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BACKGROUND: Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes. METHODS: A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications. RESULTS: Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Q
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Láseres de Estado Sólido , Hiperplasia Prostática , Tulio , Humanos , Masculino , Hiperplasia Prostática/cirugía , Estudios Prospectivos , Anciano , Láseres de Estado Sólido/uso terapéutico , Persona de Mediana Edad , Terapia por Láser/métodos , Terapia por Láser/instrumentación , Terapia por Láser/efectos adversos , Resultado del Tratamiento , Síntomas del Sistema Urinario Inferior/cirugía , Síntomas del Sistema Urinario Inferior/etiología , Calidad de Vida , Prostatectomía/métodos , Prostatectomía/efectos adversos , HolmioRESUMEN
PURPOSE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa). METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined. RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI. CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/sangre , Anciano , Estudios Prospectivos , Persona de Mediana Edad , Antígeno Prostático Específico/sangre , Biopsia , Sensibilidad y Especificidad , Imagen por Resonancia Magnética , Toma de Decisiones ClínicasRESUMEN
OBJECTIVE: To determine the accuracy of voided urinary cytology (VUC) in predicting of non-muscle-invasive bladder cancer (NMIBC) risk stratification before surgery. METHODS: We prospectively collected data from all patients diagnosed with bladder cancer in our institution over 2 years. We have analyzed VUC accuracy of positive and suspicious VUC in the detection of high-risk tumors and negative and atypical VUC in the detection of low-risk tumors. To test this accuracy, we assessed sensitivity, specificity, positive (PPV) and negative predictive values (NPV), diagnostic odds ratio (DOR), and generated ROC curves (receiver operating characteristic curve). RESULTS: With 224 patients included, the positive VUC subcategory showed a specificity of 92.4% (95%CI: 83.2%-97.5%) and a PPV of 91.4 (95%CI: 81%-97.1%). DOR in this subgroup was 6.81. In the suspicious VUC, specificity was 90.9% (95%CI: 81.3%-96.6%), PPV was 88% (95%CI: 75.7%-95.5%) and DOR was 4.23. Combined analysis of positive and suspicious cytologies for detecting high-risk NMIBC showed a sensitivity of 65% (95%CI: 57.3%-73.2%) and a DOR of 9.51. Negative VUC showed high specificity in detecting low-risk (93.2% [95%CI: 87.9%-96.7%]) and a DOR of 6.90 (95%CI: 3.07-15.46). Atypical VUC was the least accurate and had rather low specificity and predictive values. CONCLUSIONS: VUC appears to be a good, inexpensive and easily available method to determine risk stratification before surgery. This can be useful in daily practice to determine which patients should receive a single instillation of MMC and to prioritize patients more likely to have a high- risk tumor.
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Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/orina , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/diagnóstico , Neoplasias de la Vejiga Urinaria/cirugía , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Orina/citología , Medición de Riesgo/métodos , Anciano de 80 o más Años , Sensibilidad y Especificidad , Valor Predictivo de las Pruebas , Invasividad Neoplásica , Curva ROC , Neoplasias Vesicales sin Invasión Muscular , CitologíaRESUMEN
Bacillus Calmette-Guérin (BCG) has been the standard of care for the treatment of high-risk, non-muscle-invasive bladder cancer (NMIBC) for decades, but 49.6% of high-risk and very-high-risk patients will experience progression to muscle-invasive disease in five years. Furthermore, cytology and cystoscopy entail a high burden for both patients and health care systems due to the need for very long periods of follow-up. Subsequent adjuvant treatment using intravesical immunotherapy with BCG has been shown to be effective in reducing tumor recurrence and progression, but it is not free of severe adverse effects that ultimately diminish patients' quality of life. Because not all patients benefit from BCG treatment, it is of paramount importance to be able to identify responders and non-responders to BCG as soon as possible in order to offer the best available treatment and prevent unnecessary adverse events. The tumor microenvironment (TME), local immune response, and systemic immune response (both adaptive and innate) seem to play an important role in defining responders, although the way they interact remains unclear. A shift towards a proinflammatory immune response in TME is thought to be related to BCG effectiveness. The aim of this review is to collect the most relevant data available regarding BCG's mechanism of action, its role in modulating innate and adaptive immune responses and the secretion of certain cytokines, and their potential use as immunological markers of response; the aim is also to identify promising lines of investigation.
