First safety outcomes for rigicon conticlassic® artificial urinary sphincter.

The Rigicon ContiClassic® is a new sphincteric device designed to treat male stress urinary incontinence. This study evaluates the surgical outcomes and safety profile of the first 116 patients who received the implant between September 2021 and April 2022. Data were collected from patient information forms completed at the time of the implant and submitted by implanting surgeons, nursing staff in the Operating Room or company representatives present during the surgery. The study analyzed patient demographics, surgical details, and etiology of incontinence. The mean age of patients was 68.3 years +/- 9.65 yrs. Minimum age was 23 and maximum age was 83. The most common reason for implantation was urinary incontinence (58.6%) after radical prostatectomy. The results showed a revision rate of 6.90%, with three cases of fluid loss, four cases of iatrogenic mistaken sizing, and one case of patient dissatisfaction. There were no reported infections. Kaplan-Meier calculation showed survival rate of 93.2% at 12 months. This study shows the early safety outcomes for the Rigicon ContiClassic® sphincter device to be comparable to others presently on the market.

Comparing Dementia Classification by Self-Report and Administrative Records in the National Core Indicators-Aging and Disability Survey: A Predictive Modeling Approach.

Policymakers are interested in the long-term services and supports (LTSS) needs of people living with dementia. The National Core Indicators-Aging and Disability (NCI-AD) survey is conducted to evaluate LTSS care needs. However, dementia reporting in NCI-AD varies across states, and is either obtained from state administrative records or self-reported during the survey. We explored the implications of identifying dementia from administrative records versus self-report. We analyzed 24,569 NCI-AD respondents age 65+, of which 22.4% had dementia. To assess dementia accuracy by data source, we fit separate logistic regression models using the administrative and self-reported subsamples. We applied model coefficients to the population whose dementia status came from the opposite source. Using the administrative model to predict self-reported dementia resulted in higher sensitivity than using the self-report model to predict administrative dementia (43.8% vs. 37.9%). The self-report model's diminished sensitivity suggests administrative records may capture cases of dementia missed by self-report.

Penile prosthesis salvage: a historical look at the Mulcahy technique and a review of the latest literature.

Historically, management of inflatable penile prosthesis infection was explantation of the device with delayed reimplantation at a later date. In 1991, this paradigm was challenged when early attempts at washout and immediate salvage proved successful. The clinical experiences and data generated over the past 30 years have allowed implanters to refine their salvage procedures to improve patient outcomes. In this article, we review the original Mulcahy technique for salvage and discuss updates to this protocol based on recent data.

Is there still a place for malleable penile implants in the United States? Wilson's Workshop #18.

The use of semirigid rod penile prosthesis for the management of erectile dysfunction was first described over 85 years ago. Since then, there have been numerous design advancements leading to improved overall durability, concealability, rigidity, and natural feel. However, the inflatable penile prosthesis (IPP) still has a higher patient satisfaction rate and is currently the most commonly inserted prostheses in the United States. There are still certain situations and conditions where the simplicity of a rod may be preferred over an IPP. A pair of semirigid rods has been shown to have less risk of malfunction and need for revision surgery. In addition, patients with poor manual dexterity, those undergoing a salvage for infection prosthesis and those with a prolonged (> 48 h) priapic episode may be better served with a rod than an IPP. Finally, in patients compromised by infection or priapism, the rods can later successfully be exchanged for an IPP with potentially longer, wider cylinders with resultant greater patient satisfaction.

Nuances of infrapubic incision for inflatable penile prosthesis.

This workshop completes the trilogy of nuances of the various incisions used to place an inflatable penile prosthesis (IPP). Infrapubic placement was the original technique employed 50 years ago for the very first IPP surgeries. The historical perspective of the development of implantation incisions and the original Scott prosthesis highlighted in this work should be fascinating to today's younger prosthetic urologists. The developing surgeon should also find some surprising maneuvers considered important technique nuances from the highest volume infrapubic implanter in the world. Among the wonders of the infrapubic approach covered are: The surgery is conducted without the aid of an in-dwelling Foley catheter or post-operative inflation. Hydrodistension of the corpora substitutes for corporal dilatation. The "chicken choke" protects the urethra from damage. Closed suction drainage is employed despite minimal scrotal dissection. Motivated patients may use their new device as early as 14 days after implantation.

