Inflatable Penile Implants Research Articles

Search traffic for inflatable penile prosthesis increased following the COVID-19 pandemic in the United States: a Google Trends analysis.

We aimed to determine the impact of the COVID-19 pandemic on search trends for inflatable penile implants in the US. Search trends for inflatable penile implants ranging from 2016 through 2023 were analyzed utilizing Google Trends. Associations between search trends and US Census Bureau data, including average household income and per capita income, were analyzed. Pre- and post- COVID-19, the interest in inflatable penile implants has been steadily increasing on average in the US. The average household income for counties with the highest interest in inflatable penile implants during the pre-COVID era was $53,136, whereas for the counties with the highest interest in inflatable penile implants in the post-COVID era, the average decreased to $50,940. Similarly, the average per capita median decreased from $35,209 to $34,547. Search traffic for inflatable penile prosthesis increased following the pandemic in the US. Nevertheless, post-pandemic, individuals with lower income levels showed no change in interest in penile implant searches compared to the pre-pandemic period. Understanding this steadiness in interest can inform healthcare professionals and policymakers to tailor interventions and educational efforts to reach a broader audience, ensuring equitable access to information and healthcare resources.

50 years of inflatable penile implants: Where do we stand in France?

IntroductionWith 50 years’ experience, inflatable penile implants are the preferred option for erectile dysfunction refractory to pharmacological and mechanical treatment. Technical and surgical improvements have optimized patient success and satisfaction. However, multi-factorial dissatisfaction persists. ObjectiveThe aim of this study is to provide an overview of available technological improvements and innovations, as well as the perioperative management and complications of inflatable penile implant surgery. MethodA literature review was carried out over the last twenty years to answer 4 questions: what are the different inflatable penile implants available in 2023, for which indications, results and complications. ResultsFour companies propose inflatable penile implants in France. The main improvements have been in the various components of the prosthesis with better cylinder extension, more ergonomic reservoirs, and more manageable pumps, leading to a better durability. Indications have been extended to patients suffering from Peyronie's disease and in emergency cases of priapism. In response to demand from the transgender population, specific phalloplasty implants have been developed. New options are being developed for difficult cases of retracted penis. Results show a high satisfaction rate. Currently the main challenge is the management of infection with the development of rescue protocols using antibiotics to preserve implants – or replace them in a single operation. ConclusionAfter 50years’ experience, improvements in penile implants led to effective, satisfactory and safe treatment and can be proposed in new indications. Further development is sill necessary to offer solutions in difficult cases.

(156) Real World Penile Measurements Comparison Between Malleable and Three-Piece Inflatable Implants: An Objective Comparative Study

Abstract Introduction Despite the fact that malleable penile implants are easier and faster to implant surgically, yet inflatable penile implants (IPPs) have usually shown to have higher patient satisfaction rate and lower rates of distal erosion. It was felt, but never shown that IPPs simulated better erections that filled out the penis better. Nevertheless, this had never been objectively proven in the literature to our knowledge. Objective In this study, to achieve objective comparisons, we introduced the Penile Implant Intraoperative Measurements Planning (PIIMP) chart to find out whether IPPs were more likely to procure greater penile dimensions in comparison to malleable implants. Methods 193 men undergoing penile prosthesis implantation were included in the study. 153 had malleable implants, while 40 had an IPP. Penile length and circumference were measured both in a stretched and unstretched state, both before and after a PGE1 intracorporal injection (ICI). Postoperative penile dimensions were re-taken after implantation and documented together with cylinders/rods dimensions. Results In malleable implants, postoperative penile length ranged between pre and post ICI stretched length in 71.4% of times (n=110/153), fell below pre-ICI stretched length in 26.2% of cases (n=40/153) and reached beyond post-ICI stretched length in 1.96% of cases (n=3/153). In IPPs, postoperative penile length ranged between pre and post ICI stretched length in 60% of times (n= 24/40), fell below pre-ICI stretched length in 27.5% of cases (n=11/40) and reached beyond post-ICI stretched length in 12.5% of cases (n= 5/40). Using Fisher's exact test, it was found that postoperative penile length was 6.37 times more likely to rise above preoperative post-ICI stretched length in inflatable penile implants compared to malleable implant cases (12.5% vs 1.96%) (P value=0.0105) As for penile circumference, malleable implants showed a postoperative penile circumference ranging between pre and post-ICI relaxed girth in 69.9% of cases (n=10), reaching above post-ICI relaxed girth in 10.9% of cases (n=17), and falling below pre-ICI relaxed girth in 19.2% of cases (n=30). On the other hand, IPPs cases had a postoperative penile circumference ranging between pre and post ICI relaxed girth in 57.1% of cases (n=24), reaching above post-ICI relaxed girth in 27.2% of cases (n= 12), and falling below pre-ICI relaxed girth in only 9.1% (n= 4) of cases. (P <0.05) Thus IPPs were 2.5 times more likely to increase the girth of the penis (27.2% vs 10.9%) (P value <0.05) and 2.1 times less likely to cause a decrease in circumference in comparison to malleable implants (9.1% vs 19.2%) (P value <0.05) Conclusions Our study demonstrated that IPPs were superior to malleable implants in attaining greater postoperative penile lengths and girths. We introduced the PIIMP chart as an objective standardized and easily reproducible instrument for intraoperative documentation of penile dimensions. Disclosure No.

