Treatment Of Peyronie's Disease Research Articles

MP36-08 RISK FACTORS ASSOCIATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM COMPLICATIONS AMONG MEN WITH PEYRONIE’S DISEASE

You have accessJournal of UrologyCME1 Apr 2023MP36-08 RISK FACTORS ASSOCIATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM COMPLICATIONS AMONG MEN WITH PEYRONIE’S DISEASE Taher Naeem, Gal Saffati, Spoorthi Kamepalli, Sagar Patel, Basil Kaaki, Larry I. Lipshultz, and Mohit Khera Taher NaeemTaher Naeem More articles by this author , Gal SaffatiGal Saffati More articles by this author , Spoorthi KamepalliSpoorthi Kamepalli More articles by this author , Sagar PatelSagar Patel More articles by this author , Basil KaakiBasil Kaaki More articles by this author , Larry I. LipshultzLarry I. Lipshultz More articles by this author , and Mohit KheraMohit Khera More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the United States, collagenase clostridium histolyticum (CCH) injections are widely used as a treatment for patients with Peyronie’s disease (PD). Although some studies have examined adverse events associated with CCH injections, none have studied their relationship to peri-procedural patient characteristics. The objective of this study is to evaluate peri-procedural risk factors associated with various known CCH complications for PD. METHODS: We performed an IRB-approved single-center retrospective study from 2009-2022 on patients with CCH injections for PD. Clinical and demographic information was extracted from patient medical records. Multivariate logistic regression modeling was used to identify statistically significant (p<0.05) associations between peri-procedural factors and injection complications. RESULTS: We identified 282 PD patients who received CCH injections. Of these patients, 33.3% (n=94) experienced bruising, 10.6% (n=30) experienced swelling, 24.8% (n=70) experienced pain, 7.4% (n=21) experienced a hematoma, and 2.1% (n=6) experienced a penile fracture (PF). We found that patients with erectile dysfunction (ED) were 3 times (Odds Ratio [OR]: 0.3, 95% Confidence Interval [CI]: 0.1-0.9) less likely to experience bruising following CCH injection as patients without ED. Additionally, patients on anticoagulants were 17 times (OR: 17, CI: 2.2-144) more likely to develop a hematoma following CCH treatment, although being on anticoagulants was not significantly associated with bruising as an adverse effect. CONCLUSIONS: We found that most CCH complications were low-grade in nature, with rare occurrences of more severe complications such as PF. We also found that having ED and being on anti-coagulants were associated with more significant complications following CCH treatment in patients with PD. These findings highlight the overall safety of CCH injections for treatment of PD and may inform clinical decisions for patients with certain risk factors. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e481 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Taher Naeem More articles by this author Gal Saffati More articles by this author Spoorthi Kamepalli More articles by this author Sagar Patel More articles by this author Basil Kaaki More articles by this author Larry I. Lipshultz More articles by this author Mohit Khera More articles by this author Expand All Advertisement PDF downloadLoading ...

MP36-19 MACHINE-LEARNING BASED MODEL FOR PREDICTION OF CURVATURE IMPROVEMENT FOLLOWING CCH INJECTIONS FOR PEYRONIE'S DISEASE

