Improvement In Penile Curvature Research Articles

Efficacy of collagenase Clostridium histolyticum combination therapies for Peyronie's disease: a systematic review and meta-analysis.

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. 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. For penile length (MD,0.81cm; 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. 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.

(244) Participants with Penile Pain at Baseline May Benefit from Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis

Abstract Introduction Peyronie’s disease (PD) is traditionally categorized into 2 phases: acute (active) and chronic (stable) phase; however, clinical definitions and distinction between the phases vary in the literature and remain blurred.[1] The American Urological Association guidelines outline changing symptoms with the presence of pain as a defining symptom of acute disease, but provide little guidance about timeframe.[2] Historically, acute-phase characteristics include presence of penile pain and progressing deformity (eg, worsening penile curvature), with time from symptom onset to acute phase completion being <3–18 months.[1] While there may be academic utility in temporally categorizing PD, it may limit or postpone the treatment options for patients suffering from the condition. Collagenase clostridium histolyticum (CCH) is an approved nonsurgical PD treatment option and several studies suggest its safety and efficacy in acute phase PD.[3-6] In light of these studies and ambiguity in dichotomizing phases, previous clinical trial data were reanalyzed to investigate the potential for opening the gamut of treatment options at earlier timepoints in the disease process. Objective This analysis examines CCH treatment efficacy on improving penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months from the CCH clinical trial program. Methods Literature related to CCH treatment of acute phase PD was compiled and treatment outcomes assessed. Additionally, a post hoc analysis of pooled data from two phase 3 randomized, double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623) was conducted. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline based on the following study measures: penile pain on palpation, penile pain on erection, PD questionnaire (PDQ) combined questions 7–9, and PDQ question 10 only. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Results The IMPRESS I/II data analysis found that participants who experienced moderate-severe pain at baseline had penile curvature improvements by week 52 similar to participants with no pain at baseline. Across all pain measures, the percentage decreases in mean penile curvature from baseline ranged from 29%–42% for moderate-severe pain groups and 35%–37% for no penile pain groups. There were no clear differences in mean penile curvature improvement between groups for any specific pain measure when stratified by disease duration of 12–18 months (moderate-severe pain, 32%–40% improvement; no pain, 23%–29% improvement) versus >18 months (moderate-severe pain, 24%–44% improvement; no pain, 37%–40% improvement). Outcomes from the IMPRESS trials were comparable in context with published literature. Conclusions Based on a subanalysis of IMPRESS data, there were no clear differences identified in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc; Boston Scientific Corporation; Antares Pharma, Inc; PathRight Medical.

Intraplaque injections of hyaluronic acid for the treatment of stable-phase Peyronie's disease: a retrospective single-center experience.

Peyronie's disease (PD) is a condition of penile connective tissue affecting up to 10% of men worldwide. In the complexity of its management, nonsurgical treatments, such as intraplaque injections, are gaining attention. The current literature shows data on the efficacy of intraplaque injections of hyaluronic acid (HA) mainly in acute-phase PD. However, data on injections of HA in stable-phase PD are lacking. Data for this retrospective study were derived from a prospectively maintained database of private patients presenting at a private medical practice affiliated to the University of Naples "Federico II" (Naples, Italy) with stable-phase PD between January 2020 and March 2023. Patients underwent a standard protocol of three injections, each administered at a two-week interval. During the intervals, patients performed vacuum device therapy, penile stretching, and modeling exercises. All patients compiled the Peyronie's Disease Questionnaire (PDQ) and Global Assessment of Peyronie's Disease (GAPD) at baseline and 2 weeks after the third injection. A penile Doppler ultrasound was performed 2 weeks after the last injection to record the final curvature. Overall, we recruited 62 patients with stable-phase PD and a mean (±standard deviation [s.d.]) curvature of 52.7° (±9.7°). After 6 weeks, eight (12.9%) patients did not experience any curvature improvement. The remaining 54 patients had a final mean (±s.d.) curvature of 40.3° (±9.1°) with P < 0.001, compared to that before treatment. We found improvement in all PDQ domains (all P ≤ 0.01), and 50 (80.6%) patients reported subjective improvement of the penile curvature according to the GAPD. In conclusion, we demonstrated that after three injections of HA administered according to the adopted protocol, patients with stable-phase PD could experience significant improvements in penile curvature, and physical and psychological consequences of the disease without significantly relevant side effects.

