Malleable Prosthesis Research Articles

Complication and Explantation Rates of Penile Prostheses in Transmasculine Patients: A Meta-analysis

ObjectiveTo synthesize current literature on penile prosthesis implantation post-gender affirming phalloplasty to correlate implant types and complication rates. MethodsA meta-analysis of penile prosthesis in transmasculine patients was initiated in December 2022. Inclusion criteria encompassed randomized clinical trials, cohort studies, and cross-sectional studies reporting on penile prosthesis complications post-gender-affirming phalloplasty. Exclusion criteria were review articles, meta-analyses, studies that exclusively reported on cisgender patients or surgeries other than penile prosthesis implantation. An initial search of five databases yielded a total of 1593 articles. Upon screening, 15 full-text articles were eligible for inclusion. 9 studies were included in the analysis. ResultsThe overall complication rate for the inflatable prosthesis group was 38% (95% CI: 21, 59) and for the malleable prosthesis group was 37% (95% CI: 18, 62). The most probable complications in the inflatable group were infection (14.5%), dysfunction (12.9%), dislocation (5.7%), and leakage (5.4%). The most probable complications in the malleable group were dislocation (14.9%), infection (11.2%), dysfunction (9.1%), and extrusion (7.6%). There was no significant difference in the probability of any complications between the malleable and inflatable prosthesis groups.The best estimate of explantation rates for any reason for the inflatable group was 19% (95% CI: 9, 38) and for the malleable group 13% (95% CI: 4, 33). There was no significant difference in the probability of any reason for explantation between the malleable and inflatable prosthesis groups.

Salvage procedures for infected penile implants: A comprehensive review and analysis of functional outcomes

BackgroundThe salvage procedure for infected penile implants (IPs) has been a subject of interest since its inception in the late 1980s, yet its widespread adoption remains limited. The aim of this study was to realize a systematic literature review to provide a comprehensive analysis of salvage techniques for IPs and assess their efficacy, specifically focusing on functional success. MethodsA systematic literature review was conducted using PubMed, employing Mesh terms related to penile prosthesis, penile implant, infection, and salvage procedures. Articles in French or English were considered for the final analysis, with exclusion of literature reviews. ResultsFifteen articles detailing various salvage techniques for IPs were identified. Mulcahy's initial technique was described in 1996, and consisted of complete removal of infected components, extensive lavage, and subsequent replacement with a similar implant. Success rates ranged from 80% to 100%, with emerging trends favoring the use of malleable implants during salvage. Unfortunately, functional data remained limited. When salvage penile prosthesis placement involved a malleable prosthesis, between 20% and 33% of patients underwent conversion to hydraulic prosthesis. ConclusionThe salvage procedure for infected penile implants is a reliable method, with success rates surpassing 80%. The need for comparative studies assessing the type of implant used during salvage is required to tailor conservative management strategies for optimal patient outcomes. Finally, few data have been published regarding subsequent conversions from malleable penile implants to hydraulic penile implants after salvage.

(PM-06) A RARE CASE OF SCROTAL URETHROCUTANEOUS FISTULA SECONDARY TO EROSION OF PENILE PROSTHESIS CONNECTOR TUBING

Abstract Objective The scrotal urethrocutaneous fistula is an uncommon pathology which can lead to serious complications, such as infections, scrotal abscesses, or even Fournier’s gangrene. We present an unusual case of scrotal urethrocutaneous fistula secondary to erosion of a penile prosthesis tubing in a patient with a history of erectile dysfunction. Case presentation A 68-year-old patient with no previous comorbidities and a history of prostate adenocarcinoma that was treated with radical prostatectomy + lymphadenectomy, without the need for subsequent adjuvant therapy. He was diagnosed with erectile dysfunction after surgery, refractory to intracavernous therapy therefore required a 3-component penile implant placement procedure performed extra-institutionally. Two years after the surgery, he consulted with our institution for scrotal pain and urine leak from the scrotum during micturition. Physical examination shows extrusion of prosthesis tubes in the scrotal area with no signs of infection or exposure of the cylinders. The patient was hospitalized for management with antibiotics and to replace the penile implant. A retrograde urethrography with contrast medium was performed during surgery. Fluoroscopy showed a fistulous pathway between the penile urethra and the scrotum. No passage of the contrast to the corpora cavernosa was seen. The urethral lesion and fistula were identified and repaired. A malleable prosthesis was used, considering the amount of scar tissue. The patient had an adequate postoperative period. A urethral catheter and a cystotomy were used for six weeks. After catheter removal, a voiding cystogram was performed, finding no fistulas. The patient was followed for 11 months with no complications. Conclusion Although scrotal urethrocutaneous fistulas are an infrequent complication after penile prosthesis implantation, a timely diagnosis is essential for conservative treatment and to avoid life-threatening complications. Financing No conflict.

