Penile Prosthesis Implantation Research Articles

(472) The AM-EDITS: A New Tool for Evaluating the Arab Patient and Partner Satisfaction Following Penile Prosthesis Implantation

Abstract Introduction The Modified Erectile Dysfunction Inventory of Treatment Satisfaction (M-EDITS) is recognized as a useful tool in English language to assess post penile prosthetic implantation (PPI) satisfaction. Nevertheless, a more global questionnaire remains to be introduced for the Arab population, where malleable PPI (MPPI) remains more popular, compared to the inflatable types. Due to the sensitivity of the topic and the conservative nature of the Middle East and North Africa (MENA) region, a scarce body of related research is available. Objective Our primary goal was to develop a validated Arabic version of the M-EDITS adapted to the Arabic culture and introduce it as the AM-EDITS. Our secondary goal was to utilize it to investigate the levels of Arab patient and partner satisfaction after MPPI and its sustainability during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing MPPI at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). For our study, we developed a validated Arabic version of the M-EDITS, coined as the AM-EDITS. The first encounter covered general patient perioperative experience, beginning from preoperative counseling till early after surgery. The second and third encounters focused on patient and partner satisfaction regarding implant utilization. Results The mean ages for the men and their spouses were 54.7±8.4 and 32.9±4.6 years, respectively. Over 82% of the patients in our study showed a decreased level of anxiety after preoperative counseling. 96% of the patients reported a positive experience regarding their early PO days with above half exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied wives at 3 months, 78.5% were highly satisfied. Feeling sexually desirable by their husbands was reported in 93.4%. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P <0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P <0.001), respectively, compared to the 3 months follow up. Conclusions The AM-EDITS may expand the global application of the original M-EDITS. MPPI represents a good quality of life treatment option for middle to low-income countries. Time has a positive effect on the Arab men’s PO satisfaction as opposed to their partners’. These findings should be considered during perioperative counseling of both parties to ensure sustainable satisfaction. Extended studies are necessary to confirm our findings as well as assess long-term PO satisfaction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

(080) Exploring the Effects of Actinidin as a Novel Collagenase on Human Peyronie’s Disease Cells

Abstract Introduction Peyronie’s Disease (PD) is a connective tissue disorder of the penile tunica albuginea that affects approximately 10% of men. The plaques that hallmark PD contain excessive amounts of collagen and can result in penile curvature, painful erections, and/or erectile dysfunction. Intralesional Collagenase Clostridium histolyticum injection for PD are no longer available in Canada, making treatment options limited. Hayward kiwi fruit are rich in natural actinidin, a soluble enzyme that has the unique ability to hydrolyze various types of collagen and fibrinogen. Actinidin is considered a collagenase alternative; however, there have been no studies evaluating the application of actinidin on in vitro cellular PD models. Objective To determine the effectiveness of actinidin at reducing the collagen component of a 2D human PD cell model. Secondly, to determine the cytotoxicity of kiwifruit extract on human PD cells. Methods Human PD tissues obtained during penile prosthesis implantation were isolated for fibroblast cells and cultured using complete media. The cells were plated on a 96-well plate and treated with one of 4 treatment groups: media, saline, and low and high concentration actinidin treatment (0.5 mg/ml to 37.5 mg/ml). The actinidin treatments were prepared by dissolving freeze-dried kiwi powder in saline and then filtered; the low concentration was further diluted with saline. Cells were incubated at 37°C for 24 hours and then collagen was extracted and measured using a soluble collagen quantification assay kit and a fluorescent microplate reader. To measure cytotoxicity, cells were stained for the nucleus and actin filaments using DAPI and Phalloidin-conjugated FITC, respectively. A twelve-hour timelapse capturing images of FITC and DAPI fluorescein were carried through using a fluorescent confocal microscope. The total fluorescent area of each well was measured using ImageJ. Actin signals were normalized by DAPI signals, and all values were analyzed using Python and Prism10. Results The higher concentration of actinidin treatment significantly reduced cellular collagen of human PD fibroblasts compared to the media treatment (P < 0.05). The high concentration actinidin treatment had a significantly higher normalized actin signal than other treatment groups (P < 0.0001). This ratio allows us to observe the treated cells with compromised plasma membranes. The low concentration of actinidin did not have any significant difference from media and saline treatment groups. A significant increased level of normalized actin indicated that actinidin may have mechanisms to disturb the plasma membrane. Conclusions Our preliminary study suggests that the natural collagenase actinidin can break down PD cells by reducing the extracellular collagen content and compromising the cellular membrane. Further studies are underway to investigate treatment in 3D models and to determine the optimal actinidin concentration that can further reduce the collagen composition in human PD cell models. Actinidin has the potential to be a novel treatment option for patients suffering from PD. Disclosure Yes, this is sponsored by industry/sponsor: KiwiEnzyme.com Ltd Clarification No industry support in study design or execution

(489) Comparison of Penile Prostheses Outcomes in Veterans with Peyronie’s Disease: A Single-Center Analysis

