Hourglass Deformity Research Articles

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.

Surgical management of complex curvature in Peyronie’s disease

PurposeAbout 10% of Peyronie's patients are complex cases with severe curvature (>60 degrees), ventral plaque, multiplanar curvature, hour-glass/hinge deformity, notching deformity, and ossified plaque. In patients with complex Peyronie’s disease (PD), different techniques (shortening procedures, lengthening procedures, and penile prosthesis implantation (IPP)) may be necessary to achieve successful result. This review aims to analyze the various surgical techniques employed in the management of Peyronie's disease, with a specific focus on patients with complex deformity.MethodsArticles focusing on the surgical management of complex curvature in Peyronie’s disease were searched in MEDLINE and PubMed published between 1990 and 2023.ResultsShortening procedures are linked to penile shortening and are not recommended for complex cases such as notching, hour-glass deformity, or ossified plaque. Lengthening procedures are suitable for addressing complex curvatures without erectile dysfunction (ED) and are a more appropriate method for multiplanar curvatures. Penile prosthesis implantation (IPP), with or without additional procedures, is the gold standard for patients with ED and Peyronie's disease. IPP should also be the preferred option for cases of penile instability (hinge deformity) and has shown high satisfaction rates in all complex cases.ConclusionWhile surgical interventions for complex curvature in Peyronie's disease carry inherent risks, careful patient selection, meticulous surgical techniques, and post-operative care can help minimize complications and maximize positive outcome.

(097) 3 Year Follow Up After Modified Grid Incision and Sealing with Collagen Fleece for Treatment of Peyronie’s Disease

Abstract Introduction Previously, we introduced a less invasive modified technique by multiple grid incisions of Peyronie’s plaque. Objective To assess the efficacy of technique in 32 patients with 3 year follow-up. Methods From 2018, 32 patients with stable Peyronie’s disease were included with 3 major steps of surgery; 1) dissection of neurovascular bundle/urethra according to plaque location, 2) multiple deep grid incisions of plaque for complete correction of curvature/deformity, 3) sealing with TachoSil®. Prospectively, the stretched penile length (SPL), totally straightness, penile sono, erectile function at preoperative, and 6, 12, 24, 36 months postoperatively under approval of Institutional Review Board. Results Mean age was 59.2 years (46–72). Mean curvature was 53.5 (40–80) degree, 8 with hinge and 7 with hourglass deformity. IPP was inserted in 4 and 1 at postoperative 30 months for poor erectile function. Mean follow-up was 35.4 months (12–57). Daily massage softened the hard thickening of penis gradually from 3 months until 3 year. On follow-up sonography, subcutaneous thickening gradually decreased to near normal at 1–3 year and tunical breakage by grid incision reunited at postoperative 10–12 months. 2 patients immediately recurred dorsal curvature but most patients achieved totally straightness. Most patients gained preoperative length after 1.6 year. 96% of patients satisfied in GAQ at 2 year. Minor skin problem was occurred in two of IPP. Subcutaneous bulging hematoma was occurred in 3 patients but subsided in two within 3 months. One patients need revision surgery. In postoperative erectile function of 23 patients without IPP, spontaneous hard erection was recovered in 5 and the rest are satisfied with PED5 inhibitors. Conclusions Our prospective progress reports with technical modification of various plaque incisions shows that one can achieve a sufficient surgical effect without making defect of tunica albuginea but need long term follow up for 3 years at best. Disclosure No.

(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.

(224) The Use of an Acellular Dermal Matrix for Peyronie’s Plaque Excision and Grafting

