A Cross-Sectional Study of Untoward Reactions Following Homologous and Heterologous COVID-19 Booster Immunizations in Recipients Seventeen Years of Age and Older.

A booster dose after primary COVID-19 vaccination series was considered crucial after the emergence of the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants. Active surveillance was used to investigate reporting of adverse events post-booster dose of either of the licensed mRNA Comirnaty (Pfizer/BioNTech) or Spikevax (Moderna) vaccines in adult (17 years and older) recipients in central Italy. Eligible participants were enrolled and interviewed via phone using a structured questionnaire. Primary outcomes related to the occurrence of adverse events post-booster were stratified by vaccine, and frequency of local/systemic, mild/moderate/severe events. Of a total of 622 participants interviewed, 554 (89.1%) reported at least one adverse event (88.2% and 92.9% after the Comirnaty or Spikevax vaccine, respectively): 63.4% were female, and 78.5% aged 17 to 64 years, regardless of vaccine. 87.7% and 68.2% of all recipients described at least one local or systemic reaction, respectively: 97.3, 38.6 and 4.7% reported mild, moderate, or severe events, respectively. The most frequent adverse reactions were pain, redness, or swelling at the injection site and fatigue, while malaise and fever significantly occurred after the Comirnaty, and vomiting after the Spikevax booster. Compared to the primary vaccination, lymphadenopathy was more common after the booster (p < 0.001), especially after Comirnaty vaccine. The study findings revealed no serious or unexpected adverse events, and are in agreement with data available on booster dose for both mRNA vaccines. The transient, mild to moderate, and common to very common side reactions reported should be used to reassure potential recipients of the lack of safety concerns.

A SARS-CoV-2 Outbreak Among Nursing Home Residents Vaccinated with a Booster Dose of mRNA COVID-19 Vaccine.

This study describes a SARS-CoV-2 outbreak caused by the Delta (B.1.617.2) variant in a nursing home in Central Italy during October-November 2021. Trained interviewers collected data from residents, staff, and administration officers with an agreed informed consent procedure. Thirty-two (44.5%) out of 72 residents (median age 89 years) and six (26.1%) of 23 healthcare workers were found to be infected with SARS-CoV-2. Infections occurred more often among residents with a higher index of independence in daily living activities, suggesting an increased risk for those with more interactions. Twenty-five infected residents (78.1%) received the booster dose of mRNA anti-COVID-19 vaccine > 7 days before SARS-CoV-2 onset. Half of the infected residents had mild symptoms, and only three required hospitalisation, one of whom died from COVID-19 complications. The study underlines the effectiveness of a booster dose in providing a high protection against severe disease and hospitalisation even among vulnerable individuals infected with the Delta variant of concern.

Pure stress urinary incontinence: analysis of prevalence, estimation of costs, and financial impact.

BACKGROUND: The prevalence of pure stress urinary incontinence (P-SUI) and the role of urodynamic investigation (UDI) prior to surgery for stress urinary incontinence (SUI) is debated. Since the exact prevalence of P-SUI is not clear, its clinical and economic impact is not well defined. The aims of this study were to evaluate the prevalence of P-SUI in a population of women who underwent UDI for urinary incontinence (UI), also assessing: 1) the correspondence between clinical diagnosis of P-SUI and urodynamic findings; 2) the analysis of costs in terms of UDI and eventually post-UDI avoided surgical procedures. METHODS: A single cohort of women who underwent UDI for UI between January 2012 and July 2016 was prospectively collected and retrospectively analyzed. Clinical P-SUI was defined by the strict criteria of the International Continence Society. For each patient, history, physical examination and UDI were collected. The correspondence between clinical and urodynamic findings of P-SUI was analyzed. The rate of clinical P-SUI changed after performing UDI and the number of unnecessary intervention after UDI were reported. A wide cost analysis of UDIs, and the amount of surgical procedures that were believed unnecessary after UDI was reported. RESULTS: Stress urinary incontinence was present in 323/544 (59.4%) patients. The prevalence of clinical P-SUI was 20.7% (67/323), while the prevalence of complicated SUI (C-SUI) was 79.3% (256/323). After UDI, diagnosis of P-SUI decreased to 18.3% (59/232). In 10.2% of cases (6/59) the scheduled middle urethral sling (MUS) was suppressed after the UDI results because 3/6 cases had detrusor overactivity and urge incontinence, in 2/6 cases SUI was treated with a conservative management, in 1/6 case an important voiding dysfunction was detected. Considering the national reimbursement in our country, the cost of each UDI was 296.5 euros and the total amount was 17,493.5 euros. So far the surgery-related savings covered 61.7-105.0% of the costs of total number of UDIs performed in the uncomplicated patients. CONCLUSIONS: The prevalence of clinical P-SUI is relevant, involving about 20% of women with clinical SUI. Although the correspondence between clinical and urodynamic diagnosis was high, we demonstrated that UDI may help in some cases to avoid an inappropriate surgical treatment. Therefore, UDI prior to SUI surgery should be considered to achieve a correct diagnosis and a proper therapeutic strategy.

