Collagenase Clostridium Histolyticum Injection Research Articles

115 Collagenase Clostridium Histolyticum: Do Intra-Lesional Injections Increase the Risk of Late-Onset Penile Fracture?

This study serves to relay our initial clinical experience of men treated with collagenase clostridium histolyticum (CCH) injections for Peyronie’s Disease (PD). Specifically, in an effort to generate discussion regarding the standardized CCH protocol, we present four patients who were found to have intercourse-related corporal rupture at >14 days post-injection. Retrospective review of our electronic medical record from February 2014 to July 2016 was conducted to identify any patient treated with CCH who later presented with a suspected penile fracture. Full demographics were collected if the patient was found to have a true penile fracture and the injury occurred outside of the recommended post-injection 14-day observatory period. Over the study’s 17 month timeframe, a total of 67 gentlemen received intra-lesional CCH injections in the treatment of PD. Four of these patients (6.0%) were diagnosed with fractures of the tunica albuginea as a result of sexual activity after the recommended observatory period. Two men suffered injuries 15 days after their most recent injection, one patient was 17 days post-injection, and the remaining patient was 19 days post-injection. All of these men were explored surgically and tunical injuries were repaired. Intra-operatively, we encountered advanced degradation of the tunica in the area surrounding each rupture, consistent with sustained CCH effect on the tissues. None of these patients were found to have urethral involvement of their injury.

110 Correlation of Clinical Meaningfulness and Curvature Improvement in Men Undergoing Collagenase Clostridium Histolyticum Injections for Peyronie's Disease

110 Correlation of Clinical Meaningfulness and Curvature Improvement in Men Undergoing Collagenase Clostridium Histolyticum Injections for Peyronie's Disease

Treatment of Dupuytren's disease with collagenase Clostridium histolyticum

Dupuytren's disease as abenign fibroproliferative disease leads to hyperplasia of the collagen fibers of the fascia of the palm, which can result in severe impairment of the functionality of the hand. Examination of the significance of non-operative treatment of Dupuytren's disease with injectable collagenase clostridium histolyticum (CCH) METHODS: Observation of 120 patients treated with injectable collagenase. Documentation of the range of motion before the intervention, 12months after the intervention, and documentation of any adverse events. All in all, 120 patients were treated (107 male, 13female) (mean age 62years, range 30-84 years). In 49% the little finger, in 44% the ring finger, in 4% the middle finger, and in 3% the index finger were treated. Full release was accomplished in 71%, partial release in 26%, and no change in 3% of the patients. The median contracture before the treatment was 37° for the metacarpophalangeal (MP) joint (range 25-100°) and 51° for the proximal interphalangeal (PIP) joint (range 30-97°). After 12months, the mean contracture for the MP joint was 9° (range 0-25°) and 21° (range 10-36°) or the PIP joint. Adverse events occurred in 96% of patients within 3months after treatment. No tendon ruptures, anaphylactic reactions, nerve, or ligament injuries were observed.

Re: Results of SMSNA survey regarding complications following intralesional injection therapy with collagenase clostridium histolyticum for Peyronie's disease.

In this survey sent to the members of the Sexual Medicine Society of North American (SMSNA), Yafi et al . assessed the providers’ experience with intralesional injection of collagenase clostridium histolyticum (CCh) for Peyronie’s disease (PD). The anonymous, 33-question survey was sent to 693 members of SMSNA with valid email addresses and requested responses from CCh prescribers. The 100 responders (14.4% response rate), were relatively evenly distributed in their experience administering CCh injections with 36%, 23% and 41% of responders performing injections on ≤10 patients, 10–20 patients, and >20 patients respectively.

Expanding the role of injectable collagenase clostridium histolyticum for the treatment of active phase Peyronie's disease.

Collagenase clostridium histolyticum (CCH) (Xiaflex TM ) has recently become the mainstay and gold standard of minimally invasive management of Peyronie’s disease. Approved by the FDA in 2013 after phase III studies demonstrated efficacy and safety, collagenase is a popular and promising, albeit expensive treatment option. With the exception of phase II and phase III study data, there is a dearth of published outcomes and safety data. At present, Yang and Bennett’s single-provider, prospectively collected series of 49 patients undergoing Xiaflex injections, is only the second published series cataloging efficacy and safety (1).

