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INTRODUCTION: Collagenase clostridium histolyticum (CCH) therapy for Peyronie's disease (PD) yields satisfaction rates of roughly 50% to 67% within 1 year of treatment completion, but little is known about long-term patient satisfaction. Our study aimed to identify clinical predictors of long-term satisfaction with CCH for PD and the impact of its side effect profile. METHODS: The Treatment Satisfaction Questionnaire for Medication (TSQM) survey was distributed to patients who received CCH for PD at a high-volume men's health academic center from 2009 to 2022. Through retrospective chart review, demographic and clinical data of the disease were collected. RESULTS: Of 242 eligible patients, 80 (32.9%) responded, with questionnaires completed at a median of 5.1 (interquartile range 2.4-6.7) years after the last CCH injection. Thirty-four (42.5%) respondents reported satisfaction with CCH therapy. Older age was associated with significantly greater side effect domain scores (P < .004 for all). Curvature degree, plaque diameter, and plaque volume before CCH treatment, the mean reduction, and the mean percent reduction in these parameters were not significantly correlated with TSQM totals. Patients with greater final curvature and plaque volume measured after CCH completion had significantly lower TSQM totals (Spearman's ρ = -0.36, -0.32; P < .04 for both). Ten (12.5%) patients with depression and 10 (12.5%) patients who proceeded to surgery exhibited significantly decreased TSQM totals (P < .04 for both). CONCLUSIONS: While a significant proportion of our cohort reported long-term satisfaction with CCH therapy, patient satisfaction with CCH therapy is multifaceted. Our findings can be used to better counsel and manage patient expectations of treatment outcomes before initiating CCH.
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Background: In patients with a high recurrence risk after treatment for Dupuytren contracture (DC) by Collagenase Clostridium histolyticum (CCH), adjuvant medical therapy may improve the outcome. Non-steroidal anti-inflammatory drugs have been used in the treatment of similar fibroproliferative processes. The aim of this study was to investigate if adjuvant anti-inflammatory medication could improve the outcome of CCH treatment for DC. Methods: In a prospective double blinded randomised trial, the effect of adjuvant peroral celecoxib on the outcome of DC treated with CCH was investigated in 32 patients with a high fibrosis diathesis. Primary outcome was the increase in Total Passive Extension Deficit (TPED)/ray. Secondary outcomes were the TPED of the individual finger joints, Tubiana index, Disability of Arm, Shoulder and Hand score (DASH) and visual analogue scale (VAS) for pain and satisfaction. Results: A significantly greater improvement in the celecoxib group for TPED and metacarpophalangeal contracture was found. For the proximal interphalangeal joint, the effect was much less pronounced. The VAS for pain and satisfaction were better at 6 and 12 weeks in the celecoxib group. The other outcome parameters did not significantly differ between both groups. Conclusions: Adjuvant peroral administration of celecoxib might improve the gain in TPED after treatment with CCH in patients with DC and a high fibrosis diathesis, with a beneficial effect up to 24 months. Level of Evidence: Level II (Therapeutic).
