Consensus document on the implications of standardization of BCG supply in the management of patients with non-muscle-invasive bladder cancer.

Patients with non-muscle-invasive bladder cancer (NMIBC) in the intermediate and high-risk groups must receive adjuvant treatment with intravesical Bacillus Calmette-Guérin (BCG) following transurethral resection (TUR), as it reduces the risk of recurrence and presumably the risk of progression as well. Optimization of BCG efficacy is achieved by administering maintenance therapy. However, since many immunological aspects of the mechanism of action of BCG in the bladder remain unknown, the implementation of the optimal dose, number of instillations, strains and adequate maintenance regimen over the last decades has been heterogeneous. Additionally, this has hindered the interpretation of efficacy in terms of oncologic outcomes. This, together with the shortages of BCG in recent years, have forced scientific societies to adapt their clinical practice guidelines and modify their protocols of adjuvant treatment with BCG. This includes changes to strains, doses, and maintenance during this period of time. This consensus document evaluates the current status of adjuvant BCG treatment and the implications of BCG supply availability in the treatment of patients with NMIBC. It also addresses the implementation of novel therapies that will improve cancer prognosis and the quality of life of patients with NMIBC in the future.

Identifying prognostic parameters related to surgical technique in patients treated by robotic radical prostatectomy.

INTRODUCTION AND OBJECTIVE: The most frequently studied factors in patients treated by robotic radical prostatectomy are PSA and pathological features of the biopsy and prostatectomy specimen. Studies on the factors associated with the surgical technique are scarce and with controversial results. The objective is to identify all possible surgical factors and their relationship with disease-free and metastasis-free survival. PATIENTS AND METHOD: Prospective study approved by the Ethics Committee, including patients who underwent robotic radical prostatectomy since January 2009 with a minimum follow-up of 5 years. Surgeon, surgical time, blood loss, fascial access, continence techniques, preservation of the fascia, neurovascular bundles, bladder neck, urethra, learning curve and surgical complications, were analyzed as possible prognostic factors. We performed univariate and matched comparisons of survival using Kaplan-Meier estimation and long-rank tests. The significance level for multiple comparisons was established with False Discovery Rate-adjustment (adjusted p). RESULTS: Cohort of 667 patients with a median follow-up of 69 months. In univariate analysis, surgeon (adjp=0.018), preservation of puboprostatic ligaments (adjp=0.02), preservation of endopelvic fascia (adjp=0.001) and performing periurethral suspension (adjp<0.001) are poor prognostic factors for disease-free survival. Fascia preservation also negatively affects metastasis-free survival (adjp=0.04). Previous abdominal surgeries, prostate, surgical time, blood loss, type of residual urethra, middle lobe, fascial access, fascia or bladder neck preservation, have no statistical significance. CONCLUSIONS: The surgeon and specific aspects of the surgical technique are determining factors in disease-free survival. Preservation of the fascia is the only factor that negatively affects metastasis-free survival.

Hormone sensitive protocol for metastatic prostate cancer, an update.

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology.

Non-metastatic castration-resistant prostate cancer: management recommendations.

INTRODUCTION AND OBJECTIVE: Survival and quality of life (QoL) of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) deteriorate significantly when they develop metastases. New generation antiandrogens (apalutamide, enzalutamide and darolutamide) can prolong metastasis-free survival (MFS) and overall survival (OS) in these patients, maintaining their QoL. MATERIAL AND METHODS: After the performance of a systematic review of the literature, a scientific committee reached a consensus on simple and practical recommendations to consolidate and improve the management of patients with nmCRPC in urology consultations. RESULTS: Recommendations are made on the frequency of PSA determination and imaging tests in patients with nmCRPC. The importance of co-morbidities in patients with nmCRPC is also highlighted, and recommendations are also made on functional and QoL assessment that can be carried out during urology consultations. The efficacy, safety, and effects on QoL of new generation antiandrogens are reviewed. CONCLUSIONS: To evaluate treatment of patients with nmCRPC, it is necessary to consider co-morbidities and QoL, in addition to age. New generation antiandrogens are a safe and effective treatment option for patients with nmCRPC. The recommendations of this review can be helpful in optimizing the management of nmCRPC patients in urology consultations.

Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. / Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real.

INTRODUCTION AND OBJECTIVES: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. MATERIAL AND METHODS: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. RESULTS: The mean age of the 26 patients included was 63.7±11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). CONCLUSION: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies.

Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice. / Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual.

BACKGROUND: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. MATERIAL AND METHODS: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. RESULTS: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) <48h, >48h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade1. There were no statistically significant differences between the strains. CONCLUSIONS: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed.

Radium-223 in the therapeutic sequence of metastatic castration-resistant prostate cancer. / Radio-223 en la secuencia terapéutica del cáncer de próstata resistente a la castración metastásico.

CONTEXT: Radium-223 is an □ -particle transmitter with specific action on bone metastases. The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study showed that radium-223 extended overall survival and delayed the onset of bone events in patients with symptomatic castration-resistant prostate cancer with bone metastases (mCRPC) and without visceral metastases, with a good safety profile. OBJECTIVE: To review the new scientific evidence on radium-223 based on prespecified and post-hoc analyses of the ALSYMPCA study and on early-access programs after the publication of the ALSYMPCA study, thereby providing new data on the management of patients with mCRPC. ACQUISITION OF EVIDENCE: We searched for evidence on PubMed and in the abstracts of international urology and oncology congresses, as well as ongoing clinical trials (ClinicalTrials.gov). SYNTHESIS OF THE EVIDENCE: The results of the reviewed studies offer promising results that will broaden the therapeutic benefits of radium-223 to patients with mild symptoms and those with no symptoms. The results also provide preliminary evidence on the benefit of radium-223 treatment after the failure of docetaxel, enzalutamide or abiraterone or the combination of radium-223 with these agents or other therapeutic agents such as bone-targeted agents and immunotherapy. CONCLUSION: Radium-223 can be a treatment option for patients with mild symptoms and can provide a therapeutic benefit after failure of currently available treatments or in combination with these treatments. This evidence should be corroborated in clinical trials before being added to clinical practice.

Bladder cancer in Spain 2011: population based study.

PURPOSE: We estimate the annual incidence of bladder cancer in Spain and describe the clinical profile of patients with bladder cancer enrolled in a population based study. MATERIALS AND METHODS: Using the structure of the Spanish National Health System as a basis, in 2011 the AEU (Spanish Association of Urology) conducted this study with a representative sample from 26 public hospitals and a reference population of 10,146,534 inhabitants, comprising 21.5% of the Spanish population. RESULTS: A total of 4,285 episodes of bladder cancer were diagnosed, of which 2,476 (57.8%) were new cases and 1,809 (42.2%) were cases of recurrence, representing an estimated 11,539 new diagnoses annually in Spain. The incidence of bladder cancer in Spain, age adjusted to the standard European population, was 20.08 cases per 100,000 inhabitants (95% CI 13.9, 26.3). Of patients diagnosed with a first episode of bladder cancer 84.3% were male, generally older than 59 years (81.7%) with a mean ± SD age of 70.5 ± 11.4 years. Of these patients 87.5% presented with some type of clinical symptom, with macroscopic hematuria (90.8%) being the most commonly detected. The majority of primary tumors were nonmuscle invasive (76.7%) but included a high proportion of high grade tumors (43.7%). According to the ISUP (International Society of Urologic Pathology)/WHO (2004) classification 51.1% was papillary high grade carcinoma. Carcinoma in situ was found in 2.2% of primary and 5.8% of recurrent cases. CONCLUSIONS: The incidence of bladder cancer in Spain, age adjusted to the standard European population, confirms that Spain has one of the highest incidences in Europe. Most primary nonmuscle invasive bladder cancer corresponded to high risk patients but with a low detected incidence of carcinoma in situ.

