ABSTRACT Introduction IPP revision after implant malfunction yields rare insight into patient preference and perception of penile implant variations in brand and size. Objective To assess patients’ perception of their penile implant after IPP revision. Methods Retrospective review of all patients undergoing revision surgery for purely mechanical malfunction (fluid leak) at our institution since 2017. Patients with greater than 6 months follow-up after revision were contacted to comment on changes in penile size and device preference. Patients were asked 1. “Did you notice any change in penile length or girth after your last surgery, explain, and 2. “Please describe your preference (if any) of implant and why”. We utilize the Coloplast Titan with “classic” (genesis) pump in most cases, with AMS Cx cylinders being used in cases with attenuated corpora (aneurysm). Results 21 patients were identified that met criteria with an average age of 70. 15/21 were successfully contacted. 9 Coloplast, 2 Mentor, and 12 AMS devices (Cx =7, LGX =4, Ultrex =1) were revised. Device brand used to replace the broken IPP was n= 19 for Coloplast and n=3 for AMS (Cx =2, Lgx =1). Mean and median time to revision was 9 years overall (2-26) and was similar between Coloplast and AMS. Fluid leak location showed no discernable pattern. Total average implant length increased 2.2 cm from 20.6 cm to 22.8 cm. 8/10 patients were reached that had had both AMS and Coloplast devices (all AMS initially). 12 patients stayed within the manufacturer. Despite change in implanted length, most patients did not discern a definitive change in penile length unless cylinders increased by > 3 cm (perhaps reflecting under-sizing of initial implant). All patients correctly described improvement or no change in penile girth when compared to actual cylinder sizes. Patients preferred Coloplast (6 – girth/erection quality/pump), AMS (1 pump/flaccidity) and undecided (1). Several patients felt consistently cycling the device after revision led to relative length improvement and ease of use. Conclusions Our small cohort of IPP revision patients for mechanical failure reveals that revision often requires longer cylinders but this is often imperceptible to the patient. Increased cylinder girth was a key factor in driving device preference. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast
227 The Clinical Significance of Imperfection: Do Asymmetry or Occult Curvature Matter in Penile Prosthesis Placement?
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S114-S115
ABSTRACT Introduction Patient satisfaction after inflatable penile prosthesis (IPP) placement has been linked to preexisting curvature. Intraoperative findings such as curvature on artificial erection (AE) or asymmetric corporal measurements (ACM) are incompletely characterized in terms of impact on IPP outcome. Objective We sought to evaluate the clinical utility of AE and the significance of ACM during IPP surgery. Methods A single institution retrospective review of patients undergoing primary IPP placement between 7/2019-9/2020 was performed. Patient characteristics and intraoperative measurements were compared. Threshold for statistical significance was p≤0.05. Results A total of 130 patients underwent primary placement of penile prosthesis. Median age was 67 years (IQR 13). Comorbidities included prostatectomy in 33.8%, and known Peyronie's disease in 21.5%. Of the 27.7% (n=36) of patients who underwent intraoperative AE, 63.9% (n=23) had visible curvature. Of the patients with visible curvature, 70% (n=16) had a preoperative diagnosis of Peyronie's disease and 56.3% (n=9) underwent straightening procedures compared to 28.6% (n=2) of the 30% (n=7) with no known curvature. Incision and grafting was most frequently performed (6/11)- with a minority undergoing plication (2/11). Of the 72.3% (n=94) who did not undergo AE, only 2.1% (n=2) required additional measures for curvature correction. Median corporal measurement was 21 (IQR 2) bilaterally and median cylinder size 20 cm (IQR 4) bilaterally with 1cm rear tip extenders. Of the 18.5% (24/130) of patients with ACM, asymmetry was as follows: 20.8% (5/24) had less than 1 cm, 70.8% (17/24) had 1 to <2 cm, and 8.3% (2/24) had 2 cm or greater. Of these patients 87.5% (21/24) underwent placement of an asymmetric device, only 5% (1/21) of which had residual curvature less than 30 degrees. Despite ACMs, 12.5% (3/24) of patients had a symmetric device placed, one of which had residual curvature. Only 2 patients underwent straightening procedures including plication and incision/grafting. Conclusions Intraoperative AE is effective at revealing occult penile curvature at time of IPP placement, however most men with newly detected curvature do not require additional straightening measures. We also found that 1 in 5 patients undergoing IPP had ACM but this did not correspond to residual curvature following IPP or requirement for adjunct straightening. These findings may provide reassurance to urologists who do not routinely perform AE or those who encounter ACM during corporal dilation Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast