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Celecoxib , Contractura de Dupuytren , Colagenasa Microbiana , Sulfonamidas , Humanos , Contractura de Dupuytren/tratamiento farmacológico , Celecoxib/uso terapéutico , Celecoxib/administración & dosificación , Método Doble Ciego , Masculino , Femenino , Persona de Mediana Edad , Colagenasa Microbiana/administración & dosificación , Colagenasa Microbiana/uso terapéutico , Anciano , Sulfonamidas/administración & dosificación , Sulfonamidas/uso terapéutico , Sulfonamidas/farmacología , Estudios Prospectivos , Pirazoles/uso terapéutico , Pirazoles/administración & dosificación , Pirazoles/efectos adversos , Resultado del Tratamiento , Inhibidores de la Ciclooxigenasa 2/uso terapéutico , Inhibidores de la Ciclooxigenasa 2/administración & dosificación , Dimensión del Dolor , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/uso terapéutico , Inyecciones Intralesiones , Quimioterapia Adyuvante/efectos adversosRESUMEN
INTRODUCTION: Peyronie's disease (PD) is a common penile disorder characterized by the formation of fibrous noncompliant hard nodules in the tunica albuginea of the penis. Collagenase Clostridium histolyticum (CCH) is an injectable drug that treats PD by enzymatically degrading plaque interstitial collagen. CCH has been used in patients with varying curvature, as well as in the acute and stable phases of the disease, through a variety of treatment regimens and combinations. We carried out a systematic review and meta-analysis to assess the efficacy of CCH combination therapies for PD. METHODS: We selected 4 observational comparative studies and 3 randomized controlled trials including 532 participants from the PubMed, Embase, and Cochrane databases (until December 2023) to evaluate the efficacy of CCH combination therapies for PD. The primary outcome was clinical efficacy as evaluated by improvement in penile curvature and penile length, as well as by scores on the Peyronie's Disease Questionnaire (PDQ) for symptom bother, penile pain, and psychological symptoms. Continuous data were represented by mean difference (MD) and 95% CI. All data were analyzed by Review Manager version 5.3. RESULTS: For penile length (MD, 0.81 cm; 95% CI, 0.17-1.45; P = .01), PDQ symptom bother (MD, -1.02; 95% CI, -1.83 to -0.21; P = .01), and PDQ penile pain (MD, -0.93; 95% CI, -1.50 to -0.36; P = .001), CCH combination therapy showed significantly greater improvements vs CCH monotherapy. However, in the other indicators, penile curvature and PDQ psychological symptoms, there was no significant difference between the therapies. CONCLUSION: This meta-analysis supports that CCH combination therapies can partially increase penile length and ameliorate symptom bother and penile pain to some extent. However, CCH combination therapies still need to be evaluated through more high-quality research.
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Colagenasa Microbiana , Induración Peniana , Induración Peniana/tratamiento farmacológico , Humanos , Masculino , Colagenasa Microbiana/uso terapéutico , Colagenasa Microbiana/administración & dosificación , Quimioterapia Combinada , Resultado del Tratamiento , Pene/efectos de los fármacosRESUMEN
INTRODUCTION: Collagenase Clostridium histolyticum (CCH) remains the only Food and Drug Administration-approved medical treatment for Peyronie's disease (PD). The initial IMPRESS I and II trials (Investigation for Maximal Peyronie's Reduction Efficacy and Safety), which led to Food and Drug Administration approval, revealed a rate of treatment-related adverse events as high as 84%. Studies fail to provide clear definitions of complications. OBJECTIVES: To review complications, provide a CCH complication atlas, and propose management strategies for commonly encountered complications. METHODS: We performed a literature review using PubMed. A photographic atlas was provided regarding complications in patients in a high-volume CCH center for PD. RESULTS: Complications were identified and classified by nature and severity. We followed a standardized previously published grading system for hematomas. Complications include bruising, swelling, hematoma formation, back pain, and, rarely, corporal rupture. Complications were discussed, and hematomas were graded by penile surface area. Complication photographs were graded and displayed. Treatment-related adverse effects do not affect overall results. CONCLUSION: Recognizing and grading complications associated with CCH therapy for PD is crucial for effective patient management and informed decision making. A standardized grading system allows for consistency in reporting and comparing hematoma complication rates across studies and patient populations. Herein we provide images that will help clinicians identify and confidently manage common complications that may occur in any CCH program.
