The Virtue quadratic male sling for postradical prostatectomy urinary incontinence: 3-Year outcome measurements and a predictive model of surgical outcome from a European prospective observational study.

AIMS: This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months. METHODS: Objective assessment was based on a 24-h pad weight test with improvement defined by a decrease >50% and cure by less than 1.3 g. Subjective assessment was based on the patient global impression of improvement and International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) questionnaires. Subgroups were analyzed by baseline severity of incontinence on a 24-h-pad test, body mass index (BMI), and pads usage. Factors associated with treatment response were assessed using logistic regression at Months 36. Complications were reported. RESULTS: We analyzed data from 117 men. Objective and subjective improvement were achieved in 54% and 35% and 51% and 34% at 12 and 36 months, respectively. Twenty-one percent and 19% were considered cured, respectively, at 12 and 36 months. No differences per baseline incontinence severity, BMI and pads usage were found at 36 months. Mean ICIQ-UI-SF score decreased from 15 to 9. Predictive factors were BMI, postvoid residual urine, number of nighttime urination, and ICIQ total score. Seven Clavien-Dindo Grade III (5.1%) including four Virtue sling revisions were reported. The most frequent Grade II complications were overactive bladder symptoms and pain reported in 10.3% and 2.9%, respectively. No complications required explantation. CONCLUSIONS: Virtue male sling is safe and effective in males with mild to severe postprostatectomy urinary incontinence over 36 months. Virtue could be considered an interesting option for postradical prostatectomy urinary incontinence with positive results over time even in patients with high BMI. The predictive model should be validated by further studies.

A Prospective Randomized Study Comparing Postoperative Pain, Biological Fixation, and Clinical Outcomes Between Two Uncemented Rotating Platform Tibial Tray Designs.

BACKGROUND: With the demand for arthroplasty increasing worldwide year on year, there is a drive to improve prosthesis longevity. Biological fixation from cementless implants has been one method of trying to achieve this. We hypothesized that the addition of a hydroxyapatite (HA) coating and 4 pegs to a porous-coated tibial tray would provide a reduction in time to implant osseointegration, allowing for normal physiological stress transfer, thus improving early postoperative pain and rehabilitation as well as the elimination of radiolucent lines (RLLs). METHODS: A prospective, randomized controlled single-blinded study was undertaken, comparing postoperative pain, radiographic evidence of biological fixation, and clinical outcomes between patients undergoing primary total knee arthroplasty with either LCS Complete POROCOAT (porous coating only) or LCS Complete DUOFIX (porous coating plus HA and pegs) knee systems (DePuy Synthes, Warsaw, IN). In total, 197 patients (205 knees) were recruited into the study between November 2006 and November 2008 and have been followed for up to 10 years. RESULTS: There were no clinically significant differences in pain or patient-reported outcome measures when comparing the 2 designs but the tibial tray with pegs and HA showed fewer RLLs at all time points. There was no correlation between RLLs and pain and no instances of loosening or osteolysis in either group. There was 1 revision for infection in the porous coating only group. CONCLUSION: The tray design with HA and additional fixation pegs did not confer any benefit in terms of reduced early postoperative pain or improved patient-reported outcomes, although it did result in significantly fewer RLLs. Both implants demonstrated excellent survivorship. With a cementless porous-coated tibial component, nonprogressive RLLs should be considered normal.

Acute Kidney Injury After Prophylactic Cefuroxime and Gentamicin in Patients Undergoing Primary Hip and Knee Arthroplasty-A Propensity Score-Matched Study.