(281) Linguistic and Cultural Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI) for Brazilian Portuguese and Tri-Continental Spanish Speakers

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) has been validated in English. No validated Portuguese and Spanish versions currently exist. Objective We aimed to linguistically validate SSIPI in Portuguese and Spanish to evaluate satisfaction outcomes with a validated instrument. Methods Our methodology adhered to best practices established by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and involved: forward translation of the 16-item SSIPI into Portuguese and Spanish by 2 independent IPP surgeons, reconciliation, back translation into English by 2 different independent bilingual IPP surgeons, and comparison to the original SSIPI for conceptual equivalence. The translated SSIPI versions underwent in-parallel cognitive debriefing (CD) at the US, Colombia, Spain, and Brazil centers. All interviews were recorded in person or via secure video conference to determine if misunderstandings or modifications were needed. Results 12 and 17 native Portuguese and Spanish speakers, respectively, with IPPs, participated in the CD process for their native language SSIPI. Interviews lasted approximately 1 hour each. The Portuguese SSIPI validation was conducted at 2 different centers in Brazil, resulting in 83% of the patients reporting that the survey was easy to answer. Of 16 questions, only 3 (Q7, Q11, and Q16) raised concerns for 6 patients. 5 patients had issues with the concept of the word “naturalness” and “spontaneity” from Q7 and Q16. One patient struggled with interpreting the word “conceal” in Q11. Regarding the duration taken to answer, 10/12 patients said it was acceptable. The Spanish SSIPI was tested at 4 US, Colombia, and Spain academic centers. 63% indicated the survey was easy to answer. In most cases, replacing a single word in the item with another was proposed. 53% had difficulties comprehending the answer choice options with Q3; however, all participants perceived the time required to complete the SSIPI as reasonable. Conclusions While the Portuguese SSIPI has been demonstrated to be easier to read and interpret than the Spanish SSIPI, with minor changes to wording/phrasing, both versions have the potential to improve IPP outcomes literature globally. Concerning questions will be modified before conducting the final validation steps. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman.

(170) Satisfaction with Penile Prosthesis Implantation among Patients with Peyronie’s Disease Using a Contemporary Questionnaire