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Colagenasa Microbiana , Induración Peniana , Humanos , Induración Peniana/tratamiento farmacológico , Masculino , Colagenasa Microbiana/uso terapéutico , Colagenasa Microbiana/efectos adversos , Pene/anatomía & histología , Inyecciones IntralesionesRESUMEN
Dupuytren's disease (DD) is a fibroproliferative disorder that manifests as an abnormal growth of myofibroblasts, causing nodule formation and contractures and affecting digit function. If left untreated, these contractures can lead to a loss of mobility and potentially impact hand function. This systematic review critically compares and evaluates the existing literature on the complications and patient satisfaction following injectable collagenase Clostridium histolyticum (CCH) versus limited fasciectomy (LF) for DD. We performed a comprehensive search of the PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), The Cochrane Library, and Excerpta Medica database (EMBASE) databases from 2006 to August 2023. This research targeted all clinical studies involving adults who underwent injectable collagenase and/or limited fasciectomy in the management of DD. Out of the 437 identified studies, only 53 were considered eligible for our analysis, and merely 14 met our inclusion criteria. These selected studies encompassed a total of 967 patients with 1,344 treated joints, with an average follow-up duration of 19.22 (ranging from one to 84.06) months. Within this cohort, 498 joints from 385 patients underwent LF, while 846 joints from 491 patients received CCH injections. Notably, among the 491 patients treated with CCH, 1,060 complications were reported, averaging 2.15 complications per patient, with the most common being contusion/bruising/hematoma/ecchymosis (22.54%), and edema/swelling (18.96%). In contrast, among the 385 patients treated with LF, only 97 complications were reported, translating to 0.25 complications per patient, with the most frequent being paraesthesia or numbness (23.7%), scar sequelae like skin laceration, tear, fissure, or hypertrophic scar (23.7%), and neuropraxia or nerve injury (22.6%). Our meta-analysis indicates that paraesthesia or numbness is more frequently observed in LF than CCH injections, although without statistical significance, with a risk ratio (RR) of 0.39 (95% confidence interval (CI) 0.13-1.18, p-value 0.1). However, scar sequelae (hypertrophic scar, skin laceration, tear, or fissure) show a contrasting pattern, being more commonly associated with CCH injections than LF, with an RR of 1.98 (95% CI 0.26-14.85, p-value 0.51), which, upon eliminating the source of heterogeneity, becomes statistically significant, with an RR of 4.98 (95% CI 1.40-17.72, p-value 0.01). Our data revealed a higher frequency of complications with CCH compared to LF, although more severe adverse effects were observed in the LF group, such as neuropraxia or nerve injury. Scar sequelae were more common with CCH injections. Despite both treatments showing increased patient satisfaction at the final follow-up, CCH injection resulted in earlier improvements in satisfaction.
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BACKGROUND: Testosterone plays an important role in collagen metabolism, transforming growth factor-ß1 expression, and wound healing, which are all critical factors in pathogenesis of Peyronie's disease. Some clinical studies have suggested an association between Peyronie's disease and hypogonadism. OBJECTIVE: We sought to investigate whether baseline total testosterone levels influence response to intralesional collagenase clostridium histolyticum in Peyronie's disease. METHODS: A retrospective review of patients receiving collagenase clostridium histolyticum injections with available total testosterone levels within 1 year of initial injection was conducted at a single institution. Baseline demographics, hypogonadal status, total testosterone, number of collagenase clostridium histolyticum cycles, and pre- and post-treatment degrees of curvature were collected. Hypogonadism was defined as total testosterone <300 ng/dL. RESULTS AND DISCUSSION: Thirty-six men were included with mean age of 58.2 years (SD 10.4) and mean body mass index 26.8 (SD 3.2). The mean total testosterone was 459.2 ng/dL (SD 144.0), and four (11.1%) were hypogonadal. Mean pre-treatment curvature was 47.6°, and mean post-treatment curvature was 27.8°, with mean improvement of 19.9° (40.1%). Hypogonadal status was not significantly associated with more severe curvature, 46.4° among hypogonadal men as to 57.5° among eugonadal men (p = 0.32). On linear regression analysis, total testosterone did not significantly predict improvement in degrees (ß = -0.02; R2 = 0.06; p = 0.14) or percent (ß = 0.0; R2 = 0.05; p = 0.18). Improvement in neither degrees nor percent differed significantly by hypogonadal status (p = 0.41 and 0.82, respectively). The cycle number did significantly predict greater improvement in curvature on both univariate and multivariate analyses (ß = 5.7; R2 = 0.34; p < 0.01). CONCLUSION: Neither total testosterone nor hypogonadism is associated with a degree of improvement after collagenase clostridium histolyticum treatment.
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Hipogonadismo , Induración Peniana , Masculino , Humanos , Persona de Mediana Edad , Colagenasa Microbiana/uso terapéutico , Induración Peniana/tratamiento farmacológico , Induración Peniana/patología , Testosterona/uso terapéutico , Resultado del Tratamiento , Inyecciones Intralesiones , Congéneres de la Testosterona , Hipogonadismo/tratamiento farmacológico , Hipogonadismo/patología , Pene/patologíaRESUMEN
BACKGROUND: 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. AIM: The study sought to evaluate outcomes of CCH treatment in men with ventral curvatures secondary to PD. METHODS: 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. OUTCOMES: Changes in penile curvature, Peyronie's Disease Questionnaire scores, International Index of Erectile Function scores, nonstandardized assessments, and adverse events. RESULTS: 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. CLINICAL IMPLICATIONS: Data support the use of CCH for the treatment of ventral as well as nonventral penile curvatures in men with PD. STRENGTHS AND LIMITATIONS: 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. CONCLUSION: CCH was safe and effective in the treatment of both ventral and nonventral penile curvatures in men with PD.
