Peyronie's Disease Patients Research Articles

Comment on: Penile prosthesis implantation is safe and effective in Peyronie's Disease patients with and without erectile dysfunction.

Comment on: Penile prosthesis implantation is safe and effective in Peyronie's Disease patients with and without erectile dysfunction.

Combining ultrasound and elastography for the detection of a non-palpable, non-sonographically visualized Peyronie's plaques. Our experience.

B-mode ultrasound (US) medical imaging is very effective in localizing and describing Peyronie's disease (PD). Moreover, elastography is a new technique used to evaluate tissue elasticity to detect penile Peyronie's plaques that are not visible using standard B-mode US. The main objective of this study was to evaluate the diagnostic efficacy of real-time elastography (RTE) in PD patients and to determine whether its combined use with standard US improved diagnostic accuracy. RTE is also known as strain elastography (SE). Additionally, this study aimed to assess whether RTE was useful for monitoring PD patients undergoing conservative treatment. A group of 37 PD patients in the active phase was selected based on US examination showing isoechoic or hypo-isoechoic plaques, with or without associated hyperechoic or calcified plaque areas. All patients underwent traditional US combined with RTE before starting conservative treatment with antioxidants, during treatmentand after treatment. After each examination with RTE, a specific "Strain Ratio"(SR) was used to identify the specific elasticity of the tissue. Using B-mode US with RTE, we detected all 13 non-palpable penile plaques present in the 37 PD patients (100% of cases). Using only B-mode US, we detected only 8 of the 13 non-palpable plaques (61.5% of cases). The DI of the plaque decreased during and after treatment in all cases, indicating that RTE is effective for monitoring conservative PD treatment. A statistically significant correlation was found between the DI and plaque volume in all patients (p=0.002). Our study has shown that the combination of US and RTE methods allowed for a more accurate diagnosis in PD patients.

Response to comment on: penile prosthesis implantation is safe and effective in Peyronie's disease patients with and without erectile dysfunction.

Response to comment on: penile prosthesis implantation is safe and effective in Peyronie's disease patients with and without erectile dysfunction.

Penile curvature severity in patients with Peyronie's disease does not correlate with dynamic color doppler duplex ultrasound parameters: findings from a real-life cross-sectional study.

There is inconsistent data regarding the possible inaccuracies in dynamic penile color Doppler duplex ultrasound (CDDU) measurements in men with penile curvature because of Peyronie's disease (PD). We sought to explore the relationship between the degree of penile curvature and CDDU parameters in men with PD. Comprehensive data from 154 consecutive men presenting with PD as their primary complaint at a single academic center were prospectively collected and analyzed. All men underwent CDDU. Penile curvature was measured using a goniometer at time of maximum erection during CDDU. Patients were grouped based on CDDU parameters into-normal (average peak systolic velocity [PSV] ≥ 35cm/s and resistance index [RI] ≥ 0.85) and pathological CDDU (average PSV<35cm/s and/or RI<0.85). Descriptive statistics was used to compare the two subcohorts. Linear regression models were fitted to explore the association between the degree of penile curvature and dynamic CDDU parameters. Overall, the median interquartile range (IQR) age was 56 (48-63) years. The median (IQR) PSV and degree of penile curvature were 48.8cm/s (37.9-58.5) and 40 degrees (30-60), respectively. At CDDU, the degrees of penile curvature were as follows: 10-30 degrees in 63 (40.9%) men, 30-70 degrees in 70 (45.5%) men, and 70-90 degrees in 21 (13.6%) men, respectively. Of all, 116 (75.3%) patients showed a PSV>35cm/s and RI ≥ 0.85. Patients with pathologic vs. normal CDDU parameters did not differ in median (IQR) curvature (32.5° [30°-58.7°] vs. 40° [30°-65°], p=0.5) or in the distribution across curvature range groups. Linear regression analysis revealed that the degree of penile curvature did not significantly correlate with PSV at CDDU (coefficient: 0.06, p=0.3). Our study confirms the lack of a significant correlation between the severity of penile curvature and CDDU parameters in men presenting with PD. These findings emerge to be relevant in terms of a more accurate management work-up for PD patients and hold insightful medicolegal implications and in the real-life setting.

Penile prosthesis implantation is safe and effective in Peyronie's disease patients with and without erectile dysfunction.