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) is a recently validated 16-question survey used to quantitatively measure patient outcomes after penile prosthetic surgery. The survey consists of four subdomain scores representing the appearance, pain, satisfaction, and function of the penile implant. Since its validation, there have been limited studies examining its use in patients with Peyronie’s disease (PD). Objective The objective of this study is to explore the use of the SSIPI in men with Peyronie’s Disease and to determine if any factors predict patient-perceived postoperative outcomes. Methods Preoperative, intraoperative, and postoperative data for patients with PD undergoing implantation of an inflatable penile prosthesis (IPP) by a single surgeon at a tertiary care institution was retrospectively collected into a secure database. Only those patients with at least one completed SSIPI postoperatively were included in the analysis. For those patients with multiple completed SSIPI’s, only the most recently completed one was used. Linear regression and Fischer’s exact test were used to determine if there were any significant relationships between variables and the SSIPI scores. Results There were a total of 44 men with PD who underwent surgery for an IPP. 31 of them were Caucasian, 11 were African-American, and one each were Hispanic and American Indian/Native American. Median time between surgery and completion of the SSIPI at a follow-up visit was 291 days (IQR 107.75-403.50). 35 men received a Coloplast Titan and 9 received an AMS 700 CX. There was no significant difference in the overall SSIPI score and any of the subdomains between men who received different types of implants or between men of different races. All four subdomains were significantly negatively correlated with the residual curvature which was measured intraoperatively after the IPP was implanted and any adjunctive straightening techniques were used (Fig 1a-d). The appearance domain was also significantly negatively correlated with the preoperative total testosterone indicating that men with a lower total testosterone level were more satisfied with the appearance of their penis. (p < 0.05, R2 = 0.32). Interestingly, those men who underwent manual modeling (n=36) had a significantly lower score in the appearance domain (p < 0.05). Conclusions Post-operative residual curvature in men with PD undergoing implantation of an IPP is a predictor of satisfaction with the IPP. The role of preoperative testosterone and intraoperative manual modeling in how men with PD perceive the appearance of their penis postoperatively requires further investigation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific.

(130) Antibiotic Solutions are the Ideal Irrigation Choice for Inflatable Penile Implant Hydrophilic Surfaces

Abstract Introduction Inflatable penile prostheses (IPP) may be colonized by bacteria, which may contribute to clinical infections. Current attempts to reduce bacterial colonization include altered implant surface binding properties and mechanical irrigations with antiseptic solutions. Previous data has shown that prophylactically dipping IPPs in a solution of 2mg/mL vancomycin and 160μg/mL gentamicin (VG) reduces biofilm formation more than chlorhexidine gluconate (CHG) does. However, there is a paucity of data looking at VG as an irrigation step after a prophylactic dip. Objective To determine if VG irrigation of a previously CHG- or NS-dipped IPP decreases bacterial colonization more effectively than irrigation with normal saline. Methods Sterile 8mm diameter IPP pieces (Coloplast, Minneapolis, MN) were split into 4 groups with a minimum of 12 replicates each and submerged for 3 minutes in 3mL of normal saline (NS), 0.05% CHG in sterile water (Irrimax, Lawrenceville, GA), or VG (Sigma-Aldrich, Burlington, MA). Pieces were then rinsed in NS for five seconds, re-submerged in a separate well containing 2mL of NS or VG for 2 minutes, and finally rinsed for five seconds in a large volume of NS. After a 5 sec PBS rinse, pieces were incubated with 1 X 10^5 colony forming units per milliliter (CFU)/mL of methicillin-sensitive Staphylococcus aureus ATCC25923 in trypticase soy broth (TSB) for 48 hours. Samples were then rinsed with PBS and biofilm was removed by shaking in 0.3% Tween-20. Suspended bacteria were serially diluted, plated onto 3M PetriFilms (Maplewood, MN), and then colony counts were recorded. Mann-Whitney U tests were performed to compare outcomes, p<0.05 considered significant. Results Average bacterial counts with 95% CI are plotted in Figure 1. NS controls showed an average of 1.0E7 CFU/mL adherent bacteria. In this study, the introduction of VG to an NS or CHG-coated implant resulted in significant reduction in adherent bacteria; the NS-VG group showed a ~5 log decrease in adherent bacteria (3.0E1, standard deviation=3.3E4, p<0.01), and the CHG-VG group similarly showed a ~5 log decrease in adherent bacteria (4.4E2, standard deviation=6.9E5, p<0.01). Neither treatment group consistently reduced biofilm counts as effectively as the implant pieces incubated in VG as both a prophylactic dip and a rinse solution (~5 log decrease in counts, p<0.01). However, neither treatment group consistently reduced biofilm counts as effectively as the implant pieces incubated in VG as both a prophylactic dip and a rinse solution, also with a ~5 log decrease in adherent bacteria (1.0E2, standard deviation=2.4E2, p<0.01) (Figure 1). Conclusions VG is the ideal choice for both coating the implant prior to implantation and as an intraoperative irrigation solution. However, further studies are needed to compare VG with CHG as mechanical irrigants as opposed to static irrigants. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast (material not financial support). Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.