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Disfunción Eréctil , Induración Peniana , Humanos , Masculino , Clostridium histolyticum , Inyecciones Intralesiones , Colagenasa Microbiana , Pene , Resultado del TratamientoRESUMEN
Male urethral stricture disease is highly prevalent and difficult to treat due to potential complications. Minimally invasive treatments tend to have high recurrence rates, keeping urethroplasty as the gold standard. Collagenase Clostridium histolyticum (CCH) has been used in humans to treat fibrosis in a minimally invasive manner. Herein, we present the preliminary results from treatments of three males with urethral stricture as a feasibility and safety evaluation of the first-in-human CCH treatment for male urethral stricture disease.
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BACKGROUND: Dupuytren disease is a common fibroproliferative disease that affects the palmar fascia of the hands. Currently, there is limited consensus regarding the optimal therapy for this condition, with treatment decisions based largely on surgeon preference. Therefore, the aim of this study was to determine which treatments are the most effective for Dupuytren disease. METHOD: A systematic review and network meta-analyses were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Medline, EMBASE, and Web of Science were searched for randomized trials comparing treatments for Dupuytren disease in adults. Eligible treatments included open limited fasciectomy, collagenase injection, and percutaneous needle fasciotomy. Study selection, data extraction, and quality appraisal were performed in duplicate. The methodological quality was evaluated with the Cochrane risk-of-bias critical appraisal tool. RESULTS: Eleven randomized clinical trials were included in this study. At short-term (1-12 weeks) and long-term (2-5 years) time points, fasciectomy improved contracture release more than collagenase and needle fasciotomy as inferred by a lower total passive extension deficit. However, there was no difference between the groups regarding the best possible outcome at any time point. Fasciectomy was also superior in terms of recurrence and patient satisfaction compared with collagenase and needle fasciotomy, but only at later time points. There was no difference in skin damage-related and nerve damage-related complications following fasciectomy compared with other modalities. Risk of bias was generally moderate. CONCLUSIONS: Fasciectomy provides superior long-term advantages in terms of patient outcomes when compared with collagenase and needle fasciotomy. Larger trials with better blinding of outcome assessors are needed in the future.
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BACKGROUND: The purpose of this study was to determine the perioperative complication rate of surgical fasciectomy following previous treatment with collagenase clostridium histolyticum (CCH) treatment in patients with Dupuytren disease. METHODS: A retrospective review of all patients at a large health system undergoing CCH treatment and subsequent limited surgical fasciectomy for recurrence on the same digit between 2010 and 2020 was performed. Fifty-two patients with 62 affected digits met inclusion criteria, and cases were reviewed for preoperative demographics, treatment characteristics, clinical outcomes, and perioperative complications. RESULTS: Fifty-five digits in 48 patients were treated with CCH and underwent subsequent limited surgical fasciectomy. Of all digits in the present study, 3 (6.3%) had a documented surgical complication following open surgical fasciectomy. There were zero postoperative infections, vascular injuries, or tendon injuries. The rate of nerve injury was 2.1%. The rate of postoperative skin necrosis was 4.2%. These rates were comparable or lower than those of historical published data. CONCLUSIONS: The rate of perioperative complications in patients undergoing limited surgical fasciectomy after previous CCH treatment is low. The findings of this study will aid the counseling of Dupuytren patients in deciding whether to pursue treatment with CCH versus open surgical fasciectomy.