Penile prosthesis (PP) is the mainstay of treatment in Peyronie's disease (PD) with co-existent refractory erectile dysfunction (ED). This study aimed to assess the clinical outcomes of patients who underwent PP as the first-line surgical treatment in PD without ED. A total of 636 patients underwent PP for PD from 2012 to 2022, but only 168 patients who underwent PP as first-line surgical management for PD with or without ED were included in the study. The mean (SD) age of 168 patients was 56.3 years (12.4). The mean curvature of the "PD with ED" group and the "PD without ED" group were 38.2 (5.6) degrees and 42.2 (5.9) degrees. The median (IQR) follow-up was 56.0 months (34.5- 61.4). Most (86.9%) patients underwent 3-piece inflatable PP. An important finding is that 33 patients (19.6%) without ED had undergone PP. Mechanical failure requiring revision surgery was less common in the 'without ED' group than in the ED group (6.8% vs. 10.2%, p 0.04). Most PD patients without ED (87.9%, 29/33) and with ED (88.9%, 120/135) were "satisfied" after PP implantation at six months, as defined by a score of ≥4 on a 5-point Likert scale. If surgery is offered in PD, PP may be considered a safe and effective first-line surgical treatment regardless of the ED, given the acceptable complications and high satisfaction rates. However, this new concept warrants further research.

Clinical Presentation of Peyronie's Disease: A Retrospective Study of 564 Cases.

Peyronie's disease (PD) affects the penile albuginea, resulting in penile deformity, pain, erectile dysfunction (ED), and an anxious-depressive state. PD diagnosis involves a thorough medical history, penile palpation, documentation of the penile deformation, a dynamic penile echo color Doppler ultrasound (PCDU), and the completion of questionnaires for the evaluation of pain, ED, and psychometric tests. The aim of this study was to evaluate the symptoms of PD and their prevalence in PD patients in the active phase who had access to our andrology clinic. Inclusion criteria: availability of data on patients diagnosed with PD, including detailed medical history, blood tests, penile palpation, photographic documentation of penile deformity, and penile PCDU. Exclusion criteria: PD patients in the stable phase or those without the specified tests and data mentioned above. Our study found a higher prevalence of PD in younger patients (24.2%), a higher coexistence of PD with chronic prostatitis (35.6%), a higher percentage of cases of association between penile deformity and penile curvature (84.4%), a higher prevalence of "significant anxiety" (88.4%), a higher presence of plaque calcification (35.6%), and the detection of a longer duration of the first phase of PD (>18 months). The most frequently observed type of penile curvature was dorsal, followed by left lateral, right lateral, and, less commonly, ventral. We observed a significant statistical correlation between patient age and IIEF score, indicating that patients over the age of 40 years are at a higher risk of experiencing ED. We found a strong statistical relationship between VAS score and age. As age increases, the VAS score decreases, suggesting that younger patients reported more penile pain compared to those who were older than 40 years. Furthermore, we found that penile pain has a significant impact on the psychological state of PD patients. We also found that 38.8% of PD patients suffered from severe anxiety. In relation to this, psychotherapy should be integrated into PD treatment to improve the quality of life and treatment adherence.

TGF-β1 induces formation of TSG-6-enriched extracellular vesicles in fibroblasts which can prevent myofibroblast transformation by modulating Erk1/2 phosphorylation

Extracellular vesicles have emerged as important mediators of cell-to-cell communication in the pathophysiology of fibrotic diseases. One such disease is Peyronie’s disease (PD), a fibrotic disorder of the penis caused by uncontrolled transformation of resident fibroblasts to alpha-smooth muscle actin positive myofibroblasts. These cells produce large amounts of extracellular matrix, leading to formation of a plaque in the penile tunica albuginea (TA), causing pain, penile curvature, and erectile dysfunction. We have used primary fibroblasts derived from the TA of PD patients to explore the role of transforming growth factor beta 1 (TGF-β1), a key signalling factor in this process. TGF-β1 treatment elicited a range of responses from the myofibroblasts: (i) they secreted extracellular vesicles (EVs) that were more numerous and differed in size and shape from those secreted by fibroblasts, (ii) these EVs prevented TGF-β1-induced transformation of fibroblasts in a manner that was dependent on vesicle uptake and (iii) they prevented phosphorylation of Erk1/2, a critical component in modulating fibrogenic phenotypic responses, but did not affect TGF-β1-induced Smad-signalling. We posit that this effect could be linked to enrichment of TSG-6 in myofibroblast-derived EVs. The ability of myofibroblast-derived vesicles to prevent further myofibroblast transformation may establish them as part of an anti-fibrotic negative feedback loop, with potential to be exploited for future therapeutic approaches.

Extratunical grafting for minimally invasive management of complex Peyronie's disease deformities.

