Abstract Introduction Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of men with post-RP erectile dysfunction (ED) and climacturia and/or minimal stress urinary incontinence (SUI). We sought to report the 5-year outcomes from this original cohort. Objective To assess long-term safety and efficacy of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia Methods We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI (2 ppd) and underwent IPP insertion with simultaneous placement of a Mini-Jupette sling. Data including current ppd, improvement in climacturia, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up were collected. Results Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD= 8.8) with a mean age of 69 years (SD= 6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean ppd decreased from 1.4 preoperatively to 0.3 at a mean 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions The Mini-Jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus, Intuitive Surgical, Fidalis, Hims & Hers Health Inc
(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.
AUA-recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis
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<0.0001), use of rear tip extenders (RTE) (p=0.04), lower RTE length (p<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
Impact of Antimicrobial Dipping Solutions on Postoperative Infection Rates in Patients with Diabetes Undergoing Primary Insertion of a Coloplast Titan Inflatable Penile Prosthesis
Abstract Background Modern-day penile prostheses use infection retardant coating to decrease rates of postoperative infection, subsequently reducing explantation and revision rates as well. The Coloplast Titan models are dipped into antimicrobial solutions right before implantation, and the components used for dipping can be tailored toward the patient. Aim To compare infection, explantation, and revision rates among different dipping solutions used before implantation for patients with diabetes receiving a Coloplast Titan implant. Methods We systematically reviewed 932 patients with diabetes receiving a primary penile implant across 18 different centers from the period April 2003 to August 2018. Of those patients, 473 received a Coloplast device, whereas 459 received an AMS device. Data regarding the type of antimicrobial solution used before implantation were recorded for 468 patients receiving a Coloplast Titan, including whether or not they suffered a postoperative infection and if they underwent explantation and/or revision. Outcome rates were compared using Fisher’s exact and Pearson’s chi-square tests, and logistic regression modeling was performed to account for covariates. Outcomes The main outcome measures of this study were postoperative infection, explantation, and revision rates. Results Of the total 932 patients reviewed, 33 suffered a postoperative infection. Of 468 patients receiving Coloplast implants, there was a 3.4% infection rate. The most commonly used antibiotic combination before dipping was vancomycin + gentamicin (59.0%). There was a significantly lower rate of postoperative infection, explantation, and revision when vancomycin + gentamicin was used than those associated with the use of all other dipping solutions ([1.4% vs 6.4%; P = .004], [1.1% vs 8.3%; P < .001], and [2.5% vs 12.5; P < .001], respectively). After adjusting for age, body mass index, preoperative blood glucose level, and hemoglobin A1c, the use of other dips was an independent predictor of postoperative infection (odds ratio: 0.191; P = .049). The inclusion of rifampin in the dipping solution trended toward being a significant risk factor for infection (P = .057). Including antifungals in the dipping solution did not affect infection (P = .414), explantation (P = .421), or revision (P = .328) rates. Clinical Implications Vancomycin + gentamicin was the most efficacious combination of antibiotics used for dipping in terms of preventing postoperative infection and subsequent explantation and revision. Strengths and Limitations Data were sampled across multiple institutions providing a large sample that may be more representative of the population of interest. A key limitation of the study was its retrospective nature, which prevented us from controlling certain variables. Conclusion The use of rifampin did not provide the same type of protection, possibly representing a shift in resistance patterns of common bacteria responsible for device infection.
A Multicenter Investigation Examining American Urological Association Recommended Antibiotic Prophylaxis vs Nonstandard Prophylaxis in Preventing Device Infections in Penile Prosthesis Surgery in Diabetic Patients
Multicenter Experience Using Collagen Fleece for Plaque Incision with Grafting to Correct Residual Curvature at the Time of Inflatable Penile Prosthesis Placement in Patients with Peyronie's Disease
Abstract Background Adjuvant maneuvers are often necessary to correct residual curvature during inflatable penile prosthesis (IPP) placement in patients with Peyronie's disease (PD). Aim We present our multicenter experience using collagen fleece as graft material for plaque incision and grafting (PIG) during IPP placement in patients with moderate to severe PD. Methods We retrospectively reviewed 51 patients with IPP from 3 sites who underwent PIG with Tachosil (Baxter, IL) collagen fleece. Coloplast (Minneapolis, MN) IPP devices were used. Factors associated with residual curvature, revision, and patient satisfaction were performed using chi-squared analysis. Outcomes We evaluated postoperative outcomes including factors associated with residual curvature, revision, and patient satisfaction. Results The mean compound curvature was 69.6°. The mean follow-up was 10.6 (range 1–38) months. All patients reported erections sufficient for penetrative intercourse at the last follow-up. Residual curvature <15° was noted in 6 of 51 (12%) patients. 3 patients required device revision. 2 patients experienced temporary glanular paresthesia, and no patients experienced device infection. Clinical Implications In our multicenter study, patients experienced substantial curve correction with minimal complications, and in the few patients who had persistent mild curvature, severe preoperative curvature (>60°) was found to be the only risk factor. Strengths & Limitations Our study represents the largest series of patients coming from multiple centers undergoing surgical correction of PD with IPP and collagen fleece grafting. Limitations of this study include the retrospective study design, lack of a comparison group, and modest follow-up. Conclusion PIG using collagen fleece is a safe and effective means of correcting residual curvature after IPP placement in patients with moderate to severe PD.
152 Multi-Center Experience Utilizing Collagen Fleece for Plaque Incision with Grafting to Correct Residual Curvature at Time of Inflatable Penile Prosthesis Placement in Peyronie's Disease Patients
105 Impact of Antimicrobial Dipping Solutions on Post-Operative Infection Rates in Diabetic Patients Undergoing Primary Insertion of a Coloplast Titan Inflatable Penile Prosthesis