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BACKGROUND: Peyronie's disease (PD) is a fibrotic condition of the penis characterized by abnormal plaque formation. Intralesional collagenase Clostridium histolyticum (CCh) is effective in noncalcified PD; however, its effectiveness in calcified PD is not well characterized. OBJECTIVE: To assess curvature improvement in calcified PD plaques treated with CCh. DESIGN, SETTING, AND PARTICIPANTS: We prospectively evaluated men with calcified PD electing CCh treatment at our institution from October 2018 to November 2020. We assessed curvature with artificial erection and goniometer before and at least 3 mo after treatment. We classified the type of plaque calcification based on ultrasound. INTERVENTION: Intralesional CCh. Each treatment cycle consisted of two CCh injections (0.58 mg) into the plaque at the point of maximal penile curvature. The second injection was performed 72 h to 1 wk later, after which participants began modeling. All men were intended to receive a total of eight injections in four cycles, each 6 wk apart. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Change in penile curvature after CCh was measured. We assessed for differences in outcomes based on the number of injections and type of calcification. Unless otherwise specified, data are presented as medians (interquartile range). RESULTS AND LIMITATIONS: Sixty men with calcified PD elected CCh; 47 had complete follow-up data. Thirty-nine men completed treatments with eight injections, while the remaining discontinued after a median of five (four to six) injections. There was no difference in response between type 2 and type 3 plaques. Curvature significantly improved by 17.5° (37.5-10.0°) in patients who completed treatment and by 15.0° (20.0-0.0°) in those who discontinued. Limitations include a small sample. CONCLUSIONS: Men with calcified PD plaques improve with CCh treatment and show similar improvements regardless of calcification type. PATIENT SUMMARY: In this study, we evaluated the efficacy of collagenase Clostridium histolyticum (CCh) treatment in calcified Peyronie's disease (PD) plaques. We found that treatment in calcified plaques demonstrated significant improvement in curvature and the grading of calcification did not impact the degree of curvature improvement. We conclude that participants with calcified PD plaques can benefit from nonsurgical CCh treatment.
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Induración Peniana , Masculino , Humanos , Induración Peniana/diagnóstico por imagen , Induración Peniana/tratamiento farmacológico , Induración Peniana/cirugía , Colagenasa Microbiana/uso terapéutico , Resultado del Tratamiento , Inyecciones Intralesiones , Pene/diagnóstico por imagen , Pene/cirugíaRESUMEN
AIMS: Dupuytren's contracture (DC) is a chronic debilitating fibroproliferative disorder. Common treatment options include collagenase clostridium histolyticum injections (CI), percutaneous needle fasciotomy (NF) and limited fasciectomy (LF). Superiority of one specific treatment remains controversial. This study aims to assess the short-term efficacy and safety of CI, NF, and LF for the treatment of DC. METHODS: We included randomized controlled trials of CI compared with placebo, NF and LF for patients with DC. PubMed, Embase and the Cochrane Library were searched from inception to August 2021. Contracture reduction rates in treated joints (within 0-5° of full extension within 30 days), relative reduction in total passive extension deficit (TPED), occurrence of one or more adverse events and number of treatment-related adverse events per patient were the outcomes of interest. The Cochrane risk-of-bias tool was employed for quality assessment of the studies. A network meta-analysis was performed using MetaXL. RESULTS: Nine studies met our inclusion criteria (n = 903). Overall, risk bias was mixed and mostly low. Short term TPED reduction achieved with LF was superior compared to CI and NF. Although CI achieved greater TPED reduction compared to NF, it was associated with the highest risk of overall adverse effects. The analyzed data was limited to a maximum three-year follow-up period and therefore insufficient for long-term outcome evaluation. CONCLUSIONS: In DC, LF may be able to provide patients with severe disease, superior flexion contracture release postoperatively. CI is a valid treatment alternative to NF, however the higher risk of overall adverse effects must be considered. The quality-of-evidence is limited due to short-term follow-up periods and a lack of standardized definitions of complications and adverse events.