Penile deformities due to Peyronie's Disease (PD) often significantly impair men's sexual health and quality of life. In this article we discuss the extratunical graft (ETG) procedure as a management strategy for PD patients with hourglass or indent penile deformities. We compiled descriptions of surgical techniques and performed a review of the literature regarding ETG for PD. The ETG procedure appears to have promising results in the management of indent/hourglass deformity of PD. The findings of this review of the literature demonstrate that ETG is a safe and effective reconstructive technique for penile deformity with minimal side effects. We recommend utilizing ETG with or without plication for PD patients with indent or hourglass deformities. Strengths of ETG are the improvement in patients with tunical indents and hourglass deformities secondary to PD. Additionally, patients who underwent ETG maintained sexual function given no significant change in penile length and intact erectile function. Limitations, however, are that the procedure is relatively new, and data are limited to small cohorts. The ETG procedure is a safe and effective for management of complex PD in the short- and intermediate-term follow-up cohort.

BMP4 and GREM1 are targets of SHH signaling and downstream regulators of collagen in the penis.

Cavernous nerve (CN) injury, caused by prostatectomy and diabetes, initiates a remodeling process (smooth muscle apoptosis and increased collagen) in the corpora cavernosa of the penis of patients and animal models that is an underlying cause of erectile dysfunction (ED), and the Sonic hedgehog (SHH) pathway plays an essential role in the response of the penis to denervation, as collagen increases with SHH inhibition and decreases with SHH treatment. We examined if part of the mechanism of how SHH prevents penile remodeling and increased collagen with CN injury involves bone morphogenetic protein 4 (BMP4) and gremlin1 (GREM1) and examined the relationship between SHH, BMP4, GREM1, and collagen in penis of ED patients and rat models of CN injury, SHH inhibition, and SHH, BMP4, and GREM1 treatment. Corpora cavernosa of Peyronie's disease (control), prostatectomy, and diabetic ED patients were obtained (N= 30). Adult Sprague Dawley rats (n = 90) underwent (1) CN crush (1-7days) or sham surgery; (2) CN injury and BMP4, GREM1, or mouse serum albumin (control) treatment via Affi-Gel beads or peptide amphiphile (PA) for 14days; (3) 5E1 SHH inhibitor, IgG, or phosphate-buffered saline (control) treatment for 2 to 4days; or (4) CN crush with mouse serum albumin or SHH for 9days. Immunohistochemical and Western analysis for BMP4 and GREM1, and collagen analysis by hydroxyproline and trichrome stain were performed. BMP4 and GREM1 proteins were identified in corpora cavernosa smooth muscle of prostatectomy, diabetic, and Peyronie's patients, and in rat smooth muscle, sympathetic nerve fibers, perineurium, blood vessels, and urethra. Collagen decreased 25.4% in rats with CN injury and BMP4 treatment (P = .02) and increased 61.3% with CN injury and GREM1 treatment (P = .005). Trichrome stain showed increased collagen in rats treated with GREM1. Western analysis identified increased BMP4 and GREM1 in corpora cavernosa of prostatectomy and diabetic patients, and after CN injury (1-2days) in our rat model. Localization of BMP4 and GREM1 changed with SHH inhibition. SHH treatment increased the monomer form of BMP4 and GREM1, altering their range of signaling. A better understanding of penile remodeling and how fibrosis occurs with loss of innervation is essential for development of novel ED therapies. The relationship between SHH, BMP4, GREM1, and collagen is complex in the penis. BMP4 and GREM1 are downstream targets of SHH that impact collagen and may be useful in collaboration with SHH to prevent penile remodeling and ED.

(135) Systematic Review on the Association of Peyronie’s Disease Development and Severity to Testosterone Level: Do we Have Enough Data?

Abstract Introduction Exact pathophysiology of Peyronie's disease (PD) are still poorly known with the combination of tissue ischemia to predefined hereditary variables. Due to the anti-inflammatory factors and ability to regulate collagen metabolism and wound healing, androgens have been the subject of several clinical research studying their role in the onset and severity of PD. Objective The aim of this study is to investigate the relationship between testosterone level to the development and severity of PD. Methods A systematic search on PubMed, Scopus, and Embase was conducted on April 4th, 2023 using the keywords of testosterone, hypogonadism, and Peyronie’s disease. All studies that compare the testosterone levels of the patients with or without PD or evaluate the association of PD severity were considered. Each included studies are evaluated for its quality and risk of bias. Results Eleven studies comprising 1.106 patients with PD and 507 control were included. Three of the four studies examining the association of testosterone level to PD development found that testosterone/DHEA-s levels were lower in the PD group compared to the control. In addition, four of seven studies found that the severity or degree of penile curvature among patients with PD has lower testosterone levels. On contrary, only two of six studies support the correlation of testosterone level to penile plaque diameter. In two studies that confirmed the correlation of penile plaque and degree of curvature to testosterone levels, they also found that PD patients with normal or higher testosterone levels responds better to medical treatment. Conclusions Contemporary literature on the correlation between PD and testosterone levels shows conflicting results. Although around half of the studies support its possible correlation to penile curvature severity, no definitive conclusion can be made. Further research is warranted to seek the impact of low testosterone level to PD and whether it needs to be routinely evaluated in clinical practice. Disclosure No.