(170) Missed Urinary Leak During an Inflatable Penile Prosthesis Insertion Presenting as a Post-Operative Hydrocoele

Abstract Introduction This is a case of a revision of a three-piece penile prosthesis in a 53-year-old gentleman who had received an infrapubic implantable penile prosthesis (IPP) in Turkey over 12 months ago. He complained of an unsupported floppy shaft when the prosthesis was inflated, as well as a right hemi scrotal bulging which was exacerbated by activity but showed no signs of infection. A hydrocele had occurred 2 months following the IPP insertion and was confirmed on imaging. The MRI showed the pump within the hydrocele. He had previously had a laparoscopy gastric banding and a bilateral inguinal hernia repair with mesh. Objective Video to demonstrate the surgical case Methods This is a video demonstrating the steps of this operation. The procedure started with a transverse penoscrotal incision and dissection through the dartos muscle. The initial corporotomy allowed removal of the first cylinder of the prosthesis. Upon removing the right cylinder, the hydrocele was opened to reveal the presence of turbid fluid, 150ml of fluid was aspirated and sent for microbiology investigations. The next stage involved removal of the left cylinder and 7.5cm of rear-tip extenders (RTE) were subsequently removed intact, with further RTE from the right removed separately using a nasal speculum. Therefore, a 20cm IPP was removed with 7.5cm RTE on each side. An antibiotic salvage wash (Rifampicin/Gentamicin) was performed several times. At this point a 26cm + 1cm (13mm) malleable prosthesis was inserted as a spacer. The previous infrapubic wound was opened to remove the reservoir, 75ml of fluid was aspirated from around the reservoir prior to removal. Attempts are made to identify a possible fistula with flexible cystoscopy, but normal urethra, bladder neck and bladder are seen. Giving no evidence of any fistula into the abdominal cavity or urethral injury to explain fluid in the corporal cavities or around the components of the prosthesis. Methylene blue and distention were also used to attempt to identify a bladder leak, however this was also unremarkable. A suprapubic catheter was inserted to ensure the decompression of the urinary system to allow any small/undetected leaks to heal. This was done under direct vision using a cystoscope prior to being secured. Results The patient had a replacement of the inflatable penile prosthesis to a malleable prosthesis, a suprapubic catheter inserted and a drainage of his hydrocele. The patient recovered well from surgery and on examination the prosthesis tips were seated nicely in the glans. The fluid microbiology culture did not grow any organism. A subsequent cystogram showed no signs of any bladder leak. The patient was happy with the outcome and underwent a trial without catheter. He has a planned review and will be considered for an exchange to an inflatable device at this time. Conclusions This is an unusual presentation of a hydrocele, in the absence of any infective symptoms which is suggestive of a contained urine leak and even a missed bladder injury from the first prosthesis surgery. However, no fistula was found during the surgery or the post-operative cystogram. Disclosure No.

(262) Salvage Penile Prosthetic Surgery, Unique Surgical Technique. Institutional Experience

Abstract Introduction `-Penile prosthesis surgery represents the end-stage treatment for erectile dysfunction. It is conventionally used only in cases of erectile dysfunction refractory to pharmacological treatments. -Penile prothesis surgery is associated with a high satisfaction rate and a low complication profile. However, it must be appreciated that the complications of surgery can have devastating consequences on a patient's quality of life and satisfaction and include infection, prosthesis malfunction, penile corporal perforation and penile length loss. -This study discusses the diagnosis and management of infected penile prosthesis with highlighting special intra-operative surgical technique that might be a valuable step in Salvage penile prosthetic surgery Objective Since its introduction in 1996 Mulcahy salvage has significantly improved outcomes for the removal and replacement of infected penile prostheses. Long-term follow up data of Mulcahy salvage show an infection-free rate of 82%. In our study we evaluated the Salvage Penile Prosthetic Surgery Cases done in our tertiary institution since (2000 up to date) and introduce the unique surgical technique that resulted in reduction the re-infetion rate. Methods This is a retrospective, institutional review Results total of 13 Salvage penile prosthetic surgeries done in our tertiary center since between 2000 and 2023 out of them only one case developed reinfection and ended with penile prosthesis removal. Therefor, the rate of re-infection is 8% comparing with latest successe rate of Mulcahy technique (18%) We applied surgical step intra- operative that might be the underling reason of decreasing the the reinfection rate that will be presented in details. Conclusions This retrospective analysis of salvage procedures and replacement of infected penile prosthesis with malleable prosthesis shows a high infection-free rate. Disclosure No.