217 Health Care Provider Knowledge and Attitudes about Erectile Dysfunction and Penile Implants
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S109-S110
ABSTRACT Introduction Erectile dysfunction (ED) stems from a variety of etiologies and often requires a multidisciplinary approach to optimize patient care. Objective We sought to assess attitudes and confidence regarding the treatment of erectile dysfunction across different provider types. Methods Anonymous, email-based survey of physicians and advanced practice providers in the disciplines of urology, internal medicine, and family medicine. Responses were recorded using a five-point Likert scale. Descriptive statistical analysis of survey response data was performed. Results With 76 providers on this ongoing survey including 31 internists, 24 family physicians, and 21 urologists, 88% of providers believed there to be good options for erectile dysfunction after failing pills. Figure 1 shows attitudes of the modalities of “good” options and confidence in the ability to counsel about these options. Regarding if most patients report willingness to consider surgical intervention for ED when counseled about it an equal portion of providers had positive, neutral, and negative feedback. Figure 2 lists other specific attitudes and opinions about penile prosthesis (IPP) implants. Moreover, 78% emphasized the necessity of a multidisciplinary team-based approach to ED patients. However, only 30% of the participants were in agreement with referrals to specialists in sexual health including urologists. Conclusions This survey indicates a knowledge gap and low comfort level in 2nd and 3rd line ED treatments. Focused education on penile implant outcomes appears particularly helpful. Disclosure No
97 Efficacy of RestoreX Penile Traction Therapy in Improving Penile Length and Erectile Function Post Prostatectomy
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S49-S50
ABSTRACT Introduction Penile length loss and erectile dysfunction (ED) are common post-prostatectomy. Recent results from a randomized, controlled study (RCT) of RestoreX penile traction therapy (RxPTT) demonstrated preserved erectile function and penile length improvements in men post-prostatectomy. Objective To report outcomes of the open label phase (6-9 month time point) of the previously noted RCT comparing efficacy of RxPTT to control in men post-prostatectomy. Methods A randomized, controlled trial (NCT03500419) has been completed of 82 men post-prostatectomy. Men were randomized 1-month post-prostatectomy to no therapy (control, n=27) or RxPTT (n=55) for 5 months. Participants then entered an open label phase for 3 months. Assessments included stretched penile length (corona), standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. Comparisons were performed of men who utilized traction at least 15 minutes daily for both phases to men who were originally control and continued with no treatment (as-treated analysis). Analyses were also performed of men who crossed over from control to >15 min daily (crossover to treatment) and those who were originally in the treatment group and continued with >15 min daily use during the open label phase (ongoing treatment). Results Of the 82 men enrolled (mean age 58.6), 55 had 6-month, and 42 had 9-month data available to review. Baseline characteristics (IIEF scores, penile length) were similar between cohorts. In the as-treated analysis (no treatment n=7, RxPTT x 8 months n=12, respectively), differences were as noted: IIEF-EFD (-8 vs -0.5, p=0.19), IIEF-OFD (-3 vs -2, p=0.86), IIEF-SD (-1 vs 0.5, p=0.09), IIEF-ISD (-3 vs -0.5, p=0.31), IIEF-OSD (-2 vs 0, p=0.29), penile length (-0.1 vs +1.8 cm, p<0.01), PDE5 use (86% vs 75%, p=0.57), intracavernosal injection use (86% vs 17%, p<0.01). Comparing men who did not use therapy at any time (n=7) to those who crossed over to RxPTT during the open label phase (n=8) demonstrated the following results: IIEF-EFD (-8 vs -6, p=0.49), IIEF-OFD (-3 vs -1, p=0.90), IIEF-SD (-1 vs 0, p=0.55), IIEF-ISD (-3 vs -1, p=0.45), IIEF-OSD (-2 vs -1, p=0.51), penile length (-0.1 vs +0.69 cm, p=0.39). Men who crossed over from RxPTT to no treatment (n=10) had relatively preserved improvements compared to those who continued with RxPTT during the open label phase (n=12) compared to baseline, respectively: IIEF-EFD (0 vs -0.5, p=0.95), IIEF-OFD (-3.5 vs -2, p=0.97), IIEF-SD (0 vs 0.5, p=0.18), IIEF-ISD (0 vs -0.5, p=0.87), IIEF-OSD (0 vs 0, p=0.66), penile length (+1.8 vs +1.8, p=0.99). Conclusions Although sample size and statistical power are limited, results from the open label phase confirm earlier findings of preserved sexual function and penile length in men treated with RxPTT compared to controls. Men who crossed over from controls to treatment experience benefits, although not as significant as those who were treated beginning at 1 month post-prostatectomy. Men who stopped therapy after 6 months demonstrated stable improvements from baseline, suggesting a preserved effect of RxPTT even after discontinuing use. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Disclosure No