(289) Combined Therapy with Low-intensity Shockwave Therapy and Daily PDE5i Showed Better Pain Relieve and Sexual Function Improvement in Acute Phase of Peyronie Disease

Abstract Introduction To compare the efficacy and safety of daily use PDE5i and PDE5i combined with linear low-intensity shockwave therapy (Li-SWT) in the treatment of acute phase of Peyronie disease (PD). Objective 68 patients with acute PD within 6 month onset were collected. The patients were 26–56 years old with an average of 42.3 years. The patients were randomly divided into two groups, 35 of which were orally administered with 5 mg of tadalafil every night for 3 months; the other 33 received 4 times of Li-SWT with daily PDE5i. Li-SWT uses the Renova shock wave therapy device with an energy density of 0.09mJ/mm2, each time 3200 times in the penile plaque, 900 times in the left and right penile shaft, and once a week for 4 consecutive treatments as a cycle. All patients underwent ultrasound or MRI, penile bending angle measurement, improvement of subjective symptoms, and IIEF-5 scale before and after treatment. Methods 68 patients with acute PD within 6 month onset were collected. The patients were 26–56 years old with an average of 42.3 years. The patients were randomly divided into two groups, 35 of which were orally administered with 5 mg of tadalafil every night for 3 months; the other 33 received 4 times of Li-SWT with daily PDE5i. Li-SWT uses the Renova shock wave therapy device with an energy density of 0.09mJ/mm2, each time 3200 times in the penile plaque, 900 times in the left and right penile shaft, and once a week for 4 consecutive treatments as a cycle. All patients underwent ultrasound or MRI, penile bending angle measurement, improvement of subjective symptoms, and IIEF-5 scale before and after treatment. Results In the PDE5i group, the pain symptom relieve were improved in 80% patients (28 of 35 cases), while the combined group (PDE5i+Li-SWT) were improved in 90.9% patients (30 of 33 cases). The IIEF5 score in the PDE5i group improved from 13.8±7.9 to 19.5±8.1 and from 13.4±7.6 to 21.3±9.2 in the combined group, with both improvement between two groups. The plaque size were shrinkage 5 cases in PDE5i group and 12 cases in combined group, but penile curvature did not change significantly in both groups. In the PDE5i group, 5 patients had mild dizziness and back pain, while 3 patients had mild dizziness and back pain in combined group. There was no obvious adverse reaction observed for Li-SWT treatment. Conclusions Both the daily use PDE5i and the PDE5i combined with Li-SWT can improve the symptoms of acute PD patients, mainly to relieve pain and improve erectile function in some patients. The combined group had a better pain symptom relieve rate and more improvement for sexual function. The two methods can reduce PD plaque size in some cases, while both groups did not significantly change penile curvature. Both methods have good safety in the treatment of acute phase PD. Disclosure No.

A phase 2 randomized, placebo-controlled crossover trial to evaluate safety and efficacy of platelet-rich plasma injections for Peyronie's disease: clinical trial update.

Peyronie's Disease (PD) is characterized by fibrotic plaques in the penile tunica albuginea, causing curvature and painful erections. Current treatments have limited established efficacy. Platelet-Rich Plasma (PRP), known for modulating inflammation, offers a potential alternative. This randomized, placebo-controlled, crossover study at the University of Miami assesses PRP's safety and efficacy for PD. Forty-one PD patients were randomized into PRP-placebo (Group A) and placebo-PRP (Group B) sequences, receiving two injections of each treatment over three months, with a crossover to receive two injections of alternate treatment over the next three months. Assessments include pain scale, goniometry, questionnaires, and curvature evaluations. Preliminary analysis of 28 patients shows that PRP is safe. There were no adverse events, including penile complications, during follow-up. Pain scores during treatments showed no significant difference between PRP and placebo (p = 0.52). Over six months, the PRP-Placebo group's median PDQ score decreased from 1.9 (IQR: 1.7-2.9) to 1.4 (IQR: 0.7-2.1). This change was not statistically significant (p = 0.098). In contrast, the Placebo-PRP group showed a significant reduction from 1.8 (IQR: 1.4-2.6) to 1.2 (IQR: 1.0-2.0) (p = 0.020). No significant changes in IIEF scores were observed. Both groups initially had a median penile curvature of 40 degrees. At 3 months, the PRP-Placebo group's curvature decreased to 38 degrees (IQR: 35-47.5), while the Placebo-PRP group decreased to 35 degrees (IQR: 30-60). At 6 months, the PRP-Placebo group showed a significant reduction to 25 degrees (IQR: 20-40, p = 0.047), while the Placebo-PRP group's reduction to 32.5 degrees (IQR: 20-50) was not significant (p = 0.490). These early results indicate a delayed PRP effect, prompting further investigation into its long-term impacts. Although limited by sample size, this study suggests PRP injections as a safe treatment for PD, with ongoing research aiming to clarify its therapeutic value.

