Inflatable Penile Prosthesis Research Articles

(141) Surgical Outcomes of Infrapubic Insertion of the Inflatable Penile Prosthesis in 175 Transmen After Phalloplasty

Abstract Introduction Historically, inflatable penile prostheses (IPP) insertion in a neophallus has an estimated 40-50% surgical revision rate. Objective To review the surgical outcomes of a single center’s experience with the infrapubic approach to insertion of the IPP after phalloplasty in transmen. Methods The infrapubic prosthesis insertion after phalloplasty (IPIP) technique involves a horizontal incision anterior to the pubic symphysis, which allows dissection of the neophallus channel, the Space of Retzius, and the scrotal pocket. Surgical outcomes using the Titan (Coloplast, Minneapolis, MN) IPP by a single surgeon (MLC) were analyzed between October 2017 and June 2023. Complications were reviewed and categorized into erosions, infections, device malposition and malfunction, and less common events like necrosis and urinary tract injury. Results The IPIP technique was performed on 175 phalloplasty patients by a single surgeon (MLC): 156 patients had a prior RF phalloplasty, and 19 had a prior ALT phalloplasty. The mean followup was 32.8 months. Surgical revision was required in 35 patients (20%). There were 10 pump erosions through the neoscrotum, 1 glans erosion, 9 infections, 6 pump malpositions in the neoscrotum, 6 cylinder malposition in the neophallus, 3 mechanical malfunctions with broken tubing, 2 urethral injuries, 2 bladder injuries, and 1 glans necrosis. There were no instances of implant detachment from the pubic bone anchor site, osteomyelitis, nor total phallus loss. Conclusions Data for the IPIP technique using the commercially available Coloplast Titan IPP suggest a reduction in neophallus prosthetic surgical revision rates compared to previous reports. Longer term studies with patient reported outcomes are required for further evaluation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific.

(222) Simultaneous Inflatable Penile Prosthesis and Adjustable Male Sling: A Step-by-Step Surgical Technique

Abstract Introduction Erectile dysfunction (ED) and urinary incontinence (UI) are common complications following radical prostatectomy (1). At twenty-four months post-surgery, approximately 43% of men experience some degree of ED, while UI affects around 15% of patients between twelve to twenty-four months (2, 3). Notably, nearly 20% of patients experience both ED and UI complications (4). Initial conservative management strategies include the use of PDE-5 inhibitors, intercavernosal injections, or a vacuum erectile device for ED and pelvic floor muscle training for UI (5). However, symptoms that persist or worsen beyond six months can be considered for surgical intervention (6). Surgical options include penile prosthesis implantation for ED and diverse techniques such as the Artificial Urinary Sphincter (AUS) or adjustable male urethral sling, depending on symptom severity, for UI management. Limited evidence suggests that a simultaneous surgical approach addressing both conditions can be a cost-effective and a safe alternative to separate surgeries (7, 8). Objective In this context, the objective of this video presentation is to illustrate a detailed, step-by-step technique for the simultaneous implantation of an inflatable penile prosthesis (IPP) and an adjustable male sling (AMS), while also discussing its feasibility, safety, and functional outcomes. Methods The combined IPP and AMS surgery is a safe, viable, and cost-effective option for patients who need to address both ED and UI. Rhee (2005) initially described the concurrent placement of a penile prosthesis (PP) and male sling (MS) in a series of four post-prostatectomy patients. Results The results demonstrated successful restoration of erections and complete continence in all patients, with no postoperative complications. Our previous systematic review, comparing the outcomes of simultaneous surgical placement of PP and MS versus PP and artificial urethral sphincter (AUS), found no clinically significant differences in outcomes between the two groups (Raheem 2021). Therefore, the simultaneous placement of IPP and AMS should be considered an option for patients, as it shows comparable effectiveness to other concurrent surgical interventions. Dual implantation of PP and male sling have also demonstrated cost savings of approximately $9,000 for patients, further enhancing its advantages in managing both ED and UI (Gorbatiy 2010). Ultimately, a collaborative discussion between patients and their urologist is crucial in determining the most suitable approach for patient individual needs. Conclusions The simultaneous surgical placement of an inflatable penile prosthesis (IPP) and adjustable male sling (AMS) presents a favorable and viable solution for managing erectile dysfunction (ED) and urinary incontinence (UI) in patients who exhibit an inadequate response to conservative management following prostatectomy. Disclosure No.

(311) Reduced Glans Engorgement After Inflatable Penile Prosthesis – A Scoping Review of Factors Involved and Management Strategies