Enucleación de quiste lateral de próstata con láser holmium: una excelente alternativa / Enucleation of a lateral prostatic cyst of the prostate with the holmium laser, an excellent therapeutical alternative

Presentar un caso de sintomatología del tracto urinario inferior provocada por obstrucción al fluido urinario por un quiste lateral de próstata y los resultados de la enucleación del mismo con láser Holmium. Presentamos el caso de un paciente joven con sintomatología miccional de 1 año de evolución. Diagnosticado mediante ecografía de quiste prostático. Ante el diagnóstico de quiste obstructivo, se plantea enucleación con láser holmium obteniendo resultadospost operatorios inmediatos y excelentes. Los quistes prostáticos simples son el tipo más frecuente, siendo asintomáticos en la mayoría de los casos y descubiertos incidentalmente. Dichos quistes adquieren importancia clínica si provocan sintomatología del tracto urinario inferior, infertilidad o son el asiento de neoplasia prostática. El tratamiento habitual es la resección transuretral. En este paciente planteamos enucleación del quiste con láser holmium. Esta técnica permite et alta hospitalaria sin sonda en menos de 24 horas, se evita el riesgo de síndrome de reabsorción, provoca un mínimo sangrado y rápida remisión de la sintomatología...

The purpose of this paper is to present a case of lower urinary tract symptomatology caused by flow obstruction due to a lateral cyst of the prostate and the results obtained by enucleating using the Holmium laser. We present the case of a young patient with one year of lower urinary-tract symptoms. The diagnosis of a prostatic cyst was confirmed by ultrasound examination. Having the finding of an obstructive prostatic cyst it was treated by means of Holmium laser enucleation with excellent postoperative results. Simple prostatic cysts are the most frequent type and are generally asymptomatic and are incidentally discovered during routine examination. These cysts become clinically relevant when they cause lower urinary tract symptoms, infertility or are associated with cancer. Usual treatment is endoscopic resection. ln this case we preformed an Holmium laser enuclation of the c yst, thus permitting the discharge of the patient without catheter in less than 24h. And minimizes reabsortion syndrome and bleeding, with a very fast resolution of the clinical symptomatology...

[Is it possible to predict postoperative ileus following radical cystectomy?]. / ¿Podemos predecir el íleo postoperatorio tras cistectomía radical?

OBJECTIVE: Radical cystectomy with urinary diversion is a procedure in which a reduction of morbidity, quick postoperative rehabilitation, limited length of stay and cost containment are difficult to achieve. Postoperative ileus has been identified as the most common cause of delayed recovery and prolonged length of stay. With our review, we try to establish the main causes. MATERIAL AND METHODS: A total of 154 patients underwent radical cystectomy from 1990 to 2008. We examined demographic and perioperative variables of the patients who did and did not develop ileus. RESULTS: No significant association was found between ileus and all the factors we studied. CONCLUSIONS: Postoperative ileus stands out as one of the most frequent complications that causes increased length of stay. More detailed studies are required to determine perioperative regimens to reduce this complication.

[Socioclinical and diagnostic characteristics of prostatism in Spain at the end of the 20th century]. / Características sociosanitarias y diagnósticas del paciente prostático en España a finales del siglo XX.

RATIONALE: To study sociodemographic characteristics and current diagnostic and therapeutic behaviour with Benign Prostate Hyperplasia (BPH) patients in Spain at the end of the 20th century. METHODS: Sociodemographic, clinical, therapeutic and quality of life (QoL) data from study ESECI-98, conducted in Spain (1998-1999) in patients with BPH. RESULTS: Nine hundred and forty nine patients were evaluable, with a mean (+/- SD) age of 65.6 (+/- 7.8) years, with concomitant diseases (40%), pain/discomfort (34%) and anxiety/depression (23%); QoL score (mean +/- SD) was 72.1 +/- 16.1 on a total possible score of 100. BPH diagnosis was based on symptoms (93%), digital rectal examination (93%) and abdomino-pelvic ultrasonography (76%). PSA was mentioned for the diagnosis of BPH in 54% of the patients and 77% were receiving pharmacological treatment (61% alpha-blockers) during less than 6 months (38%) or more than a year (35%). CONCLUSIONS: In this study the diagnosis of BPH was mainly based on symptoms, digital rectal examination and abdomino-pelvic ultrasonography. It is worth mentioning that PSA for the diagnosis of BPH, was used in a half of the total number of patients. Pharmacological therapy was used in 3 out of every 4 patients. Compared to a previous national study, there is a change on diagnosis and therapy of BPH.