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PURPOSE: This study sought to determine health-related quality of life and self-reported complications associated with clean intermittent catheterization (CIC). DESIGN: Observational, cross-sectional study. SUBJECTS AND SETTING: The target population was patients cared for by the urology department at Hospital 12 de Octubre in Madrid, Spain, undergoing CIC for chronic urinary retention of any etiology (neurogenic bladder dysfunction, neobladder, and other). The sample comprised 50 respondents with a mean age of 49 years; a majority (66%, n = 33) were female. Participants performed an average of 4 CICs. METHODS: All participants completed the ISC-Q (Intermittent Self-Catheterization Questionnaire) and a questionnaire about CIC-associated complications. Data were collected in February 2019. RESULTS: A vast majority of respondents (98%, n = 49) indicated preparation for catheterization was simple, and 76% (n = 38) indicated the catheter was easy to insert. One in 5 (20%, n = 10) considered carrying catheters and supplies inconvenient, though 58% (n = 29) indicated it was easy to dispose of the catheters outside the home. Most respondents (98%, n = 49) indicated they felt self-conscious about their need to self-catheterize, and 16% (n = 8) felt that CIC created limitations when visiting friends and family. The most frequent complication was symptomatic urinary tract infections (UTIs); participants reported an average of 1.7 UTIs in the last year. Additional complications, such as epididymo-orchitis, urethral stenosis, and urethral bleeding, were reported by less than 5% (n = 2) of participants. CONCLUSIONS: Participants managed by CIC for chronic urinary retention of any cause reported acceptable levels of satisfaction with the procedure. The reported incidence of complications was low, except for UTIs.
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Cateterismo Uretral Intermitente , Vejiga Urinaria Neurogénica , Retención Urinaria , Infecciones Urinarias , Humanos , Masculino , Femenino , Persona de Mediana Edad , Cateterismo Uretral Intermitente/efectos adversos , Cateterismo Uretral Intermitente/métodos , Retención Urinaria/terapia , Retención Urinaria/complicaciones , Calidad de Vida , Autoinforme , Estudios Transversales , Infecciones Urinarias/etiología , Infecciones Urinarias/complicaciones , Cateterismo Urinario/efectos adversos , Cateterismo Urinario/métodosRESUMEN
BACKGROUND: Current pathways in early diagnosis of prostate cancer (PCa) can lead to unnecessary biopsy procedures. Here, we used telomere analysis to develop and evaluate ProsTAV®, a risk model for significant PCa (Gleason score >6), with the objective of improving the PCa diagnosis pathway. METHODS: This retrospective, multicentric study analyzed telomeres from patients with serum PSA 3-10 ng/mL. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate telomere-associated variables (TAVs) in peripheral blood mononucleated cells. ProsTAV® was developed by multivariate logistics regression based on three clinical variables and six TAVs. The predictive capacity and accuracy of ProsTAV® were summarized by receiver operating characteristic (ROC) curves and its clinical benefit with decision curves analysis. RESULTS: Telomeres from 1043 patients were analyzed. The median age of the patients was 63 years, with a median PSA of 5.2 ng/mL and a percentage of significant PCa of 23.9%. A total of 874 patients were selected for model training and 169 patients for model validation. The area under the ROC curve of ProsTAV® was 0.71 (95% confidence interval [CI], 0.62-0.79), with a sensitivity of 0.90 (95% CI, 0.88-1.0) and specificity of 0.33 (95% CI, 0.24-0.40). The positive predictive value was 0.29 (95% CI, 0.21-0.37) and the negative predictive value was 0.91 (95% CI, 0.83-0.99). ProsTAV® would make it possible to avoid 33% of biopsies. CONCLUSIONS: ProsTAV®, a predictive model based on telomere analysis through TAV, could be used to increase the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/mL.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Masculino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/genética , Biopsia , Curva ROCRESUMEN
Leiomyomas are benign mesenchymal tumors which originate from smooth muscle cells. Extrauterine leiomyomas are rare and they may arise where smooth muscle cells are found. Their diagnosis is challenging due to their heterogeneous ways of presentation. Histological analysis may reveal areas of sarcomatous differentiation; therefore, complete resection of the entire tumor is the only curative treatment. There is no adjuvant therapy proved to increase overall survival. It is essential to develop a standardized protocol, detailing how to follow up these patients since it is not reported in the literature to date; however, it is advisable to follow them because the local recurrence rate is high if small implants remain. In this review, we present 3 cases of extrauterine leiomyomas diagnosed and treated in our hospital. The management was different in each case, highlighting the heterogeneity of this condition. According to the literature, there are no solid guidelines on their management. We compare our experience with the data available to date in order to support the existing knowledge and provide our expertise for future studies.