You have accessJournal of UrologyCME1 Apr 2023MP36-19 MACHINE-LEARNING BASED MODEL FOR PREDICTION OF CURVATURE IMPROVEMENT FOLLOWING CCH INJECTIONS FOR PEYRONIE'S DISEASE Michelle Dai, Sagar Patel, Jeffrey Song, Whitney Jin, Charles Green, and Mohit Khera Michelle DaiMichelle Dai More articles by this author , Sagar PatelSagar Patel More articles by this author , Jeffrey SongJeffrey Song More articles by this author , Whitney JinWhitney Jin More articles by this author , Charles GreenCharles Green More articles by this author , and Mohit KheraMohit Khera More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Intralesional collagenase clostridium histolyticum (CCH) improved curvature by ≥20% for around half of subjects with Peyronie’s Disease (PD) in IMPRESS I/II RCTs. Improved identification of patients more likely to respond to CCH may optimize the use of a costly and time-intensive treatment. This study aims to determine factors predicting greater reduction of curvature following CCH injections for treatment of PD. METHODS: Data extraction focused on demographic and clinical variables for patients with PD who received CCH at our institute from 2009 to 2022. Analyses using various machine learning algorithms including Random Forest, Gradient Boosting, and Extreme Gradient Boosting selected the best-fitting model based on the lowest root mean square deviation (RMSE) derived from 5-fold cross-validation model on a 70% training sample. A hold-out test sample (30%) permitted characterization of the predictive accuracy for each outcome in terms of RMSE, mean absolute error (MAE), and R2. Variable importance scores identified variables with greatest predictive influence on the outcome. Partial dependence plots for each important variable characterized the relationship between that predictor variable and the outcome while accounting for the average effect of all other predictors. RESULTS: 175 patients received CCH for PD and had recorded post-treatment curvature. Of these cases, 62.3% (109) experienced a decrease in curvature. In patients with a decrease in curvature, there was an average of 34.9% (17.0 degrees) improvement. Our best-performing model predicting post-treatment curvature used Gradient Boosting (Training Sample: RMSE=14.59, MAE=11.75, R2=0.39; Test Sample: RMSE=14.83, MAE=11.63, R2=0.22). The most important variables were initial curvature, age at presentation, distance of the plaque from the coronal sulcus, volume of plaque, comorbid ED, and calcification in order of descending importance. CONCLUSIONS: Using machine learning techniques, we were able to identify important predictor variables that account for 22% of the variation in curvature outcomes following CCH injections. With further optimization of algorithm parameters and transfer learning using larger datasets, we hope to build a predictive model based on several easily attainable patient characteristics that can be used in an outpatient setting to better guide patient decision-making when selecting treatments for PD. Source of Funding: This work was supported in part by the 2022 Urology Care Foundation Summer Medical Student Fellowship Program and the AUA South Central Section © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e487 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michelle Dai More articles by this author Sagar Patel More articles by this author Jeffrey Song More articles by this author Whitney Jin More articles by this author Charles Green More articles by this author Mohit Khera More articles by this author Expand All Advertisement PDF downloadLoading ...

Real-world practice in Peyronie's disease management: Results from a national survey of urologists.

Despite many available treatments for Peyronie's disease (PD), practice patterns of available therapeutics are not well characterized. We conducted a national survey of urologists to characterize real-world practice patterns of PD management and to characterize the use of therapies discouraged by the American Urological Association guidelines on PD management. A 34-item survey was distributed via RedCap to urologists who treat patients with PD in all American Urological Association sections. Questions elicited demographic information as well as practices in the diagnosis and treatment of PD. Comparisons were made with Pearson's chi-squared test. The primary outcome was reported use of therapies discouraged by the American Urological Association guidelines on PD. A total of 145 respondents completed the survey, of whom 19% were fellowship trained in andrology/sexual medicine, 36% practiced in an academic setting, and 50% had at least 20 years in practice. Only 60% of respondents reporting performing in-office curvature assessment prior to commencing intralesional injection or surgical treatment, with higher prevalence in andrology/sexual medicine fellowship-trained versus non-fellowship-trained urologists (85%vs. 54%, p=0.003). The most popular treatment modalities were collagenase clostridium histolyticum (61% of respondents), phosphodiesterase-5 inhibitors (54%), and penile traction (53%). Twenty-one percent of respondents reported currently using a treatment that is explicitly discouraged by the American Urological Association guidelines (extracorporeal shockwave therapy for curvature, L-carnitine, omega-3 fatty acids, or vitamin E). Patients seeking PD treatment may be offered different therapies, some of which are not evidence-based, depending on the treating urologist. This study is limited by self-selection and response bias. Its strength is that it represents a cross-sectional overview of real-world practice patterns in PD management, which has not been previously described. A significant proportion of urologists reported PD management practices that are not evidence-based and not guideline-supported.

Peyronie's Disease: An Outcomes-Based Guide to Non-Surgical and Novel Treatment Modalities.

The clinical landscape of Peyronie's disease is everchanging. There has been growing interest in non-invasive therapeutic options that could assist patients with achieving a meaningful reduction in penile curvature without surgical intervention. These therapies are wide-ranging in terms of their mechanisms of action, efficacies, and short- and long-term safety profiles. Recently, an abundance of outcomes literature on longstanding and novel non-surgical treatment modalities has been published. For sexual medicine providers hoping to offer patients the most up-to-date and evidence-based treatments for the management of Peyronie's disease, it can be challenging to gain a thorough understanding of this body of literature. In this clinical management review, the workup and current theories on the pathophysiology of Peyronie's disease are reviewed, and the most recent outcomes data on the currently available non-surgical treatment modalities are presented. With an accurate understanding of the current landscape of Peyronie's disease treatment, sexual health providers will be able to better evaluate and engage in evidence-based shared decision-making with their patients.