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

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

The efficiency and safety of collagenase Clostridium histolyticum injections for Dupuytren’s contracture

The efficiency and safety of collagenase Clostridium histolyticum injections for Dupuytren’s contracture

Superior Cost Effectiveness of Penile Plication vs Intralesional Collagenase Injection for Treatment of Peyronie’s Disease Deformities

IntroductionIn 2013 injection of collagenase clostridium histolyticum became the first nonsurgical FDA (Food and Drug Administration) approved treatment for Peyronie’s disease. We evaluated the cost effectiveness of collagenase injection compared to penile plication. MethodsA decision tree model using TreeAge Pro Healthcare (TreeAge Software, Inc., Williamstown, Massachusetts) was developed for cost analysis comparing collagenase clostridium histolyticum and penile plication. Treatment success was defined as penile curvature of 30 degrees or less. Data from IMPRESS (Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) I and II were used to calculate the probability of success, and stratified by severity of disease (moderate defined as 30 to 60 degrees and severe as 61 to 90 degrees). We assumed that 50% of injection failures proceeded to secondary plication. Material costs of medications, office visits, and facility and surgical fees, and predicted costs of complications were obtained from our billing department using real-world patient data. For penile plication 90% success was assumed based on published series. All failed plications were assumed to undergo repeat plication. ResultsThe calculated probability of treatment success after injection was 49.5% for moderate curvature (30 to 60 degrees) and 12% for severe curvature (61 to 90 degrees). Per patient plication cost was $3,039, while injection pathway was $25,856 for moderate disease and $26,375 for severe disease. One-way sensitivity analyses revealed cost equivalence at $2,558 for injection. No increase in efficacy of collagenase injection accomplished cost equivalence at current pricing. ConclusionsCollagenase clostridium histolyticum treatment was at least 8 times more expensive than penile plication. Achieving cost equivalence would require a significant decrease in drug cost. Collagenase clostridium histolyticum appears to be most appropriate for men with moderate, as opposed to severe, penile deformities.

Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.

Level 3.

To remember: Radiotherapy - a successful treatment for early Dupuytren's disease.

Dupuytren's disease (DD) is a common fibroproliferative condition of the hand which tends to cause progressive digital flexion contracture. Therapeutic strategies to treat the disease include radiotherapy, injections of collagenase clostridium histolyticum, needle fasciotomy and extended surgical intervention dependent on involvement and duration of the disease. We have reviewed the literature with the aim to assess the conditions and effects of radiotherapy in DD. In early stages of the disease, radiotherapy resulted in regression of symptoms/a lack of progression found on average in 40% (range 10-85%)/81% (range 50-100%) of the patients with recurrence rates of only 12-31% after long-term follow-up (>4 years). These results proved to be significantly better than in the untreated patients with natural course of the disease (about 50% progression after a follow-up of 5-6 years). Long-term side-effects (skin dryness) are observed on average in one quarter of the patients, but are well tolerated. Local occurrence of malignancies has not been reported yet. Due to severe functional impairment leading to individual suffering and the high economic burden, treatment of DD in early stages is necessary and radiation therapy represents an effective, safe and economic treatment option.

Trends in the Treatment of Dupuytren Disease in the United States Between 2007 and 2014.

Background: Dupuytren disease is a common fibroproliferative disorder. Multiple procedural treatment options are available, with Collagenase Clostridium Histolyticum (CCH) injection being introduced in 2010. The purpose of this study was to investigate trends in the treatment of Dupuytren disease in the United States between 2007 and 2014. Methods: The PearlDiver Humana database was queried using International Classification of Diseases, Ninth Revision (ICD-9) and Current Procedural Terminology (CPT) codes for patients with Dupuytren disease that received percutaneous needle aponeurotomy (PNA), fasciotomy, fasciectomy, and CCH injection. Patients were filtered by age, number of comorbidities, and gender. Change in composition of treatments over time was analyzed for each demographic group between 2007 and 2014. Results: Patients presenting to clinic for Dupuytren disease increased from 1118 to 3280, with unchanging treatment percentage of 41. Percent fasciotomies and fasciectomies decreased from 5% to 3% and 33% to 21%, while CCH injection increased to 11% by 2012 to 2014. Percent fasciotomies decreased (P < .05) in younger healthier (age <65, 0-1 comorbidities) and older less healthy (age 65-74, 4+ comorbidities) populations. Percent fasciectomies decreased significantly in nearly all age and comorbidity groups, but by greater amounts in patients with 2+ comorbidities with increasing age. Percent CCH injections increased in all groups, at rates similar to the losses seen in open procedures. Conclusions: CCH injections have risen to substantial levels, with corresponding decreases in the percentage of patients receiving fasciotomies and fasciectomies. Patient age, comorbidities, and gender appear to have influence on the treatment chosen, likely due to their effects on surgical risk and the importance of timely return to activity.

Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms

To report on an early adopter series of collagenase Clostridium histolyticum (CCh) for Peyronie's disease (PD). Postapproval studies of CCh have been anticipated after recent Food and Drug Administration authorization of its use for men with PD as definitive and durable nonsurgical interventions have been long desired. From May 2014 to October 2015, a database consisting of PD patients with >30° of penile curvature received CCh from a single provider at a single institution. Objective penile curvature measurements and deformity directions were assessed pre- and posttreatment. Using the validated Peyronie's Disease Questionnaire (PDQ), changes in subjective symptoms of intercourse ability, penile pain, and bother were also noted. We followed 49 unique PD patients treated with CCh. Mean follow-up was 183 days with a median of 6 injections over 3 cycles performed per patient. The mean pretreatment penile curvature was 49.3 degrees. Curvature was reduced by 15.4 degrees (32.4%, P < .01) after therapy. There were 10 out of 22 patients who regained ability to perform vaginal intercourse. Subjectively, there was an improvement in the ability to perform intercourse (29.1% improvement, P < .01) and bother symptoms (mean decrease 43.2%, P < .01), but no significant changes in penile pain (P = .89). Five notable bleeding events (10.2%) were noted, including 1 penile fracture requiring operative exploration. CCh use for PD yielded improvements in penile curvature, subjective intercourse, and bother symptoms. Further postanalysis studies of greater follow-up are needed to assess long-term durability, efficacy, and safety.

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis.

Conservative and even surgical management of adhesive capsulitis often is prolonged and painful. Management of adhesive capsulitis is lacking evidence-based controlled clinical trials. We asked: (1) Does a collagenase clostridium histolyticum (CCH) injection lyse shoulder capsule collagen in adhesive capsulitis and at what dose? (2) Can a shoulder capsule injection be administered extraarticularly? (3) Do CCH injections result in better scores for pain and function than can be achieved with physical therapy among patients with adhesive capsulitis? First, 60 patients with adhesive capsulitis were evaluated by clinical examination. To make the diagnosis of adhesive capsulitis, a patient had to have restricted active ROM of at least 60° in total active ROM in the affected shoulder compared with the unaffected contralateral shoulder; with the scapula stabilized, external rotation with the elbow at the side was a very important determinant. Patients were randomized to receive a single injection of 0.5 mL placebo or 0.145, 0.29, or 0.58 mg CCH. All 60 patients were followed up at 30 days. After that, if patients did not attain treatment thresholds they were eligible for up to five open-label 0.58-mg collagenase injections. For the longer-term followup in the open-label phase, 53 patients (83%) were followed to 12 months, 46 (77%) for 24 months, 36 (60%) for 36 months, 37 (62%) for 48 months, and 25 (42%) for 60 months. The extraarticular injection was directed at the anterior shoulder capsule with the patient in the supine position. To prove that these injections could be delivered reliably to the anterior shoulder capsule extraarticularly, the next study involved volunteers without adhesive capsulitis, in which 10 volunteers received a 10-mL injection of normal saline under ultrasound guidance. Finally, to determine the efficacy and dosing of CCH, four cohorts of 10 patients received up to three ultrasound-guided injections separated by 21 days. These injections were administered at one of four dose-volume levels. A fifth cohort of 10 patients was used as a control group and performed standardized home shoulder exercises only. All patients performed standardized home shoulder exercises three times daily. For Study 3, followup was at 22, 43, 64, and 92 days. No patients were lost to followup. In the first study, a single CCH injection did not provide clinically important improvements from baseline in active ROM, passive ROM, and function and pain scores compared with patients who received placebo. Ultrasound guidance confirmed extraarticular injection of the shoulder capsule in Study 2. The CCH injection was more effective than exercise therapy alone at 0.58 mg/1 mL and 0.58 mg/2 mL compared with exercise only in the primary measure of efficacy (active forward flexion) as shown in Study 3. For active forward flexion the mean in degrees in the 0.58 mg/2 mL group was 38° compared with 12° in the exercise-only group (p=0.03). For active forward flexion the mean in the 0.58 mg/1mL group was 43° compared with 12° in the exercise-only group (p=0.01). Extraarticular injections of CCH for treatment of adhesive capsulitis were well tolerated and seem effective compared with exercise therapy. Future FDA-regulated clinical trials must verify CCH injection therapy for adhesive capsulitis. Level II, therapeutic study.

