Voided urine cytology is a useful tool predicting non-muscle-invasive bladder cancer risk before surgery.

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.

Immune Predictors of Response after Bacillus Calmette-Guérin Treatment in Non-Muscle-Invasive Bladder Cancer.

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.

ProsTAV, a novel blood-based test for biopsy decision management in significant prostate cancer.

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.

Extrauterine Retroperitoneal Leiomyomas: 3 Case Reports and Review of the Literature.

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.

Ureteral Stenosis and Fistula after Kidney Transplantation.

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.

Role of 18F-Choline PET/CT in the Initial Staging of High Risk Prostate Cancer and Comparison with Conventional Imaging Techniques.

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.

Advances in Transversal Topics Applicable to the Care of Bladder Cancer Patients in the Real-World Setting.

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.

Mitomycin C allergy after passive and device-assisted hyperthermia for non-muscle invasive bladder cancer treatment: A retrospective cohort from a high-volume center.

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 (MMC = 157, CHT = 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.

Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer: results of the HIVEC-HR randomized clinical trial.

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.

[Penile prosthesis implantation in the covid era. post-surgery follow up and management of complications]. / Implante de prótesis de pene en la era COVID. Seguimiento tras la cirugía y manejo de complicaciones.

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.

Management of Localized Muscle-Invasive Bladder Cancer from a Multidisciplinary Perspective: Current Position of the Spanish Oncology Genitourinary (SOGUG) Working Group.

This review presents challenges and recommendations on different aspects related to the management of patients with localized muscle-invasive bladder cancer (MIBC), which were discussed by a group of experts of a Spanish Oncology Genitourinary (SOGUG) Working Group within the framework of the Genitourinary Alliance project (12GU). It is necessary to clearly define which patients are candidates for radical cystectomy and which are candidates for undergoing bladder-sparing procedures. In older patients, it is necessary to include a geriatric assessment and evaluation of comorbidities. The pathological report should include a classification of the histopathological variant of MIBC, particularly the identification of subtypes with prognostic, molecular and therapeutic implications. Improvement of clinical staging, better definition of prognostic groups based on molecular subtypes, and identification of biomarkers potentially associated with maximum benefit from neoadjuvant chemotherapy are areas for further research. A current challenge in the management of MIBC is improving the selection of patients likely to be candidates for immunotherapy with checkpoint inhibitors in the neoadjuvant setting. Optimization of FDG-PET/CT reliability in staging of MIBC and the selection of patients is necessary, as well as the design of prospective studies aimed to compare the value of different imaging techniques in parallel.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients.

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Long surgical waiting list times are associated with an increased rate of negative ureteroscopies.

INTRODUCTION: Negative ureteroscopy (NURS) is "a ureteroscopy in which no stone is found during the procedure." We aimed to determine the association between the surgical waiting list time (WLT) and the NURS rate. METHODS: We retrospectively analyzed all patients scheduled for ureteroscopy in our center between January 2017 and July 2019. The inclusion criterion was unilateral, semirigid ureteroscopy for a single ureteral stone; exclusion criteria were renal-only stones, incomplete ureteroscopy, and stones >10 mm. We analyzed age; gender; body mass index; stone size, density, and location; presence of a temporary double-J (DJ) stent; use of medical expulsive therapy; and WLT. Complications while waiting for surgery were also collected and analyzed. RESULTS: We included 219 patients, 41 (18.7%) of whom had NURS. The median WLT was 74 days (interquartile range [IQR] 45-127). Variables protective against NURS were large stone size (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.66-0.93), presence of a temporary DJ stent (OR 0.43, 95% CI 0.2-0.8), and radiopaque stones (OR 0.44, 95% CI 0.21-0.88). A long WLT ((≥60 days) increased the risk of NURS (OR 2.18, 95% CI 1.02-4.61). Complications requiring emergency department visits while waiting for surgery were documented in 58/137 (42.3%) patients with indwelling DJ stents; nonetheless, a WLT greater than the median was not associated with an increased risk of complications (p=0.38). CONCLUSIONS: Long WLT has an independent, direct, and linear correlation with NURS rates. Patients at higher risk of NURS, may be offered preoperative re-evaluation with a computed tomography scan in a resource-limited setting.

Iterative renal transplantation: our experience on third transplants.

PURPOSE: To report our experience on third kidney transplantation, analyzing the complications and graft survival rates as compared to previous transplants. METHODS: Retrospective study of third renal transplants performed at our center. Outcomes were compared with a cohort of first and second transplants. RESULTS: Of a total of 4143, we performed 72 third transplants in 46 men and 26 women with an average age of 46 years and mean time on dialysis of 70 months. Thirty-seven patients were hypersensitized [panel-reactive antibody (PRA) > 50%]. They were all from deceased donors, with a mean cold ischemia time of 19.2 h. The extraperitoneal heterotopic approach was used in 88.8%, transplantectomy was performed in 80.6% and vascular anastomoses were realized mostly to external iliac vessels, using the common iliac artery in 15 cases, and the inferior vena cava in 16. The main ureteral reimplantation technique was the Politano-Leadbetter (76.4%). Third transplantation reported a significantly higher incidence of lymphocele (13.9% vs. 3.2% in first and 4.5% in second transplants; p < 0.001), rejection (34.7% vs. 14.9% and 20.5%, p < 0.001) and urinary obstruction (11.1% vs. 3.6% and 6.3%, p 0.002). Graft survival rates for first, second and third transplants were 87%, 86% and 78% at 1 year, 83%, 82% and 74% at 3 years and 80%, 79% and 65% at 5 years, respectively. CONCLUSION: Iterative transplantation constitutes a valid therapeutic option with adequate surgical and survival results compared to previous transplants. It is a challenging procedure which must be performed by experienced surgeons.