BACKGROUND: Perioperative acute kidney injury (AKI) can be associated with lower limb arthroplasty and increases morbidity, length of stay, and mortality. AKI is more prevalent in some antibiotic regimes compared with others. The aim of the present study is to assess the impact of cefuroxime (CEF), with or without gentamicin (±G), on AKI rates. METHODS: A prospective cohort study involving patients undergoing hip or knee arthroplasty was performed, between September 1, 2015 and November 30, 2016. Prophylactic intravenous antibiotics were administered according to local policy. AKI was graded according to the validated Acute Kidney Injury Network criteria based on the changes from baseline serum creatinine values. Propensity score matching was performed to identify risk factors. The local audit department approved the study. Appropriate statistical analyses were performed. RESULTS: A total of 2560 met the inclusion criteria, with a female preponderance (1447/2560; 56.5%). The mean age was 67.5 ± 10.7 years, with males being significantly younger (65.9 ± 10.9 vs 68.7 ± 10.4 years). AKI developed in 32 cases (1.25%). There was no difference in AKI rates between CEF alone and CEF in combination with gentamicin (1.07% vs 1.36%; P = .524). Overall 31/32 cases were Acute Kidney Injury Network stage I. AKI did not affect the length of stay. Postoperative infection rate was 7/2560 (0.27%). There were no incidences of Clostridium difficile-associated diarrhea. Multivariate analysis demonstrated an increased AKI risk with the use of intravenous gentamicin. CONCLUSION: C ± G yields low rates of infection and AKI compared with high-dose penicillin-based regimes. It is a safe and effective choice for lower limb arthroplasty.

A Prospective Study of Total Glans Resurfacing for Localized Penile Cancer to Maximize Oncologic and Functional Outcomes in a Tertiary Referral Network.

PURPOSE: Penile cancer is a rare malignancy worldwide, representing only 1% of all cancers affecting men. There are little data outlining the comparative effectiveness of penile preservation techniques and to our knowledge no guidelines regarding their use currently exist. Outcomes data reporting is nonstandardized and followup is not measured consistently. The aim of this study was to analyze the outcomes of total glans resurfacing in terms of oncologic control, form and function in localized penile cancer. MATERIALS AND METHODS: From 2013 to 2015, 19 prospectively enrolled patients underwent total glans resurfacing. Demographics, cosmesis, patient satisfaction and disease recurrence were assessed at followup to quantify oncologic and functional outcomes. At 3 months of followup patients completed the IIEF (International Index of Erectile Function) questionnaire detailing erectile and sexual function, and general satisfaction using a visual analog scale. All statistical analysis was performed with Prism® 6. RESULTS: No perioperative complications were experienced. Of the patients 94.7% had complete graft take with a median cosmesis score of 5 of 5 on the visual analog scale. There was 1 local and no regional nodal recurrence at a mean followup of 23 months. One-year progression-free and overall survival rates were 100% and the 1-year recurrence-free survival rate was 95%. Of the patients 81% reported an improved sex life postoperatively. CONCLUSIONS: Total glans resurfacing is a viable and acceptable option for glans preservation in patients with localized penile cancer. It demonstrates acceptable functional and oncologic outcomes. We believe that total glans resurfacing should be considered in all cases of localized penile cancer.

Penile cancer: organ-sparing techniques.

To compare the oncological safety of treating patients with penile cancer with conservative techniques developed to preserve function, cosmesis and psychological well-being with more radical ablative strategies. We conducted an extensive review of the literature of penile-preserving and ablative techniques and report on the oncological as well as functional outcomes. There were no randomised studies comparing penile-preserving and ablative techniques. Most studies consisted of retrospective cohorts. The quality of evidence was level 3 at best. Cancer-specific survival is similar in penile-preserving and ablative approaches for low-stage disease. Penile preservation is better for functional and cosmetic outcomes and should be offered as a primary treatment method in men with low-stage penile cancer.

Quantitative MRI Analysis of Patellofemoral Joint Cartilage Health 2 Years After Anterior Cruciate Ligament Reconstruction and Lateral Extra-Articular Tenodesis.