Animal experimental model of Peyronie's disease: a pilot study.

OBJECTIVE: The Peyronie's disease (PD) is an idiopathic disorder of connective tissue of the penis, that involves the tunica albuginea of the corpora cavernosa and the adjacent areolar space. It is a growing clinical evidence to support the therapeutic potential of mesenchymal stem cells and histological findings has assumed a possible application of lipofilling technique in patients with PD. The objective of this experimental study is the creation of a murine experimental model of PD, evaluating with MRI the penis of the rats (feasibility study), in order to plane the application of lipofilling technique in an animal model. METHODS: Four male Wistar rats were anesthetized, fixed in prone position and subjected to MRI. The animals underwent, subsequently, an injection of thrombin in the tunica albuginea and MRI images were acquired at 7 and 21 days after injection with incision of the dartos. RESULTS: The MRI acquisitions, both in coronal and axial projection, showed an adequate visibility of the anatomical structures. At 7 days after thrombin injection with the dartos incision it was evident an oedematous portion, visible as a hyperintense area, located at the injection area. At 21 days after injection, oedema was partially resolved: the injection part of the hyperintense area remains unchanged, while the remaining area appears to be part of a re-absorption and re-organization process. CONCLUSIONS: Since none of the various treatment modalities currently available for the management of PD is able to bring healing, the researchers' attention is increasingly directed towards innovative treatment programs, such as the use of stem cells of mesenchymal origin. At the present time, the research in PD is hampered by the lack of universally accepted animal model and this is likely attributed to the limited insight into PD mechanisms and the difficulties faced by current animal models to truly represent the complexity.

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy.

This survey investigated on adverse events after vaccination with mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine in children aged 5-11 years in central Italy through active surveillance reporting. During December 2021-January 2022, parents of children who undergone vaccination were interviewed using a structured questionnaire. 197 out of 208 contacted parents participated (94.7% response rate), of whom 166 (84.3%) had one child. Of the 229 children, the mean age was 8.9 years, 50.7% were female. 193 (84.3%) had at least one adverse event after the first dose (mean age 9.1 years; 54.4% female), and 146 (73.4%) of 199 after the second (mean age 8.9 years; 54.8% female), which was not administered to 30 children due to previous COVID-19 history. Local symptoms after the first and second dose occurred in 183 (94.8%) and 141 (96.6%) recipients (p = .435), respectively, while systemic reactions in 62 (32.1%) and 34 (23.3%) (p = .074). Mild events were reported by 81.7% and 69.8% children after the first and second dose, followed by moderate (3.9% and 10.6%) and severe (1.3% and 0.5%). After each dose, injection site reactions (79.5% and 68.8%) were the most frequent, followed by headache (13.1%) and lymphadenopathy (8.5%) after the first and second dose, respectively. The adverse events were reported to pediatricians only for 5.7% and 3.9% of children and treated for 17.6% and 15.8%. This is the first report about safety profile through active surveillance of mRNA BNT162b2 among children in Italy, revealing temporary and mild-to-moderate symptoms with no serious events after each vaccine dose.

