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The spermatogonial compartment maintains spermatogenesis throughout the reproductive lifespan. Single-cell RNA sequencing (scRNA-seq) has revealed the presence of several spermatogonial clusters characterized by specific molecular signatures. However, it is unknown whether the presence of such clusters can be confirmed in terms of protein expression and whether protein expression in the subsets overlaps. To investigate this, we analyzed the expression profile of spermatogonial markers during the seminiferous epithelial cycle in cynomolgus monkeys and compared the results with human data. We found that in cynomolgus monkeys, as in humans, undifferentiated spermatogonia are largely quiescent, and the few engaged in the cell cycle were immunoreactive to GFRA1 antibodies. Moreover, we showed that PIWIL4+ spermatogonia, considered the most primitive undifferentiated spermatogonia in scRNA-seq studies, are quiescent in primates. We also described a novel subset of early differentiating spermatogonia, detectable from stage III to stage VII of the seminiferous epithelial cycle, that were transitioning from undifferentiated to differentiating spermatogonia, suggesting that the first generation of differentiating spermatogonia arises early during the epithelial cycle. Our study makes key advances in the current understanding of male germline premeiotic expansion in primates.
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Espermatogénesis , Espermatogonias , Adulto , Humanos , Animales , Masculino , Macaca fascicularis , Primates , Ciclo CelularRESUMEN
BACKGROUND: A second transurethral resection of bladder tumour (Re-TURBT) is recommended by European Association of Urology (EAU) Guidelines on non-muscle-invasive bladder cancers (NMIBCs) due to the risk of understaging and/or persistent disease following the primary resection. However, in many cases this may be unnecessary, potentially harmful, and significantly expensive constituting overtreatment. The CUT-less trial aims to combine the preoperative staging accuracy of Vesical Imaging-Reporting and Data System (VI-RADS) and the intraoperative enhanced ability of photodynamic diagnosis (PDD) to overcome the primary TURBT pitfalls thus potentially re-defining criteria for Re-TURBT indications. STUDY DESIGN: Single-centre, non-inferiority, phase IV, open-label, randomised controlled trial with 1:1 ratio. ENDPOINTS: The primary endpoint is short-term BC recurrence between the study arms to assess whether patients preoperatively categorised as VI-RADS Score 1 and/or Score 2 (i.e., very-low and low likelihood of MIBC) could safely avoid Re-TURBT by undergoing primary PDD-TURBT. Secondary endpoints include mid- and long-term BC recurrences and progression (i-ii). Also, health-related quality of life (HRQoL) outcomes (iii) and health-economic cost-benefit analysis (iv) will be performed. PATIENTS AND METHODS: All patients will undergo preoperative Multiparametric Magnetic Resonance Imaging of the bladder with VI-RADS score determination. A total of 327 patients with intermediate-/high-risk NMIBCs, candidate for Re-TURBT according to EAU Guidelines, will be enrolled over a 3-year period. Participants will be randomised (1:1 ratio) to either standard of care (SoC), comprising primary white-light (WL) TURBT followed by second WL Re-TURBT; or the Experimental arm, comprising primary PDD-TURBT and omitting Re-TURBT. Both groups will receive adjuvant intravesical therapy and surveillance according to risk-adjusted schedules. Measure of the primary outcome will be the relative proportion of BC recurrences between the SoC and Experimental arms within 4.5 months (i.e., any 'early' recurrence detected at first follow-up cystoscopy). Secondary outcomes measures will be the relative proportion of late BC recurrences and/or BC progression detected after 4.5 months follow-up. Additionally, we will compute the HRQoL variation from NMIBC questionnaires modelled over a patient lifetime horizon and the health-economic analyses including a short-term cost-benefit assessment of incremental costs per Re-TURBT avoided and a longer-term cost-utility per quality-adjusted life year gained using 2-year clinical outcomes to drive a lifetime model across the two arms of treatment. TRIAL REGISTRATION: ClinicalTrial.gov identifier (ID): NCT05962541; European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) ID: 2023-507307-64-00.
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PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.