Unexpected nuances of the penoscrotal inflatable penile prosthesis.

The inflatable penile prosthesis was first implanted with a large vertical suprapubic incision. Nowadays, three surgical approaches are utilized: penoscrotal, infrapubic, and subcoronal. Globally the penoscrotal approach is used most often. Our first author describes nuances of the high transverse scrotal incision technique gained over 48 years of experience. Many of these methods will interest the reader because they are divergent from the common practice of implanters across the world. These distinctions are designed to diminish the risk of infection, speed up the surgery, and improve outcomes for both the patient and his surgeon.

Twenty years later: is the scrotal one-incision AUS of value?

The artificial urinary sphincter, known as AMS 800, has been the gold standard for treating moderate to severe stress urinary incontinence in males for 40 years. Yet, the number of sphincters done globally is quite small and the majority of urologists doing them are infrequent implanters. Estimates for 2019 showed half of implanters did only one implant that year and worldwide only around 13,000 implantations were performed. The traditional two-incision technique of perineal exposure for cuff placement and abdominal incision for pump and pressure regulating balloon persists as the most common technique to surgically place an artificial urinary sphincter. Present estimates are that upwards of 80% are done via the perineal approach and that approach is the highly favored incision of large volume centers. The scrotal one-incision approach was invented by Wilson 20 years ago and was aimed at making the implantation of a sphincter quicker, easier and safer for the occasional implanter. These physicians perform 1-2 devices per year, comprise 60% of implanters who perform the surgery yearly, and implant 22% of all implanted devices. Our article targets these infrequent inserters discussing the history of the two techniques and what the authors have learned about the advantages and hazards of the one scrotal incision procedure over the last two decades.

The last survivor of unitary and two-piece inflatables-the Ambicor. Does it still have a role in today's implant marketplace?

The history of the development of today's very dependable three-piece inflatable penile prostheses is fascinating. In its infancy, the three piece was plagued with frequent revisions and a relatively complex insertion and consequently unitary and two-piece prostheses flourished with the implanting urologists. While the surgery was less difficult because these devices did not require the dreaded reservoir insertion, they often proved unsatisfactory to patients in flaccidity, erection and longevity. By the turn of this century all of the unitary and two-piece inflatables had been withdrawn from the market except the Ambicor two-piece inflatable penile prosthesis. This paper covers the history of the various unitary and 2-piece inflatable models before examining a critical question: is the Ambicor 2-piece still a needed implant today?

Penile implant infection prevention part II: device coatings have changed the game.

The single most important factor in the reduction of penile implant infections has been the infection retardant coatings. Virtually every inflatable penile prosthesis (IPP) sold for the last 15 years in America has been coated and the device infection rate has dropped over 50% to less than 1% in experienced implanter practices. The vast majority of penile implants are contaminated with bacteria at time of surgery and the bacteria live within the implant spaces in a quiescent fashion protected by a biofilm secreted by the organisms that makes them impermeable to antibiotics or the body's defense mechanisms. Only very rarely do the bacteria cause a clinical infection. Medicine has no clue why this atypically happens. There are new recommendations for systemic prophylactic antibiotics-a testimonial to the changing face of the bacteria causing device infection. New washout solutions are being utilized and new salvage guidelines are being studied.

The Use of Antiseptic Solutions in the Prevention and Management of Penile Prosthesis Infections: A Review of the Cytotoxic and Microbiological Effects of Common Irrigation Solutions.