BACKGROUND: The addition of an iliotibial band-based lateral extra-articular tenodesis (LET) to anterior cruciate ligament (ACL) reconstruction (ACLR) has been shown to reduce failure rates. However, there are concerns as to the potential overconstraint of tibiofemoral kinematics that may increase the risk of cartilage degradation. To date, no clinical study has investigated the effect of LET on patellofemoral joint articular cartilage health. HYPOTHESIS: It was hypothesized that at 2 years postoperatively, (1) the addition of LET at the time of ACLR would have no effect on cartilage health on magnetic resonance imaging (MRI), and (2) higher cartilage relaxation values would be associated with worse patient-reported and functional outcomes. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A subset of patients from the STABILITY 1 randomized controlled trial were included. All patients underwent primary ACLR with a hamstring autograft. Patients were randomized to either LET augmentation or not. Cartilage status in the patellofemoral joint between the ACLR group and ACLR+LET group was compared using 2-year postoperative quantitative MRI and the ACL osteoarthritis scores of both the surgical and the contralateral nonsurgical knees. Objective functional outcomes and patient-reported outcome measures (PROMs) were attained. RESULTS: A total of 92 patients (43 patients in the ACLR group; mean age, 18.9 ± 3.2 years; 60.5% female; and 49 patients in the ACLR+LET group; mean age, 18.7 ± 3.2 years, 63.3% female) were included. No significant differences were seen in the mean values (ms) for adjusted T1ρ/T2 relaxation times in the medial patella (47.8/42.2 vs 47.3/43.2), central patella (45.5/42.5 vs 44.1/42.7), lateral patella (48.2/43.5 vs 47.3/43.0), medial trochlea (54.7/50.9 vs 56.4/50.9), central trochlea (53.3/51.1 vs 53.1/52.0), and lateral trochlea (54.9/52.1 vs 53.9/52.6) between the ACLR and ACLR+LET groups. No difference in overall ACL osteoarthritis scores was observed (P = .99). An increase in medial patellar T2 relaxation times was associated with a decreasing International Knee Documentation Committee score (P = .046), Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale score (P = .01), and total KOOS (P = .01). CONCLUSION: There was no statistical difference in patellofemoral cartilage health between knees 2 years after primary ACLR with hamstring tendon autograft with or without LET. Statistically significant correlations were found between quantitative MRI relaxation times, functional outcome scores, and PROMs; however, the correlations were weak and the clinical significance is unknown. REGISTRATION: NCT02018354 (ClinicalTrials.gov identifier).

Multiple plaque incisions with or without grafting for Peyronie's disease.

Objectives: To assess novel surgical techniques in management of Peyronie's disease. Subjects: Forty-three men underwent corrective surgery using either partial plaque incision and nongraft (PPING) or multiple plaque incisions and graft (MPIG). The technique used was determined intra-operatively. Patients were assessed at baseline and follow-up based on Peyronie's disease questionnaire patient-reported outcome measure (PDQ-PROM) and erectile function. Results: The two groups were well matched in age and erectile function. At baseline MPIG group had greater deformity and poorer patient-reported outcome. Penile curvature improved from 67.9° to 10.5° in the PPING group and 77.9° to 7.1° with MPIG. PDQ-PROM improved from 29 to 13 in those who underwent PPING and 38.5 to 17.6 in those undergoing MPIG. Erectile function was preserved in both groups. Conclusions: These novel surgeries are effective in restoring penile shape and length while preserving erectile function. This is reflected in improved patient-reported outcomes. These findings should be verified by multi-institutional study.

Penoscrotal extramammary Paget's disease: the University of Texas M. D. Anderson Cancer Center contemporary experience.