Plication surgery does not produce additional loss of length in Peyronie's disease patients.

Nesbit's procedure remains a cornerstone in surgical management of Peyronie's disease, despite the subjective loss of penile length. This retrospective study demonstrates that the perceived length loss has already occurred prior to surgery and that the Nesbit's procedure does not produce additional loss of length. Ninety-one patients who had undergone Nesbit's procedure between 2017 and 2022 at the Department of Urology of the University of Trieste were enrolled in the study. Preoperative stretched penile length and postoperative stretched penile length were measured. The curvature was uniplanar in 78 patients and biplanar in the remainder. Mean degree of the main curvature was 52.58° ± 14.13° and mean number of plications was 2.42 ± 1.07. Analysis revealed that the median of the differences between preoperative stretched penile length and postoperative stretched penile length was not significant (p = 0.466). According to our results, no significant penile shortening occurs as immediate consequence of Nesbit's procedure, as length is defined by the shorter side of the shaft affected by Peyronie's disease. Hence the length loss should have to be attributed to Peyronie's disease itself and could have been accurately predicted preoperatively allowing for a more accurate counseling of patients. Further studies are pending to assess potential postoperative loss of length due to scarring contracture.

(117) Interrater Agreement and Feasibility of Three-Dimensional Photography for Curvature Assessment in Peyronie's Disease

Abstract Introduction Curvature assessment is an iterative aspect of the evaluation of Peyronie’s Disease (PD); its accuracy is subject to patient erection quality and clinician technique. Prior studies have shown promising results when using 3D modeling software in curvature assessment, yet none have applied the technology to human subjects with complex PD in an authentic clinical scenario. Objective To evaluate the feasibility of using 3D modeling to assess penile deformity in PD patients. Methods MirrorMe3D is a HIPPA-compliant iOS mobile and web-based platform designed for 3D anatomical modeling. 2 trained urology fellows (coders 1 and 2) were trained to create models using the app by acquiring ≥ 12 images of the target obtained in a multiplanar, 360-degree fashion. Participants verbally consented to deidentified penile photography during their clinic visit for penile curvature assessment with Doppler ultrasound (CADUS). Photographs were obtained prior to performing DUS with the patient in the supine position and using a commercially available clip-on ring light and custom 3D-printed holder device placed over the penis base for stabilization. 3D models were generated upon completion of the visit and screened for quality. Curvature assessment on the 3D images included curvature direction, location, degrees, and other defects identified via visual inspection of the digital model. Results 7 unique, quality 3D images were generated using 15-20 photos per participant (Figure 1). The time required to obtain images was 1-2 minutes. Once the 3D image was developed, the curvature assessment took about 5 minutes. Quantitative results are summarized in Table 1. We observed a high rate of agreement in terms of primary direction of curvature and an acceptable variance rate when evaluating degrees of curvature within a margin of 10°; of note, coders were in agreement with each other to within a 10° margin 100% of the time (7/7 patients). We also observed a high agreement rate when evaluating the presence of absence of tapering but low agreement when assessing for the presence of indentation and hourglass deformity. Regarding the penis stabilizer, our experience suggests that it may alter the base of the penis anatomy, but it improves capture of the organ with diminished interference from surrounding anatomy (scrotum, abdomen). Factors influencing the quality of the image were exam room set-up, patient anxiety about losing an erection, lighting, and body hair. Conclusions 3D image-based PD assessment can be implemented with minimal impact to visit efficiency. The 3D technique does not appear to reproduce complex PD measurements obtained by CADUS; however, future studies will evaluate the utility of employing this technology to a larger cohort and also to monitor treatment effect in complex PD patients. Disclosure No.