Patient Satisfaction With Collagenase

To establish patient satisfaction after collagenase clostridium histolyticum (CCH) injection. In a cross-sectional study, 213 patients who had been treated for Dupuytren disease with CCH were reviewed between 37 and 1421 days after injection. A total of 73% of the patients were very satisfied or satisfied, and 21% were dissatisfied; 75% would probably or definitely have CCH again, whereas 17% probably or definitely would not. We found that satisfaction and willingness to undergo a second treatment decreased over time and had a negative relationship with recurrence. Dissatisfaction was greater in those with a poor initial outcome but not in those with an initial complication. Of 212 patients, 78 had previously experienced surgery for Dupuytren disease of whom 71% would prefer CCH to surgery and 15% the converse. Satisfaction shows a relationship with function as measured by both QuickDASH and the Southampton Dupuytren Scoring Scheme. Patient satisfaction with CCH is generally high but deteriorates over time as the disease recurs. To manage patient expectation, this issue should be made explicit to patients in the consent process. Overall satisfaction with CCH is high, with initial satisfaction rates especially good. Forewarning of complications and recurrence can help maintain satisfaction levels.

Results of SMSNA Survey Regarding Complications Following Intralesional Injection Therapy With Collagenase Clostridium Histolyticum for Peyronie's Disease.

Intralesional injection of collagenase clostridium histolyticum (CCH) for Peyronie's disease (PD) can result in serious adverse events such as hematoma formation and corporal rupture. To investigate the prevalence of complications from CCH and management trends among CCH prescribers. A survey was sent to all 693 members of the Sexual Medicine Society of North America (SMSNA) with valid email addresses. Responders were asked to participate if they were prescribers of CCH. Data regarding prescriber experience with CCH, procedural preferences, and rates and management strategies of complications were collected. One hundred SMSNA members completed the survey, with 36%, 23%, and 41% of responders having performed ≤10, 10 to 20, and >20 CCH injections, respectively. Of the responders, 94% reported hematomas in <25% of patients, with 63% preferring to observe and 37% treated with a combination of observation, application of a compressive dressing, and/or drainage of the hematoma. Corporal ruptures were encountered by 34% of physicians at a median of 5 days (0.5 to 30 days) from the last CCH injection. Rupture was located over the treated plaque in 84% of cases, and surgical intervention was the preferred management option by 67% of members. A distal circumcising degloving incision was used in 76% of cases, and 62% of responders reported the quality of tissue to be worse than would be expected with a non-CCH penile fracture. There were no significant differences in erectile function, ability to have intercourse, change in penile curvature, and patient satisfaction among patients who underwent surveillance vs surgery. One observed patient developed a penile abscess. A wide variation exists among SMSNA members' strategies to prevent and manage complications of CCH. One in 3 prescribers reported encountering a corporal rupture during CCH therapy, and it is currently undetermined if there is a benefit of surgery vs conservative management.

AB041. Experience in the use of collagenase clostridium histolyticum in the management of Peyronie’s disease

BackgroundPeyronie’s disease (PD) is a chronic disorder characterized by formation of fibrous inelastic scarring of tunica albuginea of the penis resulting in variety of penile deformities. In most cases, PD is accompanied by physical and psychological impact. Xiaflex® is an injectable collagenase clostridium Histolyticum (CCh) preparation consisting of mixture of two distinct collagenases class I (AUX-I) and class II (AUX-II) clostridial collagenases. Recently the US Food and Drug Administration (FDA) approved Xiaflex® for the non-surgical treatment of men with PD with curvature of 30° or more and tangible scar tissue plaque in their penis.MethodsWe enrolled a total of 6 patients with diagnosis of PD in the trial to study the efficacy and safety of CCh. All patients have stable dorsal plaque with penile curvature of more than 30° at time of enrollment (degree of curvature was measured and documented by pictures were taken to the patients). Informed consent was taken from each patient explaining the potential risk of developing ecchymosis, penile hematoma at site of injection, minor risk of penile fracture was explained as well.ResultsThree patients have more than 30% improvement in curvature, 2 patients have less than 30% improvement and one patient show no improvement. All patients had minor bruises at the base of the penis and site of injection after each injectionConclusionsCollagenase clostridium histolyticum is an effective treatment for dorsal and lateral penile Peyronie’s plaque. The minimal trial for ventral plaque and there is no recommendation for hour glass deformity also the price of such treatment make selection of patient is very important.