Abstract Introduction Inflatable penile prosthesis (IPP) provides a reliable stiffness along the length of the penile shaft, yet patients may express dissatisfaction as it may still differ from their recollection of their previously normal erections. A common complaint is reduced engorgement of the glans penis, which can manifest as subjective reduction in penile length or the feeling of a cold insensitive glans. Patient factors often ensure a sound justification for this complaint, namely vasculogenic erectile dysfunction (ED) or their corporo-glandular morphology despite a well-sized and well-positioned implant. Objective To identify factors that may contribute to reduced glans engorgement and possible management strategies. Methods Intervention: Any method of treating or avoiding reduced glans engorgement post-IPP. Population: Men undergoing IPP insertion or men with glans complaints post-operatively Inclusion Criteria: Articles published in English with full text available and objective outcome measures Search Strategy: Literature search was performed in June 2023 using Medline, PubMed, Embase and Scopus. PubMed search included both “Mesh” protocols and “free text” to capture the correct study population and intervention utilized. Review Type & Analysis: Although an initial systematic model was considered, a scoping model was ultimately selected due to the limited literature and inconsistent outcome measures. This approach aimed to identify gaps in knowledge and provide an overview of the existing literature, thus informing future studies in this area. The variability in outcome measures across studies prevented higher-powered analyses from being conducted. Results Initial search strategy retrieved 98 non-duplicate studies with 40 being selected for initial screening after applying inclusion criteria. Ultimately, a total of 7 articles were included and categorized by theme: Cavernous-sparing technique (1-3); Pharmacotherapy for post-IPP glans complaints (4-7) (Table 1 & 2). The cavernous-sparing technique described aims to limit disruption of cavernous tissue around the implanted cylinder. This was achieved by omitting dilatation and using Furlow directly for measurements, or by intraoperative intracavernosal (IC) prostaglandin followed by dilatation only with size 7 or 8 Hegar alone. In all studies that compared penile dimensions, girth was significantly greater in the cavernous-sparing group. A higher proportion of men in this group also had detectable cavernous arteries, thicker residual corporal tissue, better residual tumescence post-IPP and demonstrated significant increases in both PSV and EDV post-PDE5i, compared to no PDE5i. Men who had standard dilatation also responded to post-IPP PDE5i but fewer had identifiable cavernous artery and had significant increase in only PSV, compared to no PDE5i. Other articles relating to post-IPP pharmacotherapy unanimously demonstrated that post-IPP glans engorgement was improved. This equated to reported statistically improved satisfaction when compared to the IPP alone groups, as measured by IIEF and EDITS questionnaires. Post-IPP PDE5i were better tolerated than intraurethral alprostadil, which was associated with discomfort. Conclusions Post-IPP pharmacotherapy appears to enhance residual erectile tissue engorgement. It can be used as an adjunctive after-care measure. Cavernous-sparing techniques show the importance of viable residual tissue for improved prosthetic erections. More comprehensive studies are needed to enhance patient experience and explore the microanatomical and hemodynamic role of residual tissue post-IPP. Disclosure No.

(394) Penile Implant Reservoir Placement: The Current Utilized Various Techniques and the Associated Outcomes: Systematic Review and Meta-analysis

Abstract Introduction Many innovations in the field of inflatable penile prosthesis (IPP) has been emerged. Since the introduction of the IPP, reservoir positioning in the space of Retzius (SOR) was considered the classical approach that had been utilized for many years. However, in certain group of patients, reservoir insertion in such space might be difficult or even risky. As a result, many alternatives for the reservoir placement outside the SOR has emerged with the intent of safe and reliable reservoir placement. Objective To conduct a systematic review for the studies evaluating the outcomes of different techniques used for IPP reservoir placement to look for possible superiority of any approach over others. Methods A systemic review was performed utilizing (PRISMA) statement. The PubMed and Google scholar were used to look for articles published up to January 2023. Original articles reporting different techniques for IPP reservoir placement and evaluating the associated outcomes were included. Data regarding study design, sample size, approach of reservoir placement, surgical technique, device type and reported outcomes (infection rate, bladder/bowel/vascular injury, reservoir herniation, mechanical failure, auto-inflation, reservoir palpability and patients’ satisfaction) were collected. Pooled proportion was calculated and included in the meta-analysis. The Newcastle-Ottawa scale was used for assessing the quality of the studies. Results A total of 23 articles meeting the inclusion criteria, all were retrospective reviews. 11 compared more than one technique for reservoir placement whereas 12 described a single technique. In total, techniques for 6 main different reservoir locations has been reported, including SOR (7 studies), submuscular/subrectus (6 studies), Lateral retroperitoneal (1 study), subcutaneous (1 study), sub external oblique (1 study) and intraperitoneal (1 study). Another 7 modifications have been described for the SOR technique (traditional SOR, accessing SOR using blunt scissor in post-prostatectomy patients, accessing SOR using blunt scissor in virgin cases, dilating SOR using catheter balloon, accessing SOR under direct vision, accessing SOR through external oblique fascia incision, and the addition of The Tubing Hitch&Lasso, Intussusception Anchor technique (THALIA)). Another 6 modifications for the submuscular/subrectus approach have been described (posterior to transversalis fascia (PTF), anterior to transversalis fascia (ATF), high submuscular, subrectus using counter incision, subrectus with the addition of THALIA, low submuscular with trans-fascial-fixation (TFF)). None of the studies have proven the superiority of one technique over others, with most of the techniques has comparable intra-operative and post-operative outcomes (table 1). The addition of anchoring step (THALIA or TFF) resulted in neglected risk of reservoir herniation, however, related studies has small sample size with no comparison groups. Meta-analysis for the studies of SOR(n=7) and submuscular/subrectus(n=6) groups showed a statistically significant difference only in the herniation rates (figure 1). 10 studies were of strong quality (8 stars) while the remaining 13 studies were of poor quality. Conclusions Modest evidence suggests a comparable favorable outcome of various approaches used for IPP reservoir placement. The lack of enough prospective trials, short term follow up, and diversity in the techniques prescribed prevent the ability to build strong evidence. For the purpose of supporting the superiority of any technique, further prospective studies on a larger number of patients with long-term follow up are needed to reach a solid verdict. Disclosure No.