82 Utility of Ceramide Testing in Men with Erectile Dysfunction
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S43-S43
ABSTRACT Introduction Erectile dysfunction (ED) is a known precursor and sequelae to diagnosed cardiovascular disease (CVD). ED AUA guidelines recommend evaluating standard CV risk factors including serum lipids and penile doppler to help stratify CV risk, but few patients are referred for further evaluation. Plasma ceramides are metabolic byproducts that are novel predictors of adverse cardiovascular events resulting from unstable atherosclerotic plaque. CVD risk conferred by ceramide levels has been shown to be independent of conventional risk factors such as LDL and hsCRP levels. Thus, Plasma MI-Heart Ceramide is a new test that useful for evaluating shorter term major adverse cardiovascular events (MACE) in the next 1 to 5 years. Objective We sought to evaluate the utility of ceramide levels in ED patients Methods We initiated ceramide testing in all patients with ED in late 2019 (in addition to lipids and Hgba1c). We queried our electronic medical record for ceramide levels and men with a diagnosis of ED. Ceramide levels stratified patients in normal, moderate, high, and very high risk. Twenty eight patients additionally had penile duplex ultrasound (DUS). Left and right peak systolic velocity values were averaged and a value of <25 cm/s was defined as penile arterial insufficiency. Results 245 men with ED and ceramide levels were analyzed. 44% (n=107) were normal, 42% (n=103) were moderate risk, 12% (n=29) were high risk and 2% (n=6) were very high risk. As result of their ceramide and office evaluation, 42% (15/35) of high/very high risk patients were referred for cardiac evaluation. Comparing ceramide scores in men with penile arterial insufficiency (16.7 cm/sec) vs patients without (43.2 cm/sec), we found no significant difference (p=1). Similarly, when comparing DUS results between ceramide risk categories, we found no significant differences (p=1). Conclusions One in 7 men presenting to an ED clinic had a high or very high ceramide risk. DUS results did not correlate with ceramide risk. Patients undergoing DUS (even without arterial insufficiency) may benefit from additional ceramide testing and possible cardiac referral. Further study is warranted to optimize utility of ceramide in men with ED and potentially decrease peri-procedural IPP cardiac morbidity. Disclosure No
79 Outcomes of Collagenase Clostridium Histolyticum in Men with Congenital Penile Curvature
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S42-S42
ABSTRACT Introduction Congenital penile curvature is a relatively uncommon condition characterized by penile angulation. Similar to Peyronie's Disease (PD), this condition has historically been managed with various surgical techniques. Given the efficacy of Collagenase Clostridium Histolyticum (CCH) in men with PD, our team has elected to treat men with CPD with CCH injections. Objective To describe outcomes of CPD men treated with CCH injections and to compare against a traditional PD cohort. Methods A prospective database has been maintained of all men undergoing CCH injections by our team since Jan 2014. The specific CCH administration protocol has been modified over time and currently includes combined use of RestoreX traction therapy, sildenafil, 0.9 mg of CCH diluted into 0.7 ml, injections performed at the point of maximal curvature, and aggressive manual modeling. Curvatures were measured in two planes (dorsal and lateral), with the combined measure reported as a composite. Outcomes were reported based on the most recent curvature assessment obtained minus baseline. Men were included if they received at least one series of CCH injections and had at least one baseline and follow-up curvature assessment available. Results A total of 272 men comprised the current cohort, with 23 exhibiting CPD and 249 PD. Mean age was higher in PD men (57.4 vs 38.4, p<0.0001), and mean PD duration was 18 months in PD men. Median baseline curvature was non-statistically higher in PD (65 vs 55 degrees, p=0.06). Baseline curvature directions for PD and CPD, respectively were: dorsal (82% vs 35%, p<0.0001), lateral (58% vs 78%, p<0.05), ventral (11% vs 35%, p<0.01). Following treatment with CCH, median curvature improvement was similar between cohorts, with 20 degrees (IQR 5, 35) for PD and 20 degrees (IQR 5, 30) for CPD, p=0.62. Percentage improvement from baseline was non-statistically higher in PD men (33% vs 29%, p=0.99). Conclusions Treatment of CPD men with CCH is a viable therapeutic option and provides similar benefits to those observed in men with PD. Disclosure No
75 Peyronie's Disease: Identification of Patients Requiring Additional Therapy