Multi-Incision Technique (MIT) and malleable prosthesis implantation in patients with Peyronie’s Disease and severe penile shortening, with or without preoperative erectile dysfunction: A multicenter retrospective study

Multi-Incision Technique (MIT) and malleable prosthesis implantation in patients with Peyronie’s Disease and severe penile shortening, with or without preoperative erectile dysfunction: A multicenter retrospective study

Penile and testicular prosthesis following gender-affirming phalloplasty and scrotoplasty: a narrative review and technical insights.

Transgender and gender diverse (TGD) individuals may seek gender-affirming phalloplasty with specific functional goals, including erectile function sufficient for penetrative sexual intercourse. Individuals seeking penile prosthesis placement must accept the potential risks to their phallic anatomy. We review current practices at our center and narrative review of literature discussing techniques for penile prosthesis and testicular prosthesis placement after phalloplasty and scrotoplasty, as well as surgical outcomes, and quality of life outcomes where available. Early discussion of a staged approach to phallic construction with a last step of implant placement is important during initial phalloplasty counseling. Pre-operative counseling at our multi-disciplinary center includes: discussion of surgical history, complications, goals and priorities; physical exam to evaluate phallic size and position, scrotal size, and other anatomic findings that may influence prosthesis selection; urinary evaluation, including uroflowmetry with post-void residual, and a cystoscopy with retrograde urethrogram if indicated based on symptoms or urinary studies, and discussion of surgical risks, benefits and alternatives. Although none of the commercially available penile prosthesis devices in the United States are designed for phalloplasty, modern inflatable and malleable prostheses are adapted for use in the post-phalloplasty setting. Due to the lack of native corpora cavernosa, highly variable phallic anatomy, and the need to adapt implants designed for natal penile anatomy, complication rates of prosthesis placement after phalloplasty remain high, with reported ranges of complications from 20% to 80%. Major complications requiring surgical revision are common relative to implant placement in natal penile anatomy, and include: infection requiring explantation, device extrusion, erosion, migration or malposition, inadequate rigidity, poor aesthetic result, pain, decrease or loss of erogenous and/or tactile sensation, device failure, injury to the urethra, and injury to the neurovascular supply of the penis with resultant partial or complete flap loss. This broad range of complication rates represents the variability with which results are reported and reflect a lack of clear reporting guidelines, significant variability in techniques, and need for more standardization. To optimize outcomes, it is important that surgeons have an in-depth understanding of phalloplasty anatomy and are equipped to manage potential complications in the short- and long-term.

Highly Malleable Personalized Prostheses with Hierarchical Microstructure Boost the Long‐Term Osteointegration in Irregular Craniofacial Reconstruction

AbstractThe desired clinical bone prostheses should achieve satisfactory interface integration and osteoinduction, as well as good surgical convenience. Here, a highly malleable 3D printed prosthesis with compressive strength at 13 MPa is constructed by dopamine, polyvinyl alcohol, and micro‐sized hydroxyapatite (86 wt%) as composite bioinks, which is endowed with good plasticity and can quickly match irregular defects by easily trimming. Spatially decorated collagen and hyaluronan greatly enriched the hierarchical microstructure and biological activity of malleable prosthesis. This prosthesis accelerates the proliferation and osteogenic differentiation of stem cells, regulates M2 polarization of macrophage, and promotes endogenous stem cell recruitment and early angiogenesis. Meanwhile, it significantly reinforces biomineralized deposition and vascularization, reaches full coverage of new bone in the rabbit cranial defect after 15 weeks (Φ = 10 mm), and achieves well osseointegration capacity with interfacial binding strength at 71.2% of the natural skull. This osteoinductive prosthesis provides a new design idea for bone filling.

(105) A Multicenter Analysis of the AUA Recommended Antibiotic Prophylaxis for Penile Implantation Results in Higher, not Lower, Infection Risk