Abstract Introduction The optimal surgical approach for severe Peyronie’s disease (PD) and the ideal grafting material are debatable. Acellular dermal matrices (ADM), among other graft materials that have been reported in the literature, are ideal candidates for graft choice due to the ability to retain structural integrity during the healing process and low immunoreactivity levels. Their use remains novel and only a few small studies have described outcomes of ADM grafting for PD. Objective The current study reports on the largest cohort of patients in the literature undergoing PEG with ADM (FlexHD Pliable). Methods After IRB approval, we reviewed the medical records of all patients undergoing PEG with Flex HD Pliable at our institution between the period of 2014 to 2023. A total of 52 patients with PD underwent PEG with FlexHD Pliable graft, with or without simultaneous inflatable penile prosthesis (IPP) insertion. Preoperative urological assessment of plaque was undertaken using penile color duplex ultrasound (PNUS) and degree of angulation and calcifications were recorded. All patients underwent surgery by a single surgeon. Results Patient’s age was 59.1+/-8.4 (43 to 81) years old. Dorsal curvature was recorded in 46.2% of patients, 23% had lateral, 13.5% had ventral and 17.3 % of patients had a combined curvature. Average penile curvature was 61+/-16 degrees (range 30-90 degrees). Hourglass deformity was recorded in 29.4% of cases; plaque calcification was confirmed on PNUS. The mean time between onset of curvature and surgical treatment was 25±37.9 months (range: 1-204 months). 19.2% patients failed intralesional treatment with Xiaflex prior to surgery and 4% had prior surgical treatment. In 75% of cases, simultaneous IPP placement was performed and in 25% of cases we performed PEG with FlexHD Pliable grafting only. Mean operative time for PEG was 114±22 minutes and simultaneous IPP placement prolonged the average operative time to 147±38 minutes. The average defect size was 21±8.3 cm2 (range: 4-48 cm2). A complete curvature correction was achieved in 90.4% and 9.6% had an average residual curvature of 11.25 °±4.8° (range: 5 ° -15 °). Eight patients (15.4%) reported postsurgical complications. Among them, two patients (3.8%) with altered penile sensation. One patient reported absence of sensation at the tip in the right mid glans; a decreased sensation at the ventral part of the penile shaft was recorded in the second case. There was one case of reactive hydrocele following IPP placement (2%) and five patients (9.6%) developed hematomas: 2 subcapsular graft hematomas required needle aspiration under PNUS guidance, a left spermatic cord hematoma and two penile hematomas that resolved spontaneously. Recurrent curvature onset was recorded in 4 patients (7.7%), but only 2 (3.8%) required re-operation. None of the patients suffered from infection-related complications. Conclusions Our results demonstrate the largest experience with ADM grafting for PD in the literature. PEG with FlexHD Pliable is a safe alternative to other commercially available grafting materials with a low complication rate. In the absence of a gold standard treatment for PD grafting materials, FlexHD Pliable is a practical and valuable option for this surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Irrimax.

(396) Comparing Phone Based 3D Scanning App to In-Office Measurements to Assess Peyronie's Deformity

Abstract Introduction Peyronie’s disease can lead to complex deformity of the penis. Three-dimensional scanning applications available on personal phones like PD Scan from endo pharmaceuticals offer the possibility of better capturing the condition in the privacy of one’s own home and track progress over time. While the application carries a disclaimer of not being FDA approved to diagnose or treat any condition, it may prove to be a useful tool to facilitate communication between the clinician and patient. Objective We sought to evaluate the differences between 3D scans captured on the PD Scan app and office measurements done by a urologist using a goniometer. Methods This study obtained measurements using: (1) a bench-top model penis bent to represent various angles and (2) real patients who were offered to monitor progress through xialfex injections. Goniometer measurements were made by a single urologist and compared to PD Scan measurements. Patients also evaluated ease of use of the app on a lichert-scale of 1-5. Results 26 measurements were obtained comparing urologist obtained goniometer measurements and PD scan software. 10 measurements were patient-generated (4 patients) and 16 measurements were from bench-top model. Primary angle variance range was +/- 15.4 degrees. Patient measurements tended to exceed urologist obtained goniometer measurements (mean difference +9 degrees). Bench model had less variance (mean difference -5 degrees). Patients overall found the app somewhat difficult to use rating it 2/5. We found PD scan useful to better document hourglass deformity and volume loss. Conclusions PD scan software in patient hands tended to overestimate penile angulation compared to office measurements with a goniometer. When used on a bench model, the 3D scan accuracy improved suggesting a user induced variance. This can have implications for tracking progress through xiaflex treatment cycles. Disclosure No.

Postoperative Progress of Deep Grid Incision and Sealing with Collagen Fleece for Treatment of Peyronie's Disease: Prospective Observational Study for 3 Years.

