CCH) for Peyronie's Disease (PD). Methods We retrospectively explored our prospectively maintained CCH registry. We sought to identify patient-specific factors that prevented the need for surgical straightening and/or improved ability to engage in penetrative intercourse. Results Eighty-six patients underwent CCH monotherapy and had objective follow-up data available. Mean PD symptom duration was 25 months (SD 44) and baseline curvature was 65o (SD 24). Prominent indentation/hourglass deformities (defined as girth discrepancy >10%) were present in 40 patients (47%). Mean objective curve improvement was 19o (SD 20), and 60% achieved improvement ≥15o. Greater baseline curvature was associated with greater absolute improvements in curvature, although there was no association between baseline curvature and relative (%) improvement. Three of 40 patients (8%) with indentation achieved girth improvement. Patients with baseline indentation/hourglass were less likely to report that CCH prevented the need for surgery (35% vs 64%, P = .018). Patients with curve improvement Conclusion Baseline indentation/hourglass deformity and curve improvement

  • intralesional Collagenase Clostridium Histolyticum causes meaningful improvement in men with peyronie s disease results of a multi institutional analysis
    The Journal of Urology, 2019
    Co-Authors: Wayne J.g. Hellstrom, Landon Trost, Matthew Ziegelmann, Laith Alzweri, Hoang Minh Tue Nguyen, Amanda S J Chung, Ramon Virasoro, Ashley Tapscott, Martin K Gelbard
    Abstract:

    Purpose:In a multi-institutional setting we studied the efficacy and safety outcomes at multiple high volume centers where Collagenase Clostridium Histolyticum is used to treat Peyronie's disease.M...

  • plaque calcification an important predictor of Collagenase Clostridium Histolyticum treatment outcomes for men with peyronie s disease
    Urology, 2018
    Co-Authors: Kevin Wymer, J. Savage, Matthew Ziegelmann, Tobias S. Köhler, Landon Trost
    Abstract:

    Abstract Objective To compare outcomes of men with or without calcified plaques undergoing Collagenase Clostridium Histolyticum (CCH) injections for Peyronie's disease (PD) and identify predictors of CCH success. Materials and Methods From March 2014 through January 2017, data were prospectively collected on 192 patients who underwent 1-4 cycles of CCH for the treatment of PD. Of these, 115 completed ≥2 CCH cycles and had data on curvature assessment. The primary outcome was the percentage of men with >20% improvement in composite curvature. Univariate analysis was performed to compare rate of success based on patient and disease characteristics, and multivariate logistic regression was used to identify predictors of successful treatment. Results Calcified plaques were identified in 34 of 115 (30%) patients. Patients with calcified plaque were younger, had longer duration of disease, and higher rates of significant erectile dysfunction. On multivariate logistic regression controlling for calcification and degrees composite curvature, noncalcified plaque (odds ratio 2.50; 95% confidence interval 1.06-6.00; P = .03) and curvature ≥60° (odds ratio 5.01; 95% confidence interval 1.34-21.62; P = .02) were found to be significant predictors of ≥20% improvement in composite curvature. When differentiated by calcification severity, those with no calcification achieved significant improvements in curvature (28.1° vs 10.3°, P = .04), compared to moderate (shadowing) or severe (>1 cm). Conclusion Plaque calcification is associated with a significantly lower rate of success of CCH therapy for PD, while greater baseline curvature is associated with increased odds of successful curvature improvement.