Cell therapy for male sexual dysfunctions: systematic review and position statements from the European Society for Sexual Medicine.

Cell therapy (CT) is a form of regenerative medicine under investigation for the management of male sexual dysfunction (MSD). We sought to perform a systematic review of published information on CT for MSD and provide an official position statements for the European Society for Sexual Medicine. A comprehensive bibliographic search on the MEDLINE, Web of Science, Scopus, and Cochrane Library databases was conducted in February 2023. Articles were selected based on the Population, Intervention, Comparator, Outcome, Study design (PICOS) model if they included male patients (P) undergoing CT (I) with or without comparison with other treatments (C) and evaluated the impact of CT on sexual function (O). Quantitative data were reported as found in the original studies (S). Level of evidence and grade of recommendation according to the Oxford Centre for Evidence-Based Medicine were assigned to each statement. Outcomes were determined based on assessment of erectile function, ejaculatory function, orgasmic function, sexual desire, and penile curvature. A total of 19 studies and 421 patients were included. Most articles (n = 12, 63%) were case series, whereas a minority of papers (n = 6, 32%) had a comparative group; only 2 articles reported randomized controlled trials (RCTs) and 1 article reported a post hoc analysis of RCTs. Most articles (16, 84%) investigated patients with erectile dysfunction (ED). Improvements in the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) or the IIEF 5-item version (IIEF-5) were found in 11/15 (73%) studies, with mean increases in IIEF-EF, mean IIEF-5, and median IIEF-EF between 8 and 14 points, 2 and 9 points, and 4.5 and 6 points, respectively. Two papers (20%) evaluated men with Peyronie's disease (PD). In both ot these articles penile curvature improvement and plaque volume reduction were described in all patients (n = 16, 100%). Objective measurements were performed in 1 study, which showed 10°-120° (15%-100%) curvature improvement and 90%-100% plaque reduction. Mild transient adverse events at the donor or administration sites were found in 7/16 (44%) papers on ED. Priapism was reported in one case (20%) and mild penile skin complications were reported in the majority of patients after CT for PD. No severe adverse events were described. Although high-quality evidence is lacking, CT appears to have potential benefits from application in patients with ED or PD. This report is to our knowledge the most comprehensive and up-to-date systematic review on the topic of CT for the management of MSD, including the position statements of the European Society for Sexual Medicine. Overall the assessment of available studies demonstrated low quality and significant heterogeneity. Preliminary findings support potential efficacy and safety of CT in patients with ED or PD. Low-quality papers, high methodological heterogeneity, uncertainty about the magnitude of the beneficial effects, and lack of long-term data limit the available evidence.

Changes in Point of Maximal Curvature During Collagenase Clostridium Histolyticum Injections for Peyronie’s Disease