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Contractura de Dupuytren , Luxaciones Articulares , Humanos , Colagenasa Microbiana/efectos adversos , Contractura de Dupuytren/tratamiento farmacológico , Contractura de Dupuytren/cirugía , Fasciotomía/efectos adversos , Metaanálisis en Red , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Inyecciones Intralesiones , Luxaciones Articulares/etiología , Clostridium histolyticumRESUMEN
Background: Peyronie's disease (PD) is a progressive fibrotic disorder of the penis that is adverse to men's health. Currently, effective and reliable non-surgical options for PD are limited. Since the Food and Drug Administration (FDA) approved it in 2013, intralesional injection of collagenase Clostridium histolyticum (CCH) became the only licensed treatment for PD. This meta-analysis aims to evaluate the clinical efficacy and safety of CCH in treating PD, predominantly based on post-FDA studies. Methods: The primary outcome was clinical efficacy evaluated by the percentages of improvement in penile curvature (PC) and Peyronie's disease symptom bother score (PD bother score). The secondary outcome was the safety assessed by treatment-related adverse events (TRAEs). Heterogeneity was assessed by Cochran's Q and I 2 tests. Sensitivity and subgroup analyses were performed to explore the source of heterogeneity. Funnel plots and Egger's test were used to evaluate the publication bias. Results: A total of 11 studies with 1,480 intentions to treat (ITT) population were included. The pooled effect of the improvement of PC was 35% (95% CI: 0.33-0.38), and the pooled improvement of the PD bother score was 41% (95% CI: 0.37-0.45). No heterogeneity was found at the pooled improvement of PC (p = 0.845, I 2 = 0.00%). Meanwhile, some heterogeneity existed in the pooled improvement of the PD bother score (p = 0.069, I 2 = 43.4%). The pooled effect of TRAEs was 93% (95% CI 0.88-0.97) with significant heterogeneity (p < 0.000, I 2 = 92.3%). Conclusion: The intralesional injection of CCH could significantly improve the penile deformity of PD patients. Meanwhile, CCH appears to ameliorate the PD bother score to some extent and has acceptable clinical safety. Future studies are required to clarify the long-term outcomes of CCH injection in the treatment of PD.
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Background: Peyronie's disease (PD) can be subdivided into acute and chronic phases. Intralesional collagenase Clostridium histolyticum has been shown to improve curvature in the chronic phase. Initial clinical trials excluded patients in the acute phase from treatment. Recent studies show comparable results among men in the acute phase. The definition of acute phase varies among existing studies, but it is generally understood to last 12-18 months and is accompanied by penile pain and progression of deformity. We sought to evaluate the safety and efficacy of intralesional collagenase injection therapy during the acute phase of PD using multiple definitions of the acute phase. Methods: All men receiving intralesional collagenase for PD from October 2015 through December 2020 at a single academic institution were retrospectively assessed for patient demographics and comorbidities, pre- and post-treatment curvature, and adverse events. Two definitions of acute phase were used: (I) acute phase duration ≤6 months, chronic phase duration >6 months; and (II) acute phase duration ≤12 months with penile pain, chronic phase duration >12 or no penile pain. Results: Of 330 patients identified, 229 underwent intralesional collagenase treatment with pre- and post-treatment erect penile goniometry. 65 (28%) met criteria for definition 1 of acute phase, 37 (16%) met criteria for definition 2, and 76 (33%) met criteria for either. Percent change in penile curvature was not significantly different between acute and chronic phases using definition 1 (16.0% vs. 16.6%, P=0.89), definition 2 (19.9% vs. 15.7%, P=0.43), or either (16.5% vs. 16.3%, P=0.96). The rates of development of bruising, swelling, hematoma, or corporal rupture were not significantly different between the acute and chronic phases under either definition (all P>0.05). Conclusions: This single-center, retrospective cohort analysis suggests that intralesional collagenase is both safe and effective for the treatment of men with acute phase PD. Limitations exist inherent to retrospective review, since many men did not return for post-treatment goniometry, possibly skewing our cohort toward incomplete responders. Prospective, randomized studies will be required to confirm these findings.