Despite recent popularity, partial plaque excision and sealing with TachoSil has concern about tunica regeneration from graft and lack of long-term results. Previously, we introduced multiple deep grid incisions of Peyronie's plaque to minimize tunical defect with consequent veno-occlusal erectile dysfunction. To assess the efficacy of modified grid incision of plaque and sealing with collagen fleece in postoperative progress of 34 patients for 3 years. From Aug 2018, 34 patients with stable Peyronie's disease (PD) underwent surgery involving three major steps: 1) dissection of the neurovascular bundle or urethra according to plaque location, 2) multiple deep grid incisions of plaque for complete curvature correction, and 3) sealing with collagen fleece without suture. We assessed the stretched penile length, totally straightness, penile sonography, erectile function preoperatively and 3, 6, 12 months and annually postoperatively. This study was approved by the Institutional Review Board. Mean age was 59.4 years (29-72 years). Mean curvature was 53.5 degree (35-100 degree), with hinge and hourglass deformity in 12 and 8 patients, respectively. Five patients required inflatable penile prosthesis (IPP) insertion, with one more at 30 months. The mean follow-up was 42.3 months. Penile rehabilitation, including daily massage, reduced subcutaneous thickening by 12 months postoperatively. All patients initially achieved complete straightness, with two experiencing recurrent curvature. Four patients had subcutaneous hematomas, subsiding in two. Minor skin issues occurred in three IPP patients. Postoperative erectile function was satisfactory in 85.0% of patients. Most regained preoperative length by 1.6 years. Global Assessment Questionniare satisfaction increased from 69.0% at 1 year to 90.0% until 3 years. The modified grid incision with collagen fleece sealing effectively treats PD without causing tunica albuginea defects. Long-term follow-up is essential for monitoring erectile function and penile length recovery, ensuring successful clinical outcomes.

Patients' attitude with surgery for Peyronie's disease: results from a multicentric European study.

Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. To explore the rate and factors influencing patients' willingness to undergo surgery for PD. Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. Patients' willingness to undergo surgery for PD. This study included 343 patients with a median age of 57.3years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. Main limitations are the cross-sectional design and the potential neglect of confounding factors. Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.

The Use of Vacuum Devices as Adjuvant Therapy before and after Penile Curvature Surgery in Patients Affected by La Peyronie's Disease: Results from a Comparative Study.

Peyronie's disease (PD) represents a challenging urological disease, due to not optimal post-operative surgical outcomes. We aim to retrospectively evaluate if vacuum erection device (VED) treatment before penile curvature surgery is able to improve post-operative surgical outcomes. All enrolled patients were assigned to the following groups: (a) the treatment group: VED treatment (three times per week) starting 3 months before surgery and (three times per week) one month after surgery; and (b) the control group: VED treatment (three times per week) one month after surgery. Follow-up urologic visits were scheduled for 3 and 6 months after surgery, and the two groups were compared. A total of 38 patients were enrolled (median age 67 years, 57-74, IQR): 20 in the treatment group and 18 in the control group. At the follow-up visits, the two groups were different in terms of IIEF-5 (26 vs. 24; p = 0.02), "yes" to SEP2 and 3 (85% vs. 55%; p < 0.001, 85% vs. 50%; p < 0.001, respectively), and PDQ (-16 vs. -11; p = 0.03). Complete correction of penile curvature was achieved in 36 patients (94.7%). In the treatment group, no hourglass deformity was reported, whereas one patient reported a mild hourglass deformity in the control group. In the treatment group, we obtained a longer total penile length (median +1.5 cm). The overall satisfaction rate was 98% in the treatment group and 96% in the control group. The VED treatment before penile curvature surgery in patients affected by PD was able to improve surgical outcomes.

Penile indentation and hourglass deformities with Peyronie's disease-what can we reasonably offer our patients?

Penile indentation and hourglass deformities with Peyronie's disease-what can we reasonably offer our patients?

A contemporary assessment of the evaluation and management of patients presenting to a tertiary medical center with Peyronie's disease.

Peyronie's disease continues to be poorly understood. We characterize the presenting features of Peyronie's disease within a large cohort and elucidate the factors that correlate with surgical intervention. Univariate and multivariate analyses were performed on 1483 consecutive patients to assess pre-operative predictors of surgical intervention for Peyronie's disease. Overall, 1263 patients met inclusion criteria. Mean age was 55.4 ± 11.1 years with a mean duration of disease at presentation of 33.2 ± 42.5 months. Mean primary curvature was 49.8 ± 20.8°. Primary ventral curvature was present in 11.4% and 36.5% of patient had a multiplanar curvature. During penile duplex ultrasound evaluation indentation/narrowing deformities were appreciated in 76.0%, hourglass deformity in 10.1%, and hinge effect in 33.0% of patients. Calcification was seen in 30.1% of patients. Operative intervention occurred in 35.3% of patients. Degree of primary curvature (1.03 OR, p < 0.001), hourglass deformity (1.82 OR, p = 0.01), decreased tunical elasticity (1.20 OR, p = 0.03), and prior intralesional collagenase clostridium histolyticum injections (2.94 OR, p < 0.001) predicted surgical correction on multivariate analysis. Compared to historical studies, we found a higher incidence of severe degree of curvature (27.5% >60°), indentation deformities, hinge-effect, multiplanar curvature and penile calcifications. Ultimately, predictors of surgical intervention included those with worse erectile function and more severe characteristics.