(171) The Effects of Pretreatment with Xiaflex on Penile Curvature Correction with Manual Modeling During and After IPP placement

Abstract Introduction There are a variety of treatment modalities available to treat Peyronie’s disease (PD), including collagenase clostridium histolyticum (Xiaflex) injections. Patients with concomitant erectile dysfunction (ED) and PD are best served by insertion of an inflatable penile prosthesis (IPP) in order to adequately treat both conditions. Many PD patients may undergo other PD treatments, including Xiaflex, prior to IPP implantation. There are multiple methods of curvature treatment during IPP surgery, and manual modeling is the predominant method in our practice. Little data exists regarding whether Xiaflex treatments prior to IPP placement influence changes in penile curvature during and after IPP surgery with manual modeling. Objective The primary objectives were assessing the impact of pre-treatment with Xiaflex on penile curvature immediately after IPP implantation and after manual modeling. The secondary objective was change in penile curvature post-operatively. Methods All IPP patients with known preoperative penile curvature with and without a history of Xiaflex injections undergoing IPP placement by a single surgeon from January 2017 to June 2023 were included in this IRB-approved (IRB 00031589) retrospective series. All patients had a 3-piece Coloplast Titan Touch IPP (Coloplast, Minneapolis, MN, USA) ranging 16-24cm in length (mean 19.8 ± 1.9cm) with 0-3cm rear tips (mean 1.4 ± 0.9cm). Goniometer was used to assess curvature during preoperative intracavernosal injection and duplex Doppler ultrasound, at multiple points intraoperatively, and postoperatively at 2 weeks, 6 weeks, and 6 months. Biplanar curvatures were recorded as primary and secondary values. SPSS (IBM, Armonk, NY, UA) was used for statistical analyses, which included t-tests, chi-squared tests, and ANOVA. Results Sixty-one patients were included. Preoperative curvature was 35° ± 17° (10° to 70°) for the Xiaflex cohort (n=11) and 41° ± 15° (20° to 80°) for the Xiaflex naïve cohort (n=50). At the time of IPP placement, patients previously treated with Xiaflex had a 19° ± 12° absolute reduction in primary penile curvatures, corresponding to a 45% ± 36% improvement (25° reduction to 5° worsening), while Xiaflex naïve patients had a 20° ± 13° absolute reduction and 54% ± 23% improvement (50° reduction to no change). Similar mean curvature reductions were seen with IPP placement in primary dorsal curves in the Xiaflex cohort (n=7, 21° ± 4°, 51% ± 12%, 25° to 15° reduction) and Xiaflex naïve cohort (n=24, 21° ± 9°, 51% ± 22%, 40° to 5° reduction). There was little difference in change in curvature after modeling between the Xiaflex (11° ± 3°, 63% ± 23%, 15° to 5° reduction) and Xiaflex naïve patients (14° ± 9°, 70% ± 20%, 40° reduction to 5° worsening). Interval assessments postoperatively were also comparable. Sample size precluded assessment of statistical significance among groups. Conclusions Preoperative treatment of PD with Xiaflex does not impede nor significantly improve curvature correction with IPP implantation and manual modeling. Similar changes in penile curvatures were seen in both groups regardless of curvature direction, modeling, or postoperative interval. In patients with severe PD, Xiaflex may be a useful tool to improve preoperative penile curvatures such that they may be more easily correctable with an IPP. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, MenMD.

(119) Impact of Ethnicity on Clinical Outcomes of Intralesional CCH in Peyronie's Disease Patients Across Kaiser Permanente Southern California Database

Abstract Introduction Intralesional CCH injection is an effective treatment for Peyronie’s disease (PD) that utilizes collagenolytic enzymes to break down collagen plaque, thus reducing the penile deformity. The IMPRESS I and II clinical trials demonstrated efficacy of CCH in a predominant Caucasian population of men (95.8%). Little is known about treatment efficacy in the non-Caucasian population. Objective Using Kaiser Permanente’s ethnically diverse database, we sought to study the impact of race on CCH treatment outcomes. Methods This study examined the efficacy of intralesional CCH injection in a large healthcare system over 15 years. We defined treatment efficacy as percent change in penile curvature abnormality from baseline after a maximum of 4 treatment cycles. Impact of comorbidities on CCH efficacy was also examined. Patients with ventral curvature or initial curvature &amp;lt;30 ̊ or &amp;gt;90 ̊ were excluded from analysis. Standard statistical analysis was performed. Results 112 patients underwent CCH therapy and were included in this analysis. 46.4% of men completed all 4 cycles. Among men who received CCH, 66.1% were Caucasian, 22.3% Hispanic, and 9.8% African American. For co-morbidities, 87.5.% of men were not diabetic, while 22.3% of men had erectile dysfunction. The mean baseline pre-injection penile curvature was 51.63 degrees (range was 32-87 degrees). Caucasian men had the largest treatment response to CCH (45.6% decrease in penile curvature) compared to African American men (43.7%) and Hispanic men (40.5%), p = 0.9554. Non-diabetic men had a larger treatment response to CCH (44.9% decrease in curvature versus 39.3% in diabetics, p = 0.4726). Younger Men (age 18-44) also experienced a greater treatment response compared to other age groups (57.9% reduction in curvature, p = 0.171). There was a significant difference in number of cycles completed across different ethnicities (p = 0.0220). Hispanic men were significantly less likely to complete all 4 cycles of CCH compared to Caucasian and African American men (p=0.0004). Only 28.2% of Hispanic men completed all 4 treatment cycles. 48% of Hispanic patients report the need of language interpretation services during health appointments. Conclusions This is the largest post-market analysis of CCH treatment outcomes in a racially diverse PD population. Caucasian men had a greater treatment response after CCH injection possibly due to higher rate of completing all 4 treatment cycles. Nondiabetic men and younger men (aged 18 to 44) also had a greater treatment response after CCH injection. Hispanic men were significantly less likely to complete 4 cycles of injection therapy; possible explanations include language barriers. Future study is needed to determine if patient resources prepared in Spanish can improve treatment outcomes in Hispanic men with PD, and reduce these health care disparities observed in our study. Disclosure No.