(129) Prophylactic Dips and Irrigation Solutions Can Considerably Alter the Antimicrobial Efficacy of Inflatable Penile Implant Hydrophilic Surface Coatings

Abstract Introduction Inflatable penile prostheses (IPP) experience surface-associated bacterial biofilms, which may contribute to clinical infections. Current attempts to reduce bacterial colonization include antibiotic coatings, altered implant surface binding properties, and mechanical irrigations. 0.05% chlorhexidine gluconate (CHG) has been proposed as a hydrophilic surface coating and mechanical irrigation for IPP surgery. One study demonstrated reduced surface bacterial colonization on an IPP hydrophilic surface dipped and irrigated with CHG 15psi compared to normal saline. However, CHG’s efficacy has not been compared to that of an antibiotic, particularly in preventing colonization by bacteria that are commonly implicated in IPP infections. Objective To characterize the utility of 0.05% chlorhexidine or vancomycin/gentamicin (VG) as both an antibiotic dip and an intraoperative irrigation in reducing bacterial colonization on hydrophilic IPP surfaces. Methods Sterile 8mm diameter IPP pieces (Coloplast, Minneapolis, MN) underwent the following treatment protocols. 1: IPP pieces were split into three groups (10 replicates each) and submerged for 3 minutes in normal saline (NS), 0.05% CHG in sterile water (Irrimax, Lawrenceville, GA), or a solution of 2mg/mL vancomycin and 160μg/mL gentamicin (VG) (Sigma-Aldrich, Burlington, MA) 2: IPP pieces were split into six groups (>14 replicates each) and submerged for 3 minutes in either NS, 0.05% CHG, or VG. Pieces were then rinsed in NS for five seconds and re-submerged in a separate well containing NS, 0.05% CHG, or VG. The pieces were rinsed in NS to remove any unbound solution and then incubated with 1*10^5 CFU/mL of methicillin-sensitive Staphylococcus aureus ATCC25923 in trypticase soy broth (TSB) for 48 hours. Samples were then rinsed with PBS and adherent bacteria were removed by shaking in 0.3% Tween-20. Suspended bacteria were serially diluted, plated onto 3M PetriFilms (Maplewood, MN), and counted. Mann-Whitney U tests were performed to compare outcomes, p<0.05 considered significant. Results Average bacterial counts with 95% CI’s for protocols 1 and 2 are plotted in Figures 1a and 1b respectively. NS controls showed an average of 1.1E7 CFU/mL adherent bacteria. Pre-dipping the implant in 0.05% CHG inhibits bacterial growth with a nearly ~2 log decrease (4.9E5 CFU/mL, p<0.01) in counts. Pre-dipping with VG had greater potency, with a ~5 log decrease (3.7E1 CFU/mL. p<0.01). However, exposure of the previously dipped IPP surface to an antiseptic irrigation solution altered antimicrobial properties (Figure 1b). NS controls showed an average of 6.0E7 CFU/mL adherent bacteria. The introduction of NS or CHG to the VG-coated implant material resulted in a near-complete loss of antimicrobial efficacy, with a 0.5 log decrease (NS) and a slight increase (CHG) in bacterial growth (NS: 5.5E7 CFU/mL, p=0.433; CHG: 6.2E7, p=.983). VG dipping followed by VG irrigation resulted in retention of antimicrobial properties, with a similar 5 log decrease. Conclusions Dipping of the implant surface with VG was more effective than 0.05% CHG. Furthermore, the choice of irrigation solution appears to alter the efficacy of antimicrobials bound to the hydrophilic IPP surface. Surgeons should be cautious using CHG or NS as an irrigation solution, and, if utilized, should take care to limit the contact time with the antibiotic-coated implant. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast (material not financial support). Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.

Evaluation of patient satisfaction using the validated French version of the SSIPI questionnaire after inflatable penile implantation.