Multiple courses of intralesional collagenase injections for Peyronie disease: a retrospective analysis

In the original clinical trials evaluating intralesional collagenase Clostridium histolyticum for Peyronie disease (PD), treatment protocols were limited to 8 injections. We sought to describe our single-center experience with the use of multiple rounds (>8 injections) of intralesional collagenase in patients with PD. We conducted a retrospective analysis of all patients with PD receiving intralesional collagenase injections at our institution from October 2015 through December 2020. Some patients who completed 1 round of treatment elected to undergo additional rounds (16 or 24 injections) based on persistent curvature and presence of penile plaque. Clinical improvement was defined as a 20% reduction in penile curvature from the start of a given round of treatment to the end of that round of treatment. We measured erect penile curvature before and after each round and collected demographics, medical and surgical history, curvature outcomes, and treatment-related adverse events. The primary outcome was the reduction in penile curvature after multiple rounds of treatment with intralesional collagenase injections in patients with PD. A total of 330 patients underwent intralesional collagenase injections for PD, of whom 229 completed at least 8 injections and underwent pre- and posttreatment erect penile goniometry. An overall 42.8% (98/229), 38.6% (22/57), and 12.5% (1/8) of patients achieved clinical improvement after 1 round of therapy (8 injections), 2 rounds (16 injections), and 3 rounds (24 injections), respectively. Mean degree and mean percentage improvement of penile curvature for the start and end of each round of treatment were 8.3° and 16.4% (after 1 round), 7.2° and 16.8% (after 2 rounds), and 3.3° and 8.1% (after 3 rounds). Bruising was the most common complication, with an incidence of at least 50% in each round. Knowledge of patient responses to multiple rounds of intralesional collagenase injections may help guide physicians in management and counseling of patients regarding PD treatment options. This is the first study to evaluate multiple rounds (>8 injections) of intralesional collagenase for PD. Limitations include retrospective analysis and smaller sample size among patients undergoing 3 rounds (24 injections). For patients who did not achieve clinical improvement after 1 round of treatment, an additional round may be beneficial. However, no real improvement was observed for patients undergoing a third round.

Chronological perspective of substitute materials used for the surgical treatment of Peyronie's disease: A scoping review of literature.

This comprehensive scoping review aimed to identify all up-to-date original publications relating to substitute materials used for the surgical treatment of Peyronie's disease (PD), and characterize what material in which chronological trends were published in the current literature. Using the PCC framework (P: population, C: concept, and C: context), a search strategy was developed and used in four electronic databases, in addition to the Google scholar. All current published, in-press, and pre-print manuscripts with available English full-text were included. Eligible studies were required to be original research articles of any study design, reporting the usage of grafts on surgical treatment of PD. Included studies were reported in a narrative synthesis format. A total of 3379 articles were identified via an electronic search of databases and a total of 171 articles entered this scoping review. Most studies originated from Europe (n = 72) and North America (n = 66). Reports from the other continents increase in number in the 21st century. Highest number of the published papers was seen in 2001 to 2005 pentad. Autologous grafts (53.5%). Allografts (22.7%) and xenografts (15.7%) were the most frequently reported materials. Time flow of the used material and the alterations in trends for them is quite considerable. A global perspective of relevant publications on substitute materials in the surgical management of PD is presented in this review. The information in this summary may assist in establishing future research priorities in this area.

Hyaluronic acid injection for the management of peyronie's disease

To report our findings in terms of safety and efficacy of intralesional injections of hyaluronic acid (IIHA) in the treatment of Peyronie's disease (PD). Data were extrapolated from a single centre prospectively maintained database. 18 patients with PD received IIHA using the same procedure as for collagenase clostridium histolyticum. Penile curvature assessed through Intracavernosal injection of prostaglandin E1, Peyronie's Disease Questionnaire (PDQ) and the International Index of Erectile Function (IIEF) were carried out at baseline and at week 7. The Global Assessment of Peyronie's Disease (GAPD) questionnaire was completed at week 7. No patients received previous local treatment for PD and all had at least 1 year stable disease. IIHA were performed every other week under penile block of 15 mL plain mepivacaine 1% for total number of 3 injections in six weeks; investigator modelling has been fulfilled at the end of each injection. Patients were educated to home modeling, stretching and using daily vacuum device between injections. The median penile curvature at baseline was 55 (IQR= 43.75 - 65). Of the treated patients 16 (88%) showed a decrease in the angle of curvature by a mean of 13.33 ± 8.57 degrees. At 7 weeks the median measured curvature was 40 (IQR = 30 – 50) (p<0.001). A statistically significant improvement in IIEF- Intercourse Satisfaction (from 30,1 ± 7.1 to 34.7 ± 8.1; p<0.001). Hyaluronic acid injections were well tolerated by all patients and no complications were observed. Our preliminary study showed that IIHA may reduce penile curvature in patients affected by Peyronie's Disease in combination with the use of vacuum device, penile modelling and stretching. Considering the safety, the low cost and efficacy, we believe that IIHA may be a promising treatment option. The authors reported no conflict of interest.

The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie's disease: A meta-analysis of published prospective studies.