INTRODUCTION: The Mulcahy salvage fundamentally altered the management of penile prosthesis infections (PPI). Central to this procedure is a sequence of antiseptic irrigations that aims to remove and eradicate pathogenic microflora from the infected field, thus preparing for immediate reimplantation. The antiseptic solutions and their respective concentrations, however, have never been evaluated for efficacy. AIM: This review critically examines 3 commonly used antiseptic irrigation solutions (povidone-iodine [PVI], hydrogen peroxide [H2O2], and chlorhexidine gluconate [CHG]) in terms of their antimicrobial activity, cytotoxicity, and clinical use. METHODS: A PubMed literature review was performed on articles published between 2003 and 2018. Both preclinical as well as clinical studies from various surgical disciplines were included in this review. MAIN OUTCOME MEASURE: The original salvage protocol selected for irrigation solutions at concentrations that are likely detrimental to native tissue. RESULTS: All 3 agents demonstrate in vitro cytotoxic effects at subclinical concentrations, but H2O2 is associated with the most significant deleterious properties. It does not seem to broaden antimicrobial coverage beyond what is covered by PVI. Dilute PVI (0.35-3.5% with exposure time of at least 3 minutes) possesses the most robust clinical evidence as an intraoperative adjunct, reducing the incidence of postoperative infectious complications. chlorhexidine gluconate is a promising new agent but lacks clinical data. CLINICAL IMPLICATION: Improvements in the salvage protocol are warranted based on current evidence. Careful selection of lavage solution and usage of the lowest necessary concentration will help achieve desired antimicrobial activity while avoiding native tissue cytotoxicity. Strength and limitation: The study is limited by its retrospective nature, and the heterogeneity of literature reviewed precluded a formal meta-analysis. Furthermore, future studies will need to address the roles of normal saline and antibiotic irrigations as intraoperative adjuncts for infection prevention. CONCLUSION: Diluted PVI (0.35-3.5% for 3 minutes) may be beneficial in the prevention of PPI. Evidence supports its use both in the setting of primary implantation as well as salvage of infected hardware. An improved, evidence-based protocol may increase positive outcomes of urologic prosthetic surgery. Pan S, Rodriguez D, Thirumavalavan N, et al. The Use of Antiseptic Solutions in the Prevention and Management of Penile Prosthesis Infections: A Review of the Cytotoxic and Microbiological Effects of Common Irrigation Solutions. J Sex Med 2019;16:781-790.

Simulation Training in Penile Implant Surgery: Assessment of Surgical Confidence and Knowledge With Cadaveric Laboratory Training.

INTRODUCTION: Constraints on surgical resident training (work-hour mandates, shorter training programs, etc.) and availability of expert surgical educators may limit the acquisition of prosthetic surgical skills. As a result, training courses are being conducted to augment the prosthetic surgery learning experience. AIM: To evaluate the impact of a hands-on cadaver-based teaching program on resident procedural knowledge and procedural confidence with placement of a penile prosthesis. MAIN OUTCOME MEASURE: Changes in procedural knowledge and self-confidence following a focused training program on penile prosthetics. METHODS: As part of the 2017 Society of Urologic Prosthetic Surgeons and the Sexual Medicine Society of North America Annual Meeting, 31 urology residents participated in a simulation lab in prosthetic urology. The lab included didactic lectures and a hands-on cadaveric laboratory. Participants completed surveys before and after the course. Wilcoxon Signed Rank tests for matched pairs were used to compare respondents' pre- and postcourse knowledge (% questions answered correctly) and confidence ratings. Prior implant experience was assessed. RESULTS: 31 residents participated in this study. The majority of the participants were 4th- (41.9%) and 5th-year residents (38.7%). Participants showed a significant improvement in procedural knowledge test scores (68.8±13.4 vs 74.2 ± 13.0, P < .05) and self-reported increased median surgical confidence levels (4 vs 3, P value < .001) after completion of the cadaveric course. Subgroup analysis demonstrated that residents with prosthetic surgery experience of <10 cases benefited the most. In addition, improvement in surgical confidence levels observed was greater than the improvement in surgical knowledge. The overall cost of the simulation training course was approximately $1,483 per resident. CONCLUSION: Simulation training in prosthetic surgery seems to improve surgical confidence and knowledge. Further research is needed to better understand the benefits and limitations of simulation training. Lentz AC, Rodríguez D, Davis LG. Simulation training in penile implant surgery: Assessment of surgical confidence and knowledge with cadaveric laboratory training. Sex Med 2018;6:332-338.