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Bases de Datos Factuales , Stents , United States Food and Drug Administration , Uréter , Stents/efectos adversos , Humanos , Estados Unidos/epidemiología , Uréter/cirugía , Incidencia , Falla de Prótesis , Falla de Equipo/estadística & datos numéricos , Vigilancia de Productos ComercializadosRESUMEN
PURPOSE: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery. MATERIALS AND METHODS: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer. RESULTS: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value. CONCLUSIONS: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.
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Orquiectomía/métodos , Tratamientos Conservadores del Órgano/métodos , Neoplasias Testiculares/cirugía , Testículo/patología , Adulto , Biomarcadores de Tumor/sangre , Secciones por Congelación , Humanos , Masculino , Selección de Paciente , Periodo Preoperatorio , Curva ROC , Estudios Retrospectivos , Medición de Riesgo/métodos , Neoplasias Testiculares/sangre , Neoplasias Testiculares/diagnóstico , Neoplasias Testiculares/patología , Testículo/diagnóstico por imagen , Testículo/cirugía , Carga Tumoral , UltrasonografíaAsunto(s)
Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Próstata/diagnóstico por imagen , Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/terapia , Neoplasias de la Próstata/patología , Tomografía de Emisión de Positrones/métodos , Biopsia , Imagen por Resonancia Magnética/métodos , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Antígeno Prostático EspecíficoRESUMEN
OBJECTIVES: To explore the role of dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), using semiquantitative and quantitative parameters, and diffusion-weighted (DW) MRI in differentiating benign from malignant small, non-palpable solid testicular tumours. METHODS: We calculated the following DCE-MRI parameters of 47 small, non-palpable solid testicular tumours: peak enhancement (PE), time to peak (TTP), percentage of peak enhancement (Epeak), wash-in-rate (WIR), signal enhancement ratio (SER), volume transfer constant (Ktrans), rate constant (Kep), extravascular extracellular space volume fraction (Ve) and initial area under the curve (iAUC). DWI signal intensity and apparent diffusion coefficient (ADC) values were evaluated. RESULTS: Epeak, WIR, Ktrans , Kep and iAUC were higher and TTP shorter in benign compared to malignant lesions (p < 0.05). All tumours had similar ADC values (p > 0.07). Subgroup analysis limited to the most frequent histologies - Leydig cell tumours (LCTs) and seminomas - replicated the findings of the entire set. Best diagnostic cutoff value for identification of seminomas: Ktrans ≤0.135 min-1, Kep ≤0.45 min-1, iAUC ≤10.96, WIR ≤1.11, Epeak ≤96.72, TTP >99 s. CONCLUSIONS: DCE-MRI parameters are valuable in differentiating between benign and malignant small, non-palpable testicular tumours, especially when characterising LCTs and seminomas. KEY POINTS: ⢠DCE-MRI may be used to differentiate benign from malignant non-palpable testicular tumours. ⢠Seminomas show lower Ktrans, Kep and iAUC values. ⢠ADC values are not valuable in differentiating seminomas from LCTs. ⢠Semiquantitative DCE-MRI may be used to characterise small, solid testicular tumours.
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Imagen de Difusión por Resonancia Magnética/métodos , Imagenología Tridimensional/métodos , Tumor de Células de Leydig/patología , Meglumina/análogos & derivados , Estadificación de Neoplasias/métodos , Compuestos Organometálicos/administración & dosificación , Seminoma/patología , Neoplasias Testiculares/patología , Adulto , Medios de Contraste/administración & dosificación , Medios de Contraste/farmacocinética , Diagnóstico Diferencial , Humanos , Inyecciones Intravenosas , Tumor de Células de Leydig/metabolismo , Masculino , Meglumina/administración & dosificación , Meglumina/farmacocinética , Compuestos Organometálicos/farmacocinética , Palpación , Seminoma/metabolismo , Neoplasias Testiculares/metabolismoRESUMEN
BACKGROUND: To provide indicators for the likelihood of sperm retrieval in patients undergoing testicular sperm extraction is a major issue in the management of male infertility by TESE. The aim of our study was to determine the impact of different parameters, including testicular histopathology, on sperm retrieval in case of reoperation in patients undergoing testicular sperm extraction. METHODS: We retrospectively analyzed 486 patients who underwent sperm extraction for intracytoplasmic sperm injection and testicular biopsy. Histology was classified into: normal spermatogenesis; hypospermatogenesis (reduction in the number of normal spermatogenetic cells); maturation arrest (absence of the later stages of spermatogenesis); and Sertoli cell only (absence of germ cells). Semen analysis and serum FSH, LH and testosterone were measured. RESULTS: Four hundred thirty patients had non obstructive azoospermia, 53 severe oligozoospermia and 3 necrozoospermia. There were 307 (63%) successful sperm retrieval. Higher testicular volume, lower levels of FSH, and better histological features were predictive for sperm retrieval. The same parameters and younger age were predictive factors for shorter time for sperm recovery. After multivariable analysis, younger age, better semen parameters, better histological features and lower values of FSH remained predictive for shorter time for sperm retrieval while better semen and histology remained predictive factors for successful sperm retrieval. The predictive capacity of a score obtained by summing the points assigned for selected predictors (1 point for Sertoli cell only, 0.33 points for azoospermia, 0.004 points for each FSH mIU/ml) gave an area under the ROC curve of 0.843. CONCLUSIONS: This model can help the practitioner with counseling infertile men by reliably predicting the chance of obtaining spermatozoa with testicular sperm extraction when a repeat attempt is planned.