Abstract Introduction The American Urological Association (AUA) recommendations on antibiotic prophylaxis in penile implant surgery are based on low quality evidence and expert opinion. Recent evidence suggests the recommended regimens may be suboptimal. Objective To determine if the AUA recommended antibiotic regimen (vancomycin + gentamicin) for primary penile implant surgery is associated with a higher infection risk than non-standard regimens. Methods We performed a multicenter, retrospective cohort study of patients undergoing primary IPP surgery. Patients undergoing revision surgery or with a history of IPP placement were excluded. Additionally, patients who underwent concomitant procedures for Peyronie’s disease or stress urinary incontinence were excluded. Patients were divided into those receiving standard AUA antibiotic prophylaxis (vancomycin + gentamicin) and those receiving any other (non-standard) antibiotic prophylaxis. The time to postoperative device explanation due to infection via a Cox regression model, the microorganisms involved, and the management of patients with device infection were evaluated. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. Results 4,161 patients underwent primary IPP placement (2,411 received vancomycin + gentamicin and 1,750 received other regimens). The infection rate was similar between groups, 1.0 vs 1.2% for standard vs non-standard prophylaxis. In the multivariate Cox regression analysis, the use of vancomycin + gentamicin (HR: 2.74, 95%CI: 1.38-5.41, p=0.004) and diabetes (HR: 1.87, 95%CI: 1.03-3.39, p=0.04) were significantly associated with higher risk of device explantation due to infection. Concomitant infusion of antifungals (HR: 0.08, 95%CI: 0.03-0.19, p<0.001) was associated with lower risk of infection. Staphylococcus aureus and Escherichia coli were the most frequently cultured microorganisms. Device infection was most commonly managed with salvage using a malleable prosthesis (40.4%). In patients of both groups receiving gentamicin as part of perioperative antibiotic prophylaxis, the use of weight-based gentamicin compared to 80 mg gentamicin was associated with similar risk of device explantation due to infection (HR: 2.88, 95% CI: 0.83 to 10, p = 0.1). Conclusions Vancomycin + gentamicin for antibiotic prophylaxis in primary penile implant surgery is independently associated with a higher infection risk than non-standard antibiotic regimens while antifungal use is associated with lower infection risk. There does not appear to be a difference in weight-based vs low dose (80mg) gentamicin on infection risk. Our results further demonstrate the importance of antifungal use in prophylaxis regimens. Additionally, a critical review of the recommended prophylactic regimens is needed. Tailoring individual regimens to local antibiograms may provide the best infection prevention. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Antares Pharma, Clarus Therapeutics, Cynosure, Promescent, Sprout, Viome.

(470) Malleable Penile Implant Rod Diameter Predicts Complications And Patient Satisfaction

Abstract Introduction One of the most common complaints after malleable prosthesis implantation (MPI) is thinning of the penis and decreasing girth. Some surgeons try to insert the largest diameter they can to improve patient satisfaction Objective To investigate if malleable rod diameter (MRD) has an impact on outcome and patient satisfaction Methods Consecutive malleable prosthesis implanation (MPI) was assessed in a high volume center over one year. The same preoperative, intraoperative, and postoperative protocols were used for all patients and one brand of the malleable device was used only. We recorded MRD and length for all patients. All patients had data on comorbidities including glycated hemoglobin (HbA1c) and clinical Peyronie’s disease (PD). Revision cases and those who lost for follow up were excluded from the study. We also excluded patients operated on by low volume surgeons. All complications, minor (edema, ecchymosis, pain), and major (infection and erosion) were recorded. After 1-year, patients were assessed and given a Likert scale from 1-5 where 1 is dissatisfied and 5 is most satisfied with their MPI. We stratified patients according to MRD into two groups: group A for diameter 9.5 and 11 mm and group B for 13 mm. Results 183 patients had full data and filled the questionnaire after 1 year follow up. All patients had Coloplast, Genesis penile implants. Major complications rate (infection, erosion, and removal) was significantly higher in group B 11% versus 1.2% in group A (P=0.016). At 4 weeks postoperative visit, 90 % of group A showed no complications versus 60 % only in group B that was statistically significant (p=0.0003). Satisfaction rate was more in patients in group A (88.6%) compared to patients in group B (75.7%)but this did not reach to be statistically significant (P=0.0519). See Table 1. Conclusions Larger diameter of malleable penile implants are not always associated with higher patient satisfaction as there are other predictors like postoperative complications and concealement. The best implant size for a certain patient is the best fitting, neither the oversize nor the undersize. Disclosure No

(147) Multicenter Evaluation of Inflatable Penile Prosthesis Placement in Men with a History of Priapism