Penile prothesis (PP) is a recommended treatment for erectile dysfunction that is refractory to less invasive treatments, but there are few validated tools to assess patient satisfaction. The aim of this study was to assess patient satisfaction after PP implantation using the French Satisfaction Survey for Inflatable Penile Implant (SSIPI) questionnaire. Demographic, clinical, and perioperative data were collected from all consecutive patients who underwent PP implantation in our center between 2016 and 2021. The French SSIPI questionnaire was completed during a telephone call with each patient by an independent investigator. A good functional result was considered when the total SSIPI score was >48, corresponding to a score of >3 for each item. The median global SSIPI score for the cohort was 66 (interquartile range [IQR], 60-73), and 53 (89.8%) patients were satisfied. The appearance of the penis with the PP was the item that had the lowest score for satisfaction (median score 23 [IQR, 19-26]), while the patients reported almost no pain (median score 10 [IQR, 9-10]). When patients with a total score of ≤64 were compared with those with a score of >64, PP size was significantly greater in the group with better functional results (P = .03). Assessment of patient satisfaction with a PP is important because this is the main criterion used to judge the success of surgery. To our knowledge, this is the first study to evaluate the satisfaction of patients with a PP using the French-validated version of SSIPI questionnaire. However, patients came from a single center and the population size was small. Almost 90% of patients with a PP were satisfied with the device when satisfaction was assessed using the SSIPI questionnaire.

A narrative review on malleable and inflatable penile implants: choosing the right implant for the right patient.

A penile prosthesis/implant is an excellent option for men with erectile dysfunction refractory to medical treatment or with contraindications to medical management. In this narrative review, we discuss the different types of penile prostheses and the considerations for patient and device selection to maximize satisfaction. There are three main prosthesis types to choose from: three-piece inflatable devices, two-piece inflatable devices, and malleable/semirigid devices. The three-piece devices are the gold standard in advanced economy countries but require reservoir placement and manual dexterity, which can be limiting to some patients. The two-piece inflatable devices are a good option for patients who have standard-sized penises, lack significant penile pathology, have limited dexterity issues, or should avoid reservoir placement due to potential complications. The malleable devices are popular in countries where insurance coverage is limited but are increasingly used in advanced economy countries for length conservation in specific patient populations. Finally, not every patient needs an implant, and assessing partner sexual function is an important consideration for patient-partner satisfaction. Surgeons need to be familiar with the strengths and limitations of each device and the patient characteristics that will yield the best outcome from penile prosthesis surgery.

(100) Extended Reality-Assisted Surgery (XRAS): A Novel Surgical Training Tool During Cadaver Lab

Abstract Introduction XRAS (extended reality-assisted surgery) is a revolutionary modality that assists the surgeon in real-time by overlaying 3-dimensional computer-generated images into the users’ field of view. Objective To insert a Titan 3-piece inflatable penile implant (IPP) on cadaver A and a male virtue sling on cadaver B while utilizing XRAS as a training tool. Methods Two cadavers were used for this lab. While 2 surgeons were present and operating on the physical bodies, 2 additional physicians were remote and communicating via HoloLens 2 Developer Editions. By utilizing the Apoqlar©Hamburg, Germany application, the 2 remote surgeons could communicate, observe, and advise the live surgery. Cadaver A was in the supine position for a penoscrotal approach while B was in the lithotomy position for placement of the male virtue sling. A questionnaire was issued to attendees after the procedures to evaluate the role of the HoloLens in the operating room. Results While performing the respective surgeries on the two cadavers, XRAS was successfully implemented in real-time. Superimposed virtual surgical devices were placed and manipulated in 3D space during surgery to allow for augmented surgical technique during penile implant and male virtue sling insertion. The questionnaire yielded findings that, of the 4 attendees who participated in the surgery, all were in favor of integrating XRAS into the operating room. Attendees reported minimal overheating and discomfort, and sufficient battery life for a 90-minute interval. Conclusions XRAS represents the next paradigm shift in surgery and surgical training. It provides an augmented surgical view all while ergonomically positioned on the head of the surgeon. Implementation of XRAS in surgery can improve efficiency, education, accuracy, and surgical outcomes. Further studies and evolution of the software are needed to elucidate the value of such technology for real-time surgery. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

(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.