Abstract Introduction Peyronie’s disease (PD) causes erectile dysfunction (ED) in at least 40% of cases. ED refractory to medical and injection therapy can be treated with implantable penile prosthesis, which may also address the penile deformities. However, prosthesis surgery has significant associated morbidity-including erosive disease and infection-and frequently requires explant or revision. Data for Veterans Affairs (VA) patients with PD is limited, especially with respect to penile prosthesis placement. More information is needed for proper counseling and perioperative planning in this high-risk population. Objective The aim of this study is to compare outcomes and revision rates in Veteran patients with and without PD after primary penile prosthesis implantation. Methods A retrospective cohort study of the xxx VA Medical Center Informatics and Computing Infrastructure database was performed. Veterans who underwent penile prosthesis surgery between January 2013 and February 2022 were identified and included in the study. Patient factors including age, race, procedure type, and relevant comorbidities were collected. Patients with and without history of PD were identified and separated into two cohorts and patient factors of these two groups were compared using chi-square and Fisher’s exact tests. Freedom from revision was analyzed using Cox regression and hazard ratios. Results A total of 229 patients underwent penile prosthesis placement with at least 4 months follow-up. 24 patients (10.48%) with history of PD were identified. The mean age at prosthesis placement of PD patients was younger than that of non-PD patients (61.3 vs 65.0 respectively, p=0.0358). Rear tip extender length was longer in the PD cohort than the non-PD cohort (3.02 cm vs 2.32 cm respectively, p=0.0313). Operative time was shorter in patients with PD than in patients without PD (91 minutes vs 111 minutes respectively, p=0.0409). Prosthesis type, hospital stay, and post-operative complication rates were not significantly different between groups. PD was not associated with significantly increased risk of prosthesis revision or removal (p>0.05). No patients in the PD cohort experienced infection or erosion; two explants were performed for component migration and supersonic transporter deformity respectively. Conclusions Veterans with PD undergoing prosthesis placement have similar revision rates and explant rates as compared to veterans without PD. Additionally, penile prosthesis implantation for men with PD is associated with low morbidity and similar complication rates compared to men without PD undergoing prosthesis placement for erectile dysfunction. Disclosure No

(411) The “Unfolding” Technique for Penile Prosthesis Implantation in Post-priapism Corporeal Fibrosis

Abstract Introduction `- In neglected cases of ischemic priapism, there is usually severe corporeal fibrosis that can render penile prosthesis implantation later on extremely difficult. - Although many researchers described different approaches to overcome difficulties during surgery, none of them offered satisfactory results. Objective `- to describe a new technique to insert a large sized penile prosthesis in patients suffering from ED after neglected ischemic priapism with resultant severe corporeal fibrosis. Methods `- A new surgical technique was done in 15 patients suffering from ED after prolonged ischemic priapism with severe corporeal fibrosis. - Surgery starts by a circumcision incision, complete degloving & delivery of the penis through a midline perineal incision. - The penile urethra is then dissected away from the ventral surface of both corpora cavernosa - A midline ventral incision is done between both corpora cavernosa. This incision is then deepened till it reaches the inner surface of the tunica albuginea. At this point, the scalpel is then rotated 90 degrees to unfold the core of fibrosis into a flat sheet continuous with tunica albuginea. - The process is then repeated on the other side. - The proximal crura are then dilated in the usual manner by metal dilators. The distal part of the corpora are bluntly dilated by the closed blades of scissors. - After inserting the penile prosthesis, both sheets of fibrosis are closed over both prosthetic rods in the midline and the penile urethra is then fixed back to its position. - The penis is then retuned to its normal anatomical site & the skin is closed. Results `- Successful surgery was achieved in 13 out of 15 patients (86.7%). - 2 patients developed infection that necessitated surgical removal of the rods. - no incidence of urethral injury, crossover or corporal perforation Conclusions `- The new “un-folding” technique is feasible and useful technique in patients with ED after prolonged ischemic priapism - The incidence of complications esp. urethral erosion, crossover and corporal perforation. Disclosure No

(542) Socioeconomic Status is Not Associated with Complications or Patient Satisfaction Following Inflatable Penile Prosthesis Surgery