Abstract Introduction Inflatable penile prosthesis (IPP) can be used in both acute and delayed management of priapism-induced erectile dysfunction. Prolonged priapism may result in corporal fibrosis that makes IPP placement more difficult. The current literature on IPP placement in men with a history of priapism is limited to small series and often single-center experiences. Objective We sought to evaluate a multicenter experience of IPP placement in men with a history of priapism. Methods We performed a multicenter, retrospective cohort study of patients with a history of priapism undergoing IPP placement by 7 highly experienced implant surgeons. Malleable prosthesis placement patients were excluded. Demographic, intraoperative, and postoperative variables were collected. Descriptive statistics were performed using mean and standard deviation for continuous variables, whereas frequencies and percentages were used for categorical variables. We evaluated differences in complication rates in those undergoing early or delayed IPP placement. We defined early placement as ≤4 months from priapism to IPP. Results 31 patients underwent IPP placement at a mean of 97.4 ± 26.7 months following ischemic priapism. The mean duration of priapism was 52.3 ± 21.2 hours. The mean age of the cohort was 52.4 ± 4.2 years with a mean follow-up of 11.6 ± 1.3 mo. Overall, 25 patients (48.3%) had a prior shunt for priapism and 6 (19.4%) had penoscrotal decompression. Four patients (12.9%) underwent early placement and 27 (87.1%) delayed placement. Intraoperative urethral injury occurred in 1 (3.2%) patient. Infection occurred in 1 (3.2%) patient at 4 months postoperatively and was explanted without salvage. Seven (22.5%) implants were revised or removed for infectious or non-infectious complications at a mean 8.8 ± 1.0 months after implantation, of which 5 (71.4%) were cylinder-related (2 displacements of a cylinder through the corporotomy, 1 lateral displacement of the distal cylinders requiring revision, 1 proximal cylinder migration, 1 cylinder leak). No complications occurred in those undergoing early IPP placement. Full-sized cylinders (Boston Scientific CX or Coloplast Titan) were used in all cases that resulted in cylinder extrusion or migration. Narrow cylinders (Coloplast Titan NB or Boston Scientific CXR) were used in only 9 (29.1%) cases. Conclusions IPP placement in men with a history of priapism carries a notable incidence of non-infectious complications, especially in men undergoing delayed placement or when full-sized cylinders are used. Few IPPs in this series were placed early after the priapism episode, as our surgeons are predominantly at tertiary referral centers. Priapism patients should be referred to prosthetic experts early to decrease future morbidity. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Antares Pharma: SpeakBoston Scientific, Clarus Therapeutics, Coloplast, Cynosure, Promescent, Sprout, Viome

State-of-art review of current malleable penile prosthesis devices in the commercial market.

The malleable penile implant is often considered an inferior device to the three-piece inflatable penile prosthesis implant. Nonetheless, the malleable prosthesis has its unique advantages such as lower cost, easier to perform and fewer mechanical complications than inflatable prostheses. Furthermore, its role can be extended to patients with issues relating to poor manual hand dexterity, those undergoing a salvage for infection prosthesis and as an emergency surgical measure in patients presenting with acute ischaemic priapism. Over the past few decades, there have been numerous design and technological advancements to improve overall clinical efficacy, mechanical durability, axial rigidity and device concealability of malleable penile prostheses. The following article provides a narrative review of the six major contemporary malleable penile prosthesis devices in the commercial market, namely, the Coloplast Genesis prosthesis, the Boston Scientific Tactra prosthesis, the Zephyr ZSI 100 and 100 (female-to-male) FTM devices, the Rigi10 prosthesis, the TUBE malleable prosthesis and the Shah prosthesis and evaluates the published outcomes. Appropriate patient selection and strict counselling regarding what to expect with malleable prostheses coupled with adherence to safe surgical principles are paramount to ensure excellent clinical success and patient satisfaction rates.

Malleable versus inflatable penile prosthesis: systematic review

Erectile dysfunction (ED) is a prevalent condition affecting quality of life. Penile prostheses are effective for non-responsive cases, with malleable and inflatable types commonly used. Yet, a thorough comparison between them is absent. This systematic review aims to evaluate and compare malleable and inflatable penile prostheses in terms of efficacy, complications, patient satisfaction, and quality of life outcomes. A systematic search was conducted on PubMed, Embase, and Cochrane Library databases for relevant studies published between 2010 and 2022. Studies meeting predefined inclusion and exclusion criteria were selected, and their methodological quality was assessed. Data on surgical success rates, postoperative complications, patient satisfaction, sexual function, and quality of life were extracted and synthesized. A total of 40 studies were included in the review. Analysis of surgical success rates revealed comparable outcomes between malleable and inflatable penile prostheses. Postoperative complications varied, with malleable prostheses associated with lower rates of infection and mechanical failure compared to inflatable prostheses. Patient satisfaction was high for both types of prostheses, although some studies reported higher satisfaction rates with inflatable devices. Sexual function improvements were observed in both groups, but malleable prostheses had a shorter operative time and fewer device-related adverse events. Quality of life outcomes showed positive changes in psychosocial aspects for patients with both types of prostheses. This systematic review provides a comprehensive evaluation of malleable and inflatable penile prostheses for the treatment of ED. Although both prosthesis types effectively address ED, malleable ones show potential benefits: reduced infection/mechanical issues, quicker surgery, and fewer device-related problems. Yet, patient satisfaction leans toward inflatables, highlighting personal preferences in choices. Future research should probe lasting results and patient input to aid optimal prosthesis selection.