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Consejo , Infertilidad Masculina/patología , Espermatozoides/patología , Testículo/patología , Procedimientos Quirúrgicos Urológicos Masculinos , Biopsia , Humanos , Infertilidad Masculina/cirugía , Masculino , Reoperación , Análisis de SemenRESUMEN
INTRODUCTION AND OBJECTIVES: The aim of the study is to evaluate the prevalence of andrological abnormalities, such as phimosis and foreskin sliding abnormalities among male adolescents, and if these might interfere with sexuality, leading to a later onset of sexual experiences. MATERIAL AND METHODS: Between April and May 2015 a prevention campaign in andrology was conducted in an area surrounding Rome, Ostia and the Ladispoli area, among 15-19 year-old students. The screening consisted of a frontal lesson with the students in order to explain and raise the awareness of the most common andrological abnormalities and diseases. Among the routine anamnestic questions, three additional questions were submitted to 18-year-old boys: "Have you ever had sexual intercourse?", "How old were you when you had your first sexual intercourse?" and "Have you consulted a health professional about your genitals?" Finally a detailed clinical examination was performed and the outcome sent to the family and to the General Practitioner (GP). RESULTS: A total of 552 high school students were evaluated. Out of them 131 (23.7%) were at least 18 years old. Among these, 79 (60.3%) said that they had already had full sexual intercourse. The phimosis and foreskin sliding abnormalities had a prevalence of 12.9% within the 18-year-old students, with a significant prevalence among those who hadn't had any sexual intercourse at all, 21.1% vs 7.5% p = 0.023. The age of the complete first sexual experience in the circumcised young men was the same as those without phimosis; 89% of the boys with phimosis hadn't had an andrological examination in the previous years. CONCLUSIONS: Male adolescents with phimosis or preputial sliding abnormalities tend to have a late onset of sexual experiences compared to same aged boys without phimosis. These data support the urgent need of an andrological consultation for all boys at the beginning of, and during, their adolescent period because genital abnormalities may interfere with sexuality. Finally, in order not to confuse effects with causes, we suggest matching a routine genital physical examination in all studies dealing with sexual psychological aspects of male adolescents.
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Coito/fisiología , Prepucio/patología , Tamizaje Masivo/métodos , Fimosis/diagnóstico , Adolescente , Circuncisión Masculina/estadística & datos numéricos , Humanos , Italia/epidemiología , Masculino , Fimosis/epidemiología , Prevalencia , Adulto JovenRESUMEN
BACKGROUND: The purpose of the study was to investigate whether micro-TESE can improve sperm retrieval rate (SRR) compared to conventional single TESE biopsy on the same testicle or to contralateral multiple TESE, by employing a novel stepwise micro-TESE approach in a population of poor prognosis patients with non-obstructive azoospermia (NOA). METHODS: Sixty-four poor prognosis NOA men undergoing surgical testicular sperm retrieval for ICSI, from March 2007 to April 2013, were included in this study. Patients inclusion criteria were a) previous unsuccessful TESE, b) unfavorable histology (SCOS, MA, sclerahyalinosis), c) Klinefelter syndrome. We employed a stepwise micro-TESE consisting three-steps: 1) single conventional TESE biopsy; 2) micro-TESE on the same testis; 3) contralateral multiple TESE. RESULTS: SRR was 28.1 % (18/64). Sperm was obtained in both the initial single conventional TESE and in the following micro-TESE. The positive or negative sperm retrieval was further confirmed by a contralateral multiple TESE, when performed. No significant pre-operative predictors of sperm retrieval, including patients' age, previous negative TESE or serological markers (LH, FSH, inhibin B), were observed at univariate or multivariate analysis. Micro-TESE (step 2) did not improve sperm retrieval as compared to single TESE biopsy on the same testicle (step 1) or multiple contralateral TESE (step 3). CONCLUSIONS: Stepwise micro-TESE could represent an optimal approach for sperm retrieval in NOA men. In our view, it should be offered to NOA patients in order to gradually increase surgical invasiveness, when necessary. Stepwise micro-TESE might also reduce the costs, time and efforts involved in surgery.