Abstract Introduction Prior studies have demonstrated that patient socioeconomic background and neighborhood status are associated with health care outcomes. Understanding how a patient’s environment and local community status affect clinical outcomes can vastly impact surgical care, patient education and counseling, as well as surgical outcomes. The Area Deprivation Index (ADI), is a validated measurement evaluating the differences in socioeconomic status between various neighborhoods both on a state and national level. ADI incorporates a composite score of patient income, education level, employment status, and housing quality. No prior studies have looked at how a patient’s socioeconomic status and geographic residence affect postoperative outcomes and patient satisfaction following implantation of inflatable penile prosthesis (IPP). Objective To understand how a patient’s socioeconomic status as measured by the ADI affects overall surgical outcomes and patient satisfaction following IPP placement. Methods Men that underwent a new IPP placement between 6/1/13 and 3/31/22 were included in the study. Using the Neighborhood Atlas National® (Madison, WI), national ADI percentiles (1-100) were calculated for each patient using their home address at the time of surgery. Higher ADIs represent a more disadvantaged socioeconomic status while lower ADIs represent a more advantaged socioeconomic status. Complications were defined as mechanical failure, urethral erosion, infection, intractable pain, or other (ex. hematoma, herniated reservoir, pump revision). A patient satisfaction phone questionnaire was administered measuring overall satisfaction (Likert scale). In order to reduce recall bias and allow for adequate follow-up, the phone questionnaire was limited to men who underwent IPP placement between the 2016-2020. Multivariable logistic regression and multivariable ordinal logistic regression were used to identify the association between ADI and surgical complications and patient satisfaction, respectively. Results A total of 430 men who underwent IPP implantation from 2013 to 2022 were identified and data were retrospectively collected. The final cohort consisted of 83% (n=355) Caucasian men with the median age of 65 (IQR 58-69). The overall complication rate was 11.2% (n=48). Of the 48 total complications, 22 (5.1%) required surgical intervention (mechanical problem n=7, urethral erosion n=1, infection n=9, pain n=1, other n=4). The median national ADI for patients with a complication was 57 (IQR 33-72) compared to 60 (IQR 42-76) in those patients without a complication (p=0.32). A total of 163 men completed the satisfaction phone questionnaire and 70% (n=114) of men stated that they were either very satisfied or satisfied with their IPP. The median ADI for patients who were satisfied was 64 (IQR 43-80) compared to 60 (IQR 42-76) in those patients who were not satisfied (p=0.45). On multivariable analysis, national ADI was not associated with postoperative complications (p=0.57) (Table 1) or with patient satisfaction (p=0.39) (Table 2). Conclusions While living in a disadvantaged neighborhood has been associated with poor health outcomes in other areas of medicine, we found no association between a patient’s socioeconomic status and complications or satisfaction following IPP placement. Regardless of a patient’s geographic residence, patients pursuing an IPP can expect comparable outcomes and overall satisfaction rates suggesting that implant consideration should not be influenced by socioeconomic status. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(279) Total Phalloplasty with Latissimus Dorsi Myocutaneous Flap. Our Italian Experience

Abstract Introduction Total phalloplasty (TP) is used for the creation of a penis in female to male sex reassignment surgery (FTM SRS). Objective We focused our work on free flap transfer technique using latissimus dorsi myocutaneous flap (MLDF) in order to create a neophallus that allows safe performance of urethroplasty and two cylinders prosthesis implantation. Methods Five patient underwent surgery. A necessary precondition for this technique was the normal body mass index. The donor site was prepared preoperatively by skin massage at least one month before surgery to enable easier donor site closure. The first surgical step includes removal of female genitalia (transvaginal hysterectomy, adnexectomy, colpocleisis), proximal urethroplasty, perineoplasty, the formation of external male genitalia (scrotoplasty, free flap transfer phalloplasty), and 1st stage distal urethroplasty. The second stage includes distal tubularizing urethroplasty, glans plasty, and testicular prosthesis implantation. In the third stage implantation of a 2-cylinder penile prosthesis is performed through the infrapubic approach. The time between stages was 6-9 months. Results The five pts underwent just the first two stages. Penile length varies from 12-18cm and penile girth from 11-16cm. One partial flap loss occurred. Penile urethral stricture developed in 3 pts; 1 pt developed proximal urethral diverticulum. Donor site healed satisfactorily in three pts, two of them required additional scar correction. Conclusions This surgery is a high-risk, complex staged procedure, but with a satisfactory functional and esthetic outcome Disclosure No

(140) Penile Length and Girth Restoration in Mb Peyronie: Less Invasive Approach for Complex Composite Graft Corporplasty and Implantation of Inflatable Penile Prosthesis

Abstract Introduction Peyronie's disease (PD) is a fibrotic disorder of the tunica albuginea. It is both a physically and psychologically devastating disorder that causes penile deformity, curvature, narrowing and shortening, which eventually compromise sexual function. Objective The presented technique is a less invasive approach that gives few complications, has a natural cosmetic outcome with preserved preputium, and high patient satisfaction. Methods In the period between December 2017 and May 2022, 65pts aged 33y to 78y underwent complex corporoplasty with inflatable penile prosthesis implantation. Mean penile curvature was 70 o (60 o -95 o ). Average penile shortening was 3.2cm (1 - 5.5cm), and girth narrowing 2.5cm (0 - 4cm). The surgical approach was thru penos-crotal incision, followed by direct dissection of NVB from tunica albuginea, penile eversion, composite corporoplasty (for transversal grafting 0.5mm thick porcine dermal graft, and for longitudinal graft composite semi-resorbable soft mash), and 3-piece inflatable penile prosthesis implantation. Postoperative vacuum drainage and compressive dressing were left in place for one week. Results Follow-up was 2-58 months (mean 21). Penile shape (corrected curvature, length and girth) was restored in all patients. In the first 4 weeks postoperatively 12pts had mild scrotal oedema; 8pts developed mild scrotal haematoma; 7pts developed penile skin oedema; 5pts had a transitory loss of sensitivity. All patients 5 weeks postoperatively started with sexual intercourse. All patients 12 weeks after surgery reported satisfactory aesthetical and functional results with no visible scaring related to surgery. Five pts (12-23 months after surgery) had prosthesis malfunction that needed reimplantation of the prosthesis. Conclusions Penile eversion thru peno-scrotal incision with preserving the prepuce for complex reconstructive surgery of PD is safe and gives the natural aesthetic appearance and good functional result with low complication rate. The high satisfaction rate for the patients is the most important aspect of this surgical method. Disclosure No