A narrative review on synchronous concurrent versus delayed sequential surgery in the artificial urinary sphincter and penile prosthesis implantation.

In a patient who complains of both stress urinary incontinence (SUI) and erectile dysfunction (ED), prosthetic surgery with a urinary continence device and penile prosthesis implant can offer a definitive solution to address both problems. The AMS 800 artificial urinary sphincter (AUS) device is considered the standard of care to restore SUI while the inflatable penile prosthesis (IPP) device is thought to be superior to a malleable prosthesis to provide a more natural penile erection with higher patient satisfaction rates. The following article explores the current understanding of AMS 800 AUS surgery and IPP device in treating males with concurrent SUI and ED as well as evaluates the advantages and disadvantages of concurrent synchronous dual vs. delayed or staged device implantation. The available literature on AUS and IPP implantation was reviewed on PubMed and Embase databases between 1 January 2000 and 1 December 2022. This narrative review evaluates relevant key features pertaining to prosthetic surgery with an emphasis on arguments for concurrent synchronous dual vs. delayed sequential surgery for AUS and IPP devices. Additionally, this paper provides a brief surgical description of the techniques and potential complications relating to both prosthetic procedures. While a great deal is known about the excellent outcomes of both AUS and IPP implantation, there is limited literature published on the outcomes of dual AUS and IPP surgery. The decision to proceed with concurrent synchronous dual vs. delayed sequential two-stage implants is likely determined by the patient's preference, the surgeon's expertise, and the availability of prostheses. In either situation, patients should be counselled regarding the advantages and disadvantages of undergoing synchronous concurrent vs. delayed sequential implants and associated surgical challenges are likely dependent on the patient's anatomy and the surgeon's preference. For carefully selected patients with SUI and ED, dual implantation of AUS and IPP provides a definitive treatment to address both conditions at the same time. Patients should be counselled regarding the advantages and disadvantages of synchronous concurrent vs. sequentially delayed implants while technical considerations regarding the sequence of prosthetic device surgery are likely dependent on the patient's factors and the surgeon's preference and surgical expertise.

Immediate salvage with inflatable penile prosthesis in an infected field: A contemporary multi-institutional cohort

ABSTRACT Introduction Contemporary management of inflatable penile prosthesis (IPP) infections involves removal and replacement to minimize corporal fibrosis and penile shortening. Many urologists prefer a malleable prosthesis (MP) followed by staged conversion to IPP, a technique thought to improve outcomes by allowing treatment of the infection while maintaining intracorporeal volume. A staged procedure involves additional surgery with associated risks. Previous studies suggest an 18% infection risk of placing a second device in a non-infected, revision setting, and that infection risk increases with each subsequent procedure. Objective Our study aims to delineate whether immediate IPP salvage in an infected field yields similar complication rates to the staged approach. Methods Retrospective review at 5 institutions from February 2010 to October 2020 identified patients with IPP infection who underwent IPP salvage. Demographic, laboratory, operative, and microbiology data were collected. Emphasis was placed on the salvage operative technique, duration of antibiotics, and post-salvage complications. Results 19 patients underwent immediate salvage with IPP in the setting of a suspected infection. Average age at initial implantation was 59.9 years. Median time from initial implant to presentation with infectious symptoms was 2.4 months, and revision was performed a median of 1.5 days after presentation and initiation of antibiotics. Intraoperative complications were rare (5.3%), and post-salvage complications were 21.1%, including 1 cylinder herniation and 3 post salvage infections (15.8%). Only 1 post-salvage infection showed concordance with initial cultures while 1 was discordant and the third showed no growth (Table 1). Fisher's exact test showed diabetes, purulence in the operative field, use of drain, or washout type were not associated with infection post-salvage. Conclusions Immediate IPP salvage in the setting of an acutely infected field shows a complication profile not exceeding published data in the staged revision setting. Although staged MP-IPP salvage has been favored by many surgeons, the complication profile may be equivalent to immediate IPP salvage, and the risks of a subsequent operation should be considered. Disclosure Work supported by industry: no.