(168) Downgrading Surgical Recommendations After Intralesional Injections of Collagenase Clostridium Histolyticum in Peyronie’s Disease Patients

Abstract Introduction After patients undergo intralesional injections of collagenase clostridium histolyticum (CCH) as a primary treatment for Peyronie’s disease (PD), they may have residual curvature and may opt for secondary treatment with surgery. On the other hand, the initial severity of curvature may be best addressed by plaque incision and grafting (PIG), but the surgeon may offer CCH with the intent that post-CCH curvature can be treated with a penile plication (PP) rather than a PIG. Objective Our study investigated the group of PD patients who had their surgical recommendations downgraded from a plaque incision and grafting (PIG) to penile plication (PP), a less complicated procedure, after receiving CCH. Methods Our retrospective, single institution chart review included patients from 2016 to 2022 who underwent surgery to treat PD. We then looked at patients who underwent CCH then PP, and compared those who were initially recommended PIG before CCH to those who were initially recommended PP. Functional penile length was also evaluated as the length of the erect penis, from the base of the pubis to the tip of the glans, in a straight line while disregarding any curvature. Results Our study included 53 men who underwent surgery for treatment of PD, with mean age 56.0 (SD 11.3) at presentation. Of the 24 patients who underwent CCH, their pre-CCH and post-CCH surgery recommendations were: PP then PP in 5 patients (21%), PIG then PP in 11 (46%), PIG then PIG in 8 (33%) (Figure 1). The PIG then PP recommended group had a pre-CCH primary curvature range of 30 to 64 degrees, and post-CCH range of 16 to 46 degrees (Table 1). These patients had no significant difference in operative duration, difficulty, functional penile length, or complications (Table 2). The PIG then PP recommended group had 5 patients (46%) who reported functional residual curves that were manage conservatively, which was not significantly different from the PP then PP recommended group (0 patients, 0%, p=0.08). Conclusions Intralesional injections of CCH helped to downgrade surgical recommendations from the more drastic PIG to the simpler PP in a subset of PD patients, without compromising operative difficulty or postoperative outcomes. This finding is encouraging given that PP can be performed in a shorter operative time, by less experienced surgeons, and with lower risk of postoperative sensation and erectile issues. Disclosure No.

Phosphodiesterase type 5 inhibitors do not prevent curvature progression but shorten pain duration in the active phase of Peyronie’s Disease: A retrospective cohort study

Treatment with Phosphodiesterase Type 5 inhibitors (PDE5is) has shown promise in managing Peyronie’s disease (PD) during its active phase. In a retrospective cohort study of 133 PD patients, we compared daily PDE5i treatment (sildenafil 25 mg or tadalafil 5 mg) in Group 1 (n = 101) to no treatment in Group 2 (n = 32). The mean age ± SD was 58.5 ± 10, (range: 29-77) years in Group 1 and 59 ± 13.7 years (range: 23-80) in Group 2 (p = 0.5). Mean symptom onset-to-visit time was 10.6 ± 7.2 months (range: 1-37) in Group 1 and 11 ± 6.3 months (range 3-27) in Group 2 (p = 0.5). Mean penile curvature change was +0.87° (95% CI: -1.8, 3.5) in Group 1 and +5.72° (95% CI: 1.4, 10) in Group 2 (p = 0.07) between first and last observations. Group 1 experienced shorter mean pain duration (9.1 ± 4.7 months, range: 2.5-24) than Group 2 (12.2 ± 6.5 months, range: 5-28) (p = 0.04). When controlling for baseline curvature and symptom onset-to-visit time, there were no differences between groups (-4.7, 95% CI: -10, 0.6) (p = 0.08). In conclusion, continuous PDE5i treatment did not affect PD curvature progression but showed a promising effect on pain.