A novel technique for unilateral dissection of the penile neurovascular bundle to prevent loss of penile sensation during treatment of Peyronie's disease-Initial results of a pilot study.

Plaque incision/excision and grafting are surgical techniques used to treat patients with Peyronie's disease who are refractory to less invasive interventions, have severe penile curvature, or have an hourglass deformity. However, the procedure carries the risk of penile sensory loss because of the need for dissection of the neurovascular bundle (NVB). The aim of this study was to assess the feasibility of a novel technique for unilateral NVB dissection and its ability to preserve penile sensitivity while maintaining adequate correction of the penile curvature. Charts of patients who underwent unilateral NVB dissection during Peyronie's plaque incision/excision and grafting were retrospectively reviewed. All patients received preprocedural intracavernosal injections of TriMix, and the curvature was measured to be >70 degrees. In 3 cases, an incision and minimal excision of the plaque were performed at the point of maximum curvature on the concave side of the curvature. In 3 cases, Tutoplast allografts (Coloplast US, Minneapolis, MN) were used, whereas autografts were used in 2 other cases. All patients were examined at 1, 3, and 6 months after the procedure when curvature and penile sensation were assessed. Five patients underwent this procedure. The mean age of patients was 55 years (45-70 years). All plaques were dorsally located. The mean preoperative curvature was 78 degrees (75-90 degrees). At the 6-month follow-up, all patients had <15 degrees residual curvature and were satisfied with their cosmetic results. Only 1 patient continued with phosphodiesterase-5 inhibitors to improve potency at the 6-month follow-up. All patients reported normal penile glans sensation. Four patients experienced decreased sensation at the site of NVB dissection, but this was only detected when compared with the contralateral side. Only 2 patients reported a difference after 6 months, and only a minor area of involvement was noted. Unilateral NVB dissection is a feasible technique that does not compromise surgical success in curvature correction and helps avoid sensory injury to the penile glans.

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.

(424) A Contemporary Assessment of Patients Presenting to a Tertiary Medical Center with Peyronie’s Disease

Abstract Introduction Peyronie’s disease (PD) is a progressive wound-healing disorder resulting in plaque formation within the tunica albuginea. PD continues to be poorly understood and an area of investigation, with increased awareness by patients and clinicians. Most commonly, PD patients will have a singular plaque and uniplanar curvature in the dorsal or lateral direction. However, previous studies have categorized less common deformities as “atypical”, which includes ventral curvature, multiplanar curvatures, unilateral indentations, hourglass deformity, and severe loss of penile length. Objective We aim to characterize the presenting features of PD within a large cohort of patients presenting to a tertiary referral center. Furthermore, we seek to elucidate the pre-operative factors that correlate with subsequent surgical intervention. Methods 1483 consecutive patients presenting with PD from 2016 to 2021 were retrospectively identified. Patients were excluded if they only had virtual visits, refused penile duplex evaluation, or had PD surgical correction prior to presentation. Baseline demographics, prior treatments, physical exam findings, penile duplex assessment (PDDU), subsequent interventions, and clinical outcomes were documented. Univariate and multivariate analyses were performed to assess pre-operative predictors of subsequent surgical intervention. Results In total, 1263 patients met inclusion criteria. Mean age at presentation was 55.4 ± 11.1 years with a mean duration of PD at presentation of 33.2 ± 42.5 months. Mean primary curvature was 49.8 ± 20.8°. Primary ventral curvature was present in 11.4% and 36.5% of patients had a multiplanar curvature. Mean composite curvature was 60.4 ± 28.2°. Subjective penile shortening was reported by 64.8% of patients with a mean reported loss of 3.8 ± 2.1 cm. During PDDU, indentation/narrowing deformities was appreciated in 73.7%, hourglass deformity in 10.1%, and hinge effect in 33.0% of patients. Calcification was seen in 30.1% of patients. Operative intervention occurred in 35.3% of patients. Hypogonadism (1.56 OR, p=0.04), severity of primary curvature (1.03 OR, p&amp;lt;0.001), hourglass deformity (1.82 OR, p=0.01), decreased tunical elasticity (1.20 OR, p=0.03), and prior intralesional Xiaflex injections (2.94 OR, p &amp;lt;0.001) predicted subsequent surgical correction. Negative predictors of surgical intervention included use of any oral PD treatment (0.43 OR, &amp;lt;0.001) and ability to perform penetrative sex (0.72 OR, p=0.04). 446 (35.3%) patients underwent surgical intervention with 170 (38.1%) plaque incision/excision and grafting, 110 (24.7%) tunical plication, and 166 (37.2%) inflatable penile prosthesis cases. Conclusions Peyronie’s disease remains an incompletely understood disease and presenting features may be changing as a result of more sophisticated evaluation and physician experience. Ventral curvature, multiplanar curvatures, indentation deformity, hourglass deformity, and severe loss of penile length have been described as “atypical”, but these changes are not rare in our cohort of referred patients. Patients with worse erectile function and more severe PD characteristics were predictors of surgical intervention. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(259) Computed Tomography for Evaluation of Complex Calcified Peyronie's Disease