(346) Long Term Experience with AMS-700 CXR™ Prosthesis in High-Risk Patients with Corporal Fibrosis

Abstract Introduction Although commonly utilized for high-risk patients with corporal fibrosis, outcome data for narrow inflatable penile prosthesis (IPP) cylinders are relatively sparse. Objective The objective of this study is to assess the outcomes of a cohort of patients who underwent IPP placement with the AMS-700 CXR™ (CXR) cylinders at our tertiary referral center. Methods We retrospectively reviewed our institutional IPP database for patients who underwent CXR cylinder implantation between 2007 and 2021. Indications, clinical factors, and surgical outcomes were documented for all patients. Kaplan-Meier survival analysis was performed to illustrate implant survival. Patient satisfaction was assessed with a phone survey in which patients provided feedback on penile length, girth, rigidity, and overall satisfaction with the CXR implant. Results Among 1149 IPP surgeries reviewed during the study interval, 49 (4%) underwent CXR implantation with a mean (SD) age of 64 years (±11). Indications for CXR implantation included history of infected IPP (30/49, 62%), ischemic priapism 8/49 (16%), and idiopathic fibrosis (11/49, 22%). Postoperative complications occurred in 6/49 (12%) patients including infection 3/49 (6%), cylinder herniation 2/49 (4%), and glans necrosis 1/49 (2%). Discordant intraoperative corporal measurements were common (13/49, 27%), as were discordant rear tip extender lengths (16/49, 33%). The explantation and revision rates were 3/49 (6%) and 4/49 (8%), respectively. Forty percent (19/48) of patients were available for phone survey response (Figure). A total of 47% (9/19) of patients were dissatisfied with their implant, primarily due to perceived loss of penile length (12/19, 63%) and girth (10/19, 53%). Five (5/9, 55%) of these patients had a history of IPP explantation. Fifty-three percent (10/19) of those surveyed are still satisfied with their implant with 58% (11/19) pleased with the rigidity the CXR implant provides. Conclusions Narrow based inflatable penile implants have acceptable long-term survival. Cylinder lengths are often discordant in corporal fibrosis patients. Despite use in a high-risk group, patient satisfaction remains acceptable, although many complain of perceived loss of penile length and girth. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast.

(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

History of penile implants: from implants made of bone to modern inflatable penile implants.

Penile prostheses are implantable devices used to definitively treat erectile dysfunction when previous forms of treatment have failed. The first example of a penile implant dates to 1935, when a rib was inserted in a neo-phallus reconstructed after a traumatic amputation. Since then, alternative artificial devices were adopted as penile prosthetic implants. The evolution of prosthetic devices had a dramatic thrust in 1973 when the first inflatable penile prosthesis was worldwide presented. Thanks to advances in device materials, design, surgical implant techniques, and perioperative management, nowadays inflatable penile prostheses are one of the most adopted definitive therapy for patients with drug-refractory erectile dysfunction or refusing alternative forms of treatments. Moreover, the clinical indications for inflatable penile prosthesis have also expanded, including female-to-male transmen or men underwent penile reconstruction due to congenital aphallia or traumatic or surgical penile amputation. In order to summarise the process behind the development and evolution of penile prosthesis, we aimed at performing a historical review of the currently available literature to provide an easy and comprehensive overview of the topic. The understanding of the historical process behind the evolution of inflatable penile prostheses will drive further innovation to increase efficiency and the rate of patients satisfaction.

Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction

BackgroundMost of the published literature addressing the satisfaction postinflatable penile implant (IPP) placement includes non-validated surveys. AimThe study aims to report the survey outcomes of the English version of The QoLSPP and to evaluate the different factors that could influence these results. MethodsPatients who underwent inflatable penile implant placement from January 2017 to December 2019 received a survey by phone and had a visit scheduled no sooner than 27 months after surgery. In the clinic, they were inquired about the penile size and underwent measurements of postoperative penile length and diameter. The survey responses were rated from zero to 5 following QoLSPP, and answers ≥3 were considered positive. An evaluation of the factors influencing the quality-of-life score of patients post-IPP placement was performed. Variables included age (<60, 60–70, >70), BMI classification, Charlson Comorbidity Index, diabetes diagnosis, implant type (AMS 700CX vs Titan), ED etiology, revisions, postoperative time in months (<30, 30–40, >40) and preoperative vs postoperative penile dimensions in those who attended the clinic. OutcomesThe primary outcome was to obtain accurate patient-reported satisfaction after inflatable penile implantation. ResultsWithin the timeframe, 542 patients underwent first-time IPP placements. Of that group, 322(n) completed the surveys, and 109 patients attended the clinic to compare preoperative vs postoperative dimensions. Of note, 67 (61.4%) and 54 (49.4 %) demonstrated enlargement in length and diameter, respectively. Conversely, 12 (11%) and 4 (3.7%) experienced a shortening in length and girth. We found 66 (60.5%) patients who complained about a penile size decrease after the intervention. The survey had a positive response in 93.1% of the cases. There were no statistically significant differences in positive responses concerning the variables investigated. The subpopulation analysis of the penile-sized group neither showed response variations. Clinical implicationsThe investigation allowed a better understanding of patient-reported satisfaction post-IPP placement. Strengths & LimitationsThe performance of all the procedures in a high-volume center by a single surgeon limits its generalization. ConclusionThe overall results after IPP surgery are positive in most patients who underwent the procedure and the variables investigated did not influence the overall outcomes of the QoLSPP survey in the study.Luna E, Rodriguez D, Barrios D, et al. Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction. J Sex Med 2022;19:1472–1478.

Current Practices in High and Low Volume Centers Regarding Corporotomy Localization During Penoscrotal Inflatable Penile Implant Surgery

ABSTRACT Introduction Literature concerning corporotomy location in multi-component inflatable penile prosthetic surgery via a penoscrotal approach is scarce if not non-existent. However, corporotomy location represents an important issue that may influence immediate and long-term outcomes regarding patient and partner satisfaction as well as device durability. Objective To report practices in low- and high-volume penile implant centers regarding corporotomy location. Methods Data from 18 (13 European and 5 American) implant centers were collected retrospectively between September 1st, 2018 and August 31st, 2019. Variables included: intraoperative proximal and distal corpus cavernosum length measurement, total corporal length measurement, total penile implant cylinder length, and length of rear tip extenders. Additionally, patient characteristics, indication for penile implant, operative time, type of implant utilized, reservoir characteristics and short term complications were reported. Results 809 virgin penile implant cases were included in the analysis. Mean age of participants was 61.5 +/- 9.6 years old. In total, 299 AMS 700TM (Boston Scientific) and 510 Coloplast Titan® devices were implanted. The mean proximal/distal corporal measurement ratio during corporotomy was 0.93 +/- 0.29. A statistically significant correlation between lower proximal /distal measurement ratio and higher age (p=0.0013), lower BMI (p&amp;lt;0.0001), use of rear tip extenders (RTE) (p=0.04), lower RTE length (p&amp;lt;0.0001) and absence of diabetes (p=0.0004) was reported. In a 3-month follow up period 49 complications and 37 revision procedures were reported. Conclusions This is the first study reporting and evaluating the current practices regarding corporotomy location during IPP placement in a multicenter cohort, particularly when including such a high number of patients. Nevertheless, the retrospective design limits the study outcomes. Even in experienced hands proximal length measurement in relation to distal length measurement in penoscrotal IPP surgery is in many cases sub-optimal, particularly when the tubing-cylinder connection of each device is taken into account. Disclosure No

Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI)

No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. The SSIPI has demonstrated robust psychometric properties.