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Leiomioma , Humanos , Leiomioma/diagnóstico por imagen , Leiomioma/cirugía , Espacio Retroperitoneal , Miocitos del Músculo Liso/patologíaRESUMEN
INTRODUCTION: Ureteral complications after kidney transplantation are frequent and may have a negative impact on morbidity and graft function. Treatment modalities include conservative, endourological, and surgical techniques, with variable outcomes. The purpose of this study was to report the incidence, characteristics, treatment, and outcomes of ureteral complications at our center. METHODS: Retrospective study of kidney transplants performed at our unit between 2015 and 2020, analyzing incidence, characteristics, treatment, and outcomes of ureteral stenoses and fistulas. RESULTS: Of 648 kidney transplants, we present 3.24% stenosis and 2.16% ureteral fistulas, with a mean time from transplantation of 101.4 and 24.4 days, respectively. Primary treatment was open surgical repair in 52.4% stenosis and 100% fistulas, with a success rate of 90.9% and 71.4%, respectively. Anterograde balloon dilatations were performed in 33.3% of stenosis with 40% success. Three patients required surgery as a secondary approach with 100% success. Major complications (Clavien-Dindo III) were observed in 18.5% following surgical repair. After a mean follow-up of 31.1 ± 20.9 months, we observe 88.6% of functioning grafts. We found no significant differences in graft survival between patients with or without ureteral complications (p 0.948). CONCLUSION: Surgical repair of ureteral complications offers satisfactory results with low associated morbidity. Endourological techniques are less effective and should be reserved for selected cases. With adequate management, there is no impact on graft survival.
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Trasplante de Riñón , Obstrucción Ureteral , Fístula Urinaria , Humanos , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/métodos , Constricción Patológica/cirugía , Estudios Retrospectivos , Obstrucción Ureteral/etiología , Obstrucción Ureteral/cirugía , Fístula Urinaria/etiología , Fístula Urinaria/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugíaRESUMEN
OBJECTIVE: To assess the diagnostic accuracy of 18F-Choline PET/CT in the initial staging of high-risk prostate cancer (PC), and to compare it with conventional imaging techniques and to assess the changes in therapeutic attitude derived from its results. SECONDARY OBJECTIVES: To assess the concordance between 18F-Choline PET/CT and conventional study and to find related prognostic factors. MATERIAL AND METHODS: Retrospective observational study of 78 patients with high-risk PC undergoing 18F-Choline PET/CT after conventional initial staging (CT + BS). Sensitivity, specificity and predictive values of 18F-Choline PET/CT and CT + BS were calculated. The golden standard was histological result or follow-up. Tumor characteristics were collected and univariate and multivariate analyzes were performed. RESULTS: The median age was 67 years old and mean PSA was 42.39 ng/mL. The sensitivity, specificity and NPV in global initial staging for PET/CT 18F-Choline and conventional imaging were: 92.9% vs 38.5%, 83.3% vs 42.3%, and 90.9% vs 40.7%, respectively. Lymph node staging: sensitivity 96.3% vs 61.5% and specificity 80% vs 76%, respectively. Bone staging: sensitivity 91.7% vs 21.4% and specificity 97.4% vs 83.8%, respectively. There was agreement in 25 patients (32%) (p = 0.004), Kappa index 0.134 (p = 0.011). The treatment was modified in 47.4% patients. PSA, PSADT% positive cores and cT were related to PET results. PSA level <8.9 ng/mL was considered an independent protective factor for positive PET (OR 0.03) (95% CI: 0.002-0.435, p 0.010). CONCLUSIONS: 18F-Choline PET/CT seems to be superior to CT + BS for initial staging in high-risk PC. It could be considered because its results can change the treatment decision in almost half of the patients.