Hypertension and Low Cholesterol as Risk Factors for Infection after Penile Prosthesis Surgery

ABSTRACT Introduction Erectile Dysfunction (ED) is a common urologic condition affecting a large proportion of men. Typically, first-line treatment consists of oral medications. Inflatable penile prosthesis surgery (IPPS) represents a useful surgical intervention in the treatment of ED, with an estimated 25,000 IPP procedures performed on a yearly basis in the United States. Infection is a devastating complication of IPPS. The most common risk factors for IPP infection include diabetes, immunocompromised status, and urinary tract infection. Given the significant risk of infection following IPPS, there is an ongoing need to identify contributing risk factors. Objective We sought to evaluate the association between medical comorbidities, medications, and serum metabolic lab values and infection in our ethnically diverse population. Methods A retrospective chart review was performed on all men who had primary IPPS between 2017-2019 at our institution. Variables collected include patient demographics, comorbidities, lab values (hemoglobin A1c, testosterone, cholesterol and LDL within 6 months pre-op), and pre-operative urine cultures. Rates of post-operative infection through 60 days and management was also collected. An unpaired t-test (p = 0.05) was used to compare variables between the cohort of men that developed an infection after IPPS surgery and those who did not. Results 293 men underwent primary IPPS, of whom 14 (4.78%) had post-IPPS infection (Table 1). All patients with an infected prosthesis were treated successfully with antibiotics, penile prosthesis removal and replacement with a malleable prosthesis. The most common organisms obtained from wound cultures were Methicillin-Resistant Staphylococcus Aureus (MRSA), E. coli and normal skin flora. Lower postoperative cholesterol (p=0.024), history of hypertension (HTN) (p=0.026), and anti-lipidemic medications (p=0.039) were significantly different between the infected and non-infected cohorts (Table 2). There was no significant difference between the groups with respect to pre-op hemoglobin A1c and testosterone. Conclusions IPP is an excellent option for men with refractory ED despite the known risk of infection. In this study, HTN and anti-lipidemic medications were more common in men who developed infection post-IPPS. As HTN can disrupt both macro- and microvasculature over time, it may contribute to poor post-IPPS healing. Despite their potentially beneficial implications in wound healing, statins have been shown to have immunomodulatory effects including inhibition of the immune response, which may make patients more vulnerable to implant infection. It is unclear whether statins’ anti-inflammatory properties lead to worse wound healing and impaired ability to fight infection, or whether the fact that patients on anti-cholesterol medications may have worse overall metabolic profile and thus worse wound healing. Further research is needed to confirm these findings and to determine whether maintaining cholesterol within an appropriate range can improve post-IPPS outcomes. Disclosure No

Penile Invagination and Corporal Excavation for Penile Prosthesis Placement in Severe Corporal Fibrosis

ABSTRACT Introduction The penile prosthesis is a standard treatment for men with erectile dysfunction refractory to vacuum, medical, or injection therapies. In patients with virgin tissue planes and normal anatomy, prosthesis placement can be technically straight forward and associated with minimal morbidity. Patients with corporal fibrosis present a unique surgical challenge for implantation and there is no standardized approach to care. Selection of the appropriate surgical technique can vary depending on the extent of corporal fibrosis and surgeon experience. In this case, our patient's corporal fibrosis resulted from two episodes of prolonged priapism as well as two distal shunts and a failed attempt at inflatable penile prosthesis placement resulting in a prolonged wound infection. Objective We present our unique surgical approach for penile prosthesis implantation in the most severe cases of corporal fibrosis. Methods Video demonstration of corporal excavation and penile prosthesis placement via a perineal incision with complete penile invagination. Results Comprehensive pre-operative planning guided our decision to utilize a malleable prosthesis given the severe degree of corporal fibrosis and higher risk of complications with a three-piece IPP. Our penile invagination technique allowed us to achieve complete longitudinal corporal exposure while avoiding multiple incisions or overlapping incisions near the corporotomy and cylinders. Tachosil or other biologic grafts should be available for use in cases where primary corporotomy closure is not possible. Conclusions We demonstrated that penile invagination, corporal excavation, and implantation with a malleable prosthesis is a safe and effective treatment for patients with the most severe corporal fibrosis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific

Immediate Salvage with Inflatable Penile Prosthesis in an Infected Field: A Contemporary Multi-institutional Cohort