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Azoospermia/patología , Biopsia/métodos , Microcirugia/métodos , Recuperación de la Esperma , Espermatozoides/patología , Testículo/patología , Adulto , Azoospermia/cirugía , Humanos , MasculinoRESUMEN
Lichen sclerosus (LS) is an inflammatory and chronic disease that causes itching, pain, dysuria, urinary retention, dyspareunia and sexual dysfunction, in both men and women. The first line pharmacological treatment is based on the use of topical steroids, which have proved their efficacy in 60-70% of cases but with a high rate of relapses in time (50-80% of the patients of both sexes). The purpose of our non-randomised prospective pilot study was to evaluate the efficacy and tolerability of a new loco regional therapy with polydeoxyribonucleotides (PDRN) in the treatment of male genital LS. PDRN is an healing and anti-dystrophic drug with anti-inflammatory effects, through the reduction of cytokine. Twenty one male patients suffering from genital LS were recruited. All the patients were submitted to treatment using loco-regional intradermal injections with PDRN. Dermatology Life Quality Index (DLQI), International Index of Erectile Function (IIEF-5) and PGI-I questionnaires were administered at baseline and at the end of treatment in order to evaluate the results of this treatment. The statistical evaluation of the data obtained with the DLQI questionnaire showed a marked improvement of the overall conditions in terms of quality of life, with an average change of scores from 15 to 4 (p < 0.0001). PGI-I questionnaire showed that 80% of the patients treated considered their post-treatment conditions as 'improved'. There was no significant change in terms of sexual function according to the IIEF questionnaire (p = 0.189). The results obtained show the excellent tolerability and the therapeutic efficacy of PDRN, with clear improvement of the local symptoms and of the quality of life.
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Enfermedades de los Genitales Masculinos/tratamiento farmacológico , Liquen Escleroso y Atrófico/tratamiento farmacológico , Polidesoxirribonucleótidos/uso terapéutico , Adulto , Anciano , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Proyectos Piloto , Estudios Prospectivos , Autoinforme , Resultado del TratamientoRESUMEN
The goal of this study is to evaluate MYOInositol effects on spermatozoa motility, in patients' ejaculates with severe varicocele or hyper viscosity. The study included normal viscosity ejaculate from 30 patients affected by varicocele and hyper viscosity ejaculate from 33 patients without any testicular pathologies. All selected samples showed sperm concentration > 2 million/ml and progressive motility < 32%. In both groups, the pellet obtained after centrifugation in buffered medium, was divided in two aliquots, both incubated for 15 minutes at 37°C: one with MYO-Inositol and the other one, as control, only in phosphate buffered saline (PBS). Afterwards, the sperm progressive motility was assessed using Computer Assisted Sperm Analysis (CASA system). Incubation with MYO-Inositol improved sperm progressive motility in high viscosity samples compared to control group (38.9% ± 3.0 vs 24.35% ± 2.41, respectively; p ≤ 0.0001). Conversely, no statistically significant difference was observed in total sperm progressive motility in varicocele samples compared with control group (22.7% ± 2.07 vs 26.7% ± 3.31, respectively; p = 0.085). The MYO-Inositol positive effect on spermatozoa motility may depend on the type of sperm damage: heavy structural and biochemical defects which typically affects patients with varicocele are not restored by Inositol. On the contrary, MYOInositol is able to improve sperm motility in semen samples with high viscosity, since those samples show no substantial structural sperm defects.