Seizures and Neuropsychiatric Toxicity in Patients with Non-Metastatic CRPC Treated with New Antiandrogens: Systematic Review and Meta-Analysis.

INTRODUCTION: Recently, enzalutamide, apalutamide, and darolutamide have shown benefits in metastasis-free survival in non-metastatic castration-resistant prostate cancer (nmCRPC) patients compared to placebo. Previous evidence about the safety profile of these new androgens is limited. This meta-analysis studies seizure and neuropsychiatric effects of new anti-androgens compared to placebo in nmCRPC patients. METHODS: PubMed and Cochrane databases were systematically reviewed until 1 March 2020 by 2 independent researchers using a pre-specified search strategy. Placebo-compared randomized controlled trials (RCTs) of nmCRPC patients treated with new anti-androgens providing data on neuropsychiatric events and seizures were included. Variables were seizure, headache, mental impairment, and dizziness. Pooled risk ratios (RR) were calculated using the Mantel-Hansel random effects model and Review Manager v5.3 software. RESULTS: After systematic review, 3 eligible RCTs were selected that included 4,104 patients; 2,687 comprised the treatment group and 1,417 the control group. No significant increase in RR for seizures was registered with the new anti-androgens compared to placebo (RR 1.96; 95% confidence interval [CI] 0.40-9.61). However, 2 trials excluded patients with risk factors or a history of seizures. There was also no significant increase RR for grade ≥3 seizures (RR 2.50; 95% CI 0.12-52.02). RR for suffering dizziness (any grade) was 1.57 (95% CI 1.07-2.32) with the new anti-androgens, but no significant differences were found in the other study regarding neuropsychiatric events or grade ≥3 events. CONCLUSIONS: New anti-androgens (i.e., enzalutamide, apalutamide, and darolutamide) are acceptably safe in terms of seizures and neuropsychiatric toxicity compared to placebo in patients with nmCRPC.

Role of neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios in Peyronie's disease: a new diagnostic approach to predict the stage of the disease?

Neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) have been associated with multiple entities and several types of cancers. They can be assumed as markers of inflammatory imbalance. The objective of this study is to evaluate the NLR and PLR in Peyronie's disease (PD) and to establish a comparison of its values in the acute and chronic stages. We recruited patients with PD from March 2018 to March 2019. The patients enrolled underwent medical and sexual history as well as a physical examination. The values of blood count of each patient were collected both in the acute and chronic stages. Wilcoxon test was used to compare the acute and chronic stage ratios. Kruskal-Wallis test was carried out to evaluate the impact of treatments on the ratios. To identify cutoff values, we used sensibility and specificity tables and receiver operating characteristic (ROC) curves. A total of 120 patients were enrolled. Their mean age was 55.85 (range: 18-77) years and the mean penile curvature was 48.43° (range: 10°-100°). In the acute stage, the mean NLR was 2.35 and the mean PLR was 111.22. These ratios, in the chronic stage, were 1.57 and 100.00, respectively. Statistically significant differences between acute and stable stages for both indices were found (NLR: P< 0.0001; PLR: P= 0.0202). The optimal cutoff for classification in acute or stable stage was 2 for NLR and 102 for PLR. According to our results, with an ordinary blood count, we could have important indications regarding the disease stage of the patient, and consequently on the most appropriate type of therapy to choose.

Treatment of peyronie's disease with combination of clostridium histolyticum collagenase and penile traction therapy: a prospective, multicenter, single-arm study.

The aim of this paper is to analyze our experience with intraplaque administration of collagenase from Clostridium Histolyticum (CCH) together with penile modeling for selected patients with Peyronie's disease (PD). We conducted a prospective, multicenter, single-arm study. Patients were included from October 2015 to August 2019. We carried out the I + E PROTOCOL (IMPRESS + extender). Each cycle involved administration of two injections of CCH separated 24-72 h, up to a maximum of four cycles. 24-48 h after injection patients underwent penile modeling maneuvers with the use of a PTD at home for at least 4 h a day. After each cycle, penile curvature was evaluated by the Kelami test. Mean pretreatment curvature was 57° (30-100). Eighty-seven patients underwent at least a single cycle and were eligible for analysis. Mean number of cycles administered was 2. Final average curvature after treatment, regardless of the number of cycles was 34°, with a mean reduction in curvature of -23.29° (-41%). Across the first three cycles we found statistically significant differences in the means in terms of the degrees of curvature after each cycle (p < 0.05), however this was not maintained in the fourth cycle. Statistical significance was also found when comparing the initial and final curvature after the complete treatment. We can conclude that treatment with CCH for PD is safe and effective. The concomitant use of CCH and PTT may limit the number of treatment cycles necessary to optimize outcomes when compared with CCH alone.