Measurement of Oxidative Stress Index (OSI) in Penile Corpora Cavernosa and Peripheral Blood of Peyronie's Disease Patients: A Report of 49 Cases.

Peyronie's disease (PD) is a chronic inflammatory disease affecting the penile albuginea. Oxidative stress (OS) is important for the development of the disease; therefore, it seemed interesting to us to directly measure OS at both the site of the disease and in peripheral blood. For a precise OS study, it is necessary to evaluate not only the single results of the total oxidant status (TOS) and total antioxidant status (TAS) but also their ratio: OS index (OSI) (arbitrary unit) = TOS/TAS × 100. This study included 49 PD patients examined and diagnosed in our Peyronie's care center and a control group of 50 cases. We collected blood samples from both the penis and a vein in the upper extremity; we used d-ROMs and PAT-test (FRAS kit) for OS measurement. Pearson's study found a statistical correlation between penile OSI values and PD plaque volumes: p-value = 0.002. No correlation was found between systemic OSI values and PD plaque volumes: p-value = 0.27. Penile OSI values were significantly reduced after the elimination of the PD plaque (p < 0.00001). The mean value of the penile OSI indices in the PD patients after plaque elimination corresponded to 0.090 ± 0.016 (p = 0.004). The comparison between the penile OSI values of the PD patients (with plaque elimination) and the control group revealed no statistically significant differences (p = 0.130). The absence of a correlation between Peyronie's plaque volume and systemic OSI values indicates that it is preferable to carry out the OS study by taking a sample directly from the site of the disease. By carrying out a penile OSI study, it would be possible to obtain a precise plaque-volume-dependent oxidative marker. Even if the study did not demonstrate any correlation between OSI indices and anxious-depressive state, we detected a high prevalence of anxiety (81.6%) and depression (59.1%) in PD patients.

The Efficacy and Safety of Low‐Intensity Pulsed Ultrasound Therapy for the Treatment of Peyronie’s Disease (A Report of 106 Cases): A Retrospective Study

Objective: To evaluate the efficacy and safety of low‑intensity pulsed ultrasound (LIPUS) for the treatment of Peyronie’s disease (PD).Methods: To analyze the treatment effect of 106 PD patients, 56 patients treated with LIPUS as therapy group and 50 patients with oral L‐carnitine and vitamin E as control group. 56 patients were treated with LIPUS three times per week for four consecutive weeks (12 times totally). Penile erectile pain, erectile function, the size of penile plaques, and penile curvature were assessed for all of these 106 PD patients before treatment and at 4‐ and 24‐week follow‐ups to evaluate the treatment effect. Erectile pain was assessed by visual analog scale (VAS), while erectile function using the International Index of Erectile Function scale (IIEF‐5), and penile plaque size was measured by ultrasound. After alprostadil was injected into the penile body to induce a full erection, the penis was measured with a protractor at the maximum bending degree.Results: After 4‐weeks follow‐up, the VAS scores of the LIPUS group were significantly lower than the baseline (P &lt; 0.01), while no significant differences were found in the control group (P &gt; 0.05). After 24‐weeks follow‐up, the VAS scores of the control group reduced significantly but also were significantly higher than the LIPUS group (P &lt; 0.01). The IIEF‐5 scores of the LIPUS group were significantly higher than the baseline (P &lt; 0.01). While the IIEF‐5 scores of the control group showed no significant differences both after 4‐ and 24‐weeks follow‐up (P &gt; 0.05). The penile plaque size showed no significant differences after 4‐ and 24‐weeks follow‐up both in the LIPUS group and the control group (P &gt; 0.05). The penile curvature degrees showed a significant reduction after 4‐weeks follow‐up in LIPUS group (P &lt; 0.01). While the penile curvature degrees of the control group showed no significant differences both after 4‐ and 24‐weeks follow‐up (P &gt; 0.05). No complications, such as penile pain, hematoma, or skin ecchymosis, were observed during the entire process of LIPUS treatment, nor did they appear during follow‐up.Conclusions: In patients with acute PD, LIPUS could relieve erectile pain and improve erectile dysfunction. Moreover, it appears not to reduce plaque size and not to have a clinically significant effect on penile curvature. Furthermore, LIPUS also shows a good safety profile during the management of PD and should be recommended for the clinical management of PD.