(189) Modified Mini-jupette Sling for Climacturia During IPP Placement

Abstract Introduction Climacturia, the inadvertent leak of urine during orgasm, is a well-known complication following radical prostatectomy and can cause significant patient/partner bother. The Mini-Jupette sling treats climacturia during placement of an inflatable penile prosthesis (IPP) but requires an extended corporotomy with a complex closure. Our modified Mini-Jupette technique utilizes a standard corporotomy and places the sling inferior as opposed to integrated into the corporotomy. Additionally, we perform an intraoperative drip test for urethral occlusion, which eliminates the need for guessing on sling tension. Corset sutures can then be utilized intraoperatively or in future revision surgeries in the event of sling loosening or recurrent climacturia. Objective To visually demonstrate the modified mini-jupette technique and intraoperative drip test. Methods An IPP surgical candidate with climacturia was identified. Intraoperative video of the Mini-Jupette technique was recorded using an overhead camera. The Mini-Jupette sling is placed with four vertical Ethibond (00) sutures placed inferior to the corporotomy stay sutures. The drip test is set up by retracting the catheter to the distal urethra and connecting it to a bedside irrigation system set 60cm above the patient. Stoppage of fluid flow during IPP inflation indicates that the sling is appropriately occluding the urethra. Results Successful demonstration of a modified Mini-Jupette technique and intraoperative drip test without complications. Conclusions Our modified Mini-Jupette and intraoperative drip test provide a reasonable alternative to the standard Mini-Jupette technique. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

(391) A Comparative Meta-analysis of Revision Strategies for Malfunctioning Inflatable Penile Prosthesis: Partial Vs Complete Component Replacement With or Without Retained Reservoir

Abstract Introduction In cases of non-infected malfunctioning Inflatable penile prosthesis (IPP) device, surgeon often opt to exchange all the device rather than the defective component for fear of increased infection rate and future mechanical dysfunction. Objective To assess whether partial component exchange of IPP device has comparable outcomes to complete explant and replacement of IPP device with or without retained reservoir. Methods A meta-analysis was completed in line with PRISMA 2020 and AMSTAR guidelines. A comprehensive search was done on MEDLINE (OVID), PubMed, and Cochrane Library electronic databases from their inceptions until May 2023, identifying studies that reported on outcomes and complications of revision surgery for non-infected malfunctioning IPP device. Three groups were compared: the first group underwent a single or two-component exchange, the second group had a complete explant replacement of the entire device, and the third group had replacement of all components with a 'drained and retained' primary reservoir. Results A total of 9 articles were included in the analysis. 12,152 patients had complete replacement of their device, 128 had partial exchange of their device and 151 patients had “drained and retained” reservoir following revision. The mean age was similar among the 3 groups between 62-68 years. The median follow up time ranged between 12 and 79 months. Partial component exchange had a higher rates of mechanical failure 10.3% versus 1.3% and 2.3 % (p=0.03) for complete and “drain and retain” groups respectively. (Figure 1) Similarly, partial component exchange had higher perioperative complications at 21.2% compared to complete replacement group 9.5% and “drain and retain” group 14.5% (p=0.022). However, the infection rate was similar among the three groups, 7.7%, 2.7% and 3.3% respectively (p= 0.301). (Figure 2) Conclusions Partial component exchange during IPP revision has higher rates of perioperative complication and future mechanical failure but has similar rate of infection compared to complete component replacement with or without “drain and retain” of original reservoir. Disclosure No.

(373) Economic Benefits of Patient Care for Prostate Cancer Survivors with Stress Urinary Incontinence and/or Erectile Dysfunction: A Physician Reimbursement Analysis

Abstract Introduction Reconstructive urological procedures play a vital role in enhancing the satisfaction and quality of life of patients with prostate cancer (PCa) following radical prostatectomy (RP). Providing comprehensive postoperative care for common side effects of post-RP, including stress urinary incontinence (SUI) and erectile dysfunction (ED), may result in a greater number of patients with PCa receiving needed consultations and therapies. This analysis sought to explore the potential economic benefits of offering men’s health consultations and reconstructive care for PCa survivors. Objective This study quantified the relative value units (RVUs) generated from providing patient care to PCa survivors covered by Medicare Fee-for-Service who may experience SUI and/or ED due to RP. Methods This physician reimbursement analysis was based on typical patient care pathway scenarios for patients at risk of developing SUI or ED post-RP. Current Procedural Terminology (CPT) codes were utilized to identify and describe the care provided to patients in each scenario, leading to an artificial urinary sphincter (AUS) or male sling for SUI and/or an inflatable penile prosthesis (IPP) for ED. The 2023 CMS Physician and Clinical Laboratory Fee Schedule and Medicare reimbursement rates were used to obtain the most recent RVUs and reimbursement for each CPT. RVUs represent the value assigned to a service or procedure performed by a physician and are used to capture the relative cost values associated with patient care. For each scenario, we reported the total RVUs, which include work, non-facility or facility, and malpractice RVUs, and the total physician reimbursement. The 2023 Physician Conversion Factor was used to calculate the Medicare physician reimbursement. The Medicare physician reimbursement was used as a conservative estimate. Results The four clinical pathway scenarios were patients who did not experience recurrent SUI or ED (no recurrent SUI/ED), patients who only experienced SUI (only SUI), patients who only experienced ED (only ED), and patients who experienced both SUI and ED (SUI + ED). For the no SUI/ED scenario, the total RVUs from providing patient care were 5.26 RVUs, resulting in $205 in physician reimbursement. For the only SUI scenario, the total RVUs were 56.20 RVUs with an average of $1,996 in physician reimbursement for those receiving AUS and 55.54 RVUs with an average of $1,974 in physician reimbursement for those receiving male sling. For the only ED scenario, the total RVUs were 42.51 RVUs, resulting in $1,550 in physician reimbursement. For the SUI + ED scenario, the total RVUs were 98.71 RVUs with an average of $3,547 in physician reimbursement for those receiving AUS and 98.05 RVUs with an average of $3,524 in physician reimbursement for those receiving male sling. Conclusions This study justified the economic benefits of expanding patient care to men who underwent RP for PCa and provided urology practice insight into the potential physician reimbursement when PCa survivors were seen by reconstructive urologists. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(393) Advancements in Ectopic Reservoir Placement for Inflatable Penile Prostheses