(115) Mechanical and Anatomic Indications for Inflatable Penile Prosthesis Revision

Abstract Introduction Implantation of an inflatable penile prosthesis (IPP) is considered the gold standard for definitive treatment of men with refractory erectile dysfunction. As mechanical devices, IPPs have a finite lifespan, thus often requiring surgical revision or replacement of components over time. Objective To characterize the location of IPP mechanical component failure in patients presenting for revision or explant and stratify them by device manufacturer [Boston Scientific (BSc) and Coloplast (CP)]. Methods A retrospective chart review of our large, single-surgeon, tertiary referral center penile prosthesis database between 2007-2022 was completed to identify all men who underwent IPP revision (partial or full device) or explant. Only cases having intraoperative documentation of cause for IPP failure and device manufacturer were included. Reasons for revision or replacement surgery were categorized into mechanical (tubing, cylinder, or reservoir leak and pump malfunction) and non-mechanical (component herniation, erosion, or crossover). All revisions performed due to non-mechanical reasons were excluded from analysis. Chi-square analysis was used to assess failure rates and causes. A Student’s T-test was used to assess time to revision and demographics. Results Among 933 IPP cases, we identified 133 patients who underwent 272 revision procedures; 154 met inclusion criteria (96 BSc and 58 CP). Forty-four (29%) of those surgeries were revisions of devices placed by outside surgeons, and 110 (71%) were revisions of IPPs inserted at our institution. Average patient age was 67 years for BSc and 63 years for CP (p = 0.086), and the average BMI was 28.7 for BSc and 30.8 for CP (p = 0.122). Time to revision was similar between brands at an average of 39 months for BSc and 56 months for CP (p = 0.11). Eighty-one (53%) of the surgeries were revisions of one affected implant component, 56 (36%) were full device removal/replacement, and 17 (11%) were full explants. Coloplast devices required revision more frequently due to tubing fracture (p < 0.01), and BSc devices required revision more frequently due to pump malfunction (p = 0.02). Both devices rarely failed due to cylinder or reservoir defects (Figure). Conclusions Although time to revision was similar between the two brands, CP devices malfunctioned more often due to tubing fracture whereas BSc devices failed more often due to pump malfunction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast

(242) Antimicrobial Prophylaxis for Inflatable Penile Prosthesis Surgery: Trends after Publication of the AUA Best Practice Statement

Abstract Introduction In April 2008, the American Urological Association (AUA) released a Best Practice Statement on antimicrobial use in urologic surgery, in which the combination of an aminoglycoside with either vancomycin or a 1st/2nd generation cephalosporin was recommended as the preferred antimicrobial regimen for inflatable penile prosthesis (IPP) implantation. This recommendation has come under scrutiny due to weak evidence supporting these combinations. Objective To assess changes in antibiotic prophylaxis for IPP surgery following publication of the AUA Best Practice Statement in April 2008. Methods The Premier Healthcare Database, an all-payer dataset that captures approximately 20% of hospital discharges in the United States, was queried for IPP surgeries from January 2000 to March 2020. The primary outcome was administration of an AUA-adherent antimicrobial regimen and secondary outcome was 90-day explant. Piecewise linear regression was used to compare antimicrobial trends before vs. after guideline publication. Multivariable logistic regression models were constructed for primary and secondary outcomes. Results A total of 26,574 patients who underwent IPP surgery were identified, of whom 17,754 (67%) received AUA-adherent antibiotics. After guideline publication, there was a 42% relative increase in AUA-adherent regimen usage, with an increase in the usage trend on piecewise linear regression (from 0.1% to 0.8% of encounters per quarter, R2=0.75, p<0.001). Increased usage trends were also observed for gentamicin (from 0.0% to 1.0% of encounters per quarter, R2=0.84, p<0.001) and vancomycin (0.1% to 0.7%, R2=0.77, p<0.001). On multivariable regression, odds of AUA-adherence increased after guideline publication (OR: 1.67, 95% CI: 1.54 – 1.80, p<0.001) and with surgery by a high-volume surgeon (OR: 2.21, 95% CI: 2.07 – 2.35, p<0.01). The risk of 90-day IPP explant was not associated with adherence to an AUA-recommended regimen (OR: 0.94, 95% CI: 0.75 – 1.18, p=0.6). Conclusions Publication of the AUA Best Practice Statement on Antimicrobial Prophylaxis was associated with a subsequent increase in the usage of AUA-recommended antibiotic regimens, with gentamicin and vancomycin being the most frequently used combination. No association was observed between AUA-adherent regimens and risk of 90-day explant. These findings suggest that the AUA Best Practice Statement, among other relevant communications on antimicrobial use at the time, led to significant changes in prophylactic antibiotic choice in IPP surgery, despite the absence of level-1 evidence regarding a superior choice. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman Health.