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.

Peyronie's disease development and management in diabetic men.

Peyronie's disease (PD) is a fibrosing disorder of the penis resulting in plaque formation and penile deformity that negatively affect sexual and psychosocial function of patients. A multifactorial etiology of PD is assumed with diabetes mellitus (DM) being a potential risk factor. The aim of this narrative review was to investigate diabetes role in PD pathophysiology, diagnosis, and treatment. A non-systematic narrative review of original articles, meta-analyses, and randomized trials was conducted, including articles in the pre-clinical setting to support relevant findings. Diabetes is one of the most common comorbidity observed in PD patients, with a prevalence of about 11% and a strong association with erectile dysfunction (ED). DM is associated with both a higher risk of developing PD and has also an impact on the outcomes of PD's treatments. Evidence from literature underlines that metabolic alterations typical of DM are pivotal factors in the development of PD and resistance to its medical treatment. The role of DM in development of PD is still debated, while its role in PD development is not completely clear, there is a clear impact of DM on PD treatment outcomes.

Clinical Significance of Shortened Penile Length and Alterations in Penile Length Following Treatment for Peyronie's Disease.

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. 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. 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. 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. 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.

The SAPOC technique: A novel approach utilizing multiple slices around point of maximal curvature for the correction of penile curvature at the time of penile prosthesis placement in patients with severe Peyronie's Disease

ABSTRACT Introduction Placement of an inflatable penile prosthesis (IPP) is indicated for patients with severe Peyronie's disease (PD) and erectile dysfunction (ED) that do not respond to medications. When utilizing plaque incision and graft placement, most surgeons perform an incision at the point of maximal curvature. In most cases of severe PD, this incision results in a large defect that requires placement of a large graft while postoperative penile shortening remains a concern among patients. Objective To present a novel technique for the treatment of severe PD and ED during IPP implantation, in which multiple relaxing incisions are made around the point of maximal curvature. This technique minimizes the size or even the need of a graft and maximizes length restoration. Methods A total of 35 patients with PD and severe ED underwent IPP placement with penoplasty by a single surgeon from October 2018 to March 2021. 27 of these patients underwent the SAPOC technique at the time of IPP placement through a non-degloving approach. This technique involves elevation of the neurovascular bundle for dorsal or lateral curvatures along with elevation of the urethra for ventral curvatures. After the point of maximal curvature is identified, 2 to 4 transverse relaxing incisions (slices) are made around the point of curvature approximately 1 to 1.5cm apart in order to minimize the size of the defect, and hence the size of the graft, while allowing for maximal restoration of length. Primary outcome measurements included straightening rates, patient satisfaction, change in penile length, immediate and late complications. Results The SAPOC technique was applied to 27 patients. Mean patient age was 58.2. Mean preoperative curvature was 71.9 degrees. Mean pre-operative stretched penile length at the time of surgery was 14.18 cm. Mean increase in erect penile length after IPP with SAPOC technique was 0.94 cm (p=0.006) (range 0 to 2.5 cm). A total of 12 patients (44.4%) did not require graft placement. After a mean follow-up of 13.5 months, 23 of 27 (85.2%) patients had a totally straight penis. 4 patients (14.8%) had less than 20 degrees residual curvature which was sufficient for penetrative intercourse. 26 patients (96.2%) were satisfied with their postoperative result. Complications included delayed ejaculation (n=4, 11%, all of which resolved within 12 months), device malfunction (n=1) after 2 years of initial surgery which was revised successfully, device infection at 6 weeks (n=1) and intractable pain 2 years after implantation (n=1), both of which required removal of the prosthesis. Conclusion The SAPOC technique at the time of IPP placement is a novel, safe and feasible technique for the management of complex Peyronie's disease and erectile dysfunction. This technique allows the surgeon to complete the procedure without graft placement in some occasions which theoretically will decrease operative time. It also provides for length restoration which will increase patient satisfaction. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Consultant for Coloplast and Boston Scientific).

PD23-05 PATIENT REFERRAL TRENDS AND OUTCOMES OF PENILE PLICATION IN THE CONTEMPORARY ERA: IS XIAFLEX® DRIVING PATIENTS TO SURGERY?