Abstract Introduction The presence and extent of penile calcifications is an important factor in disease management of Peyronie’s Disease (PD). Calcified plaques may necessitate plaque excision and grafting (E&amp;G) in addition to other therapies or surgeries. PD pathology such as corporal septal involvement, multifocal calcifications, and circumferential corporal calcification can be difficult to assess on color doppler ultrasound (CDDU) due to device limitations. Computed tomography (CT) can be utilized for further characterization of PD. Objective The objective of our study was to review patients who underwent CT imaging for characterization of their Peyronie's Disease. Methods Twenty-three patients with a diagnosis of PD were retrospectively evaluated between 2017 and 2021. Patients underwent CDDU examination with artificial erection and were evaluated based on erectile function, plaque dimension, hourglass deformity, plaque septal involvement, and suspected calcification status. Patients with CDDU examination suggestive of calcification or significant complexity underwent non-contrast CT scan for 3-dimensional evaluation of the plaque prior to surgical discussion. CT complexity was defined as concern for multifocal calcified plaques (&amp;gt;2), partial/complete circumferential corpus cavernosum involvement, or septal involvement. Results All 23 patients had concerning findings on initial examination for calcified plaque which led to their CT evaluation; 9 of 23 (39.1%) patients had exam findings with hourglass deformity. On CT evaluation, calcification was confirmed in 22 of 23 patients (95.7%). Plaque dimensions on CT scan ranged from 0.4 x 0.2 x 0.5 cm to 4.0 x 2.0 x1.7 cm. Many of these measurements were approximations due to circumferential calcified plaque. A classic “gull-wing” appearance was noted in 6 of 23 (26%) patients; 12 of 23 (52.2%) of patients had septal involvement on CT; 8 of 23 patients (34.8%) had significant multifocal disease; 8 of 23 patients (34.8%) decided to proceed with surgical correction via E&amp;G (n = 3), IPP with E&amp;G (n =1), or via IPP with manual remodeling via Wilson technique (n = 4). Conclusions Non-contrast penile CT scan identifies calcification well in patients with Peyronie's Disease. CT allows for increased accuracy of surgical planning especially when evaluating for multifocal disease, circumferential plaque and/or septal involvement. These elements are critical for for providing accurate surgical recommendations and preoperative discussions. Disclosure No

(156) CLINiC Score - A Novel Prediction Model of Collagenase Clostridium Histolyticum Outcomes in Men with Peyronie’s Disease