Practical Considerations in Inflatable Penile Implant Surgery

BackgroundPenile prosthesis implantation remains an effective solution for men with medical-refractory erectile dysfunction (ED) following radical pelvic surgery. Despite the distortion of pelvic anatomy, a penile implant can be performed with excellent clinical outcomes provided strict patient selection, proper preoperative workup and safe surgical principles are adhered to. AimTo provide practical recommendations on inflatable penile prosthesis (IPP) implantation in patients with medical-refractory ED, with an emphasis on patient selection and counselling, preoperative workup as well as surgical considerations to minimize intraoperative complications. MethodsA Medline search on relevant English-only articles on penile prostheses and pelvic surgery was undertaken and the following terms were included in the search for articles of interest: “bladder cancer”, “prostate cancer”, “rectal cancer”, “pelvic surgery” and “inflatable penile implant”. OutcomesClinical key recommendations on patient selection, preoperative workup and surgical principles. ResultsPatients should be made aware of the mechanics of IPP and the informed consent process should outline the benefits and disadvantages of IPP surgery, alternative treatment options, cost, potential prosthetic complications and patient's expectations on clinical outcomes. Specialised diagnostic test for workup for ED is often not necessary although preoperative workup should include screening for active infection and optimising pre-existing medical comorbidities. Precautionary measures should be carried out to minimise infective complication. Corporal dilation and reservoir placement can be challenging in this group, and surgeons may require knowledge of advanced reconstructive surgical techniques when dealing with specific cases such as coexisting Peyronie's disease and continence issue. Clinical translationStrict patient selection and counselling process coupled with safe surgical principles are important to achieve excellent linical outcomes and patient satisfaction rates. Strengths and limitationsThis masterclass paper provides an overview of the practical considerations for men who are undergoing IPP surgery following radical pelvic surgery. Limitations include the lack of highquality data and detailed surgical description on each surgical troubleshooting steps for various prosthetic-related complications. ConclusionThe IPP implantation can be performed efficiently and safely in patients following radical pelvic surgery. Chung E, Mulhall J. Practical Considerations in Inflatable Penile Implant Surgery. J Sex Med 2021;18:1320–1327.

Penile Hemodynamic Response to Phosphodiesterase Type V Inhibitors after Cavernosal Sparing Inflatable Penile Prosthesis Implantation: A Prospective Randomized Open-Blinded End-Point (PROBE) Study.

Forceful corporal dilatation amidst penile prosthesis implantation may injure cavernosal arteries compromising penile vasculature. In this study, we aimed to compare the conventional and cavernosal sparing techniques regarding cavernosal artery preservation. Overall, 33 patients underwent inflatable penile prosthesis implantation with Coloplast Titan Touch® three-piece inflatable penile implants. 16 patients had conventional implantations with serial vigorous dilatations, while 17 patients were implanted with the cavernosal sparing technique, consisting of a single minimal corporal dilatation after an intraoperative intracavernosal injection (ICI) of Alprostadil. Postoperatively, a penile duplex Doppler ultrasound study was performed. Whenever a cavernosal artery was spared and thus successfully probed, its hemodynamics were studied before and after an oral administration of a phosphodiesterase type 5 inhibitor (PDE5i). A cavernosal artery was successfully probed in 16/17 (94%) of patients in the cavernosal sparing group compared to 5/16 (31%) of patients in the conventional group with a significant statistical difference (P=0.001). This demonstrated that the cavernosal sparing technique was superior to the conventional approach in preserving the cavernosal artery (odds ratio 35.2, 95% IC 3.5–344.2; P=0.0022). Whenever a cavernosal artery could be probed, its hemodynamic responsiveness was also preserved. This trial is registered with NCT03733860.

P-02-34 Advanced Cases of Peyronies Disease (PD) Sometimes Mislead to Challenging Surgical Procedures Which Increase the Risk of Complications. These Patients Seek Regaining Anatomical Normality of Their Phallus, Erectile Function and Recovery of Their Sexual Activity

Patient num 1 is a 48 year experienced ventral deviation , pain and moderate loss of erectile function 3 months after a traumatic episode. He was proposed for shock wave therapy elsewhere, and went through a first session where he complained about pain during the session, the next week he received another session which was also painful, and 3 days after that he experienced an increase in the deviation reaching 45º, he was proposed by our team for a high resolution dopplerultrasound (HRDU) and after seeing the result, for inflatable penile implant (IPP), but refused , 16th months later he underwent implant; curve 135º after having had other types of treatments with no result. Patient num 2 is a 44 year old , which commented that since childhood he had experienced that his shaft had a "stick” in it which caused a curvature of 50º and made sexual intercourse impossible. High resolution ultrasound was performed and proposal of IPP performed, which he accepted.