Abstract Introduction Traditional reservoir placement (RP) into the space of Retzius (SOR) during three-piece inflatable penile prosthesis (IPP) implantation has been associated with dire bladder, iliac vessel, and bowel complications, leading many surgeons to pioneer alternative, “ectopic” methods. Despite the extensive literature on ectopic RP, there is little direct comparison of these techniques to one another with respect to efficacy and/or safety. Objective To document an up-to-date, comprehensive analysis of ectopic RP techniques regarding both patient satisfaction and clinical complications. Methods A PubMed literature search of English language articles from 1986-2023 with keywords “inflatable,” “penile prosthesis,” “reservoir,” and “placement” gave 113 publications, 62 of which were included in a comprehensive chronology and investigation after abstract review (last updated 7/3/2023). Analysis of published data yielded 12 retrospective studies detailing 8 ectopic RP techniques that were included for comparison (Table 1). Results Of the ectopic RP methods explored, 8 have sufficient data for comparison: posterior & anterior to transversalis fascia (PTF & ATF); high submuscular (HSM); high submuscular ‘Five-Step’ technique (HSM-FST); lateral retroperitoneal (LR); sub-external oblique (SEO); direct vision, transfascial (DVT); low submuscular with transfascial fixation (LSM w/ TFF); and midline submuscular reservoir (MSMR). Although rare, serious complications have occurred in ectopic RP: PTF reports 2 bladder perforations on implantation, HSM reports a delayed bowel obstruction, and LR reports a colonic injury in a patient with a history of colon surgery. When unsure, a counterincision can be used to lower risk of violating fascial planes and causing visceral injury. Aside from these cases, herniation is the most relevant clinical complication in ectopic RP. There is no reported herniation with LR, SEO, LSM w/ TFF, or MSMR, likely due to fixation steps and/or reinforced spaces. Reports of newer ectopic strategies often have small sample sizes and limited follow-up which potentially under- or overestimate complication rates, indicating a need for more robust longitudinal study. In regards to patient satisfaction, HSM, HSM-FST, and LSM w/ TFF have high and similar rates of patient satisfaction while other techniques do not provide data. In addition to increased rates of reporting, a validated patient survey is needed to standardize comparison of efficacy and patient perspective between different techniques. Importantly, reservoir palpability/visibility relates directly to patient satisfaction. PTF & ATF, HSM, HSM-FST, SEO, and LSM w/ TFF report levels of palpability and/or visibility while LR, DVT, and MSMR have no reported palpability. Conclusions Without standardized patient surveys, consistency in complication reporting, and larger sample sizes, it is impossible to properly compare different ectopic methods. The prosthetic community needs a large, prospective, multisurgeon study comparing ectopic methods to each other, not just to SOR. Until such data is available, implanters should assess different methods in regards to their unique benefit and complication profiles, becoming experts in those that can best serve their patient population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant: AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast // Investor: Sprout.

(176) Prior Intracavernosal Injection Therapy and Prostate Cancer Treatment are Both Independently Associated with Increased Risks of Complications in Men Undergoing Inflatable Penile Prosthesis Placement

Abstract Introduction Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods A retrospective cohort study of primary IPP cases from 2016-2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p<0.001) and/or radiation (5.51% vs 10.9%, p<0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts.

(363) A Global Survey of Sexual Dysfunction Management Among Urologists and Sexual Medicine Experts