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH), few studies have been able to identify variables which predict curve improvements, with baseline extent of curvature most highly correlated. In addition to extent of baseline curvature, our team has previously identified curve direction and plaque calcification as additional predictive variables. We therefore sought to create an integrated predictive model which incorporated several factors to better estimate anticipated outcomes. Objective To report outcomes of a novel scoring system designed to better predict outcomes of men undergoing CCH injections for Peyronie’s disease (PD). Methods A prospective database has been maintained of men undergoing CCH injections for PD. Data were reviewed to identify variables predictive of curve improvements in men with isolated curvature as well as among those with key characteristics, including indentations, hourglass deformities, penile tapering, and calcification. A predictive model was subsequently developed to improve correlations between disease factors and subsequent CCH outcomes. The final model (CLINiC Score) assigned points as follows: +1 point for every 10 degrees of curvature (C for Curvature), +5 points for penile narrowing &amp;gt;25% (IN for INdent), +3 points for narrowing 0-25%, -4 points for pure lateral curvatures (L for Lateral), and -2 points for plaque calcification (C for Calcification). Patients were assigned scores based on the CLINiC model, and results were correlated with final curve outcomes. Results A total of 476 PD men were included in the current analysis. Baseline variables for the cohort included a mean age of 55.6 yrs (SD 10.9), PD duration 31.9 months (SD 61.4), composite curvature 64.6 degrees (SD 23.9), 47% with indentations, 42% with hourglass deformity, and 17% with calcification. The mean CLINiC score for the cohort was 6.9 (SD 3.4). For the overall cohort, the use of the CLINiC score increased the correlation coefficient from 0.35 to 0.46 (r-squared 0.13 vs 0.21), with a predictive linear formula of 2.1 - 3.2 * CLINiC score. The difference was more pronounced among a subset cohort of men who had pure lateral curvatures, plaque calcification, or narrowing deformity. In comparing the CLINiC predictive model to baseline curve alone, the correlation coefficient increased to 0.54 (r-squared 0.29, p&amp;lt;0.0001) compared to 0.38 (r-squared 0.15, p&amp;lt;0.001). The linear equation to predict curve improvement outcomes using the CLINiC score was 2.2 - 3.5 * total CLINiC score. Conclusions Use of a novel scoring system (CLINiC) improves upon baseline curvature alone to predict post-CCH curve improvements, with the difference more pronounced among men with pure lateral curvatures, plaque calcification, and/or narrowing deformities. External validation is warranted. Disclosure No

(258) Agatston Calcium Score Assessment of Plaque Calcification in Peyronie’s Disease

Abstract Introduction Peyronie’s disease (PD) is characterized by penile pain, penile deformation and curvature, sexual dysfunction, and psychological implications. Fibrosis and plaque formation are often part of PD pathophysiology. Calcified plaques can alter treatment planning. Penile ultrasound with Doppler (PUS) is used to exclude erectile dysfunction and identify plaques. However, plaque extent and distribution can be obscured by acoustic shadowing, limiting complete plaque characterization. Non-contrast pelvis computed tomography (CT) provides a noninvasive method to identify plaques in 3 dimensions and quantify plaque Ca burden. Objective Our objective was to utilize Agatston Ca scoring measure Ca burden in patients with Peyronie's disease. Methods A retrospective database from 1/1/2017 and 6/30/2021 identified 25 men with calcified plaques on CT after PUS performed by a single urologist. Two abdominal radiologists reviewed CTs in consensus to measure calcified plaque size and distribution on Visage PACS. Semiautomated Agatston Ca scoring values were obtained with Syngo.via. Total Ca volume (mm3), total Ca score were correlated with hourglass deformity on clinical exam, plaque complexity on CT (&amp;gt;2 discrete calcified plaques, circumferential corpus cavernosum involvement, septal involvement), and surgical management using descriptive statistics and t-test. Results Mean Ca volume was 1417 mm3 (range 1.4-5425.7, standard deviation (SD) 1570); mean Ca score was 1691 (range 1.6-6048; SD 1862) with significantly higher Ca volume in patients with complex plaques (265 mm3 vs 472 mm3, p&amp;lt;0.05), and significantly longer plaque dimension for longest plaque dimension measured by CT vs US (31 vs 23, p&amp;lt;0.05). There was no significant difference in Ca volume for nonsurgical vs surgical (1791 vs 893, p=0.06) or for no hourglass vs hourglass deformity (1173 vs 1904, p=0.19). Conclusions CT scan and calcium scoring are useful tools in the assessment of PD. Semiautomated Ca scoring may help noninvasively identify complex calcified penile plaques to guide medical and surgical therapy for Peyronie’s disease. Disclosure No

(309) Risk Factors Associated with the Utilization of Xiaflex Injections for Peyronie’s Disease