ObjectivesTo determine change in the point of maximal curvature (POMC) during Collagenase Clostridium histolyticum (CCH) injections for Peyronie’s disease (PD). MethodsA prospective database has been maintained of all men undergoing CCH injections since March 2014. For the current study, data were abstracted on the POMC with each curve assessment and correlated with demographic and clinical factors. Maximal changes were defined as the largest change in POMC from baseline. Results618 men underwent ≥1 series of CCH, with 313 having a baseline and subsequent POMC measurements available. Median baseline curvature was 60.0° and POMC 2.8 cm. Among 189 men who were satisfied or completed 8 CCH injections, the median improvement in penile curvature was -27.5° (40.9%). The median maximal change in POMC during CCH treatment was 1.0 cm (IQR, 0.5, 1.8). Overall, 55.6% had changes in POMC of ≥1 cm, 23.6% ≥2 cm, 8.9% ≥3 cm, and 3.8% ≥4 cm. Multivariate logistic regression identified ventral curvature as a predictor of larger change in POMC, after controlling for other variables. Study limitations included the observational, non-randomized study design and potential for intra- and inter-individual measurement variability. Strengths are the inclusion of an all-comer population, large series, prospective database, and routine objective assessments. ConclusionsApproximately half of PD men undergoing CCH experience ≥1 cm of change in POMC during the treatment course, with nearly 1/4 experiencing ≥2 cm. Pending external validation, findings suggest that patients may benefit from repeat curvature assessments with each CCH series to optimize accuracy of drug administration.

Safety and feasibility of percutaneous needle tunneling with platelet-rich plasma injections for Peyronie's disease in the outpatient setting: a pilot study.

The objective of this study is to evaluate the safety and feasibility of the combined simultaneous percutaneous needle tunneling coupled with injection of platelet-rich plasma in the outpatient department for the treatment of Peyronie's disease. This prospective, non-randomized, cohort and preliminary study included patients who underwent this procedure from November 2020 to July 2022. The main outcome was an improvement in penile curvature. Fifty-four patients were enrolled and underwent 6 sessions under local anesthesia followed by vacuum therapy for the treatment of Peyronie's disease in our outpatient unit. The amendment of the curvature angle was significant with a median correction percentage of -44.40% interquartile range (-66.70 to (-39.70)), [p-value = 0.001, 95% CI (-29.76 to (-18.02)), paired Student's t-test]. The median pre-treatment curvature angle was 45° (40-75), and the median post-treatment was 30° (20-40). The median score for pain during the procedure was 3 (0-4.25) according to a 10-point visual analogic scale. After two hours, 20.37% of patients still had pain but none required any pain medication. 50% of patients had a minor hematoma and 75.93% patients reported penile ecchymosis. A single patient reported an injection site skin infection. In our experience percutaneous needle tunneling with platelet-rich plasma injections for Peyronie's disease in the outpatient setting is a safe, effective, and feasible treatment of penile deformity for PD.

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

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

(260) Further Characterizing Treatment Success with Intralesional Collagenase for Peyronie’s Disease

Abstract Introduction Intralesional Collagenase Clostridium histolyticum (CCH) is approved for men with Peyronie’s Disease (PD). Most studies use curve improvement ≥ 20% to define treatment success. Objective Here, we sought to further characterize objective and subjective treatment outcomes with CCH. Methods We reviewed our prospectively maintained database for all patients who underwent CCH at our institution from 2013 through the present. We specifically identified those who completed four series of CCH (or elected to discontinue prior to completing four series due to satisfactory penile straightening or lack of results) and had available curvature assessment data. Treatment outcomes were broken down by level of curve improvement (0%, 10%, 20%, 30%, and &amp;gt; 40% improvement). Treatment success was also evaluated by improvements in the ability to engage in penetrative sexual intercourse and perceived surgery avoidance. Statistical analyses were performed using JMP Pro 14.1.0 (SAS Institute, Cary, NC). Results 127 patients had complete data available. The mean age was 57 years (SD 8.4). The mean PD duration was 27 months (SD 59). The mean baseline curvature was 66.1O, and the mean post-treatment curvature was 45.1O (p&amp;lt;0001). The mean curvature improvement was 32% (SD 33). 68% of patients achieved a 20% or greater improvement in penile curvature, including 38% who achieved ≥ 40% improvement. 72% (n=48/67) felt that CCH prevented the need for surgery, and 68% reported CCH restored the ability to penetrate. Stretched flaccid penile length (SPL) increased by ≥ 1 cm in 50% of patients who used concurrent penile traction (PTT) and CCH, including 28% of patients who experienced ≥ 2 cm of length gain. In contrast, only 16% of patients who did not perform concurrent PTT had a ≥ 1 cm increase in SPL (p&amp;lt;0.0001). Conclusions CCH may restore the ability to penetrate with intercourse, and most patients feel that CCH prevents the need for surgery. Almost 40% of patients experienced a 40% or greater curvature improvement. However, 13% of patients may go through the entire series with minimal improvement. Concurrent PTT allows for simultaneous penile length gain in some patients. These data are helpful when counseling patients on expected outcomes. Disclosure No