ABSTRACT Introduction Contemporary management of inflatable penile prosthesis (IPP) infections involves removal and replacement to minimize corporal fibrosis and penile shortening. Many urologists prefer a malleable prosthesis (MP) followed by staged conversion to IPP, a technique thought to improve outcomes by allowing treatment of the infection while maintaining intracorporeal volume. A staged procedure involves additional surgery with associated risks. Previous studies suggest an 18% infection risk of placing a second device in a non-infected, revision setting, and that infection risk increases with each subsequent procedure. Objective Our study aims to delineate whether immediate IPP salvage in an infected field yields similar complication rates to the staged approach. Methods Retrospective review at 5 different institutions from February 2010 to October 2020 identified patients with IPP infection who underwent IPP salvage. Patient demographic, laboratory, operative, and microbiology data were collected. Emphasis was placed on the salvage operative technique, duration of antibiotics, and post-salvage complications. Results Overall, 19 patients underwent immediate salvage with IPP in the setting of a suspected infection. Average age at initial implantation was 59.9 years. Median time from initial implant to presentation with infectious symptoms was 2.4 months, and revision was performed a median of 1.5 days after presentation and initiation of antibiotics. Intraoperative complications were rare (5.3%), and post-salvage complications were 21.1%, including 1 cylinder herniation and 3 post salvage infections (15.8%). Only 1 post-salvage infection showed concordance with initial cultures while 1 was discordant and the third showed no growth (Table 1). Fisher's exact test showed diabetes, purulence in the operative field, use of drain, or washout type were not associated with infection post-salvage. Conclusions Immediate IPP salvage in the setting of an acutely infected field shows a complication profile not exceeding published data in the staged revision setting. Although staged MP-IPP salvage has been favored by many surgeons, the complication profile may be equivalent to immediate IPP salvage, and the risks of a subsequent operation should be considered. Disclosure No

Malleable Penile Implant Rod Diameter Predicts Complications and Patient Satisfaction.

BackgroundOne of the most common complaints after malleable prosthesis implantation (MPI) is thinning of the penis and decreasing girth. Some surgeons try to insert the largest diameter they can to improve patient satisfactionAimTo investigate if malleable rod diameter (MRD) has an impact on outcome and patient satisfactionMethodsConsecutive malleable prosthesis implantation (MPI) was assessed in a high-volume center over 1 year. The same preoperative, intraoperative, and postoperative protocols were used for all patients and one brand of the malleable device was used only. We recorded MRD and length for all patients. All patients had data on comorbidities including glycated hemoglobin (HbA1c) and clinical Peyronie's disease (PD). Revision cases and those who lost for follow-up were excluded from the study. We also excluded patients operated on by low-volume surgeons. All complications, minor (edema, ecchymosis, pain), and major (infection and erosion) were recorded. After 1-year, patients were assessed and given a Likert scale from 1 to 5 where 5 is most satisfied with their MPI. We stratified patients according to MRD into 2 groups: group A for diameter 9.5 and 11 mm and group B for 13 mm.Outcome: Larger diameter of malleable penile implants may be associated with more complicationsResults183 patients had full data and filled the questionnaire after 1-year follow-up. All patients had Coloplast, Genesis penile implants. Major complications rate (infection, erosion, and removal) was significantly higher in group B 11% vs 1.2% in group A (P = .016). At 4 weeks postoperative visit, 90 % of group A showed no complications vs 60% only in group B that was statistically significant (P = .0003). Satisfaction rate was more in patients in group A (88.6%) compared to patients in group B (75.7%) but this did not reach to be statistically significant (P = .0519)Clinical ImplicationsMRD predicts outcome.Strengths & LimitationsThe strengths of our study include that it is the first prospective study with good number of malleable implants. Limitations include: no validated satisfaction instrument and MRD choice was based on surgeon preference.ConclusionsLarger diameter of malleable penile implants are not associated with a higher rate of patient satisfactionHabous M, Omar M, Farag M et al. Malleable Penile Implant Rod Diameter Predicts Complications and Patient Satisfaction. Sex Med 2022;10:100486.

Intravesical reservoir erosion as a late complication of a 3-piece inflatable penile prosthesis: ectopic placement in a high-subrectus space: a rare case report

Background: Inflatable penile prosthesis (IPP) is the mainstream treatment of refractory erectile dysfunction (ED). Usually, Space of Retzius (SOR) is the usual IPP reservoir placement space, however, more concerns regarding this space complication have emerged due to its anatomical proximity to some major structures. Intravesical reservoir erosion is the most common reported reservoir complication. Hematuria is the main presentation, sometimes, dysuria and urinary tract infection take place. We present a case of late intravesical reservoir erosion after 3 years of IPP implantation. Methods: Revision surgery was made including placement of AMS Conceal® reservoir in an ectopic high-subrectus space and anterior to transversalis fascia, contralaterally. Results: Recently, ectopic placement has gained popularity among implanters due to its safety and efficacy. Specifically, submuscular space placement, after inventing the lock-out valve to avoid undesirable auto-inflation due to the high back-pressure. Conclusion: Ectopic placement utilizes more choices in cases like hostile pelvis for implanting a 3-piece IPP instead of a malleable prosthesis. Ectopic placement is safe and highly acceptable between high-volume implanters, which may prime a new era of reservoir placement.