Post-void residual urine ratio: A novel clinical approach to the post-void residual urine in the assessment of males with lower urinary tract symptoms.

PURPOSE: To assess the correlation between post-void residual urine ratio (PVR-R) and pathological bladder emptying diagnosed by pressure-flow studies (PFS) in males with lower urinary tract symptoms (LUTS). MATERIALS AND METHODS: PVR-R and PVR urine were evaluated in 410 males underwent PFS for LUTS. PVR-R was the percentage of PVR to bladder volume (voided volume+PVR). Schafer and International Continence Society (ICS) nomograms, Bladder Contractility Index (BCI) were used to diagnose bladder outlet obstruction (BOO) and detrusor underactivity (DUA). We subdivided the cohort in 4 groups: Group I, BOO+/DUA+; Group II, BOO-/DUA+; Group III, BOO+/DUA-; Group IV, BOO-/DUA- (control group). We subdivided the 4 groups according to PVR-R strata: (1) 0%-20%; (2) 21%-40%; (3) 41%-60%; (4) 61%-80%; (5) 81%-100%. RESULTS: Group I had a greater median PVR-R (50%) with a >40% in 61.4% of the cohort. Median PVR-R was 16.6% in Group II, 24% in Group III, and 0% in the control Group. According to ICS nomograms and BCI, median PVR-R and PVR were significantly higher (p<0.001) in obstructed and underactive males. PVR-R threshold of 20% allowed to recognize males with voiding disorders with high sensibility, specificity, PPV, and NPV. A PVR-R cut-off of 40% identified males with associated BOO and DUA and more severe voiding dysfunction. CONCLUSIONS: A higher PVR-R is related to a more severe pathological bladder emptying, and to the association of BOO and DUA. PVR-R may have a clinical role in first assessment of males with LUTS and severe voiding dysfunction.

Original flow chart for the management of hydroureteronephrosis caused by pessary placement.

INTRODUCTION: The use of a pessary to treat a pelvic organ prolapse (POP) is a valid non-invasive option. Severe complications are usually associated with neglected, oversized, or misplaced pessaries. Major complications include fistulas, bowel or bladder erosion, and hydroureteronephrosis (HUN). MATERIALS AND METHODS: We reviewed the literature and our experience in the management of HUN in the last decade, as a consequence of pessary placement. RESULTS: We used flow charts to take an accurate medical history of each patient. Blood and urine analyses were taken at admission to assess the potential presence of sepsis, renal failure, and urinary tract infection. Physical examination included vaginal examination. In cases of pessary presence with a concomitant increase of serum creatinine value, a possible ureteral obstruction is suspected. In order to assess the presence of HUN and its underlying causes, a computed tomography (CT) scan should be performed to assess the mechanism of urinary tract obstruction. However, in case of renal insufficiency, abdominal ultrasonography (US) could be sufficient. If HUN is detected in a patient with no signs of urosepsis, we suggest a conservative management by the removal of the pessary and catheter placement. When urosepsis is suspected, it is mandatory to administer antibiotic therapy and evaluate the HUN drainage by nephrostomy. CONCLUSIONS: There is no uniform management of women with HUN and a concomitant pessary. For this reason, and based on the literature and our experience, we propose an original management flowchart.

Incidental adrenal pheochromocytoma. Report on 5 operated patients and update of the literature.