Incremental Treatment Response by Cycle With Collagenase Clostridium Histolyticum for Peyronie's Disease: A Pooled Analysis of Two Phase 3 Trials

OBJECTIVETo evaluate cumulative and incremental changes in penile curvature after each treatment cycle of collagenase clostridium histolyticum (CCH) in men with Peyronie's disease (PD). METHODSData from 2 phase 3, randomized, placebo-controlled trials were analyzed post hoc. Treatment was administered in up to 4 treatment cycles (per cycle: 2 injections, 1-3 days apart, of CCH 0.58 mg or placebo; subsequent penile modeling) at 6-week intervals. Penile curvature was measured at baseline and after each treatment cycle (weeks 6, 12, 18, and 24). Successful response was defined as ≥20% reduction from baseline penile curvature. RESULTSOverall, 832 men (CCH, n = 551; placebo, n = 281) were included in the analysis. After each cycle, mean cumulative percent reduction from baseline penile curvature was significantly greater with CCH vs placebo (P <.001). Following one cycle, 29.9% of CCH recipients exhibited a successful response. Among nonresponders, additional cycles of injections led to further successful responses: 60.8% of first cycle failures achieved response after fourth cycle (8 injections), 42.7% of cycle 1-2 failures achieved response after fourth cycle, and 23.5% of cycle 1-3 failures achieved response after fourth cycle. CONCLUSIONData showed incremental benefits from each of the 4 CCH treatment cycles. Completion of a full series of 4 CCH treatment cycles may optimize improvements in penile curvature in men with PD, including among those who did not clinically respond to previous treatment cycles.

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.

Predictors of Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum

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. To identify predictor factors associated with improvements of penile curvature outcomes in men with PD treated with CCH. 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. Degrees of the curvature changes between the baseline and after the cycles of CCH. 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). 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. 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. Penile curvature improvement was significantly more common in patients with greater baseline curvature, reaching up to 60% for patients with ≥ 60 degrees.

Penile Modeling in Peyronie's Disease: A Systematic Review of the Literature.

Penile modeling to correct the penile curvature in Peyronie's disease (PD) may be achieved manually (intra-operatively or post-injection) or by using assisted devices (penile traction, vacuum device, or penile prosthesis). To evaluate the efficacy, safety, and satisfaction associated with penile modeling in patients with PD. A PROSPERO registered (CRD42021241729) systematic search in MEDLINE and Cochrane Library was done following PRISMA. PICO: Studies were deemed eligible if they assessed patients with PD (P) undergoing modeling procedures (I) with or without a comparative group(C) evaluating the efficacy, safety, or patient satisfaction (O). Retrospective and prospective primary studies were included. The primary outcome measure is the change in penile curvature after modeling. The secondary outcome measures are the change in stretched penile length, adverse events, and patient satisfaction after modeling. A total of 23 studies, involving 1,238 patients were included. Most studies (13, 56.5%) evaluated penile traction therapy. The studies were of low and intermediate quality (mean Newcastle-Ottawa Scale score of 5.7 and mean Jadad score of 3.3) with a mean level of evidence of 3.4. The mean penile curvature at baseline was between 31 and 80.8 degrees. Nine (39.1%) studies found a significant improvement (P < .05) of penile curvature after penile modeling, ranging between 11.7, and 37.2 degrees. An increase in mean stretched penile length was reported in 7 (30.4%) articles, varying between 0.4, and 1.8 cm. Serious complications such as penile prosthesis malfunctions (3.3-11.1%) and urethral injuries (2.9%) were only reported for intra-operative manual modeling. Although individual studies have noted improvement in penile curvature and stretched penile length, specific recommendations regarding penile modeling in PD cannot be provided due to limited evidence available. Further RCTs with adequate sample size, validated assessment tools, and longer follow-up are needed. Krishnappa P, Manfredi C, Sinha M etal. Penile Modeling in Peyronie's Disease: A Systematic Review of the Literature. Sex Med Rev 2022;10:427-443.