The Prevention and Management of Noninfectious Complications of Penile Implants.

INTRODUCTION: Penile implants have been a mainstay in the treatment of erectile dysfunction for more than four decades. The satisfaction rate with the functioning of these devices has been very high. Problems can develop with the device itself or with the tissues surrounding it. Knowledge of preventing and managing these adverse events is critical to a successful outcome and sustained patient satisfaction. AIM: A narrative of the prevention and management of noninfectious complications of penile implant placement gained from the author's extensive experience is presented. METHODS: Each category of penile implant complications is presented as a separate subtitle. The initial categories are intraoperative problems; the subsequent groups involve postoperative adverse events. MAIN OUTCOME MEASURE: To gather information for this manuscript, I reviewed 40 publications and found 32 relevant and helpful. RESULTS: Attending to the details necessary for proper placement of prosthetic parts during the initial surgery will minimize the chance of problems developing. Prompt attention to postoperative problems will thwart their progression to a more extensive adverse situation, which will be more difficult to remedy. CONCLUSIONS: Complications during penile implant placement and in the postoperative period may occur. Knowledge of maneuvers to avoid their occurrence and prompt attention to correcting problems as they arise are paramount to a successful outcome and to maintaining high satisfaction rates. Mulcahy JJ. The prevention and management of noninfectious complications of penile implants. Sex Med Rev 2015;3:203-213.

Long-term infection rates in diabetic patients implanted with antibiotic-impregnated versus nonimpregnated inflatable penile prostheses: 7-year outcomes.

BACKGROUND: Diabetic patients may be more prone to penile-implant infections than other men. OBJECTIVE: We sought to determine whether revision surgeries due to infection were less common in diabetic men after implantation of an inflatable penile prosthesis (IPP) impregnated with minocycline and rifampin (M/R) versus a nonimpregnated prosthesis. DESIGN, SETTING, AND PARTICIPANTS: Infection-related revisions for M/R-impregnated and nonimpregnated implants were compared during a retrospective review of patient-implant and removal data recorded in the manufacturer's database. The data set included men with diabetes as an etiology of erectile dysfunction and who were implanted with their first IPPs between 2001 and 2008. INTERVENTION: All men received three-piece IPPs. MEASUREMENTS: The number of first revisions due to infection reported at any time during the study period were summarized for each group. Freedom from infection-related revisions for initial M/R-impregnated implants were compared to nonimpregnated implants with ≤ 84 mo of follow-up using life-table survival analysis. Infection-free survival was also compared for diabetics versus nondiabetics. RESULTS AND LIMITATIONS: Mean age was 59.1 yr for the 6071 diabetic men in the M/R-impregnated group. The nonimpregnated group included 624 diabetics with a mean age of 57.6 yr. Initial revisions due to infection were reported for 1.47% of M/R-impregnated versus 4.17% of nonimpregnated implants. At 7 yr, the rate of infection-related revisions was significantly lower for M/R-impregnated (1.62%) than for nonimpregnated implants (4.24%; log-rank p < 0.0001). Diabetic men had a significantly higher rate of revisions due to infection at 7 yr (1.88%) than men without diabetes (1.53%; log-rank p = 0.0052). CONCLUSIONS: This long-term evidence from the largest known database of diabetic IPP recipients establishes that the use of an antibiotic-impregnated IPP can decrease revisions due to infection. Reducing the incidence of this devastating complication represents a significant medical advance in erectile restoration for diabetic patients.

Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup.