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Inositol/farmacología , Semen , Motilidad Espermática/efectos de los fármacos , Varicocele , Adulto , Humanos , Masculino , Índice de Severidad de la Enfermedad , Varicocele/fisiopatología , ViscosidadRESUMEN
OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.
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Disfunción Eréctil/cirugía , Implantación de Pene/métodos , Prótesis de Pene , Estudios de Seguimiento , Humanos , Complicaciones Intraoperatorias/epidemiología , Italia , Masculino , Estudios Prospectivos , Calidad de Vida , Sistema de Registros , Reoperación/estadística & datos numéricosRESUMEN
PURPOSE: To evaluate the diagnostic accuracy of unenhanced and quantitative contrast-enhanced ultrasonography (US) in the differential diagnosis of small nonpalpable testicular lesions. MATERIALS AND METHODS: The local review board approved the protocol, and all patients provided written informed consent. One hundred fifteen patients (median age, 34 years; age range, 14-61 years) with nonpalpable testicular lesions were consecutively enrolled between 2006 and 2012 and underwent unenhanced scrotal US, contrast-enhanced US, surgical enucleation, and at least 18 months of follow-up. Clinical and histologic features were recorded, and qualitative and quantitative analysis of contrast-enhanced US time-intensity curves were performed. Logistic regression analysis was performed to explore features of malignancy. Receiver operating characteristic ( ROC receiver operating characteristic ) curves were developed for cumulative unenhanced and contrast-enhanced US scores. RESULTS: All lesions were 1.5 cm or smaller. Forty-four of the 115 patients (38%) had malignant tumors, 42 had benign tumors (37%), and 29 (25%) had nonneoplastic lesions. The features at unenhanced US that enabled the best differentiation of tumors versus nonneoplastic lesions and benign versus malignant tumors were parenchymal microlithiasis (26 of 86 patients with tumors vs five of 29 patients with nonneoplastic lesions [P = .178]; four of 42 patients with benign lesions vs 22 of 44 patients with malignant tumors [P < .001]), irregular margins (26 of 86 patients with tumors vs three of 29 patients with nonneoplastic lesions [P < .001]; eight of 42 patients with benign lesions vs 18 of 44 patients with malignant tumors [P < .001]), and internal vascularization (70 of 86 patients with tumors vs seven of 29 patients with nonneoplastic lesions [P < .001]; 28 of 42 patients with benign lesions vs 42 of 44 patients with malignant tumors [P < .001]). For contrast-enhanced US, the rapidity of wash-in (34 of 44 patients vs 15 of 42 patients, P < .001) and washout (33 of 44 patients vs five of 42 patients, P < .001) were the parameters that best differentiated malignant from benign tumors, with a typical prolonged washout observed in Leydig cell tumors (12 of 21 patients, P < .001 when compared with seminomas). Overall, the combination of unenhanced and contrast-enhanced US achieved a high accuracy in the diagnosis of small testicular malignancies (area under the ROC receiver operating characteristic curve performance: 0.927; 95% confidence interval: 0.872, 0.981). CONCLUSION: Benign testicular tumors are frequent incidental findings. Quantitative scrotal contrast-enhanced US is a noninvasive diagnostic tool that could improve the differential diagnosis and individualized management of small testicular lesions.
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Neoplasias Testiculares/diagnóstico por imagen , Adulto , Medios de Contraste , Diagnóstico Diferencial , Humanos , Hallazgos Incidentales , Masculino , Fosfolípidos , Estudios Prospectivos , Hexafluoruro de Azufre , Neoplasias Testiculares/patología , Neoplasias Testiculares/cirugía , UltrasonografíaRESUMEN
BACKGROUND: The aim of this study was to evaluate whether the sequential use of Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) is superior to BCG alone in reducing the risk of disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC) with high risk of progression. METHODS: Prospective randomized trial was conducted from March 2021 to March 2023 and included 72 patients with high risk NMIBC. Trial registration number: NCT03790384; EUDRACT Number: 2017-004540-37. Thirty-one patients underwent to BCG alone and forty-one to MMC plus BCG during the induction course. The BCG schedule comprised six weekly instillation of 81 mg Connaught strain BCG as the induction course, followed by a further three-monthly instillation at three, six and twelve months, as the maintenance course. Forty mg of MMC were administered the day prior to each weekly BCG instillation in BCG plus MMC arm. A planned interim analysis was carried out in June 2023, at the end of the 12mo follow-up period. RESULTS: Six out of thirteen 6/31(19.3%) and 10/41 (24.4%) patients experienced recurrence in BCG and BCG plus MMC group (P=0.611), respectively. BCG plus MMC did not improve Disease Free Interval (HR: 1.23 95% CI:0.46-3.50; P=0.640). Patients receiving sequential treatment experienced similar AEs (P>0.05) and more urinary symptoms (P<0.05). CONCLUSIONS: This interim pre-planned analysis suggested absence of clinical advantages in terms of disease recurrence rate when MMC is administered one day prior to BCG during induction course.