A systematic review of modeling in Peyronie's Disease

ABSTRACT Introduction Penile modeling to correct the penile curvature in Peyronie's disease (PD) may be achieved manually (intra-operatively or post-injection) or by using assisted devices (penile traction, vacuum device or penile prosthesis). To the best of our knowledge this is the first systematic review of the literature comprehensively evaluating penile modeling procedures. Objective To evaluate the efficacy, safety and satisfaction associated with penile modeling in patients with PD. Methods A PROSPERO registered (CRD42021241729) systematic search in MEDLINE and Cochrane Library was done in accordance with PRISMA. PICO: Studies were deemed eligible if they assessed patients with PD (P) undergoing modeling procedures (I) with or without comparative group(C) evaluating the efficacy, safety or patient satisfaction (O). Results A total of 23 studies, involving 1,238 patients were included in the systematic review. The majority (n=13) studied penile traction therapy and the least being manual modeling at home and manual modeling after collagenase injection (1 each). The studies were of low and intermediate quality (mean Newcastle-Ottawa Scale score of 5.7 and mean Jadad score of 3.3) with a mean level of evidence of 3.4. The mean penile curvature at baseline was between 31 and 80.8 degrees. Nine (39.1%) studies found a significant improvement (p&amp;lt;0.05) of penile curvature after penile modeling, ranging between 11.7 and 37.2 degrees. A increase in mean stretched penile length was reported in 7 (30.4%) articles, varying between 0.4 and 1.8 cm. Serious complications such as penile prosthesis malfunctions (3.3%-11.1%) and urethral injuries (2.9%) were only reported for intra-operative manual modeling. Conclusion Although individual studies have noted improvement in penile curvature and stretched penile length, specific recommendations regarding penile modeling in PD cannot be provided due to the inability to perform a pooled analysis of the included studies with significant heterogeneity and the absence of standardized methods to report complications and patient satisfaction. Further RCTs with adequate sample size, validated assessment tools and longer follow-up are needed. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific).

Efficacité et tolérance des traitements locaux en injections pour le traitement de la maladie de La Peyronie : revue de la littérature

To assess the efficacy and safety of local injection used to reduce penile curvature in Peyronie's disease.A review of the literature was carried out according to the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) on the Medline database in April 2020, with the research: "collagenase"[All Fields] OR "Interferon"[All Fields] OR "verapamil"[All Fields] OR "betamethasone"[All Fields] OR "hyaluronic acid"[All Fields] OR "Platelet-Rich Plasma"[All Fields] OR "Stem Cells"[All Fields] AND "peyronie's"[All Fields] AND Controlled Clinical Trial[ptyp]. Only controlled studies with placebo group were included in this review.Of the 35 articles identified, 6 placebo-controlled studies were finally included. Intra-plaque injections of verapamil did not show improvement in penile curvature. Injections of interferon α 2b and clostridium histolyticum collagenase allowed a statistically significant improvement in terms of curvature reduction: 13.5 versus 4.5 degrees P<0.01) and 17 versus 9.3 degrees P<0.0001 respectively. However, interferon α 2b is not available in France for Peyronie's disease and clostridium histolyticum collagenase is no longer authorized since March 1, 2020. No controlled studies are available on corticosteroids, hyaluronic acid, platelet-rich plasma or stem cells injections.To correct the deformity in Peyronie's disease in the chronic phase, there is no effective solution currently available in France based on controlled studies. Surgery retains its place for the correction of a curvature of at least 30° associated with a sexual handicap in the stable phase, however at the cost of potential adverse effects. Stem cell or Platelet-Rich Plasma injection might be an injectable therapeutic alternative but need controlled studies.