(225) Rabbits Provide a Viable Model for Preclinical Penile Implant Studies

Abstract Introduction Inflatable penile implants (IPP) are the mainstay treatment for refractory erectile dysfunction (ED), but device infection is common and confers significant morbidity. Besides the addition of antibiotic and hydrophilic coatings, improvements targeting this complication are lacking. Preclinical in vivo studies to study methods of decreasing biofilm and mitigating infection sequelae are hindered by the lack of animal models containing functional IPPs. Previously, IPP fragments have been subcutaneously placed to study antimicrobial strategies, but the placement of complete, functioning IPP cylinders has not been demonstrated. Objective This biocompatibility study aimed to demonstrate the feasibility of placing and inflating IPPs in rabbits, with the goal of developing a viable model to study penile implant infections. Methods This study utilized 2 cadaveric and 2 live male New Zealand White rabbits. Experimental protocols were approved by IACUC (21-08-418). Cadaveric rabbits were utilized to evaluate surgical technique and ultrasound parameters prior to in vivo study. Following anesthesia and surgical site preparation, functioning IPPs were placed into the rabbits’ flanks. Upon dissection down to the plane between the panniculus carnosus and underlying muscle fascia, a subcutaneous pouch was developed to accommodate the implant. Following implantation, unrestricted ambulation was permitted, and the rabbits were observed daily for activity and recovery. Wounds were inspected daily for drainage, erythema, warmth, and swelling. Inflation-deflation cycling was performed following a 3-day post-implantation recovery period and evaluated via ultrasound. Surveillance was conducted for 14 days, after which the animals were euthanized. Results A single cylinder 14 cm implant without rear tip extender was successfully placed into each rabbit. IPP cycling mimicking the inflation protocol was successfully completed without tissue damage or harm to the animals. All IPP components were successfully visualized via ultrasound, which demonstrated the superficial position of the implant (Figure 1). Over a 14-day observation period, no concerns were identified, and signals of pain or distress, including gait disturbance, hypoactivity, restlessness, weight loss, dehydration, or reduced eating/drinking, were not observed, indicating the biocompatibility of functioning penile implants in the back of rabbits. Conclusions Preclinical in vivo models are the primary representative way to investigate IPP infection. This rabbit model may serve as an effective tool for the evaluation of novel infection prevention strategies following penile prosthesis implantation for ED. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: PHC: Boston Scientific and Coloplast.

(110) Evaluation of Men Under 35 Who Underwent Penile Implant Surgery

Abstract Introduction Erectile Dysfunction (ED) has become an increasingly common disorder in young adult males. There are multiple etiologies of ED ranging from vascular, neurogenic, and structural causes. Often times, ED presenting in young men is psychiatric in nature as opposed to the other causes that typically present in older patients. ED found in young, healthy men with no history of systemic disease or traumatic injury, can be challenging. Past research has shown that men ages 18-35 typically have normal lab results and are treated with PDE-5 inhibitors. However, our data suggests that patients whose symptoms do not improve following the use of PDE-5 inhibitors may have a vascular etiology of ED. Objective Our objective is to determine the prevalence of venous leaks in young adult males who present with ED, but do not respond well to PDE-5 inhibitors. Methods Patients who underwent inflatable penile prosthesis (IPP) surgery for the treatment of ED over a 36-month period under the age of 35 who had failed PDE-5 inhibitors were identified from our database retrospectively. All patients completed an IIEF-5 questionnaire and had a penile doppler ultrasound (PDUS) performed preoperatively. PDUS was used to identify and record cavernous arterial flow signals before and after stimulation. Veno-occlusive ED was described as persistent End Diastolic Velocity (EDV) over 5 cm/sec during all phases of erection. The relationships, according to Doppler diagnosis, IIEF-5 score, SHIM scale, and erection score were evaluated as well as surgical outcomes and patient comorbidities. Results 1,558 patients were evaluated in this series, of whom 32 met inclusion criteria. Patients ages ranged from 18 to 35, with a mean age of 28.4. PDUS determined that 27 (84%) suffered from veno-occlusive disease, while 3 (9%) had arterial insufficiency due to DMI and 2 (7%) had neuropraxia. Of those veno-occlusive disease patients, EDV values ranged from 7.4 to 21.2, with a mean of 13.4, with peak systolic velocity values ranging from 45 to 122cm, with a mean of 97. All patients in this cohort had successful penile prosthesis implantation without complications or need for revision. Conclusions Doppler examination does indeed suggest that patients with cavernous venous occlusive dysfunction have moderate to severe leaks. We strongly recommend a baseline PDUS following PDE-5 inhibitor failure due to the significant prevalence of veno-ccclusive disease in this rare patient population. Furthermore, if veno-occlusive disease is identified during PDUS, we encourage frank discussion of penile prosthesis placement with the patient as well as the severity of veno-occlusive disease and its resultant effect of worsening ED. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: coloplast, boston scientific

(428) Complex Treatment of Venous Leak with Embolisation and Autological Stem Cells Injections