Abstract Introduction Collagenase clostridium histolyticum (CCH), known as Xiaflex (Endo Pharmaceuticals Dublin, Ireland) is the only FDA approved medication for Peyronie’s Disease (PD) in the United States. While Xiaflex has shown efficacy with improvement of curvature by &amp;gt;20% in over half of recipients, patients are hesitant to pursue treatment due to the monetary costs, length of treatment, and perception of injectable therapy. Objective The aim of this study is to determine if demographic and clinical factors are associated with clinical decision making to pursue Xiaflex injections for treatment of PD. Methods We retrospectively reviewed patients who presented to our institute from 2009 to present with PD. Demographic and clinical parameters were extracted. Independent T-test and Wilcoxon rank sum tests were used to determine correlation between continuous variables and whether Xiaflex was selected. Odds ratios with 95% confidence interval were used to determine association between categorical variables and whether Xiaflex was pursued. Results 143 patients presented with PD. Of these cases, 24.5% (35) received Xiaflex and 75.5% (108) declined Xiaflex. There was no significant difference in age, months since curvature was first noted, history of erectile dysfunction (ED), ED response to PDE5 inhibitors, history of hypogonadism, lowest total and free testosterone levels documented, history of GU trauma, history of depression or anxiety, hourglass deformity, past urethral instrumentation, SHIM score, plaque volume, maximum plaque diameter on ultrasound, distance of curve apex from coronal sulcus, or history of Dupuytren’s contracture between the treatment and nontreatment group (P&amp;gt;0.05). Subjects who chose treatment had significantly greater predicted curvature and degree of curvature on initial ultrasound at the time therapy was offered compared to those who did not select treatment. Patients who received Xiaflex had an average predicted curvature at presentation of 49.5 degrees (sd = 28.1) and degree of curvature on initial ultrasound of 50.02 degrees (sd=20.0) respectively. Patients who did not receive Xiaflex had an average predicted degree of curvature at presentation of 37 degrees (sd=23.8) and degree of curvature on initial ultrasound of 37.6 (sd=23.0). Conclusions Our data suggests that PD patients who chose treatment with Xiaflex had greater penile average curvature compared to those who did not choose treatment. Despite erectile function, comorbidities, and radiographic findings, degree of penile curvature remains a key risk factor for selecting injectable therapy for PD. Disclosure No

(161) Xiaflex Nonresponders Show Alteration in Penile Measurements: Post-Market Analysis of Predictors for Treatment Success

Abstract Introduction The IMPRESS trial revealed that intralesional collagenase clostridium histolyticum, Xiaflex, is safe and efficacious for treating the physical and subjective effects of Peyronie’s Disease (PD). However, little is known about the other manifestations of PD, namely penile shortening and efficacy for patients of diverse racial backgrounds or with severe penile curvatures. Objective To evaluate predictors associated with response to treatment and alterations in penile morphological measurements. Methods Consecutive patients treated with Xiaflex for dorsal, lateral, and ventral penile curvatures ≥ 25°, in the absence of hourglass deformity, were included in this study. Before treatment and eight weeks after the last injection cycle, during penile duplex Doppler ultrasound evaluation, penile curvature was measured with a goniometer after induced artificial erection via injection of prostaglandin E1 (PGE1). IIEF score, PGE1 dose, circumference, and erectile as well as stretched penile length were also assessed at these times. Based on the results of the IMPRESS trial, patients were considered Xiaflex responders if the decrease in their penile curvature were ≥ 15° (n =134) and Xiaflex nonresponders if the decrease in their penile curvature were &amp;lt; 15° (n =89). Initial measurements were in increments of 5°. Intention to treat analysis was performed. Results Two hundred and twenty-three patients with penile curvature ≥ 25° who received XIAFLEX were included in this study. One hundred and thirty-four patients (60.1%) responded to Xiaflex, while 89 (39.9%) patients did not respond. African American men were 3 times more likely to respond to treatment than their non-African American counterparts (Odds Ratio (OR) =3.35 (95% CI, 1.15-10.70), p =0.031). On the other hand, men with an initial penile curvature of greater than 60° were less likely to respond to Xiaflex (OR = 0.34; 95% CI, 0.16-0.69; p=0.003). However, patients with lateral and ventral curvatures responded at comparable rates to those with dorsal curvatures. Subsequently, changes in penile morphologic measurements post Xiaflex were analyzed. Average stretched penile length, erectile length, and erectile circumference prior to treatment for responders were 13.93 cm, 13.39 cm, and 11.81 cm, respectively; for nonresponders, it was 14.27 cm, 13.72 cm, 11.64 cm, respectively. Nonresponders were shown to experience a significant decrease in penile erect length (-0.55 cm) and circumference (-0.58 cm) (p=0.002 and p=0.002, respectively), whereas responders showed no significant alterations in penile morphologic measurements. Conclusions Our analysis revealed that men with penile curvatures ≥ 60° are less likely to respond to Xiaflex injections and thus may be considered for surgical intervention upon initial presentation. Furthermore, men who do not respond may even be at a higher risk for shortening of penile erect length and circumference. The actual clinical significance of a decrease in average erect length of 0.55 cm and circumference of 0.58 cm is difficult to determine and should be considered per patient preferences. Further investigations into predictors for response to Xiaflex and the pathophysiology behind penile shortening in Xiaflex nonresponders are warranted. Disclosure No