Augmenting Intralesional Collagenase Treatment with Testosterone Therapy Provides Greater Self-Assessed Improvement in Penile Curvature due to Peyronie's Disease

Introduction: Testosterone (T) deficiency has been reported to be associated with Peyronie's disease (PD). This study investigated response rates to intralesional injections of collagenase clostridium histolyticum (Xiaflex™) (CCx) for penile curvature in men who simultaneously received T therapy (TTh) and in men who received CCx without TTh. Methods: Search of electronic records identified all men treated with CCx from 2013 to 2018, and whether they also received TTh during that time. Laboratory results for baseline serum T, free T, and luteinizing hormone were available for all men. Response to CCx was categorized as no change, mild change, substantial change, or complete resolution based on subjective reports by patients. Results: A total of 117 men received treatment with CCx. Of these, 72 received CCx alone (henceforth referred to as XA group) and 45 received CCx plus TTh (referred to as XT group). Mean baseline serum T was 458 ng/dL for the XA group and 384 ng/dL for the XT group (p = 0.10). Mean age was 60.4 years for the XT group and 56.5 years for the XA group (p = 0.028). Baseline mean curvature was 46° for the XA group and 45° for the XT group. Mean number of treatment cycles (two injections per cycle) was 2.7 for both groups. Overall, 67.5% reported some improvement in curve with CCx. Reports of any improvement were 84.4% for the XT group and 56.9% for the XA group (p < 0.001). Conversely, rates of no improvement were 15.6% for the XT group and 43.1% for the XA group. Substantial improvement or complete resolution of curve was noted by 48.8% of the XT group and 20.8% of the XA group (p = 0.001). Conclusions: These pilot observational results suggest that TTh may improve the response to intralesional CCx treatment of PD. A prospective study is warranted to investigate this further.

MP33-14 CLINICAL OUTCOMES OF PATIENTS WITH ATYPICAL PEYRONIE’S DISEASE UNDERGOING INTRALESIONAL XIAFLEX INJECTIONS

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie's Disease (MP33)1 Apr 2020MP33-14 CLINICAL OUTCOMES OF PATIENTS WITH ATYPICAL PEYRONIE’S DISEASE UNDERGOING INTRALESIONAL XIAFLEX INJECTIONS Farouk M. El-Khatib*, Mohamad M. Osman, Linda M. Huynh, Maxwell Towe, and Faysal A. Yafi Farouk M. El-Khatib*Farouk M. El-Khatib* More articles by this author , Mohamad M. OsmanMohamad M. Osman More articles by this author , Linda M. HuynhLinda M. Huynh More articles by this author , Maxwell ToweMaxwell Towe More articles by this author , and Faysal A. YafiFaysal A. Yafi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000877.014AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Peyronie’s disease (PD) is an acquired condition typically characterized by plaque formation and dorsal/lateral penile curvature. Atypical PD is a term used to describe less common PD presentations such as ventral curvature, multiplanar curvature, penile indentation and hourglass deformity. We sought to assess the outcomes of patients presenting atypical PD presenting to a men’s health clinic and treated with Xiaflex. METHODS: We conducted a retrospective review of charts of men who presented to one clinic with atypical PD between October 2016 and June 2019. Patients were included if they were considered to be in the stable phase of the disease and had completed a Penile Duplex Doppler Ultrasound (PDDU) prior to any intervention. Gathered data included patient demographics and treatment details, outcomes and complications. Patients presenting with indentation or hourglass deformity were asked to answer the symptom bother domain of the Peyronie’s Disease Questionnaire (PDQ) and were scored on a scale of 0-16 before and after treatment. Offered treatments included intralesional injection of Xiaflex, tunical plication, partial excision and grafting and insertion of inflatable penile prosthesis. Men who received Xiaflex injections as a treatment were only included in this study. RESULTS: During this period, 93 men with stable PD underwent PDDU, 61/93 (65.6%) were found to have atypical PD. Overall, 37/61 (60.7%) opted for treatment 21/37 (58.3%) chose Xiaflex: 5, 6, 17 and 5 had ventral curvature, multiplanar curvature, indentations and hourglass deformity respectively. The mean number of Xiaflex injections used was 8.4±3.3. 80.0% of responders said they would pursue this treatment again. There was 1 penile fracture which required surgical repair. Full results can be seen below in table 1. CONCLUSIONS: Patients with atypical PD represent a significant proportion of men with PD and Xiaflex demonstrates favorable improvements in penile curvature and bother score in such cases. Outcomes with Xiaflex in patients with atypical PD are comparable to those reported in the IMPRESS trials. Source of Funding: none © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e499-e500 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Farouk M. El-Khatib* More articles by this author Mohamad M. Osman More articles by this author Linda M. Huynh More articles by this author Maxwell Towe More articles by this author Faysal A. Yafi More articles by this author Expand All Advertisement PDF downloadLoading ...