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INTRODUCTION: Penile curvature is the most common abnormality that is observed by men with Peyronie's disease (PD). Collagenase Clostridium histolyticum (CCH) has become a standard treatment for PD patients. AIM: To identify predictor factors associated with improvements of penile curvature outcomes in men with PD treated with CCH. METHODS: We retrospectively collected the data of patients with PD treated with CCH up to 8 injections divided into 4 cycles between January 2014 and July 2020. Per protocol, penile curvature was assessed at baseline, and after the second and ford CCH cycle. If after cycle 2, curvature demonstrated no improvement, or penile curvature was significantly improved and the patient was happy, no further treatment was recommended. However, if penile curvature was significantly improved and the patient remained dissatisfied, 4 cycles were completed. Three categories of response were evaluated: improvement (≥10 degrees or ≥20%, either 1 happens), unchanged (±10 degrees or ±20%) or worsened (≥10 degrees or ≥20%, either 1 happens). Logistic regression analyses were performed to evaluate predictive factors associated with penile curvature improvements. OUTCOMES: Degrees of the curvature changes between the baseline and after the cycles of CCH. RESULTS: A total of 114 patients underwent CCH treatment. Median age was 57 years. Median PD duration was 11 months. At baseline, mean curvature was 47 degrees, 65% had dorsal curvature, 53% mid-shaft location, and 15% calcification. After CCH treatment, the mean final curvature was 40 degrees. A total of 44% improved the curvature, 39% had no change while 17% worsened after CCH treatment. Of men who had penile curvature improvement with CCH treatment, the mean curvature decreasing in degrees and percentage were 22 degrees and 41%, respectively. Men with baseline curvature ≤ 30, 31-59, and ≥ 60 degrees, the percentage curvature improvement were 29%, 43%, and 60%, respectively. Baseline curvature was the only significant predictor of penile curvature improvement after CCH (OR 1.33, 95% CI = 1.1, 1.7). CLINICAL IMPLICATIONS: We confirmed baseline penile curvature is the most important predictive factor, and this is the first report describing proportions of penile curvature improvement with CCH treatment. STRENGTHS AND LIMITATIONS: This study has several strengths, including the use of validated instruments. Nonetheless, there are limitations: the retrospective nature of the study, a single institution; and modelling device was not controlled. CONCLUSION: Penile curvature improvement was significantly more common in patients with greater baseline curvature, reaching up to 60% for patients with ≥ 60 degrees. Flores JM, Nascimento B, Punjani N, et al. Predictors of Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum. J Sex Med 2022;19:1680-1686.
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Colagenasa Microbiana , Induración Peniana , Masculino , Humanos , Persona de Mediana Edad , Induración Peniana/tratamiento farmacológico , Estudios Retrospectivos , Inyecciones Intralesiones , Resultado del Tratamiento , Pene , Clostridium histolyticumRESUMEN
INTRODUCTION: Across many cultures, penis size has been associated with virility, and concerns about penile length are commonplace. Peyronie's disease (PD) is a known acquired cause of penile shortening. OBJECTIVES: This paper describes the psychosocial impacts of penile length on men and their partners, both generally and in men with PD, and evaluates the effect of PD treatments (eg, collagenase clostridium histolyticum , surgery, mechanical therapy) on this outcome measure. METHODS: A PubMed database search was performed for English language articles through July 2021. Main outcome measures were association of penile length with emotional well-being, selfesteem, and relationship satisfaction in men with PD, and change from baseline penile length after treatment. RESULTS: Shortened penile length caused by PD can negatively impact patient and partner quality of life, including effects on body image, emotional well-being, sexual function, and interpersonal relationships. In men with PD, studies have demonstrated an association between loss of penile length and emotional problems, reduced satisfaction with sexual performance, poor self-esteem, depression, and relationship difficulties. Loss of penile length can frequently occur after surgery for PD (including plication, plaque incision/excision with grafting, and penile implant). Advanced surgical techniques may preserve/increase penile length, but the increased risks associated with these complex procedures must be carefully considered. Treatment with collagenase clostridium histolyticum does not appear to negatively impact penile length, and 5-year follow-up data suggest potential longterm posttreatment improvements in this outcome measure. Penile traction therapy, either alone or as adjunctive therapy, may increase penile length in men with PD, but nonadherence may limit improvement. CONCLUSION: Changes in penile length are important to many men, particularly those with PD, and should be considered during PD treatment selection. Penile length should be measured objectively before and after treatment for PD and should be included as an outcome measure in future studies on treatment effectiveness. Goldstein I, Gelbard MK, Lipshultz LI. Clinical Significance of Shortened Penile Length and Alterations in Penile Length Following Treatment for Peyronie's Disease. Sex Med Rev 2022;10:409-420.