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Vacuna BCG , Mitomicina , Invasividad Neoplásica , Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/patología , Mitomicina/administración & dosificación , Mitomicina/uso terapéutico , Mitomicina/efectos adversos , Vacuna BCG/uso terapéutico , Vacuna BCG/administración & dosificación , Masculino , Femenino , Estudios Prospectivos , Anciano , Persona de Mediana Edad , Adyuvantes Inmunológicos/uso terapéutico , Adyuvantes Inmunológicos/administración & dosificación , Quimioterapia Adyuvante , Antibióticos Antineoplásicos/uso terapéutico , Antibióticos Antineoplásicos/administración & dosificación , Quimioterapia Combinada , Recurrencia Local de Neoplasia/prevención & control , Recurrencia Local de Neoplasia/patología , Resultado del Tratamiento , Administración IntravesicalRESUMEN
BACKGROUND: Prostate cancer (PCa) management is moving towards patient-tailored strategies. Advances in molecular and genetic profiling of tumor tissues, integrated with clinical risk assessments, provide deeper insights into disease aggressiveness. This study aims to offer a comprehensive overview of the pivotal genomic tests supporting PCa treatment decisions, analyzing-through real-world data-trends in their use and the growth of supporting literature evidence. METHODS: A retrospective analysis was conducted using the extensive PearlDiver™ Mariner database, which contains de-identified patient records, in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes were employed to identify patients diagnosed with PCa during the study period-2011 to 2021. We determined the utilization of primary tissue-based genetic tests (Oncocyte DX®, Prolaris®, Decipher®, and ProMark®) across all patients diagnosed with PCa. Subsequently, within the overall PCa cohort, patients who underwent radical prostatectomy (RP) and received genetic testing postoperatively were identified. The yearly distribution of these tests and the corresponding trends were illustrated with graphs. RESULTS: During the study period, 1,561,203 patients with a PCa diagnosis were recorded. Of these, 20,748 underwent tissue-based genetic testing following diagnosis, representing 1.3% of the total cohort. An increasing trend was observed in the use of all genetic tests. Linear regression analysis showed a statistically significant increase over time in the use of individual tests (all p-values < 0.05). Among the patients who underwent RP, 3076 received genetic analysis following surgery, representing 1.27% of this group. CONCLUSIONS: Our analysis indicates a growing trend in the utilization of tissue-based genomic testing for PCa. Nevertheless, they are utilized in less than 2% of PCa patients, whether at initial diagnosis or after surgical treatment. Although it is anticipated that their use may increase as more scientific evidence becomes available, their role requires further elucidation.
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BACKGROUND: Contrast-enhanced ultrasound (CEUS) is a diagnostic tool that is gaining popularity for its ability to improve overall diagnostic accuracy in bladder cancer (BC) staging. Our aim is to determine the cumulative diagnostic performance of CEUS in predicting preoperative muscle invasiveness using a comprehensive systematic review and pooled meta-analysis. METHODS: A systematic review until October 2023 was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Patients with BC suspicion were offered CEUS before the transurethral resection of the bladder tumor (TURBT). The diagnostic performance of CEUS was evaluated based on non-muscle-invasive bladder cancer (NMIBC) vs. muscle-invasive bladder cancer (MIBC) confirmed at the final histopathological examination after TURBT. The outcomes were determined through pooled sensitivity, specificity, pooled positive likelihood ratio (PLR+), negative likelihood ratio (PLR-), and area under the summary receiver operating characteristic (SROC) along with their respective 95% confidence intervals (CI). RESULTS: Overall, five studies were included. In these studies, a total of 362 patients underwent CEUS prior to TURBT. The pooled sensitivity and specificity were 0.88 (95% CI: 0.81-0.93) and 0.88 (95% CI: 0.82-0.92), respectively. SROC curve depicted a diagnostic accuracy of 0.94 (95% CI: 0.81-0.98). The pooled PLR+ and PLR- were 7.3 (95% CI: 4.8-11.2) and 0.14 (95% CI: 0.08-0.23), respectively. CONCLUSIONS: Our meta-analysis indicates that CEUS is highly accurate in the diagnosis and staging for BC. Beyond its accuracy, CEUS offers the advantage of being a cost-effective, safe, and versatile imaging tool.