You have accessJournal of UrologyCME1 May 2022PD23-05 PATIENT REFERRAL TRENDS AND OUTCOMES OF PENILE PLICATION IN THE CONTEMPORARY ERA: IS XIAFLEX® DRIVING PATIENTS TO SURGERY? Sam Kusin, Shervin Badkhshan, Samantha Nealon, Gregory Joice, Sarah Sanders, Steven Hudak, and Allen Morey Sam KusinSam Kusin More articles by this author , Shervin BadkhshanShervin Badkhshan More articles by this author , Samantha NealonSamantha Nealon More articles by this author , Gregory JoiceGregory Joice More articles by this author , Sarah SandersSarah Sanders More articles by this author , Steven HudakSteven Hudak More articles by this author , and Allen MoreyAllen Morey More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002565.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Injection of Clostridium Histolyticum (Xiaflex®, CCH) has become increasingly more common since its FDA approval for non-surgical treatment for Peyronie’s Disease (PD) in December 2013. We evaluated practice patterns for PD in the Xiaflex® era and the outcomes for penile plication (PP) after CCH failure at our tertiary referral center. METHODS: We performed a retrospective study of our single-surgeon PP database from 2013-2021. Patients who underwent PP were stratified by history of CCH treatment for PD. Variables compared included number of CCH cycles, time from CCH to PP, change in degree of curvature, and need for revision plication. The EPIC SlicerDicer program was used to identify all clinic visits with a primary PD diagnosis using ICD-10 code N48.6. Two-tailed t-tests for continuous variables were performed using PRISM 9.2. RESULTS: The annual number of clinic visits for PD during the study period nearly doubled (242 in 2013-14 vs. 436 in 2019-20, p <0.01). The annual number of PPs performed and the proportion with prior CCH failure escalated at a similar rate (Figure 1). Among 43 men who underwent PP after prior CCH treatment, a mean of 3.6 treatment cycles (range 1 – 6) were completed with an average time from final CCH treatment to PP of 13.0 months (range 4 – 25). Patients frequently reported no change (19/43 41.3%) or mild improvement (12/43, 26.0%) following CCH treatment. Worsening curvature (8/43, 17.4%) and corporal rupture (2/46, 4.3%) were also reported after CCH. Mean pre-CCH curvature was 61.6° ± 20.7° with an average improvement of 13° ± 17° with CCH. PP further improved curvature by 49° ± 20° with residual curvature of 3° ± 7°. There was no significant difference in the need for revision PP between the CCH and non-CCH groups (2/43, 4.7% vs. 14/372, 3.8%, p <0.01). CONCLUSIONS: The introduction of CCH for the treatment of PD has led to a significant increase in clinic visits for surgical consultation and PP in patients with previous CCH failure. Post-CCH PP appears to be feasible and safe with overall excellent improvement in curvature. Source of Funding: NA © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e410 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sam Kusin More articles by this author Shervin Badkhshan More articles by this author Samantha Nealon More articles by this author Gregory Joice More articles by this author Sarah Sanders More articles by this author Steven Hudak More articles by this author Allen Morey More articles by this author Expand All Advertisement PDF DownloadLoading ...

Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009-2019).

BackgroundCollagenase Clostridium histolyticum (CCH), which was approved by the FDA for the treatment of Peyronie's disease (PD) in 2013, may obviate the need for surgery but its historically high cost must be considered when offering CCH vs surgical intervention to affected patients.AimTo compare trends of intralesional injections vs surgical treatment for PD and assess the contemporary cost of treatment with CCH vs surgical intervention.MethodsWe reviewed 2009–2019 MarketScan Commercial Claims data to identify all men 18 years and older with PD. CPT and HCPCS codes were used to identify PD treatments for each patient. Associated insurance claims in USD were summed for each treatment type.OutcomesTotal and out-of-pocket costs, as well as frequencies, for treatments were calculated on a yearly basis and the Cochran-Armitage test was used to compare frequencies before and after FDA approval of CCH.ResultsOf 89,205 men diagnosed with PD, 21,605 (24.2%) underwent treatment; most required only intralesional injections, however 1,519 (7.0%) received only surgical therapy and 1,951 (9.0%) required medical and surgical therapy. Intralesional CCH use sharply increased after its FDA-approval in 2013 with a concomitant fall of intralesional verapamil use. The use of both surgical plication and plaque grafting decreased steadily from 2009 to 2019. The median cost per patient for all 3 treatments increased over the study time-period: $1,856 to $3,196 for plication, $2,233 to $3,631 for plaque grafting, and $6,940 to $8,895 per cycle for CCH. Out-of-pocket median patient contribution for plication, plaque grafting, and per cycle intralesional CCH injection were similar over the study period and never exceeded $300.Clinical ImplicationsCCH is significantly more expensive than any surgical treatment option, however, the out-of-pocket patient contribution for surgery and CCH are similar.Strengths & LimitationsThis study incorporated all procedure costs and is the most contemporary, comprehensive, and accurate reflection of overall and out-of-pocket costs to patients for surgical and intralesional PD therapies. We anticipate these data to allow for a more complete discussion between patients and providers regarding their care. The use of a commercial claims database prohibited assessment of post-procedural costs and treatment outcomes.ConclusionCCH use has increased significantly since its FDA approval in 2013 with out-of-pocket patient contribution comparable to surgical therapy despite significantly higher total treatment costs.Walton EL, Quinn TP, Mulloy E, et al. Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009–2019). Sex Med 2022;10:100517.