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Induración Peniana , Prótesis de Pene , Humanos , Masculino , Colagenasa Microbiana/uso terapéutico , Induración Peniana/tratamiento farmacológico , Induración Peniana/cirugía , Pene/cirugía , Calidad de VidaRESUMEN
Background: The primary objective of this study was to assess patient preferences for collagenase Clostridium histolyticum (CCH) treatment versus limited surgical fasciectomy in a cohort that has undergone both treatments for Dupuytren contracture. Methods: We retrospectively identified 68 patients who have undergone both limited surgical fasciectomy and CCH treatment for digital flexion contractures from Dupuytren disease. Patients were contacted by telephone and asked whether they preferred surgery or CCH treatment for their Dupuytren contracture. Multivariable logistic regression was used to determine factors associated with preference for surgery versus CCH treatment. Results: Of the 68 patients who were treated with both CCH and surgery, 37 patients (54.4%) preferred CCH treatment over surgery, 26 (38.2%) preferred surgery over CCH treatment, and 5 (7.4%) were unable to decide. Patients expressed common themes of the perceived ease of recovery following CCH treatment versus the perceived durability of contracture correction with surgery. Preference for surgical fasciectomy over CCH treatment was associated with lower American Society of Anesthesiologists Physical Status Classification (ASA) [odds ratio (OR): 0.32, 95% confidence interval (CI): 0.14-0.75]. The order of treatment was also associated with the treatment preference; treatment with surgery after CCH compared to treatment with CCH after surgery was associated with a preference for surgery (OR: 6.51, 95% CI: 2.15-19.7). Conclusions: In a cohort of patients who have undergone both treatments, patients were divided in their preferences, with a slight majority preferring CCH treatment over surgery. Treatment recommendations should be individualised to each patient's long-term goals and expectations. Level of Evidence: Level III (Therapeutic).
Asunto(s)
Contractura de Dupuytren , Colagenasas/uso terapéutico , Contractura de Dupuytren/tratamiento farmacológico , Contractura de Dupuytren/cirugía , Fasciotomía , Humanos , Colagenasa Microbiana/uso terapéutico , Prioridad del Paciente , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Peyronie's disease (PD) is a chronic wound healing disorder, mainly involving tunica albuginea. Collagenase Clostridium Histolyticum (CCH) has shown its effectiveness in treating PD, but its efficacy and safety remain controversial, which propelled us to conduct the first evidence-based research on this topic. METHODS: We searched the Web of Science, PubMed, Embase, and ClinicalTrials.gov for related randomized controlled trials (RCTs). A systematic review and meta-analysis were performed to compare the penile curvature deformity (PCD), Peyronie's Disease Questionnaire peyronie's disease symptom bother (PDSB), penile pain score, total treatment-related adverse events (TAEs), and specific adverse events, including penile pain, penile edema, injection site pain, and contusion. Cochrane Collaboration's tool and Review Manager 5.3.0 version were applied, respectively, to evaluate the study quality and heterogeneity. RESULTS: Four articles (five RCTs) with 1,227 patients were finally included in the meta-analysis. The results revealed that CCH had excellent efficacy in relieving PCD (weighted mean difference [WMD]: -318.77, p < 0.001) and PDSB (WMD: -1.20, p < 0.001) compared to the placebo group, but there was no difference in the penile pain score (WMD: -0.64, P = 0.39) between the two groups. Furthermore, the incidence of TAEs in the CCH group was higher [odds ratio (OR): 12.86, p < 0.001]. CONCLUSIONS: The current evidence suggests that CCH has a significant effect on treating PD. Considering that all these adverse events are acceptable and curable, CCH could slow the disease progression in the acute phase or act as a substitute for patients unable or unwilling to undergo surgery. However, the conclusion could not be certainly drawn until RCTs with a larger scale proved it.
RESUMEN
Dupuytren's disease is a fibroproliferative condition that causes shortening, thickening, and fibrosis of the palmar fascia and a flexion deformity of metacarpophalangeal and proximal interphalangeal joints. Although the etiology is unknown, a variety of risk factors, such as age greater than 50 years, male sex, family history, or tobacco and alcohol use may lead to disease development. At the present time there is no cure and symptoms may recur; however, surgical procedures (eg, limited fasciectomy) and nonsurgical treatment (eg, needle aponeurotomy, injection of collagenase clostridium histolyticum) can help patients manage the disease's symptoms. Patients may experience wound-healing complications after fasciectomy and skin fissures after needle aponeurotomy. Recurrence rates for needle aponeurotomy and collagenase clostridium histolyticum injection are similar. Perioperative nurses should provide individualized patient care during procedures, participate in effective team communication regarding patient needs, and provide patient education throughout the perioperative continuum.