Abstract Introduction Understanding and addressing sexual dysfunction is of paramount importance to enhance the overall well-being and quality of life of individuals worldwide. While significant progress has been made in the field of sexual medicine, variability in practice patterns among healthcare professionals remains a potential barrier to optimal patient care. To bridge this knowledge gap and identify the prevailing trends in sexual dysfunction management, we conducted an international survey targeting urologists specializing in Andrology, Sexual Medicine, and related fields. Objective This international survey aimed to assess male and female sexual dysfunction management practices among sexual medicine physicians across to globe to identify variability in practice patterns. Methods A survey was distributed globally to urologists specializing in Andrology, Sexual Medicine, and related fields who are members of International Society for Sexual Medicine (ISSM) or affiliated regional societies (SMSNA, ESSM, MESSM, APSSM, SASSM, SLAMS, ISSWSH, SIU). Demographic information (age, gender, specialty, and practice setting) and treatment approaches for male and female sexual dysfunction were collected. Respondents also reported the percentage of their practice dedicated to sexual dysfunction and whether treatments were covered by health insurance. Results A total of 200/3000 practitioners participated, with 101 (50.7%) identifying as urologists. The majority were male (72.9%) and worked in private practice or community hospitals (32.7%) or a mixture of both (34.2%). Male sexual dysfunction was treated by 71.4% of respondents, with 25.7% dedicating 75-100% of their practice to it. Female sexual dysfunction was treated by 36.9% of respondents, with 64% dedicating 0-25% of their practice to it. Health insurance covered 25-49% of their care for 41.2% of respondents, predominantly provided by private companies (45.9%). The most common treatments for erectile dysfunction were oral medications (86.5%), injections (61.7%), and inflatable penile prostheses (45.1). For Peyronie's disease, oral therapies (59.1%) and penile traction therapy (34.4%) were most frequently offered, while surgical treatment for Peyronie's disease was offered by 58.2% of respondents, with penile prostheses being the primary choice (79.7%). Regarding female sexual dysfunction, 58.4% of respondents offered treatments for genitourinary syndrome of menopause/atrophic vaginitis, with vaginal estrogen being the most common choice (50%). For dyspareunia due to vaginismus/hypertonic pelvic floor dysfunction, 50.3% of respondents offered treatment, with pelvic floor exercise/physiotherapy being the most recommended (66%). Conclusions This study provides valuable insights for healthcare professionals, policymakers, and researchers regarding the current landscape of sexual dysfunction management. The results underscore the importance of continuous efforts to develop comprehensive and individualized approaches, ensuring that both male and female patients receive effective and accessible care for their sexual health concerns. By addressing issues related to insurance coverage and fostering interdisciplinary collaboration, the medical community can collectively work towards improving sexual well-being and quality of life for patients worldwide. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

(316) Age Is Not a Number When It Comes to Penile Prosthesis Implantation. A Mini–Case Series

Abstract Introduction Given the overall aging of the population, erectile dysfunction has become an increasingly relevant issue among the elderly. When elective surgery is offered, the patient's age is often taken into consideration as a potential limiting factor. Moreover, the importance of addressing the quality of life and sexual satisfaction of older men tends to be overlooked in the management of erectile dysfunction. Objective The aim of this study is to investigate the safety of implanting penile prostheses (PP) in patients aged 90 years and older, as well as the potential complications associated with this age group. Methods The database of patients was screened between the years 2003 and 2023, to identify patients at least 90 years and older who underwent the implantation of penile prosthesis by a single surgeon at two large volume centers. We collected demographic information for the patients, including their past medical and surgical history, medication list, anesthesia peri-operative assessment and recommendations, details of the surgical procedure, intra-operative and postoperative recovery period, as well as clinic follow-up. Results Between 2003 and 2023, a total of 2000 men underwent PP surgery at the two centers. Out of the total number of patients, only two were 90 years or older at the time of implantation. One patient was a first timer, while the other had two previous PP surgeries over the span of 15 years for mechanical failure reasons. Both surgeries were performed using different device types, without any intra-operative or postoperative complications. At their three and six months follow up visits, both patients demonstrated the ability to cycle the implant smoothly, reported satisfactory penetrative intercourse with their partners, and improved sexual intimacy through Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. They were followed for a total of 1 year with no long-term negative effects. Conclusions Despite reporting only two cases in this specific cohort, it demonstrates that implantation of PP is a safe and effective treatment for elderly men with ED. Maintaining satisfactory sexual activity in this age group is vital and achievable through inflatable penile prosthesis (IPP) insertion. There are several complex factors that must be considered prior to operating on an older patient due to medical co-morbidities and age. However, with proper patient selection, pre-operative counseling and optimization, this operation can be effectively performed in patients who are at least 90 years old. Simply, age is not a limitation to undergo penile implant. Disclosure No.

(190) Modified Technique for a Mini-Jupette Urethral Sling

Abstract Introduction In this video we present our technique for mini jupette sling (MJS) placement during the placement of an inflatable penile prosthesis (IPP). The technique is initially described by Dr Andrianne, and our technique is modified from the mini-jupette as employed by Dr Yafi. Objective MJS could be considered in patients who are experiencing incontinence or climacturia, common complications of radical prostatectomy and prostate cancer treatment. Methods The standard dissection and exposure is done using a typical penoscrotal or subcoronal approach. The corporotomies and dilation are done in the typical fashion. However, instead of placing stay sutures on either side of the corporotomies, we only place them on the lateral sides. When the mini jupette is placed it is secured with a running suture, and a loop is tied in the middle and divided to create four free ends, after the start and end of the running suture are completed. These four free ends match up with the four stay sutures placed lateral to the corporotomies. The pairs are tied together once the cylinders are placed, closing the corporotomies and securing the mini-jupette at the same time. The corporotomies are eventually closed by tying the stay sutures across the incision. Results This technique allows for a secure sling placement, without bunching of the sling. Since the corporotomies can be tied closed, there is no risk of needle injury to the cylinders Conclusions Operative time is not significantly increased when adding this procedure. We have encountered no complications related to the mini-jupette with this method Disclosure No.