Abstract Introduction The venous leakage is one of the most often reason of erectile dysfunction (ED) in young and middle age men. The main reason of veno-occlusive ED (VOED) is the insufficiency venous obstruction in corpora cavernosa under tunica albuginea that is why all types of veno-occlusive operations have particular and short term effect up to renovation of venous leakage in half year. Conservative treatment of VOED with PDE-5 has a low effectiveness. Evermore young patients deny Penile prosthesis implantation for psychological reason. Objective We want to stimulate growth of endothelial valves under tunica albuginea with injections autological mesenchymal stem cells (ASC) and autological VEGF (Vascular endothelial growth factor) and combine it with veno-occlusive surgeries (embolization and/or ligation). Methods On the basis of Andrology deratment in 2012-2022 we treated 184 patients with VOED. The average patient age is 36.1 +4.1 years. Patients with prostatitis or depression/anxiety were excluded from the investigation or treated previously. We embolizated deep dorsal and Santorini plexus veins for patients with distal form of VOED–47 patients -Group 1. We ligated deep dorsal and penile veins for proximal form of VOED – 68 patients – Group 2. And we made both methods together for 71 patients –Group 3 with combination of proximal and distal leak. Patients with only surgical methods created subgroup A – 106 men. For improving of veno-occlusive mechanism for 78 patients (subgroup B) we injected to each corpus cavernosa 1 mln of autological stem cells 5 times (2 times before and 3 times after surgery) each 1.5-2 months and we performed 15 microinjections of VEGF each 10 days. Then we compared short (2 months) and long term (10 months) results. Results The efficacy of surgical treatment according to subjective data (questionnaires on IIEF-5) in 2 months was almost equal (16.7+3.1 and 16.9+3.0), but in 10 months significantly higher in SubGroup B (14.3+3.2 and 19.7+3.4). According to Ultrasound and Cavernosography in 10 months adding microinjections ASC and VEGF to surgery significantly improves Erectile function (absence of venous leakage) 56.4% - subgroup A and 87.4% - subgroup B. Conclusions Half year injections of autological stem cells and VEGF improve of veno-occlusive mechanism and increases effectiveness and long term result of veno-occlusive operations for treatment of VOED. This method can be offer as second line therapy of ED for young patients with venous leak. Disclosure No

(444) Long-term Outcomes of Inflatable Penile Prosthesis in a VA Practice

Abstract Introduction Inflatable penile prostheses have favorable short-term results for men with refractory erectile dysfunction, but few studies have evaluated the long-term outcomes, including in a VA population. Objective This study aims to evaluate the outcomes and satisfaction rates using the novel validated survey, the Satisfaction Survey for Inflatable Penile Implant (SSIPI) of a long-term single-center VA practice. Methods Chart reviews were completed as a Quality Improvement project. All patients who underwent a primary inflatable penile prosthesis implantation from 1993-2021 were included. Demographics and data were collected; SSIPI was administered to men who could be reached. Statistical analyses were performed. Results 114 men were identified, 82 alive and 32 deceased. In the cohort we contacted, mean age at time of surgery was 62.6 years old and mean follow-up 78.2 months (5-234 months). Average SSIPI scores were 64.5/80 (26-80). Smokers were less satisfied with length of penis vs. non-smokers (SSIPI#8 = 2.89 vs 3.93, p=0.032). Men with diabetes were more likely to express regret about undergoing IPP surgery compared to men without (SSIPI#4 = 4.05 vs 4.38, p=0.0029). Men with an ASA score of 2 or less had higher total SSIPI scores compared to ASA score of 3+ (70.36 vs. 61.13, p=0.046). Conclusions Long-term satisfaction with IPP in a veteran population appears favorable. However, a significant number of these men still score poorly on SSIPI and/or have complications. The utility of this novel assessment instrument appears excellent. Men with smoking, diabetes, and higher overall comorbidities may find fewer positive results. Disclosure No

(019) Longitudinal Observation on the Prevalence and Impact of Psychological Distress Among Patients Treated for Erectile Dysfunction During the COVID Pandemic

Abstract Introduction The COVID global pandemic has significantly affected the delivery of the healthcare system with valued resources diverted to cope with more urgent clinical services. Erectile dysfunction (ED) is considered a non-urgent medical condition and hence, males with ED were not prioritised and invariably faced long delays in clinical management including postponement in surgical waitlist during this pandemic. Objective To assess the prevalence and impact of psychological distress among males with ED during the COVID pandemic based on changes in the outcomes of validated questionnaires such as the International Index of Erectile Function (IIEF), Depression and Anxiety Stress Scales (DASS-21), Sexual Distress Scale (SDS) and Decisional Engagement Scale (DES-10), as well as perceived availability of medical support. Methods Following ethics approval, this prospective longitudinal study tracked males with ED at a tertiary medical centre between June 2020 and June 2022. Inclusion criteria included males aged 20 to 70 years, who have pre-existing ED (greater than 6 months), receiving medical therapies for ED, and had enrolled in the prospective database at the time of the study. Exclusion criteria were those who have undergone penile prosthesis implantation or received major abdominopelvic surgery during the study period that may preclude sexual activity. All patients completed validated questionnaires at 0, 6, 12, 18 and 24 months with additional data collected during the peak periods of local COVID social measure lockdown. Results A total of 80 patients were identified during the 24 months and 20 patients dropped out due to surgery (15 patients) and incomplete follow-up (5 patients). The mean age of males was 46.8 (21-69) years, and the duration of ED was 14.5 (6-33) months. Almost one-third of the patients showed increased DASS scores on depression (38 patients) and anxiety (42 patients) subscales and one-quarter on stress (29 patients) subscales, with worse DASS scores during the peak periods of social measures. On the SDS questionnaire, higher concerns were registered across all domains apart from the question on regrets about your sexuality. The analyses showed a worsening of the IIEF scores (p<0.021), anxiety and stress (DASS score with p=0.045 and p=0.038, respectively) as well as SDS score (p=0.048) during this pandemic. However, the DES-10 scores were more positive with most patients reporting a score above 7 out of 10 in terms of items on accepting current arrangement (75%) and confidence in clinician decision-making about the treatment (80%) although most patients (92%) indicated the desire to be kept updated and provided with more detailed information on their clinical care. Conclusions The COVID pandemic has caused an adverse psychosexual impact on many patients’ erectile function and mental well-being, and social measures lockdown invariably heightened patient psychosexual distress. Our study showed regular clinical contact and medical reassurance coupled with an explanation of reasons for clinical delays in the non-urgent medical condition resulted in a high level of confidence in clinicians and potentially minimised emotional adjustment in the patients. Disclosure No