PURPOSE: Extramammary Paget's disease is a rare intra-epithelial malignancy that is occasionally associated with an invasive adenocarcinoma component as well as other secondary cancers. We investigated a consecutive series of patients referred for extramammary Paget's disease of the penis or scrotum at a single center in the contemporary era to determine the presence of secondary cancers and treatment outcomes. MATERIALS AND METHODS: Between December 1990 and February 2009, 20 patients with extramammary Paget's disease of the scrotum and/or penis were seen. Patients were investigated with computerized tomography of the abdomen/pelvis, chest x-ray, cystoscopy, colonoscopy and serum prostate specific antigen measurement to rule out obvious secondary cancer. Clinical charts were reviewed with institutional review board approval. Mean followup of treated cases was 48 months (range 7 to 208). RESULTS: Patients were 50 to 86 years old with a history of symptoms of between 6 months and 10 years. Eight patients had invasive adenocarcinoma, of whom 2 died of the disease and 3 who had disease at 5, 7 and 40 months, respectively, were undergoing multimodal therapy. No patient with confirmed intra-epidermal disease only died of the disease. Invasive disease predicted nodal and metastatic progression. CONCLUSIONS: Surgical resection to achieve tumor-free margins resulted in durable relapse-free survival of patients with intra-epidermal extramammary Paget's disease alone. Extramammary Paget's disease with invasion was associated with regional metastatic progression. The latter scenario as well as failure to treat localized extramammary Paget's disease alone was associated with a fatal outcome. Systemic chemotherapy should be further explored in patients with invasive adenocarcinoma or lymph node positive disease.

The association of Coronavirus Disease-19 mortality and prior bacille Calmette-Guerin vaccination: a robust ecological analysis using unsupervised machine learning.

Population-level data have suggested that bacille Calmette-Guerin (BCG) vaccination may lessen the severity of Coronavirus Disease-19 (COVID-19) prompting clinical trials in this area. Some reports have demonstrated conflicting results. We performed a robust, ecologic analysis comparing COVID-19 related mortality (CRM) between strictly selected countries based on BCG vaccination program status utilizing publicly available databases and machine learning methods to define the association between active BCG vaccination programs and CRM. Validation was performed using linear regression and country-specific modeling. CRM was lower for the majority of countries with a BCG vaccination policy for at least the preceding 15 years (BCG15). CRM increased significantly for each increase in the percent population over age 65. A higher total population of a country and BCG15 were significantly associated with improved CRM. There was a consistent association between countries with a BCG vaccination for the preceding 15 years, but not other vaccination programs, and CRM. BCG vaccination programs continued to be associated with decreased CRM even for populations < 40 years old where CRM events are less frequent.

COVID-19 and Bacillus Calmette-Guérin: What is the Link?

The debate around the role of vaccination with Bacillus Calmette-Guérin has revived right in the time of the Coronavirus disease 19 pandemic. Since Bacillus Calmette-Guérin is one of the most commonly delivered therapies in urology, in this editorial we discuss some points that we think will be of interest and guidance to practicing urologists during this public health emergency.

The role of the urologist, BCG vaccine administration, and SARS-CoV-2: An overview.

OBJECTIVES: To summarize the available literature regarding bacillus Calmette-Guerin (BCG) administration, severe acute respiratory syndrome conoravirus-2 (SARS-CoV-2), and the resulting clinical condition coronavirus disease (COVID-19) in light of recent epidemiologic work suggesting decreased infection severity in BCG immunized populations while highlighting the potential role of the urologist in clinical trials and ongoing research efforts. MATERIALS AND METHODS: We reviewed the available literature regarding COVID-19 and BCG vaccination. Specifically, the epidemiologic evidence for decreased COVID-19 morbidity in countries with BCG vaccination programs, current clinical trials for BCG vaccination to protect against COVID-19, potential mechanisms and rationale for this protection, and the role of the urologist and urology clinic in providing support and/or leading ongoing efforts. RESULTS: Epidemiologic evidence suggests that the crude case fatality rates are lower for countries with BCG vaccination compared to those without such programs. Four prospective, randomized clinical trials for BCG vaccination were identified including NCT04348370 (BADAS), NCT04327206 (BRACE), NCT04328441 (BCG-CORONA), and NCT04350931. BCG administration may contribute to innate and adaptive immune priming with several opportunities for translational research. CONCLUSIONS: The urologist's expertise with BCG and the infrastructure of urologic clinics may afford several opportunities for collaboration and leadership to evaluate and understand the potential role of BCG in the current COVID-19 pandemic.

Association between lymph node density and disease specific survival in patients with penile cancer.