(181) Prior Radiation Therapy is Associated with Increased Risk of Intra-Operative Complications in Patients Undergoing Primary Inflatable Penile Prosthesis Placement: Results from a Large Multi-Institutional Collaborative

Abstract Introduction Radiation therapy (RT) can predispose the onset of corporal fibrosis and microvasculopathy. The impact of RT on intra-operative complications is not well described in the literature. Objective In this study, we assess intra-operative and post-operative outcomes among patients with or without prior history of RT following primary Inflatable Penile Prosthesis (IPP) implantation. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between January 2015 and December 2022. A total of 3530 patients were identified, of which 3319 had no prior history of RT and 211 patients had history of RT. After 1:1 propensity score matching for all confounding variables, 211 patients with a history of RT were compared to 211 nonradiated patients for intra-operative and post-operative outcomes. Chi-square and Mann-Whitney tests were used for statistical analysis for categorial and continuous variables respectively. For multivariable analysis, we used a forward stepwise model and included significant variables found on pre-operative characteristics of patients. Kaplan-Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with history of RT encountered more intra-operative complications (4.3% vs 0.9%, p=0.032); specifically, these men experienced more distal crossover events (1.9% vs 0, p=0.044). On multivariable analysis, history of prior RT (OR 5.29, 95% CI 1.07-26.3, p=0.041) and diabetes mellitus (OR 10.5, 95% CI 2.58-43.5, p=0.01) were associated with increased risk of intra-operative complications. History of obesity (OR 0.11, 95% CI 0.01-0.91, p=0.040) reduced risk of intra-operative complications. There was no significant difference in early or late post-operative non-infectious complications between both groups and there was also no significant difference in risk of post-operative complications within 24 months on Kaplan Meier analysis (log rank p=0.9). Conclusions In this large multi-institutional cohort, history of RT is an independent predictor of intra-operative complications but not post-operative complications during primary IPP placement. These findings may help inform patient-specific counseling while guiding surgical planning to prevent untoward morbidity following surgery. 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.

(187) The SAPOC Technique: Slices Around Point of Maximal Curvature at Time of IPP placement in Severe Peyronie's Disease

Abstract Introduction Placement of an inflatable penile prosthesis (IPP) is indicated for patients with severe Peyronie's disease and erectile dysfunction (ED). Most cases involving plaque incision and graft placement are performed at the point of maximal curvature which result in a large defect that requires placement of a large graft while postoperative penile shortening remains a significant concern among patients. Objective To present a video of a novel modification of the multiple slit technique (MUST) for the treatment of severe PD and ED during IPP placement. This technique involves multiple relaxing incisions made around the point of maximal curvature (POMC) which minimizes the size or even the need of a graft while allowing for length restoration. Methods This technique involves elevation of the neurovascular bundle for dorsal or lateral curvatures along with elevation of the urethra for ventral curvatures. After the POMC is identified, 2 to 4 transverse relaxing incisions (slices) are made around the POMC approximately 1 to 1.5cm apart in order to minimize the size of the defect and hence the need or size of the graft. Each slice allows for maximal restoration of length. Results The SAPOC technique results in correction of curvature and length restoration. Conclusions The SAPOC technique at the time of IPP placement is a novel, safe and feasible technique for the management of complex PD and ED. This technique allows the surgeon to complete the procedure without graft placement in some occasions which theoretically will decrease operative time. It also provides for length restoration which will increase patient satisfaction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for Boston Scientific and Coloplast.

(230) Investigating the Efficacy, Satisfaction, and Predictors of Response to Low-Intensity Shockwave Therapy for Erectile Dysfunction

Abstract Introduction Erectile dysfunction (ED) affects 52% of men in the US, with treatment modalities varying significantly in their degree of invasiveness. Low-intensity shockwave therapy (LI-SWT) is an emerging non-invasive therapy that uses acoustic waves to improve cavernosal arterial flow by inducing microtrauma and subsequent angiogenesis, in addition to enhancing tissue regeneration and reducing local inflammation. Objective Our objective is to investigate the efficacy of LI-SWT, identify factors predictive of response, and explore patient satisfaction and attitudes towards the therapy. Methods An IRB-approved retrospective chart review and survey study was conducted, examining 102 men who underwent LI-SWT for ED between 2009-2022 at a single tertiary referral center. Univariate and multivariate analyses were performed in JMP. Results Out of 102 men, 50 (49.0%) subjects responded to the survey. 22 (44.0%) men reported clinical responses to LI-SWT, with an average improvement of 1.46 on the validated Erection Hardness Score (EHS; scale 0-5). Clinical responders noticed their first response after a mean of 3.53 treatments. 48 of the respondents (96.0%) had previously trialed PDE5 inhibitors, while 18 (36.0%) men previously trialed intracavernosal injections (ICI). On univariate analysis, alcohol use (OR 0.23, 95% CI 0.07-0.77, p =0.015) and prior ICI (OR 0.23, 95% CI 0.05-0.95, p=0.036) use were both associated with lower odds of response to LI-SWT. Interestingly, history of radical prostatectomy (RP) did not correlate with LI-SWT response (p=0.117). These results were redemonstrated on multivariate logistic regression, with alcohol use (OR 0.23, p=0.039) and prior ICI use (OR 0.17, p=0.047) again predicting lower odds of LI-SWT response. Of 28 men who did not benefit from LI-SWT, 5 (18%) progressed to ICI, and 3 (11%) progressed to inflatable penile prosthesis (IPP). Out of all respondents, only 2 men (4%) experienced side effects, which consisted of mild transient pain/paresthesia. No hematomas or bruising were reported, including 8 men on anticoagulants. Clinical responders demonstrated a higher mean satisfaction score of 7.1 on the 10-point Likert scale (somewhat satisfied) compared to non-responders who scored an average satisfaction score of 2.3 (somewhat dissatisfied). Surprisingly, the majority (66%) of the survey respondents were willing to try LI-SWT again, including 54% of first time non-responders. Conclusions Patients with a history of alcohol use and/or prior ICI use were associated with a lower likelihood of response to LI-SWT. LI-SWT demonstrated promising results as a non-invasive option for ED treatment, including treatment refractory ED as well as post-prostatectomy ED, with minimal adverse events. Responders viewed LI-SWT favorably as a modality for treating ED, and the majority of patients who had undergone LI-SWT were willing to try it again. These findings support the use of LI-SWT before resorting to more invasive ED therapies, including surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mohit Khera - consultant for Endo, Petros, AbbVie, Tolmar, Marius, Halozyme, Boston Scientific.