(474) Trends and Costs of Ambulatory vs Inpatient Penile Prosthesis Placement

Abstract Introduction Current literature is limited in assessing nationwide trends of penile prosthesis (PP) placement in the United States largely due to a lack of data on outpatient PP placement. Particularly no nationwide comparison of ambulatory surgery center (ASC) versus inpatient hospital (IH) PP placement has been published. Objective Our objective is to determine the trends of PP placement in ASCs vs IHs utilizing representative nationwide data. Additionally, we examined patient demographics that are associated with the setting for PP placement. Methods Inpatient and outpatient encounters for PP placement between 2016 and 2019 were analyzed using data from the Nationwide Inpatient Sample (NIS) and the Nationwide Ambulatory Surgery Sample (NASS) from the Healthcare Cost and Utilization Project (HCUP). These are the largest publicly available inpatient and ambulatory surgery databases available in the United States. PP operations were identified by CPT and ICD-10-PCS codes. Subsequent analysis was performed using the established weighting provided by the HCUP, which utilizes stratified cluster sampling to create national estimates. Comparisons of demographics were performed using t-tests and chi-square tests with a p-value for significance <0.05. Results Over the study period, there were 67,722 PP placements in the United States. The percentage placed in ASCs was 93.1%. In 2016, 16,290 PP placements occurred, of which 92.3% were placed in ASCs. Comparatively in 2019, there was a 7.3% increase (17,473) in the number of PP placements, with 94.5% placed in ASCs (p<0.01). Over the study period, 33,008 PP placements were performed in the South (93.8% ASCs), 12,481 in the Midwest (94.6% ASCs), 12,192 in the Northeast (92.4% ASCs), and 10,040 in the West (90.1% ASCs, p<0.01). The average age of patients receiving a PP placement was 64.4 in ASCs compared with 62.5 in IHs (p<0.01). The average cost associated with PP placement in ASCs was $25,935, about half the cost of inpatient settings, which averaged $51,594 (p<0.01). Of all PP implants, the primary payer was medicare for 57.1% (38,660; 93.1% ASCs), medicaid for 4.4% (2980; 86.6% ASCs), private for 33.6% (22,778; 94.3% ASCs), and self-pay for 1.1% (768; 90.9% ASCs, p <0.01). Conclusions Our results suggest that the number of PP placements is consistently rising each year, with an increasing majority of PP placements performed in ASCs. The procedure costs roughly half on average when performed in ASCs compared to IHs. Further investigation is needed to compare complication rates and outcomes of PP placements in ASC versus IH. Disclosure No

Anatomic considerations of inflatable penile prosthetics: lessons gleaned from surgical body donor workshops.

Surgical implantation of an inflatable penile prosthesis (IPP) remains the gold-standard treatment for severe erectile dysfunction. The ideal surgical technique requires a thorough understanding of the relevant anatomy. This includes anatomic considerations related to, but not limited to, dissection and exposure of penoscrotal fasciae and tissues, corporal configuration, and abdominal structures. Insights obtained from pre-dissected anatomic specimens can obviate urethral injury, nerve damage, corporal perforation, inappropriate sizing, crossover, or implant malposition. We present penile implant-specific anatomic dissections and topographic landmarks identified over the last decade in the course of surgical training programs provided for IPP implantation.

Value of prolonged scrotal drainage after penile prosthesis implantation: a multicenter prospective nonrandomized pilot study.

We aimed to understand the risks and benefits of post-inflatable penile prosthesis (IPP) implantation drainage and optimal duration. Our patients were divided into 3 groups: Group 1 (n = 114) had no drain placed, Group 2 had a drain placed for 24 h (n = 114) and Group 3 had a drain placed for 72 h (n = 117). Postoperative scrotal hematoma and prosthesis infection rates were compared between the groups. The patients from Group 3 demonstrated a statistically significant lower incidence of hematoma on the 10th postoperative day: (n = 1, 0.9%) compared to Group 2: (n = 11, 9.6%) and Group 1: (n = 8, 7%), (p = 0.013). However, on the 3rd postoperative day, there was a statistically significant lower incidence of hematoma in both Groups 3 and 2: (0.9% and 6.1%, respectively) vs. Group 1: (11.4%), (p = 0.004). Hematoma rates followed the same group order after the first day of surgery: 1.7% (n = 2), 5.3% (n = 6), and 8.8% (n = 10), respectively, (p = 0.05). Five patients (4.4%) in Group 1 and four patients (3.5%) in Group 2 developed an IPP associated infection, opposed to only a single patient (0.85%) in Group 3, (p = 0.210). We concluded that prolonged scrotal drainage for 72 h after virgin IPP implantation significantly reduces hematoma and infection rates.