Plaque excision with the Shah Penile Implant™ and tunica vaginalis graft in Peyronie's disease with erectile dysfunction: A case report.

Peyronie's disease (PD) is a condition characterized by the deposition of scar tissue in the tunica albuginea of the penis. Peyronie's disease often causes pain, worsens the quality of erections, a variable degree of penile deformation and shortening, which can cause severe distress for the patient and the partner and impact negatively on self-esteem and quality of life in general. Surgery still represents the gold standard treatment for PD in the chronic phase, and it aims to guarantee a penis straight and rigid enough to allow the patient to resume penetrative sex with confidence. Penile prosthesis implantation should be reserved for patients with refractory erectile dysfunction or in these patients with complex deformities and impaired erections. Herein is reported the case of a 51-year-old male with a large ossified PD plaque and erectile dysfunction who underwent simultaneous plaque excision and grafting and penile implantation surgery with a semirigid penile prosthesis. This was the first case of penile prosthesis implantation for Peyronie's disease in Indonesia.

Time to presentation of Peyronie's Disease in the era of injections and information

ABSTRACT Introduction Characterized by acquired fibrosis of the tunica albuginea, Peyronie's disease (PD) can cause penile curvature, pain, and plaque, as well as erectile dysfunction and difficulty with penetration. Using online surveys in 2007-2008, Dibenedetti et al found that the prevalence of PD in adult men in the US was 0.5% based on PD diagnosis; 0.8% based on PD diagnosis or treatment of PD; and 13.1% based on diagnosis, treatment, or any symptom of PD. They found that 68% of patients saw a doctor when they first noticed symptoms, at a mean time to see a doctor of 16.8 (SD = 5.5) months. The other third, or 32%, of patients who sought treatment later in the disease course, had a mean time of 46.2 (SD = 8.4) months. Only 5% of patients presented with current pain, thus in the active phase. Objective Our study investigated how patient presentation for PD changed after two sentinel events: 1) the FDA approval of intralesional injections of collagenase clostridium histolyticum (CCH) in 2013, and 2) the national publicity surge for PD in 2016-2017. We then aimed to compare this data to a prior study by Dibenedetti et al conducted for patients in 2007-2008. Methods Our retrospective, single institution study was conducted as a chart review of patients presenting from 2014 to 2020 with penile curvature, pain, or plaque. Descriptive statistics were used to compile data at the time of initial evaluation by the reconstructive urologist, including patient demographics, pre-treatment assessments, and time to evaluation. Results Our study included 152 adult men, and mean age was 57.9 years old (SD = 8.1) (Table 1). Initial symptoms included penile curvature (87%), pain (30%), and plaque (8%). 38% of patients were in the active phase of PD at time of evaluation. The mean time from onset of symptoms to evaluation by the specialized urologist was 27.5 months (SD = 53.2, range 1 to 360 months) (Figure 1). For the 2/3 of patients, or 68%, who had the shortest time to evaluation, the mean duration of PD symptoms prior to evaluation by a specialized urologist was 10.0 months (SD = 4.6) (Figure 2). For the 1/3 of patients, or 32%, who had the longest time to evaluation, the mean duration of PD symptoms prior to evaluation was 69.7 months (SD = 80.6). Conclusions Over the years, the majority of PD patients are presenting sooner in their PD course. The outlier patients, or those who have suffered from PD for a relatively long time, are also presenting for evaluation and treatment. These trends are likely influenced by the FDA approval of intralesional injections of CCH and by the national media efforts to raise awareness of the underdiagnosed and undertreated disease. Disclosure No

The SAPOC Technique: A Novel Approach Utilizing Multiple Slices Around Point of Maximal Curvature for the Correction of Penile Curvature at the Time of Penile Prosthesis Placement in Patients with Severe Peyronie's Disease