PD45-01 RESTORATION OF PENILE FUNCTION AND PATIENT SATISFACTION WITH INTRALESIONAL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM INJECTION FOR PEYRONIE’S DISEASE

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie’s Disease1 Apr 2016PD45-01 RESTORATION OF PENILE FUNCTION AND PATIENT SATISFACTION WITH INTRALESIONAL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM INJECTION FOR PEYRONIE’S DISEASE Matthew Ziegelmann, Boyd R Viers, Kelly L McAlvany, George C Bailey, Joshua B Savage, and Landon W Trost Matthew ZiegelmannMatthew Ziegelmann More articles by this author , Boyd R ViersBoyd R Viers More articles by this author , Kelly L McAlvanyKelly L McAlvany More articles by this author , George C BaileyGeorge C Bailey More articles by this author , Joshua B SavageJoshua B Savage More articles by this author , and Landon W TrostLandon W Trost More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2101AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Collagenase clostridium histolyticum (CCH) is approved for the treatment of Peyronie’s disease (PD). To date, no post-release study has evaluated patient perceived outcomes and satisfaction. Therefore, we sought to evaluate patient perceived experience with CCH injection for PD in a clinical practice. METHODS From March 2014 to July 2015, 66 patients underwent one to four series of CCH injections for PD at our institution. Objective changes in penile curvature as well as patient-reported functional outcomes and patient perceived curvature improvements were evaluated. RESULTS In total, 27 (41%) patients completed four trials, 35 (53%) three trials, and 50 (76%) two trials. Subjective improvements in curvature increased with each series (Trial 1-14%, Trial 2-27%, Trial 3-33%, and Trial 4-40%, p<0.05). Among those completing therapy, 65% reported that CCH injections negated a need for surgery, and 66% reported restoration of penetration. Eighty percent of men perceived CCH treatment as meaningful, and 87% reported subjective improvements following four series of injections. Objective measures demonstrated a mean 22 degree curvature improvement (36%, p<0.0001). Six patients (9.1%) experienced penile hematomas and no patients experienced tunical rupture. CONCLUSIONS CCH injections reduced the need for surgery and restored penetration in the majority of patients completing four series of injections. Subjective improvements in curvature increased with each series of CCH injections, and the majority of patients felt that the therapy was worthwhile. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1061 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Matthew Ziegelmann More articles by this author Boyd R Viers More articles by this author Kelly L McAlvany More articles by this author George C Bailey More articles by this author Joshua B Savage More articles by this author Landon W Trost More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD45-04 NON-INDUSTRY SPONSORED SAFETY ANALYSIS FOLLOWING COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX®) INJECTION IN MEN WITH PEYRONIE’S DISEASE