PURPOSE: Although some studies suggest that most infections associated with inflatable penile prosthesis implantation develop within year 1 after surgery, device related infections have been reported 5 years after implantation or later and the infection risk with time is not well characterized. We previously reported a statistically significantly lower infection rate for original inflatable penile prostheses impregnated with antibiotic treatment with minocycline and rifampin vs nonimpregnated inflatable penile prostheses at 1-year followup. Long-term data are now available on infection revision after initial implantation of antibiotic impregnated vs nonimpregnated prostheses. MATERIALS AND METHODS: We retrospectively reviewed patient information forms voluntarily filed with the manufacturer after the initial implantation of more than 39,000 inflatable penile prostheses to compare the revision rate due to infection for antibiotic impregnated vs nonimpregnated implants between May 1, 2001 and December 31, 2008. Life table analysis was used to evaluate device survival from revision surgery. RESULTS: On life table survival analysis initial revision events due to infection were significantly less common in the impregnated vs the nonimpregnated group (log rank p <0.0001). At up to 7.7 years of followup 1.1% of 35,737 vs 2.5% of 3,268 men with impregnated vs nonimpregnated implants underwent initial revision due to infection. CONCLUSIONS: To our knowledge this long-term outcome analysis provides the first substantial clinical evidence of a decrease in costly infection related revision using an antibiotic impregnated inflatable penile prosthesis.

Selective endothelin-1 receptor type A inhibition in subjects undergoing cardiac surgery with preexisting left ventricular dysfunction: Influence on early postoperative hemodynamics.

OBJECTIVE: A robust release of endothelin-1 with subsequent endothelin-A subtype receptor activation occurs in patients after cardiac surgery requiring cardiopulmonary bypass. Increased endothelin-A subtype receptor activation has been identified in patients with poor left ventricular function (reduced ejection fraction). Accordingly, this study tested the hypothesis that a selective endothelin-A subtype receptor antagonist administered perioperatively would favorably affect post-cardiopulmonary bypass hemodynamic profiles in patients with a preexisting poor left ventricular ejection fraction. METHODS: Patients (n = 29; 66 +/- 2 years) with a reduced left ventricular ejection fraction (37% +/- 2%) were prospectively randomized in a blinded fashion, at the time of elective coronary revascularization or valve replacement requiring cardiopulmonary bypass, to infusion of the highly selective and potent endothelin-A subtype receptor antagonist sitaxsentan at 1 or 2 mg/kg (intravenous bolus; n = 9, 10 respectively) or vehicle (saline; n = 10). Infusion of the endothelin-A subtype receptor antagonist/vehicle was performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass. Endothelin and hemodynamic measurements were performed at baseline, at separation from cardiopulmonary bypass (time 0), and at 0.5, 6, 12, and 24 hours after cardiopulmonary bypass. RESULTS: Baseline plasma endothelin (4.0 +/- 0.3 fmol/mL) was identical across all 3 groups, but when compared with preoperative values, baseline values obtained from age-matched subjects with a normal left ventricular ejection fraction (n = 37; left ventricular ejection fraction > 50%) were significantly increased (2.9 +/- 0.2 fmol/mL, P < .05). Baseline systemic (1358 +/- 83 dynes/sec/cm(-5)) and pulmonary (180 +/- 23 dynes/sec/cm(-5)) vascular resistance were equivalent in all 3 groups. As a function of time 0, systemic vascular resistance changed in an equivalent fashion in the post-cardiopulmonary bypass period, but a significant endothelin-A subtype receptor antagonist effect was observed for pulmonary vascular resistance (analysis of variance; P < .05). For example, at 24 hours post-cardiopulmonary bypass, pulmonary vascular resistance increased by 40 dynes/sec/cm(-5) in the vehicle group but directionally decreased by more than 40 dynes/sec/cm(-5) in the 2 mg/kg endothelin-A subtype receptor antagonist group (P < .05). Total adverse events were equivalently distributed across the endothelin-A subtype receptor antagonist/placebo groups. CONCLUSION: These unique findings demonstrated that infusion of an endothelin-A subtype receptor antagonist in high-risk patients undergoing cardiac surgery was not associated with significant hemodynamic compromise. Moreover, the endothelin-A subtype receptor antagonist favorably affected pulmonary vascular resistance in the early postoperative period. Thus, the endothelin-A subtype receptor serves as a potential pharmacologic target for improving outcomes after cardiac surgery in patients with compromised left ventricular function.