(312) Manhandling: Post-IPP Mechanical Therapy – A Scoping Review

Abstract Introduction While inflatable penile prosthesis (IPP) allows reliable axial rigidity, common complaints are perceived shorter penis and reduced glans engorgement. Pre-operative factors, such as vasculogenic erectile dysfunction (ED) or corporoglandular morphology, provide a convenient explanation. However, post-operative factors are more recently being interrogated. Post-IPP mechanical therapy protocols, like vacuum erection devices (VED), are being instituted to ameliorate these complaints. The physiological rationale is to improve perfusion of the residual erectile tissues and limit cavernous fibrosis or pseudo-capsule formation. This has been hypothetically explained by upregulating release of endothelial nitrous oxide synthase, decreasing hypoxia inducible factor  and tissue growth factor □1. Post-IPP maximal inflation protocols may similarly result in a more capacious and compliant tunica albuginea and capsule. Objective To assess the utility of post-IPP mechanical therapy in addressing common post-operative complaints and enhance prosthetic erection. Methods Intervention: Post-op mechanical therapy Population: Men with IPP for ED, with/without Peyronie’s disease (PD) Inclusion Criteria: Articles published in English with full-text available Search Strategy: Literature search was performed in June 2023 using Medline, PubMed, Embase and Scopus. PubMed search included both “Mesh” protocols and “free text” to capture the correct study population. Articles relating to the intervention were identified with free text search searches (“VED,” “vacuum erection device,” “vacuum constriction device,” “vacuum,” “penis pump,” “mechanical therapy,” or “rehabilitation”). Review Type & Analysis: While a systematic model was initially adopted, a scoping model was ultimately chosen given the limited available literature and variable outcome measures. In this way, we sought to identify knowledge gaps and the scope of current literature to guide further studies in this field. Higher-powered analyses were not possible due to inter-study outcome measure variability. Results Initial search strategy retrieved 81 non-duplicate studies with 30 selected for initial screening after search limitations. Ultimately, 5 satisfied inclusion criteria after full-text review and were divided into 3 categories relating to the post-IPP protocol employed: Early activation (1), Maximal inflation (2,3) and VED (4,5) (Table 1). A common theme encountered was that mechanical therapy improved post-IPP penile length and girth, compared to immediate post-operative measurements. Only one study used a control group who had their device activated for the first time after 4 weeks. The intervention employed in this study was device activation immediately after surgery, left 80% inflated and deflated at 2-3 weeks, then full erection at night for 3-4 further weeks. Compared to the control, at maximum inflation, penile length mean was 3.28 cm longer and circumference was 1 cm greater. In each of these studies, the differences reported were statistically significant. This was also associated with an increased number of pumps required to achieve full inflation over time, irrespective of mechanical protocol used. Articles that reported IIEF-5 and EDITS scores also demonstrated a statistically significant improvement over time with post-op intervention. Conclusions Within limits of the included studies, post-implantation mechanical therapy appears to be useful in improving penile dimensions and patient satisfaction over time. The correlation with increasing number of pumps implies that compliance of the tunica albuginea and residual cavernous tissue may play a role in the pathogenesis of shorter penis post-IPP. Further high-powered studies in this area are warranted. Disclosure No.

(310) Severe Delayed Skin Reaction to Antiseptic Irrigation Solution Managed with Pinch Skin Grafting After Inflatable Penile Prosthesis Surgery: A Case Report

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a common procedure for treating erectile dysfunction, and skin preparation with antiseptic solutions is a standard practice to reduce infection risk. However, some antiseptic solutions, such as chlorhexidine-based Irrisept, have been associated with severe skin reactions. Several studies have reported cases of contact dermatitis, blistering, and chemical burns following the use of chlorhexidine-based antiseptic solutions before surgery. Objective This case report aims to highlight the potential risk of severe skin reactions when using Irrisept and other chlorhexidine antiseptic solutions during penile prosthesis surgery. It also explores the novel technique of pinch skin autografting used to salvage the implant and achieve successful wound healing after delayed skin necrosis. Methods 61-year-old male with a history of prostate cancer and erectile dysfunction who underwent insertion of an IPP. Results The patient's penile shaft developed blisters 3 weeks post-implantation, which progressed to full-thickness necrosis despite conservative treatment. The distribution and location of the reaction led to the hypothesis that it was caused by the chlorhexidine-based Irrisept antiseptic. The antiseptic solution used copiously throughout the case and 10CC was injected under pressure into the drain which also may explain the reaction observed. The patient underwent wound debridement and was treated with pinch skin autografts from the bilateral thighs. The autografts resulted in 95% epithelialization with excellent cosmetic outcomes with no other complications. To the best of our knowledge, this is the first reported case of Irrisept-induced delayed skin necrosis and the use of pinch skin grafting to salvage the implant after penile prosthesis surgery. Conclusions Skin reactions to Irrisept antiseptic solution during penile prosthesis surgery are rare but can be severe. Surgeons should be cautious and consider alternative skin preparation methods in patients with a history of skin allergies or sensitivities. This case also highlights the potential of pinch skin autografting as a salvage technique for post-IPP skin reactions. A multidisciplinary approach involving reconstructive burn surgeons and specialty wound care teams may be beneficial in optimizing outcomes in such cases. Disclosure No.