MP36-05 CLINIC SCORE - A NOVEL PREDICTION MODEL OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM OUTCOMES IN MEN WITH PEYRONIE’S DISEASE

You have accessJournal of UrologyCME1 Apr 2023MP36-05 CLINIC SCORE - A NOVEL PREDICTION MODEL OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM OUTCOMES IN MEN WITH PEYRONIE’S DISEASE Courtney Pierce, Benjamin Green, Joshua Savage, Klint Brearton, Matthew Ziegelmann, Sevann Helo, Tobias Kohler, and Landon Trost Courtney PierceCourtney Pierce More articles by this author , Benjamin GreenBenjamin Green More articles by this author , Joshua SavageJoshua Savage More articles by this author , Klint BreartonKlint Brearton More articles by this author , Matthew ZiegelmannMatthew Ziegelmann More articles by this author , Sevann HeloSevann Helo More articles by this author , Tobias KohlerTobias Kohler More articles by this author , and Landon TrostLandon Trost More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Since the FDA approval of Collagenase Clostridium Histolyticum (CCH), few studies have been able to identify variables which predict curve improvements, with baseline extent of curvature most highly correlated. In addition to extent of baseline curvature, our team has previously identified curve direction and plaque calcification as additional predictive variables. We therefore sought to create an integrated predictive model which incorporated several factors to better estimate anticipated outcomes. METHODS: A prospective database has been maintained of men undergoing CCH injections for PD. Data were reviewed to identify variables predictive of curve improvements in men with isolated curvature as well as among those with key characteristics, including indentations, hourglass deformities, penile tapering, and calcification. A predictive model was subsequently developed to improve correlations between disease factors and subsequent CCH outcomes. The final model (CLINiC Score) assigned points as follows: +1 point for every 10 degrees of curvature (C for Curvature), +5 points for penile narrowing >25% (IN for INdent), +3 points for narrowing 0-25%, -4 points for pure lateral curvatures (L for Lateral), and -2 points for plaque calcification (C for Calcification). Patients were assigned scores based on the CLINiC model, and results were correlated with final curve outcomes. RESULTS: A total of 476 PD men were included in the current analysis. Baseline variables for the cohort included a mean age of 55.6 yrs (SD 10.9), PD duration 31.9 months (SD 61.4), composite curvature 64.6 degrees (SD 23.9), 47% with indentations, 42% with hourglass deformity, and 17% with calcification. The mean CLINiC score for the cohort was 6.9 (SD 3.4). For the overall cohort, the use of the CLINiC score increased the correlation coefficient from 0.35 to 0.46 (r-squared 0.13 vs 0.21), with a predictive linear formula of 2.1 - 3.2*CLINiC score. The difference was more pronounced among a subset cohort of men who had pure lateral curvatures, plaque calcification, or narrowing deformity. In comparing the CLINiC predictive model to baseline curve alone, the correlation coefficient increased to 0.54 (r-squared 0.29, p<0.0001) compared to 0.38 (r-squared 0.15, p<0.001). The linear equation to predict curve improvement outcomes using the CLINiC score was 2.2 - 3.5*total CLINiC score. CONCLUSIONS: Use of a novel scoring system (CLINiC) improves upon baseline curvature alone to predict post-CCH curve improvements, with the difference more pronounced among men with pure lateral curvatures, plaque calcification, and/or narrowing deformities. External validation is warranted. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e480 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Courtney Pierce More articles by this author Benjamin Green More articles by this author Joshua Savage More articles by this author Klint Brearton More articles by this author Matthew Ziegelmann More articles by this author Sevann Helo More articles by this author Tobias Kohler More articles by this author Landon Trost More articles by this author Expand All Advertisement PDF downloadLoading ...