Upsizing of inflatable penile implant cylinders in patients with corporal fibrosis.

INTRODUCTION: Placement of an inflatable penile prosthesis in a patient with scarred corporal bodies secondary to priapism or removal of a previously infected implant is a formidable surgical challenge; use of downsized implants has improved chances of successful reimplantation. Nevertheless, patients are frequently dissatisfied with the resulting short penises. AIM: This study investigates the use of downsized inflatable penile prosthesis cylinders as tissue expanders in patients with corporal fibrosis. MAIN OUTCOMES MEASURES: Corporal length and width were calibrated before implantation of downsized prostheses and after 1 year of their use as tissue expanders. METHODS: Thirty-seven patients had insertion of Mentor Narrow Base (18), AMS CXM (9), or AMS CXR (10) into scarred corporal bodies. Etiology was previously infected and removed implant (29) or priapism (8). In each of these cases it was not possible to dilate to 12 mm in order to place standard-sized cylinders. Patients were encouraged to inflate their implant for up to 3 hours daily. After several months intracorporal stretching occurred. The patients were reoperated; corporal length and width were recalibrated. RESULTS: Upon reoperation, it was possible to pass dilators of 12 mm width proximally allowing the substitution of standard-sized AMS 700 CX (23), Mentor Alpha 1 (10), or Mentor Titan (2). Additionally, corporal length measurements in the previously infected patients increased an average of 2.2 cm allowing placement of longer cylinders. Although priapism patients did not show this phenomenon of corporal lengthening, the implant space widened enough to permit replacement with standard-size cylinders improving girth, rigidity, and appearance. CONCLUSIONS: Wider and sometimes longer cylinders can be substituted in patients with corporal fibrosis that required implantation with downsized cylinders because of fibrotic corpora. Prolonged inflation over an 8- to 12-month period results in expansion of the cylinder cavity, permitting standard-sized cylinders in all patients.

Salvage procedure for infected noneroded artificial urinary sphincters.

PURPOSE: We report our experience with removal, antiseptic irrigation and immediate reimplantation of infected noneroded artificial urinary sphincters. MATERIALS AND METHODS: From April 1996 to October 2000, 8 patients with an infected artificial urinary sphincter underwent a total of 9 salvage operations. All patients underwent cystoscopy before salvage to ensure nonerosion of the sphincter cuff. All previously implanted material was removed, the wounds were copiously irrigated according to a 7 solution protocol and an identical new system was implanted. All patients were discharged home the following morning on oral antibiotics. RESULTS: Followup was 5 to 66 months (mean 33). The predominant organisms cultured at salvage were gram-positive cocci. Time from implantation to salvage was from 2 weeks to 64 months (mean 13.7 months). Prostatectomy was the etiology of incontinence in all except 1 case. In 5 of the 8 men a double cuff system was placed and 3 underwent concurrent 3-piece inflatable penile prosthesis salvage. The salvage procedure was done twice in 1 patient 5 months apart. The system was removed 16 months later secondary to urethral erosion. At the most recent followup the other 7 patients were free of infection with a functioning artificial urinary sphincter. CONCLUSIONS: Salvage and immediate reimplantation of an infected, noneroded single or double cuff artificial urinary sphincter appears to be a valid option. Our overall success rate was 87%. The usual offending organisms are gram-positive skin flora. An associated inflatable penile prosthesis does not prohibit simultaneous salvage of the 2 devices.