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie’s Disease1 Apr 2016PD45-04 NON-INDUSTRY SPONSORED SAFETY ANALYSIS FOLLOWING COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX®) INJECTION IN MEN WITH PEYRONIE’S DISEASE Ryan Owen, Chris Winter, Michael Jennings, Jonathan Angelle, Wesley White, LeRoy Jones, and Edward Kim Ryan OwenRyan Owen More articles by this author , Chris WinterChris Winter More articles by this author , Michael JenningsMichael Jennings More articles by this author , Jonathan AngelleJonathan Angelle More articles by this author , Wesley WhiteWesley White More articles by this author , LeRoy JonesLeRoy Jones More articles by this author , and Edward KimEdward Kim More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2104AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In 2013, the FDA approved collagenase clostridium histolyticum (CCH) (Xiaflex®) for use in men with Peyronie's disease who demonstrate a palpable penile plaque and penile curvature of >30°. Currently, there is limited data on the clinical outcomes since approval of this medication. Given this gap in knowledge, we conducted a review of all patient visits for CCH administration with the aim of reporting on real world clinical outcomes and adverse effects. METHODS After IRB approval, a retrospective study from 2 large-volume centers was conducted to assess patient outcomes and complications associated with CCH injection. Eligible study candidates included those with documented penile curvature of between 30° and 90° and a palpable penile plaque. The risk evaluation and mitigation strategy (REMS) protocol was followed as described in the CCH prescribing information. Adverse events and treatment response were documented after each patient encounter. RESULTS Fifty-five men received 338 plaque injections with CCH from April 2014 thru August 2015. Of the 55 men identified, 36 (65.5%) experienced penile, suprapubic or scrotal ecchymosis. Additional adverse effects included post injection penile erythema (30.9%), penile pain (23.6%), penile edema (18.4%), hematoma formation (9.1%), penile blister (7.3%), penile hemorrhage (3.6%) and corporal rupture (3.6%). One corporal rupture occurred with aggressive vacuum erection device use within 2 weeks of CCH injection. The injury was diagnosed with pelvic MRI and required no operative intervention. The second occurred with penile fracture during sexual activity 4 weeks after the first cycle and operative intervention was required. Plaque softening was observed in 50 (89.5%) men while 41 (73.7%) reported improvement in curvature. CONCLUSIONS CCH is a safe and effective treatment option for men with Peyronie's disease. Minor adverse effects may be anticipated but are typically short lived. This study emphasizes the need for strict compliance with the REMS program, as corporal rupture is being reported in real-world clinical experience. Physicians administering Xiaflex® need to be able to manage corporal rupture. Additionally, the majority of men report improvement in penile curvature and plaque composition. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1062 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ryan Owen More articles by this author Chris Winter More articles by this author Michael Jennings More articles by this author Jonathan Angelle More articles by this author Wesley White More articles by this author LeRoy Jones More articles by this author Edward Kim More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Collagenase Clostridium histolyticum in the management of Peyronie's disease: a review of the evidence.

Peyronie's disease (PD) is a connective tissue disorder resulting in the abnormal accumulation of scar or plaques in the tunica albuginea of the penis. The condition is characterized by two phases: an active, inflammatory phase, and a stable, chronic phase. Collagenase Clostridium histolyticum (CCH) was isolated in the mid-1900s and postulated as a potential pharmacologic strategy for breaking down the abnormal connective tissue plaques of PD. Prior to the introduction of CCH, a wide variety of treatment modalities for PD were used in clinical practice, including oral and topical medications, intralesional injections, electromotive drug administration, extracorporeal shockwave therapy, traction, and invasive surgery, all with variable results. This review aims to examine the known data surrounding the use of intralesional CCH injections in the treatment of PD. CCH is a recently US Food and Drug Administration approved pharmacologic treatment for PD. Clinical trials using intralesional CCH injection therapy for the treatment of PD were reviewed for clinical safety and efficacy of treatment. Studies demonstrated that CCH treatment administered in multiple cycles led to significant benefit in both the psychological and physical aspects of PD. The strongest evidence for CCH's effectiveness was revealed in large, multicenter randomized controlled trials (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II) in which intralesional CCH was combined with manual modeling of the penis. Although adverse events from treatment are relatively common, the majority are mild to moderate in degree, including penile pain, swelling, and bruising, which all resolve spontaneously. Overall, evidence indicates that CCH is a valuable, effective, and safe minimally invasive treatment option for men with PD.

Peyronie's disease: What's around the bend?

Introduction:Peyronie's disease (PD) is a fibrotic diathesis of the tunica albuginea that results in penile plaque formation and penile deformity, negatively affecting sexual and psychosocial function of both patients and their partners. In this review, we discuss the PD literature and PD treatment options, with special emphasis on potential future therapies.Methods:The PD literature was reviewed, and articles of interest were identified using keyword search in PubMed. Articles evaluating investigational and novel PD treatments were emphasized.Results:Existing PD treatment modalities are diverse and include oral, topical, intralesional, mechanical, and surgical therapies. Surgical treatment has high success rates and is indicated in men with significant, stable deformity. The United States Food and Drug Administration-approved intralesional collagenase Clostridium histolyticum injection therapy is a minimally invasive option with demonstrated efficacy in PD. Other nonsurgical therapies have been reported, including Botox and stem cell therapy, but these currently have little or equivocal evidence to support their efficacy.Conclusions:Further research is essential to develop novel, safe, and effective minimally invasive PD treatment options. This work is ongoing, with the promise of specific, targeted, and highly effective therapies on the horizon.