ABSTRACT Introduction Placement of an inflatable penile prosthesis (IPP) is indicated for patients with severe Peyronie's disease (PD) and erectile dysfunction (ED) that do not respond to medications. When utilizing plaque incision and graft placement, most surgeons perform an incision at the point of maximal curvature. In most cases of severe PD, this incision results in a large defect that requires placement of a large graft while postoperative penile shortening remains a concern among patients. Objective To present a novel technique for the treatment of severe PD and ED during IPP implantation, in which multiple relaxing incisions are made around the point of maximal curvature. This technique minimizes the size or even the need of a graft and maximizes length restoration. Methods A total of 35 patients with PD and severe ED underwent IPP placement with penoplasty by a single surgeon from October 2018 to March 2021. 27 of these patients underwent the SAPOC technique at the time of IPP placement through a non-degloving approach. This technique involves elevation of the neurovascular bundle for dorsal or lateral curvatures along with elevation of the urethra for ventral curvatures. After the point of maximal curvature is identified, 2 to 4 transverse relaxing incisions (slices) are made around the point of curvature approximately 1 to 1.5cm apart in order to minimize the size of the defect, and hence the size of the graft, while allowing for maximal restoration of length. Primary outcome measurements included straightening rates, patient satisfaction, change in penile length, immediate and late complications. Results The SAPOC technique was applied to 27 patients. Mean patient age was 58.2. Mean preoperative curvature was 71.9 degrees. Mean pre-operative stretched penile length at the time of surgery was 14.18 cm. Mean increase in erect penile length after IPP with SAPOC technique was 0.94 cm (p=0.006) (range 0 to 2.5 cm). A total of 12 patients (44.4%) did not require graft placement. After a mean follow-up of 13.5 months, 23 of 27 (85.2%) patients had a totally straight penis. 4 patients (14.8%) had less than 20 degrees residual curvature which was sufficient for penetrative intercourse. 26 patients (96.2%) were satisfied with their postoperative result. Complications included delayed ejaculation (n=4, 11%, all of which resolved within 12 months), device malfunction (n=1) after 2 years of initial surgery which was revised successfully, device infection at 6 weeks (n=1) and intractable pain 2 years after implantation (n=1), both of which required removal of the prosthesis. Conclusions The SAPOC technique at the time of IPP placement is a novel, safe and feasible technique for the management of complex Peyronie's disease and erectile dysfunction. This technique allows the surgeon to complete the procedure without graft placement in some occasions which theoretically will decrease operative time. It also provides for length restoration which will increase patient satisfaction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for Coloplast, Boston Scientific, and Endo Pharmaceuticals

Platelet-Rich Plasma Injections for Erectile Dysfunction and Peyronie's Disease: A Systematic Review of Evidence.

Erectile Dysfunction (ED) and Peyronie's Disease (PD) are debilitating medical conditions affecting patients' quality of life (QoL). Platelet-rich plasma (PRP) injections are one of the various emerging approaches proposed to treat these medical conditions. To describe the evidence of the potential role of PRP injections in ED and PD. The authors conducted a systematic review according to the PRISMA statement using the following databases in November 2019: The National Library of Medicine (PubMed), Ovid Medline, Cochrane, Scopus, Embase, and Embase classic. The search was performed using keywords drawn from studies on the use of PRP in ED and PD in clinical and preclinical studies. Eighteen articles met the inclusion criteria for review, including 12 studies on the use of PRP in humans and 6 on the use of PRP in rats. Ten studies reported on the efficacy of PRP in ED exclusively, 7 in PD exclusively and one in both conditions. In humans, 6 and 3 studies showed promising results in PD and ED, respectively. No major complications were noted. Unwanted minor side effects were noted by studies reporting on PD, including mild penile bruising, ecchymosis, hematomas as well as transient hypotension noted in 2 out of 90 patients. PRP injections for the treatment of ED may be promising, but no recommendation can be made because of scarce evidence. Safety and effectiveness of this therapy in the treatment of ED and PD require further preclinical and clinical studies with standardized protocols to gain an adequate insight into its potential implications. Patients should be offered to be part of such trials to better understand PRP potential. Alkandari MH, Touma N, Carrier S, Platelet-Rich Plasma Injections for Erectile Dysfunction and Peyronie's Disease: A Systematic Review of Evidence. Sex Med Rev 2022;10:341-352.

Low-intensity Extracorporeal Shockwave Therapy as an Adjunct to Xiaflex® in the Treatment of Peyronie's Disease