INTRODUCTION: Adrenal masses discovered by imaging techniques for reasons unrelated to adrenal diseases are called incidentalomas with pheochromocytomas accounting for about 20%. The aim of this study was to report on our experience of 5 patients operated for incidentally discovered adrenal pheochromocytoma and update the literature concerning this subject. PATIENTS AND METHODS: From September 1976 to December 2000 we operated on 28 for adrenal incidentaloma, and pheochromocytoma was detected in 5 patients (19%). Average age was 61.4 years (range 54-65). All patients underwent adrenal hormonal as well as imaging investigation. Preoperative care for pheochromocytoma was performed in 3 patients. All patients were followed up. RESULTS: Average tumor diameter, as detected by CT, was 5.5 cm (range 3-10). Urinary 24/h excretion of VMA resulted elevated in 2 cases (40%). Two patients during adrenalectomy developed paroxysmal hypertension which was readily controlled by intravenous administration of nitroprussiate and trandate. Postoperative outcome was uneventful. Average tumor size, as detected by pathology, resulted 8.9 cm (range 3-12). Mean follow-up was 60.4 months (range 32-122) and overall survival rate was 60%. Three patients are alive and disease-free and 2 died after a follow-up of 32 and 36 months for reasons unrelated to the primary disease. CONCLUSIONS: Every incidentally discovered adrenal mass should be investigated for pheochromocytoma since accounting for about 20%. Undetected pheochromocytomas undergoing surgery without preoperative care for avoiding cardiovascular disturbances confer a high risk for morbidity and mortality, especially in pregnancy and childhood. Nonfunctional and small tumors sized 3 cm or lesser may be closely followed up by imaging and hormonal investigation. Surgery is indicated when tumors are functional or larger than 3 cm. Actually, laparoscopy is the new gold-standard in treating adrenal pheochromocytomas. Adrenal sparing surgery as well as autotransplantation of adrenal tissue are both effective and safe in treating patients with bilateral pheochromocytomas, thus improving quality of life since avoiding lifelong steroid dependency. When managed appropriately, the outlook for pheochromocytoma is excellent with a free survival rate of 92% and 80% at 5 and 10 years respectively. Unfortunately, malignant pheochromocytomas are still difficult to treat.

Primary lymphoma of the kidney. Report of a case and update of the literature.

OBJECTIVES: To report on a case of primary renal lymphoma (PRL) and update the literature concerning this topic. MATERIALS AND METHODS: A 48-year-old woman underwent surgery for the presumed diagnosis of renal cell carcinoma with bilateral adrenal metastases. RESULTS: The neoplasm was assessed as primary renal non-Hodgkin high grade lymphoma, diffuse large B-cell type. Then the patient underwent polychemotherapy according to the VACOP-B protocol. Unfortunately, 5 weeks later the patient was lost since missing chemotherapy and follow-up. CONCLUSIONS: PRL is a distinct pathological and clinical entity which is extremely rare and highly aggressive since disseminating rapidly from its origin. The disease usually affects adults with an average age of 60 years and slight male preponderance; however it has also been reported in childhood. Etiology factors for PRL are unknown. Several histogenetic theories of the disease have been postulated since the kidney does not normally contain lymphoid tissue. Investigators reported many classes of non-Hodgkin lymphoma which include large, small, intermediate and mixed cell types with high, intermediate or low grade histologies. The neoplastic lymphoid cells may express both B and T immunoblastic phenotypes, primary renal Hodgkin lymphoma has also been reported. The disease may present with progressive renal failure of either oliguric or non oliguric type. Imaging studies in diagnosing and staging primary renal lymphomas include ultrasound examination (US) and computed tomography (CT); there are also some reports of magnetic resonance imaging (MRI). Total body bone scan and bone marrow biopsy will complete disease clinical staging. Renal biopsy is important in assessing the diagnosis of PRL as well as of acute renal failure for bilateral lymphomatous infiltration of the kidneys. Up to now, there are no standard treatment modalities for this entity since the small number of cases reported. Multidrug chemotherapy is mandatory for high grade lymphoma and when the disease is diagnosed preoperatively. High dose chemotherapy in the future may offer a curative approach in primary bilateral renal disease and without end-stage renal disease. Survival is extremely poor since 75% of patients die less than 1 year after operation. Prognosis may be improved by early detection of disease and by performing systemic chemotherapy.

[Small cell carcinoma of the bladder. Report of 3 cases and review of the literature]. / Il carcinoma a piccole cellule della vescica. Descrizione di tre casi e revisione della letteratura.