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Colina , Neoplasias de la Próstata , Masculino , Humanos , Anciano , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Antígeno Prostático Específico , Neoplasias de la Próstata/patología , Ganglios Linfáticos/patología , Estadificación de Neoplasias , Tomografía de Emisión de PositronesRESUMEN
Objective: To assess the diagnostic accuracy of 18F-Choline PET/CT in the initial staging of high-risk prostate cancer (PC), and to compare it with conventional imaging techniques and to assess the changes in therapeutic attitude derived from its results. Secondary Objectives: To assess the concordance between 18F-Choline PET/CT and conventional study and to find related prognostic factors. Material and Methods: Retrospective observational study of 78 patients with high-risk PC undergoing 18F-Choline PET/CT after conventional initial staging (CT + BS). Sensitivity, specificity and predictive values of 18F-Choline PET/CT and CT + BS were calculated. The golden standard was histological result or follow-up. Tumor characteristics were collected and univariate and multivariate analyzes were performed. Results: The median age was 67 years old and mean PSA was 42.39 ng/mL. The sensitivity, specificity and NPV in global initial staging for PET/CT 18F-Choline and conventional imaging were: 92.9% vs 38.5%, 83.3% vs 42.3%, and 90.9% vs 40.7%, respectively. Lymph node staging: sensitivity 96.3% vs 61.5% and specificity 80% vs 76%, respectively. Bone staging: sensitivity 91.7% vs 21.4% and specificity 97.4% vs 83.8%, respectively. There was agreement in 25 patients (32%) (p = 0.004), Kappa index 0.134 (p = 0.011). The treatment was modified in 47.4% patients. PSA, PSADT% positive cores and cT were related to PET results. PSA level <8.9 ng/mL was considered an independent protective factor for positive PET (OR 0.03) (95% CI: 0.002-0.435, p 0.010). Conclusions: 18F-Choline PET/CT seems to be superior to CT + BS for initial staging in high-risk PC. It could be considered because its results can change the treatment decision in almost half of the patients (AU)
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Humanos , Masculino , Persona de Mediana Edad , Anciano , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Tomografía Computarizada de Emisión de Fotón Único , Colina , Ganglios Linfáticos/patología , Tomografía Computarizada por Rayos X , Antígeno Prostático Específico/sangre , Estudios Retrospectivos , Sensibilidad y Especificidad , Estadificación de Neoplasias , PronósticoRESUMEN
Recommendations regarding transversal topics applicable to bladder cancer patients independent of tumor grade and stage were established by members of the Spanish Oncology Genitourinary Multidisciplinary Working Group (SOGUG). Liquid biopsy in urine and blood samples is useful in the surveillance of non-muscle-invasive and muscle-invasive bladder cancer, respectively. Multiparametric MRI is an accurate, faster and non-invasive staging method overcoming the understaging risk of other procedures. The combination of FDG-PET/MRI could improve diagnostic reliability, but definite criteria for imaging interpretation are still unclear. Hospital oncology pharmacists as members of tumor committees improve the safety of drug use. Additionally, safety recommendations during BCG preparation should be strictly followed. The initial evaluation of patients with bladder cancer should include a multidimensional geriatric assessment. Orthotopic neobladder reconstruction should be offered to motivated patients with full information of self-care requirements. Bladder-sparing protocols, including chemoradiation therapy and immune checkpoints inhibitors (ICIs), should be implemented in centers with well-coordinated multidisciplinary teams and offered to selected patients. The optimal strategy of treatment with ICIs should be defined from the initial diagnostic phase with indications based on scientific evidence. Centralized protocols combined with the experience of professional groups are needed for the integral care of bladder cancer patients.
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The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.