PURPOSE: We assessed the value of lymph node density for predicting disease specific survival after lymphadenectomy for penile cancer. MATERIALS AND METHODS: Data were collected retrospectively in 75 and prospectively in 88 consecutive patients with squamous cell carcinoma of the penis treated at M. D. Anderson Cancer Center between 1979 and 2007. We identified 45 patients with penile cancer and nodal metastasis who underwent lymphadenectomy with curative intent. Lymph node density was analyzed as a categorical variable by grouping patients into 2 or 3 categories based on equal percents. We explored the prognostic value of lymph node density for predicting disease specific survival in this cohort. RESULTS: Median followup was 23.7 months in all patients. By the time of analysis 22 patients had died, including 18 (82%) of penile cancer and 4 (18%) of other causes. Median lymph node density in patients alive or dead of other causes was 3.4% (IQR 2.9-5.9) compared to 43.3% (IQR 15.6-80) in those dead of disease (p <0.001). Median lymph node density in all patients was 6.7%. Estimated 5-year disease specific survival in patients with lymph node density 6.7% or less was significantly better than that in patients with lymph node density greater than 6.7% (91.2%, 95% CI 53.9-98.8 vs 23.3%, 95% CI 7.0-45.1, p <0.001). In models comparing lymph node density to known prognostic features lymph node density remained statistically significant, while the other factors were no longer statistically associated with disease specific survival. CONCLUSIONS: Lymph node density proved to be a significantly better prognosticator of disease specific survival than the current TNM nodal staging system in patients with penile cancer and nodal involvement. Further independent validation is required to determine the clinical usefulness of lymph node density in this patient population.

Erectile function after posterior urethroplasty for pelvic fracture-urethral distraction defect injuries.

OBJECTIVE: To determine the specific effect of pelvic fracture-urethral distraction defect (PFUDD) injuries on erectile function (EF) in men after pelvic fractures, and to compare EF to that found in other studies of men who sustained pelvic fractures, as currently the relationship between erectile dysfunction (ED) and PFUDD has not been elucidated using validated questionnaires. PATIENTS AND METHODS: With approval from the institutional review board, patients who sustained a PFUDD injury and had a posterior urethroplasty from 1990 to 2004 were identified from a database. Patients were contacted by telephone, and those who were willing to participate were given the International Index of Erectile Function (IIEF) questionnaire. Using unpaired Student's t-tests, IIEF scores were compared to normal controls, and to results of other studies of men sustaining pelvic fractures. RESULTS: In all, 26 men completed the IIEF, among whom EF was compromised in 14 (54%), including eight with severe ED (31%). Orgasmic function and ejaculation was maintained. Men with a PFUDD had significantly worse EF than men in other series with pelvic fractures. CONCLUSIONS: Men who sustain a PFUDD are at significantly greater risk of ED than those with no urethral distraction injury. Men with PFUDD injuries represent a target population for early penile rehabilitation programmes.

Penile preserving surgery and surgical strategies to maximize penile form and function in penile cancer: recommendations from the United Kingdom experience.

OBJECTIVES: The diagnosis of penile cancer can be devastating for a man and his partner. The fear of cancer is heightened by the prospect of penile amputation. While conventional radical surgery continues to be an effective approach to management, the emasculating nature of this treatment has serious psychological and sexual morbidity. Recent studies have challenged the traditional belief that a 2 cm margin was required for adequate oncological control. METHODS: We review the current options and status of such penile preserving techniques in the modern day management of penile cancer, and assess the use of the different techniques according to the stage and grade of disease based upon the combined experience of two superregional centres in the United Kingdom. RESULTS: A range of organ preserving procedures matches the clinical spectrum of patients presenting with penile cancer. These demonstrate excellent oncological control whilst maximizing penile function and form. CONCLUSION: Innovative surgical techniques can now preserve as much penile tissue and functional integrity as possible, without compromising oncological control. This minimizes the impact of disease and its treatment on the quality of life of the patient.