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Medios de Contraste , Neoplasias de la Vejiga Urinaria , Humanos , Músculos , Sensibilidad y Especificidad , Ultrasonografía/métodos , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
BACKGROUND: The minimally invasive infrapubic approach (MIIA) for inflatable penile prosthesis (IPP) placement has shown favorable peri-operative safety and efficacy profile, but scarce data exist on long-term follow-up. OBJECTIVES: We investigated the safety and efficacy of IPP implantation via the MIIA after a minimum 5-year follow-up. MATERIALS AND METHODS: We identified data of implanted patients prospectively included in our institutional database. Complications and functional outcomes were assessed by using validated tools. Specifically, quality of life and patient satisfaction were evaluated by the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. Kaplan-Meier method was used to analyze IPP survival (defined as a working IPP). RESULTS: Overall, 67 patients implanted by MIIA with a median (IQR) age of 64 years (61-70) were included. The median (IQR) follow-up duration was 71 months (63-80). Fifteen (22%) patients experienced complications: minor (Clavien ≤2) events included changes in penile sensitivity (n = 1; 1.5%), orgasmic dysfunction (n = 1; 1.5%), pain (n = 5; 7%), urinary tract infection (n = 2; 3%), and chronic discomfort (n = 1; 1.5%); major (Clavien 3) complications were represented by mechanical failure (n = 3; 4.5%), IPP infection (n = 1; 1.5%), and cylinder protrusion (n = 1; 1.5%). The estimated IPP survival was 94% (95% CI, 91.4-96.6), 92.5% (95% CI, 89.7-95.3), and 92.5% (95% CI, 89.7-95.3) at 3, 5, and 7 years after implantation, respectively. In patients using the device at follow-up (n = 61; 91%), median (IQR) scores for QoLSPP domains demonstrated favorable functional outcomes and patient satisfaction: functional 21 (19-23), personal 16 (15-18), relational 14 (12-15), and social 12 (11-14). DISCUSSION AND CONCLUSION: This study represents the longest follow-up using validated tools to assess the outcomes of IPP implantation via MIIA so far. IPP placement via MIIA confirms to be safe and to offer high satisfaction to both patients and partners at mid-term evaluation.