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Los aneurismas de la arteria renal son entidades clínicas poco frecuentes. Si bien la mayoría de casos son asintomáticos y se detectan incidentalmente, su rotura se asocia a elevadas tasas de mortalidad y de pérdida del riñón, lo que afecta a los supervivientes. Aunque la mayoría de estos aneurismas pueden tratarse mediante técnicas de reparación endovascular o in situ, esto puede no ser posible en pacientes con aneurismas complejos, como aquellos localizados en la bifurcación arterial. Presentamos el caso de un aneurisma renal complejo tratado satisfactoriamente mediante nefrectomía laparoscópica, reconstrucción vascular en banco y autotrasplante heterotópico.(AU)
renal artery aneurysms are rare clinical entities. While most cases are asymptomatic and detected incidentally, rupture is associated with high mortality rates and loss of the aff ected kidney in survivors. although most of these aneurysms can be treated by endovascular or in situ repair techniques, this may not be possible in patients with complex aneurysms, such as those located at the arterial bifurcation. We present a case of complex renal aneurysm successfully treated by laparoscopic nephrectomy, ex vivo vascular reconstruction, and heterotopic autotransplantation.(AU)
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Humanos , Femenino , Persona de Mediana Edad , Arteria Renal/cirugía , Aneurisma , Nefrectomía , Laparoscopía , Trasplante Autólogo , Trasplante Heterotópico , Angiografía por Tomografía Computarizada , Pacientes Internos , Examen Físico , Evaluación de Síntomas , Enfermedades Vasculares , Sistema Linfático , Sistema Cardiovascular , Vasos Sanguíneos/anatomía & histología , Vasos Linfáticos/anatomía & histología , Resultado del TratamientoRESUMEN
INTRODUCTION: Mitomycin C (MMC) is one of the most frequently utilized intravesical chemotherapy drugs for the management of non-muscle-invasive bladder cancer (NMIBC). Allergic reactions (Type 4 delayed hypersensitivity) are seldomly reported in the literature but not so infrequent in daily practice, its incidence has been increasing with the use of device-assisted hyperthermia. This study aims to identify the incidence, risk factors, and clinical characteristics of patients with allergic reactions to MMC. PATIENTS AND METHODS: Single-center retrospective cohort from June 2014 to August 2018. Patients with intermediate or high-risk NMIBC were included. Patients received passive MMC (4 weekly and eleven monthly instillations of 40mg of MMC) or Chemohyperthermia (CHT) with MMC (6 weekly and 6-monthly instillations, heated at 43°C [+/- 0.5°C] using Combat BRS). RESULTS: We included 258 patients (MMCâ¯=â¯157, CHTâ¯=â¯101) and found 7 (4.4%) suspected and 4 confirmed (2.4%) allergies in the passive MMC group and 11 suspected (10.9%) and 7 confirmed (6.9%) in the CHT group. The mean number of instillations received before developing the allergy was 6 in the passive MMC and 5 in the CHT group. Seven out of 18 suspected allergy cases were pseudo-allergic reactions with negative allergy tests. Early postoperative MMC instillation was associated with an increased risk of allergy (OR 2.47 [CI 1.39-4.36], P = 0.001), while neither history of atopy nor history of other medications allergy was found to increase the risk. CONCLUSION: MMC allergy risk is increased with the use of device-assisted hyperthermia with an incidence of 2.4% for passive MMC and 6.9% for CHT. History of prior allergies does not seem to increase the risk of developing MMC allergy. In this series 38% of suspected cases were found to be pseudo-allergic reactions, highlighting the need to confirm the diagnosis before definitively stopping the treatment.
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Hipersensibilidad , Hipertermia Inducida , Neoplasias de la Vejiga Urinaria , Administración Intravesical , Antibióticos Antineoplásicos/efectos adversos , Humanos , Hipersensibilidad/tratamiento farmacológico , Hipertermia Inducida/efectos adversos , Mitomicina/uso terapéutico , Estudios Retrospectivos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.
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PURPOSE: The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). METHODS: A pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ. Patients were randomized 1:1 to receive intravesical BCG for 1 year (once weekly for 6 weeks plus subsequent maintenance) or HIVEC with 40 mg MMC, administered using the Combat BRS system (once weekly instillations were given for 6 weeks, followed by once monthly instillation for 6 months). Total recirculating dwell time for HIVEC was 60 min at a target temperature of 43° ± 0.5 °C. Primary endpoint was recurrence-free survival. Secondary endpoints were time to recurrence, progression-free survival, cancer-specific survival, and overall survival at 24 months. Adverse events were routinely assessed. RESULTS: Fifty patients were enrolled. Mean age was 73.5 years. Median follow-up was 33.7 months. Recurrence-free survival at 24 months was 86.5% for HIVEC and 71.8% for BCG (p = 0.184) in the intention-to-treat analysis and 95.0% for HIVEC and 75.1% for BCG (p = 0.064) in the per protocol analysis. Time to recurrence was 21.5 and 16.1 months for HIVEC and BCG, respectively. Progression-free survival for HIVEC vs BCG was 95.7% vs 71.8% (p = 0.043) in the intention-to-treat analysis and 100% vs 75.1% (p = 0.018) in the per protocol analysis, respectively. Cancer-specific survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG. CONCLUSION: HIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages. TRIAL REGISTRATION: EudraCT 2016-001186-85. Date of registration: 17 March 2016.