Quality of life and adverse events in patients with nonmuscle invasive bladder cancer receiving adjuvant treatment with BCG, MMC, or chemohyperthermia.

INTRODUCTION: Chemohyperthermia (CHT) with mitomycin C (MMC) is together with Bacillus Calmette-Guérin (BCG), and passive MMC, a treatment option for patients with non muscle-invasive bladder cancer. There are no data published about the impact of CHT in quality of life (QoL). We evaluated QoL and adverse events (AE) in this 3-arm observational study. PATIENTS AND METHODS: Prospective observational study from September 2016 to March 2017, we recruited consecutive patients that received adjuvant treatment after transurethral resection of bladder tumor. Patients received induction courses of either BCG, CHT, or passive MMC. Patients filled the questionnaires Functional assessment of cancer therapy for bladder cancer patients (FACT-Bl) and International prostate symptom score (IPSS) before, during, and after the induction course. A urologist documented AE using Common Terminology Criteria for AE (CTCAE criteria). RESULTS: A total of 56 patients, receiving a total of 296 bladder instillations (BCG n = 27, CHT n = 14 and MMC n = 15). FACT-Bl showed statistically significant differences in the fourth week in favor of CHT versus BCG, IPSS did not show statistically significant differences before, during, and after induction course in all 3 arms. All patients recovered their baseline QoL at the end of the induction treatment. Overall 55.5%, 50% and 20% of patients presented any grade of AE in the BCG, CHT and MMC groups respectively. About 7% of patients in BCG and CHT arms had to discontinue treatment due to AE. BCG and CHT showed a similar rate of AE but in CHT were mostly grade I and BCG had grade I, II, and IV. Passive MMC had the safest profile. CONCLUSION: There are no clinically significant differences between BCG, CHT, and passive MMC regarding QoL and lower urinary tract symptoms during the induction course. CHT has a more favorable AE profile when compared with BCG.

[New endovesical chemotherapy and means of administration: EMD, HIVEC, Synergo, Unithermia.] / Nuevos quimioterápicos endovesicales y vehículos de aplicación: EMDA, Synergo, HIVEC y Unithermia.

Non-muscle invasive bladder cancer has a high recurrence and progression rate. Endovesical administration of chemotherapy after transurethral resection of bladder tumors aims to minimize the recurrence and progression rates. Over last decades BCG and MMC have been gold standard treatments. Still alarge proportion of patients recur and progress. Altogether with periods of BCG shortage has facilitate the search for alternatives. In the current manuscript we review the current drug sunder study including chemotherapy, immunotherapy and gene therapy. We also updated results on recent findings on means of intravesical administration, including hyperthermia assisted by external devices. The objectives of our products are implementing new efficient and safe alternatives and the development of technologies that increase of currently used drugs. After years without improvements in the field, nowadays we have a myriad of options available. Some of those new devices will remain and reach general urologist for their applicability. Preliminary results are promising and a positive environment surrounds the urologist in charge of bladder cancer.

La principal característica que define al cáncer de vejiga no músculo invasivo es su elevada tasa de recurrencia y progresión, lo que obliga a la administración de tratamientos adyuvantes a la resección transuretral con el objetivo de minimizar dichos riesgos. Los tratamientos de referencia durante décadas han sido el bacilo de Calmette-Guérin (BCG) y la quimioterapia intravesical, generalmente la mitomicina C (MMC). A pesar de ellos, hay un número significativo de pacientes cuya enfermedad recurre o progresa. Esto, unido a los episodios de desabastecimiento acontecidos con los citados fármacos, ha conducido a la búsqueda de nuevas alternativas para este grupo de pacientes.En este artículo llevamos a cabo una revisión, por un lado, de los fármacos en proceso de desarrollo, incluyendo quimioterápicos, inmunoterápicos y terapia génica. Por otro lado, actualizamos los datos de la literatura más reciente en lo relativo a vehículos de aplicación de fármacos por vía intravesical, tanto en novedosos sistemas de aplicación como en generación de hipertermia asistida por dispositivos externos. Los objetivos de los nuevos productos son dos: la creación de nuevas alternativas con eficacia y seguridad o el desarrollo de tecnologías que permitan incrementar la eficacia de los fármacos ya existentes. Tras años sin grandes avances en este escenario del cáncer de vejiga, en la actualidad hay un amplio abanico de nuevas soluciones en desarrollo. Idealmente, algunos de ellos continuarán su desarrollo y en los próximos años estarán disponibles para los urólogos, ampliando el arsenal terapéutico para esta condición. Los resultados preliminares son prometedores, dando lugar a una gran esperanza y sensación de optimismo en los urólogos encargados del manejo de este tipo de pacientes.