Long-term patient-reported outcomes in men with Peyronie's disease undergoing nonsurgical and nonintralesional injection management.

Peyronie's disease (PD) has a negative impact on overall quality of life for many patients and their partners. There is a significant portion of patients who elect noninvasive therapy and in this scenario we have little data with which to counsel patients. We aim to evaluate long-term patient-reported outcomes in a cohort of men with PD who elected conservative treatment. We identified all males with a diagnosis of PD evaluated at our institution by a single provider between May 2012 and January 2018. We excluded men who were <18 years old or had undergone surgical or intralesional injection (ILI) treatments. A PD-specific questionnaire was sent to those who met our inclusion criteria. 88/514 patients completed the survey and met the inclusion criteria. Penile curvature subjectively improved in 49%, remained stable in 34%, and worsened in 17%. Penile shortening was reported in 89% of patients. Penile shortening subjectively improved in 27%, remained stable in 59%, and worsened in 14%. Roughly 60% reported worsened intercourse satisfaction and erectile function. 60% reported that PD had negatively impacted their self-esteem and 69% felt that PD negatively impacted their sexual partner. Patients who utilized penile traction therapy (PTT) were significantly more likely to report improvements in penile curvature, shortening, and ability to engage in penetrative intercourse. Our survey provides important data on patient-reported outcomes in men with PD electing nonsurgical and non-ILI interventions. Although 49% of men noted at least a mild subjective improvement in their curvature over time, a majority had declining erectile function, decreased intercourse satisfaction, and psychosocial distress. These data can be used when counseling patients with a new diagnosis of PD who are considering treatment options.

Medical Management of Peyronie’s Disease: Review of the Clinical Evidence

Peyronie’s disease is a condition that causes abnormal healing of the tunica albuginea, causing penile curvature. It is difficult to treat and its management is continuing to evolve. Proposed non-surgical treatments have included oral, topical, intralesional, extracorporeal shockwave, and traction therapy. The study of Peyronie’s disease is made difficult by heterogeneity in the timing of presentation, severity and characteristics of deformity, and associated complaints. Moreover, meta-analyses of studies are difficult due to inconsistencies across study endpoints and the duration of treatments. This article reviews the current clinical evidence and guideline recommendations, with a focus on an improvement in penile curvature.

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.

Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls in penile length (1.5 vs 0 cm, p <0.001), curvature (-11.7 vs 1.3 degrees, p <0.01) and erectile function (4.3 vs -0.7, p = 0.01) according to the International Index of Erectile Function-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.

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

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