Defining the incidence and management of postoperative scrotal hematoma after primary and complex three-piece inflatable penile prosthesis surgery.

Scrotal hematoma is a challenging complication of penile prosthesis surgery. We characterize the risk of hematoma formation with implementation of standardized techniques to mitigate hematomas and assess for any associated factors in a large multi-institutional penile implant cohort. This was a retrospective review from February 2018 to December 2020 of all patients who underwent inflatable penile prosthesis implantation at 2 high volume implant centers. Cases were defined as "complex" if they involved revision, salvage with removal/replacement, or were performed with concurrent penile, scrotal or intra-abdominal surgeries. The incidence of scrotal hematoma among primary and complex IPP recipients was measured and modifiable and innate risk factors associated with hematoma formation within the two cohorts were tracked. Of 246 men who underwent penile prosthesis surgery, 194 (78.9%) patients underwent primary implantation and 52 (21.1%) were complex. Although hematoma formers in the complex group had comparable drain outputs to primary patients on postoperative day 0 (66.8cc ± 32.5 vs 48.4 ± 27.7, p = 0.470) and postoperative day 1 (40.3cc ± 20.8vs 21.8 ± 11.3 p = 0.125), hematomas in the complex group had a higher propensity for OR evacuation (p = 0.03). Difference in duration of temporary device inflation between 2 (64, 26%) and 4 weeks (182, 74%) did not contribute to hematoma formation (p = 0.562). The incidence of postoperative hematoma formation in complex cases was 9.6% (5/52) and 3.6% in primary cases (7/194) (HR = 2.61, p = 0.072). Complex IPP surgery performed for revision or with ancillary procedures are more likely to result in clinically significant hematomas that require surgical management, suggesting a need for heightened caution in managing these individuals.

Intermediate-term results of TachoSil grafting to correct residual curvature during inflatable penile prosthesis implantation in patients with Peyronie's disease.

Grafting techniques may be mandatory to improve residual penile curvature during inflatable penile prosthesis (IPP) implantation in Peyronie's disease patients. We aimed to report the intermediate-term outcomes of grafting with TachoSil (Corza Health, San Diego, USA) in patients with severe erectile dysfunction and concomitant complex Peyronie's disease through a prospective cohort study. We included 25 patients that underwent the PICS (penile implant in combination with Sealing) technique from 2017 to 2020 and were evaluated 24 months after surgery. Their mean age was 61.8 ± 8.7 years. Total straightness of the penis was achieved in 21 cases, while 4 (16%) patients presented a residual penile curvature of less than 15°. The mean penile length increased significantly (15 ± 1.2 to 16.4 ± 1.6 cm, p < 0.001). No intraoperative complications occurred, while, postoperatively, two patients developed fever and three scrotal hematoma, which resolved spontaneously. At three and six weeks, as well as at 24 months after surgery, no further complications occurred, and no cases of penile glans hyposensitivity were observed. At the 24-month follow-up evaluation, the 5-item score of the International Index of Erectile Function was 23.7 ± 1.4 (range: 20.5-25) and all patients responded positively to questions 2 and 3 of the sexual encounter profile questionnaire (p < 0.001 for all outcomes compared to baseline). Accordingly, the Erectile Dysfunction Inventory of Treatment Satisfaction score improved from 45.8 ± 6 at baseline to 25.6 ± 4.6 at 24 months, p < 0.001. Grafting with TachoSil to improve residual penile curvature during IPP is a safe and effective procedure. Nevertheless, careful patient selection and counseling, surgeon's experience with the technique, and strict postoperative penile rehabilitation are the main factors for treatment success and high satisfaction rates.

Shaeer's Cavernotome for Penile Prosthesis Implantation in Scarred Corpora Cavernosa.

Penile prosthesis implantation in scarred corporal bodies is one of the most challenging urologic procedures, with high risks of perforation and/or failure. We present Shaeer's Cavernotome (patent application number PCT/EG2021/050003). This is the forward-cutting cavernotome that relies on the principle of controlled coring and grinding rather than forward stabbing, with fibrous tissue accommodated into the hollow core, thereby ensuring high efficacy and low risk of perforation. This is a prospective study involving 18 patients with severe corporal scarring. Surgery is performed through a peno-scrotal incision with an indwelling urethral catheter. Corporotomies are incised and a 2-cm-long core of fibrous tissue is excised with a scalpel. Shaeer's Cavernotome is introduced and lodged against the fibrous tissue. Coring proceeds with the stretched corpus or crus held between the thumb and index fingers of the non-dominant hand as a guide, ahead of the tip. Shaeer's cavernotome doubles as a sizer. Following coring, penile prosthesis implantation proceeds. Dilation of the corpora cavernosa was successful in 17 out of 18 patients. Average coring time was 8 ± 3.2 minutes. Dilation was up to girth 13 Hegar in 12 patients, and 11 in 5. No perforations or infections were encountered. Shaeer's cavernotome facilitates penile prosthesis implantation in scarred corporal bodies. Full excavation of both corpora cavernosa is achievable in less than 10 minutes, with a low risk for perforation.