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S39-S40
ABSTRACT Introduction Peyronie's disease (PD) is a connective tissue disorder of the penile tunica albuginea, that can often cause penile deformity, pain, sexual dysfunction, and shortening. Therapies available include penile traction, oral medications, intralesional therapy, and surgical management. Many patients undergo multiple therapies for this disease due to poor satisfaction or lack of subjective improvement. Objective We thus sought out to delineate which patients were more likely to undergo a second therapy. Methods A cohort of 385 men who underwent therapy for Peyronie's disease from 2014-2018 were analyzed. A univariate analysis of patient demographics, subjective complaints, IIEF score parameters, primary treatments, and secondary treatment approaches was conducted. Results Of the 385 men identified, 29 patients ultimately decided to undergo a secondary treatment approach with 14 patients undergoing penile traction therapy, 7 intralesional therapy (Xiaflex) and 9 surgical therapy (5 penile plication, 2 insertion of inflatable penile prosthesis, and 2 grafting). 17 patients initially underwent surgery for PD with 23.53% of these patients undergoing a second line therapy (p<0.0469). 148 patients initially underwent Xiaflex injections with 12.16% of these patients undergoing a second line therapy (p<0.0227). Patients with poor orgasmic function as determined by IIEF questionnaire (median scores 8 vs 2, p<0.0420), men with greater objective curvature (median curvature 45 vs 35, p<0.0220), and men with greater stretched penile length (13.5 cm vs 12 cm, p=0.0284) were also more likely to undergo secondary therapy. Table 1 shows all factors associated with increased likelihood for secondary therapy. Conclusions Peyronie's disease is often a complex condition to treat due to the mental, emotional, and physical toll this disease takes on patients. It is helpful to determine which patients could likely require secondary therapy as this may help guide patient counseling and further management. Disclosure No
71 Adult Patient's Opinions on Surgical Correction of Congenital Penile Curvature
The Journal of Sexual Medicine | April 26, 2022 | Volume: 19 | Issue: Supplement_1 | Pages: S37-S38
ABSTRACT Introduction Congenital penile curvature is common and presents with varying levels of severity. The curvature may present during infancy or post-pubertal. Historically, treatment has consisted of surgical correction, typically with penile plication or complex grafting procedures. Most pediatric urologists recommend surgical management for penile curvature (PC) based on curvature severity, with previous work identifying ≥ 30° as a common threshold to recommend correction. Objective To assess adult patients’ opinions on willingness to consider surgical correction for PC in order to determine if this aligns with pediatric urologists’ opinions. Methods In this cross-sectional study, a survey was administered to adult patients and their partners (> 18 years of age) in general adult urology clinics at 3 geographically separate institutions. The survey consisted of unlabeled images of penis models with varying degrees of PC (range 10-90°). Respondents were asked to select the images they would want surgically corrected for themselves or their partners. Univariable and multivariable analyses were performed to identify demographic variables associated with willingness to consider correction (p-values < .05 considered significant). Results Response rate was 77% (300/388). The majority (80%) of participants chose to surgically correct PC, however 20% chose to not surgically correct any degree of PC. Most participants were male (70%), married (62%), heterosexual (92%), and did not work in healthcare (80%) (Table 1). Among those who endorsed willingness to surgically correct PC, the average threshold for correction was 40.5° (SD 25.3). On univariable analysis, there was a significant difference in willingness to undergo PC correction based on gender, age groups, sexual orientation, and region (Table 1). Male patients were more likely to consider surgery at a lower degree of PC compared to females (36.6° vs 50.6°, p<.001). Those who identified as heterosexual also had a lower threshold for correction compared to those identifying as LGBTQ (39.6° vs 56.4°, p=.015). Midwestern residents endorsed an average threshold for correction of 21.5° compared to other regions varying between 40° to 60° (p<.001). Regionality differences remained true on multivariable analysis when accounting for all demographic features (p<.001). Conclusions In surveying adult patients, we identified an average PC threshold of 40° beyond which surgical correction was desired. Females and LGBTQ+ participants had a higher threshold for surgical correction, but when accounting for all demographic factors, only residence in the Midwest US was associated with a lower threshold for correction. Disclosure No