(173) Initial Experience with ReSheyP Device for Intraoperative Modeling of Peyronie’s Disease After Placement of a Penile Prosthesis

Abstract Introduction Manual modeling to correct penile curvature associated with Peyronie's disease (PD) during penile prosthesis has been a recognized procedure since the 1st publication by Wilson et al in 1992. A key component to optimizing results and minimizing complications (i.e. distal urethral laceration) with manual modeling is proper technique. Manual modeling can be technically challenging as the inflated prosthesis must be maintained bent in the direction opposite to the curvature for up to 60-90 seconds and repeated several times. This can be challenging for the operating surgeon with respect to hand fatigue or even accomplishing the adequate modeling pressure. The purpose of this report is to present initial results with ReSheyP, a device designed to facilitate manual modeling in a more controlled fashion to make it easier to perform and potentially less risky than when done simply by hand. In addition, the device can be used in the postoperative setting to resolve residual curvature. Objective We present on 5 men who underwent placement of an inflatable penile prosthesis with manual modeling using the ReSheyP device. Pre- and post-modeling curvature measurement was performed with a goniometer. Men who had severe indentation deformity were excluded from the study. Methods A retrospective review was performed on patients who underwent penile prosthesis placement followed by ReSheyP modeling in 2023. During the procedure, the ReSheyP was deployed at least 2-3 times for 60-90 seconds per modeling. Data collection included demographics, pre- and post-operative assessment of penile curvature, adverse events and patient satisfaction with postoperative straightening. Results Mean pre-modeling curvature was 62 degrees (range 50-70 degrees) (Table 1). Direction of curvature was dorsal in 3 patients and lateral in 2 patient. The average intraoperative post ReSheyP modeling curvature was 11 degrees and the average change in curvature was 45 degrees. All men reported satisfaction with post-op curve correction. There were no intraoperative or postoperative complications. No patient has felt that further at home modeling was needed. Penile sensation and prosthesis function was uncompromised. Conclusions This pilot study using the ReSheyP device for intraoperative modeling to correct penile curvature after penile prosthesis placement suggests that this tool may be an effective procedure for correcting penile curvature in men with PD. Further experience is necessary and longer follow-up will be reported. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(358) Improved Healthcare Utilization Among Men with Depression Undergoing Inflatable Penile Prosthesis in a United States Commercial Population

Abstract Introduction Inflatable penile prosthesis (IPP) is widely considered medically necessary and a definitive treatment to restore erectile function, yet employer benefit exclusion and lack of insurer coverage of IPP implantation among non-Medicare men may limit their access to the treatment that can negatively impact quality of life. While previous research examined the impact of penile implants among men with depressive symptoms, limited evidence is available to quantify the impact of IPP on depression-related healthcare utilization including emergency department, inpatient, outpatient, and office visits among this patient population. Objective To evaluate the real-world healthcare utilization associated with depression among men undergoing IPP in a US commercial population. Methods A retrospective claims-based analysis was conducted using the 85% Merative™ MarketScan® commercial database to identify men aged ≥18 undergoing IPP (CPT 54405) between 2007 and 2020. Male patients were included if they had at least one claim of depression as a primary diagnosis one-year pre-index IPP and did not have any IPP during this period. Patients were required to have one-year continuous enrollment pre- and post-index IPP. Healthcare utilization associated with a primary diagnosis of depression including number of emergency department visits, inpatient visits, outpatient visits, office visits, and total healthcare visits were measured one-year pre- and post-index IPP. The total healthcare visits included all sites of service for depression. A paired t-test was conducted to evaluate the differences pre- and post-index IPP among patients using the Instant Health Data software (Panalgo, Boston MA, USA) and R, version 3.2.1 (R Foundation for Statistical Computing, Vienna, Austria). Results Among 11,177 patients identified with an IPP during the index period, 808 patients had depression. Average age was 55.26 (±6.83) and average Charlson comorbidity score was 1.63 (±1.67). A statistically significant reduction in the mean number of total healthcare visits, inpatient visits, and office visits were observed pre- and post-index IPP. The mean number of total healthcare visits in the pre-IPP period was 4.88 ± 7.71 compared to 3.82 ± 8.48 in the post-index IPP period (P<0.0001). Among these, the mean number of inpatient visits in the pre-index IPP period was 0.07 ±0.57 compared to 0.03 ±0.22 in the post-index IPP period (P=0.02) and the mean number of office visits in the pre-index IPP period was 4.25 ±7.17 compared to 3.29 ±7.84 in the post-index IPP period (P<0.0001). Conclusions The study provides evidence highlighting the benefits of IPP in alleviating the healthcare resource utilization associated with depression among men undergoing an IPP. For these benefits to be fully realized, it is critical to ensure comprehensive coverage of medically necessary IPP among commercially insured patients with depression. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.