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Hipertermia Inducida , Neoplasias de la Vejiga Urinaria , Adyuvantes Inmunológicos/uso terapéutico , Administración Intravesical , Anciano , Vacuna BCG/uso terapéutico , Humanos , Mitomicina/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/tratamiento farmacológicoRESUMEN
Objetivos: Establecer unas recomendaciones lo más seguras posibles con respecto a la implantación de prótesis peneanas, su seguimiento tras la cirugía y manejo de las posibles complicaciones durante las diferentes fases de la pandemia por la COVID-19.Material y métodos: Diseñamos una revisión narrativa crítica de los estudios que investigan el impacto de la COVID-19 en la práctica de la urología y en la implantología de prótesis de pene. Se realizó una búsqueda exhaustiva en la base de datos MEDLINE. Se utilizaron diferentes combinaciones de las siguientes palabras clave según un protocolo de texto libre: SARS-CoV-2, COVID19, COVID Urology, COVID19 surgery, penile prostheses. Fueron incluidos trabajos en idioma inglés y español, publicados hasta septiembre de 2020.Resultados: La cirugía del implante de la prótesis de pene es una cirugía electiva que siempre debería diferirse para cuando se pueda hacer en máximas condiciones de seguridad. Sin embargo, este tipo de cirugía puede conllevar en ocasiones complicaciones que deben resolverse de manera urgente, o preferente incluso dentro de la situación de pandemia por la COVID-19.Conclusiones: En la situación actual es importante desarrollar estrategias compartidas para evitar el daño colateral potencial de la pandemia de COVID-19 para nuestros pacientes. En el caso de la cirugía de la prótesis de pene ha de primar la seguridad del paciente, posponiéndola para evitar riesgos innecesarios o minimizando estos riesgos con todas las medidas necesarias. (AU)
Objectives: To provide recommendations regarding surgery, follow-up, and management of possible complications related to penile prostheses implantation, during the COVID-19 pandemic.Material and methods: We designed a critical narrative review of the studies investigating the impact of COVID-19 on urology practice and on penile prosthetic implantology. A comprehensive search in the MEDLINE database was performed. Different combinations of the following keywords were used according to a free-text protocol:: SARS-CoV-2, COVID19, COVID Urology, COVID19 surgery, penile prostheses. Papers in English and Spanish language, published until September 2020 were included in the review.Results: Penile prosthesis implantation is an elective surgery which should always be deferred when it cannot be performed in maximum safety conditions. However, it may lead to complications wich must be resolved urgently even within the COVID-19 Era.Conclusions: Currently, it is mandatory to develop shared strategies to avoid potential COVID-19-related complications for surgical patients. Penile prosthesis implantation should be deferred to avoid unnecessary risks and all preventive measures should be taken to minimize the risks in the event of non-delayable surgery. (AU)
Asunto(s)
Humanos , Masculino , Pandemias , Infecciones por Coronavirus/epidemiología , Prótesis de Pene , Urología , Bases de Datos como Asunto , Cirugía GeneralRESUMEN
OBJECTIVES: To provide recommendations regarding surgery, follow-up, and management of possible complications related to penile prostheses implantation, during the COVID-19 pandemic. MATERIAL AND METHODS: We designed a critical narrative review of the studies investigating the impact of COVID-19 on urology practice and on penile prosthetic implantology. A comprehensive search in the MEDLINE database was performed. Different combinations of the following keywords were used according to a free-text protocol:: "SARS-CoV-2", "COVID19", "COVID Urology", "COVID19 surgery", "penile prostheses". Papers in English and Spanish language, published until September 2020 were included in the review. RESULTS: Penile prosthesis implantation is an elective surgery which should always be deferred when it cannot be performed in maximum safety conditions. However, it may lead to complications wich must be resolved urgently even within the COVID-19 Era. CONCLUSIONS: Currently, it is mandatory to develop shared strategies to avoid potential COVID-19-related complications for surgical patients. Penile prosthesis implantation should be deferred to avoid unnecessary risks and all preventive measures should be taken to minimize the risks in the event of non-delayable surgery.