ABSTRACT Introduction Low-intensity extracorporeal shockwave therapy (Li-ESWT) may have physiologic effects including neo-angiogenesis, upregulation of vasoactive endothelial growth factors, nerve recovery, reduction of fibrotic changes, cavernosal tissue remodeling, and reduction in sympathetic tone. Collagenase clostridium histolyticum (CCH) is the only US FDA-approved drug for the non-surgical treatment of Peyronie's disease (PD). Treatment is intended to be completed in conjunction with penile traction therapy, but studies have demonstrated poor patient compliance. New adjunct therapies that have synergistic effects when used in combination with CCH are desirable but have not been explored. Objective To study if Li-ESWT has additive, synergistic, or no effect when used in combination with CCH to treat PD-associated fibrosis and PD-associated erectile dysfunction. Methods 40 adult male Sprague-Dawley rats were divided evenly into five groups: sham (S), control (T), CCH only (XT), low setting Li-ESWT and CCH (XTL), and CCH and high setting Li-ESWT (XTH). Normal saline was injected sub-tunical in the sham group. Transforming growth factor beta-1 (TGF-B1) was injected into the tunica albuginea of the remaining groups to induce Peyronies-like fibrosis. After 4 weeks of TGF-B1 induction, CCH was injected in all three groups over two injections separated by 48 hours, and then treatment with Li-ESWT (UroGold™ 100) was initiated. Treatment was delivered biweekly for 3 weeks (6 total sessions). Device settings were 600 shocks at 3 Hz, at level 6 (0.093 mJ/mm2) for the XTL group and at level 12 (0.125 mJ/mm2) for the XTH group. After 10 weeks, erectile function was measured by ratio of intracavernosal pressure (ICP) to mean arterial pressure (MAP). Histological analysis by H&amp;E, Trichome stain, and Western blot analysis of Collagen I (COL1A1), III (COL3A1), and alpha-smooth muscle actin (a-SMA) were also performed. Results There was no significant difference found in erectile function as measured by ICP/MAP between PD model and treatment groups (P &amp;gt; 0.05). Histological comparison showed no significant reduction of fibrosis when Li-ESWT was added to CCH, despite intensity, on microscopic examination. On Western blot analysis, there was a reduction of ∼500% in COL1A1 expression when the XT group was compared to the T group. While there was no significant change of COL1A1 between the XT group and the XTL group, there was found to be a decrease of ∼500% expression when the XT group was compared to the XTH group. Expression of COL3A1 in the treatment groups XTL and XTH was comparable to that of the XT group. There was no observable trend in a-SMA expression. Conclusions Different adjunct treatments to CCH need to be explored to augment the effect of the only approved non-surgical treatment for PD. Decreased COL1A1 expression seen in the XTH group, but not XTL, relative to the T group may suggest an energy-dependent effect to decrease fibrosis. Li-ESWT was hypothesized to be a promising candidate, but we have failed to show substantial benefit in our proposed setting. Disclosure Yes, this is sponsored by industry/sponsor: Sexual Medicine Society of North America Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals

Racial Trends in Peyronie's Disease Treatments: Analysis of the Veterans Health Administration

ABSTRACT Introduction Racial disparities are known to affect urologic care. Settings such as the Veterans Affairs (VA) health system, where access to care is more equitable, have noted reductions in racial disparities for certain diseases. Previous studies of Peyronie's Disease (PD) have investigated responses to treatment by race, but not treatment rates themselves. Frequently, racial disparities in healthcare are attributed to differences in income or decreased insurance rates among people of color. For this reason, we aimed to investigate racial disparities in PD treatments by evaluating the VA Informatics and Computing Infrastructure (VINCI), which contains data from the VA. As veterans are insured and able to obtain treatment for PD through the VHA, this population allows us to study the effects of race on treatment rates when insurance does not serve as a barrier. Objective To evaluate the treatment rates for Peyronie's Disease within the VA by race in order to determine whether racial disparities exist when insurance access is equitable. Methods We queried VINCI to obtain data for a cohort of men that have a recorded diagnosis of PD by ICD-9 or ICD-10 code between 2015-2020. We then used the following CPT codes to identify which patients had procedures known to be therapeutic for PD: plaque injection (CPT 54200), penile prosthesis (54400, 54405), penile reconstruction to correct penis angle (54360), or plaque excision (54110, 54111, 54112). We evaluated treatment rates among patients with race/ethnicity information recorded. We reported results as frequencies and used the chi-square test to evaluate significant differences in treatment rates when comparing racial groups to Whites, with statistical significance reported at p&amp;lt;.05. Results We obtained data for 17,022 patients with diagnoses of PD. Within the total population of patients diagnosed with PD, 71.4% were White (Non-Hispanic), 25.4% were Black, 5.8% were Hispanic or Latino, 0.3% were Asian or Pacific Islander (API), and 1.6% were Native American (NA), and 5.4% were unknown. Among this cohort, 13.6% of all patients, 13.6% of Whites, 14.3% of Blacks (p=0.2985), 13.5% of Hispanics (p=0.9205), 9.1% of API (p=0.3319), 16.7% of NA (p=0.1406), and 9.6% of unknown (p=0.0041) were treated. Conclusions Within the VHA population, which is not limited by access to health insurance, all patients with recorded race information were treated at similar rates for PD to Whites. Only those without racial information recorded were treated at a significantly lower rate. This study demonstrates the potential for equitable insurance and access to healthcare to reduce racial disparities. Further investigation is required to evaluate whether these treatment patterns are similar within the general population. Disclosure No

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

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