Asunto(s)
Disfunción Eréctil , Implantación de Pene , Prótesis de Pene , Masculino , Humanos , Persona de Mediana Edad , Anciano , Implantación de Pene/efectos adversos , Implantación de Pene/métodos , Disfunción Eréctil/cirugía , Disfunción Eréctil/etiología , Calidad de Vida , Prótesis de Pene/efectos adversos , Pene/cirugía , Satisfacción del Paciente , Estudios RetrospectivosRESUMEN
BACKGROUND: Postoperative urinary incontinence (UI) is a feared complication of BPH surgery. Our study aims to investigate the incidence of UI among patients undergoing different procedures for BPH. METHODS: A retrospective analysis was conducted using a large national database, containing patient records between 2011 and 2022. The most employed surgical procedures for BPH were considered, including TURP, Transurethral Incision of the Prostate (TUIP), Holmium/Thulium Laser Enucleation of the Prostate (HoLEP/ThuLEP), Open Simple Prostatectomy (OSP), minimally invasive simple prostatectomy (Lap/Rob SP), Photoselective Vaporization of the Prostate (PVP), Prostatic Urethral Lift (PUL), Robotic Waterjet Treatment (RWT - Aquablation®), Water Vapor Thermal Therapy (WVTT - Rezum®) and Prostatic Artery Embolization (PAE). Rates of any type of UI, including stress UI (SUI), urge UI (UUI) and mixed UI (MUI) were assessed. Multivariate regression analysis was used to identify predictors of "persistent" postoperative UI, defined as the presence of an active UI diagnosis at 12 months post-surgery. RESULTS: Among 274,808 patients who underwent BPH surgery, 11,017 (4.01%) experienced persistent UI. UUI rates varied between 0.62% (PAE) and 2.71% (PVP), SUI ranged from 0.04% (PAE) and 2.75% (Lap/Rob SP), while MUI between 0.11% (PAE) and 1.17% (HoLEP/ThuLEP). On multivariable analysis, HoLEP/ThuLEP (OR 1.612; 95% CI: 1.508-1.721; P<0.001), PVP (OR 1.164; 95% CI:1.122-1.208; P<0.001), Open SP (OR 1.424; 95% CI:1.241- 1.624; P<0.001), and Lap/Rob SP (OR 1.667; 95% CI:1.119-2.384; P<0.01) showed significant higher likelihood of UI compared to TURP. PUL (OR 0.604; 95% CI:0.566-0.644; P<0.001), WVTT (OR 0.661; 95% CI:0.579-0.752; P<0.001), RWT (OR 0.434; 95% CI:0.216-0.767; P<0.01), and PAE (OR 0.178; 95% CI:0.111-0.269; P<0.001) were associated with lower likelihood of UI. CONCLUSIONS: UI remains a concerning complication following BPH surgery, but it is an uncommon event affecting <5% of patients. Some differences in UI rates and risk might exist among various BPH procedures. These findings underscore the need for thorough patient selection and counseling.
Asunto(s)
Bases de Datos Factuales , Complicaciones Posoperatorias , Prostatectomía , Hiperplasia Prostática , Incontinencia Urinaria , Humanos , Hiperplasia Prostática/cirugía , Masculino , Estudios Retrospectivos , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Incontinencia Urinaria/epidemiología , Incontinencia Urinaria/etiología , Prostatectomía/efectos adversos , Prostatectomía/métodos , Incidencia , Persona de Mediana Edad , Anciano de 80 o más AñosRESUMEN
BACKGROUND: Bilateral testicular germ cell tumours (B-GCT) are rare, with an incidence of 2-5%, and can be classified as synchronous (sB-GCT) or metachronous (mB-GCT). Our study aimed to identify clinical, biochemical, and radiological risk factors for mB-GCT in a cohort of patients with GCT at a single tertiary referral centre. METHODS: This retrospective case-control study included patients with GCT referred to Policlinico Umberto I-Sapienza University of Rome, from 2005 to 2023. We evaluated clinical history, testicular ultrasound features, hormone levels, semen analysis, histological characteristics, staging, and treatments. mB-GCTs were compared with unilateral GCT patients with a follow-up longer than the median time-to-onset of the second tumour. RESULTS: Of 319 patients, 52 experienced B-GCT, with a median time-to-onset of the second tumour of 62 months (range: 8-229). The mB-GCT group showed higher gonadotropin levels (FSH 13.6mUI/mL vs. 7.4mUI/mL, p < 0.001; LH 6.6mUI/mL vs. 3.9mUI/mL, p = 0.004), lower sperm concentration (27 × 106/ejaculate vs. 78 × 106/ejaculate, p = 0.009), smaller residual testis volume (10.4 mL vs. 16.3 mL, p < 0.001), more inhomogeneous echotexture [57.5% vs. 14%, p < 0.001], and presence of microlithiasis (75% vs. 19.5%, p < 0.001). Kaplan-Meier curves confirmed that ultrasound features of the residual testis increased the cumulative risk of developing a second tumour. Microlithiasis was a strong independent predictor (OR 30.712, 95% CI 3.357-280.942, p = 0.002). CONCLUSIONS: Histological features of the first tumour or its treatment do not influence the onset of a second tumour. However, low residual testis volume, inhomogeneous echotexture, and microlithiasis significantly increase this risk. A comprehensive evaluation of the residual testis at baseline is essential for developing a personalised surveillance programme in GCT survivors, with regular ultrasound follow-up recommended beyond the conventional 5-year limit.