Primary small cell carcinoma of the urinary bladder is a highly aggressive disease and accounts for less than 0.5% of all primary bladder tumors. Quite often, clinical presentation is related to local and/or systemic involvement of the disease. Histogenesis is still unknown, but investigators consider the tumor originating from a multipotent undifferentiated stem cell of the bladder urothelium. Hematuria is the first and most frequent symptom that patients complain at the clinical presentation of the disease. The primary local tumor is treated by radical surgery or radiation therapy, while systemic involvement requires polychemotherapy according to the M-VAC protocol. Prognosis is worse and related to the pathological stage of the disease and to chemotherapy reply. Herein we report on 3 cases of primary small cell carcinoma of the urinary biadder. We also review and update the literature concerning this topic.

Malignant conjunctival T cell lymphoma diagnosed by punch biopsy as a primary manifestation of systemic cancer.

This report documents a case of T cell lymphoma manifesting only with a conjunctival mass. A 67-year-old man underwent a diagnostic punch biopsy, histopathological examination, and immunohistochemical study for a pink-yellow colored mass infiltrating the bulbar conjunctiva in the lower fornix of the eyelid. A biopsy specimen of the conjunctival mass was found histopathologically to be a malignant T cell lymphoma. Systemic involvement was diagnosed within four weeks after the initial diagnosis by computed tomography, showing evidence of extension at the level of the ethmoidal cells, optic nerve, periorbital tissue, and pancreas. T cell lymphoma of the conjunctiva as a primary manifestation of systemic cancer is an uncommon entity. Punch biopsy may be the first diagnostic pathway useful to initiate a search for systemic involvement of a malignant lymphoid tumor of T cell lineage.

Prognostic factors in patients with renal cell carcinoma: retrospective analysis of 675 cases.

OBJECTIVES: To identify independent predictors of cause-specific survival in patients affected by renal cell carcinoma (RCC). MATERIAL AND METHODS: We evaluated retrospectively 675 patients who underwent in our department from 1976 to 1999 radical nephrectomy for RCC. Pathological stage of the primary tumor (TNM, 1997) was pT1 in 326 cases (48%), pT2 in 133 (20%), pT3a in 66 (10%), pT3b in 138 (20%) and pT4 in 12 (2%). According to TNM classification (Union International Contre le Cancer (UICC), 1997) the pathological stage was I in 303 cases (45%), II in 119 (18%), III in 150 (22%) and IV in 103 (15%). Histological grading was assigned according to Fuhrman's classification in only 333 cases: G1 in 25%, G2 in 35%, G3 in 33% and G4 in 7%. RESULTS: Cause-specific survival was 77% at 5 years, 69% at 10 years, 64% at 15 years and 57% at 20 years. Five and 10 year cause-specific survival was, respectively 91.4 and 88.5% in pT1 tumors, 84.8 and 72.7% in pT2, 57.4 and 35.6% in pT3a, 47.2 and 33.6% in pT3b-c, and 29.6% in pT4 (P < 0.0001). In relation to the pathological stage according to TNM classification, 5 and 10 year cause-specific survival was, respectively 94 and 91.6% in stage I tumors, 89.7 and 78% in stage II, 63.4 and 46.4% in stage III and 28 and 16.3% in stage IV (P < 0.0001). In relation to the nuclear grade of the primary tumor 5 and 10 year cause-specific survival was, respectively 94 and 88% in G1 tumors, 86 and 75% in G2, 59 and 40% in G3 and 31% in G4 (P < 0.0001). At multivariate analysis pathological stage of the primary tumor, lymph nodes involvement, presence of distant metastases at diagnosis and nuclear grading resulted all independent predictors of cause-specific survival in patients with RCC. CONCLUSION: Pathological stage of primary tumors, lymph nodes involvement, presence of distant metastases at diagnosis and nuclear grading according to Fuhrman resulted all independent predictors of cause-specific mortality in patients with RCC.