[Trigono-cervico-prostatotomy (TCP) versus transurethral resection of the prostate (TURP). Our experience]. / Trigonocervicoprostatotomía (TCP) versus resección transuretral de próstata (RTU). Nuestra experiencia.

OBJECTIVE: Trigonocervicoprostatotomy (TCP) has been considered up to now an alternative treatment to transurethral resection of the prostate (TURP) when evaluating the size of the prostate. This paper demonstrates that endoscopic visualization is more important when choosing the surgical procedure and that both techniques can achieve satisfactory results. METHODS: The prostate volume is evaluated by ultrasound and according to the endoscopic findings, TURP or TCP is performed. The prostatic lobes are routinely biopsied if the latter procedure is chosen. RESULTS: We compared the results of 34 TCP and 30 TURP procedures using the values of I-PSS and uroflowmetry before and after surgery. In 86.2% of the TCPs and 80% of the TURPs, the patients are asymptomatic with I-PSS less than 7 and significantly improved uroflowmetry data. Biopsy disclosed adenocarcinoma in one patient submitted to TCP. CONCLUSIONS: TCP represents an alternative to TURP not only for small prostates (30 gm) but also for medium-sized prostates (50-60 gms), depending on the endoscopic findings. TCP is not indicated for lateral lobes that fall on the prostate floor. Performing a biopsy routinely in TCP does not prolong the operating time significantly and permits detecting subclinical adenocarcinoma of the prostate.

[Renal-cell adenocarcinoma as an incidental finding. Its diagnosis and tumor evolution]. / Adenocarcinoma renal como hallazgo incidental. Diagnóstico y evolución tumoral.

OBJECTIVES: We attempted to determine whether or not incidental renal cell carcinoma had a better prognosis. METHODS: We reviewed 53 cases of renal cell carcinoma that had been surgically treated over the periods 1985-1988 and 1989-1993. The form of presentation, stage of the incidental tumors, sex, compromised side and the diagnostic imaging technique utilized were analyzed. RESULTS: GI pathology most frequently led to the diagnosis of the tumor. Tumor stages were A or B with a slightly higher prevalence for the incidental tumors. However, the prognosis was not better than that of clinically suspected renal cell carcinoma. The male to female ratio was 1.17:1, the mean age was 63 years, the tumors were frequently right-sided and ultrasound was superior in the diagnosis of incidental tumors. CONCLUSIONS: No prognostic difference was observed between clinically suspected and incidental renal cell carcinoma of the same tumor stage.

[Cysts of the ejaculatory ducts. Diagnosis and clinical course after treatment]. / Quistes de conducto eyaculador. Diagnóstico y evolución tras tratamiento.

Confusion surrounding diagnosis of central prostate cysts is explained for the rarity of the condition. Deferento-vesiculography is diagnostic and must be performed independently (right-left) for a better anatomical evaluation of the area. The endoscopic images do not allow differential diagnosis from other prostate cysts. Recovery of bearer's fertile ability following endoscopic resection does not result, in our experience, as effective as it could be expected from resolving the obstructive cause.

[Bladder hernia. Report of 4 cases]. / Hernias vesicales. Aportación de cuatro casos.

Four cases of vesicoscrotal herniation are described. The different etiology and forms of presentation (from an incidental finding to one requiring emergency treatment) of this condition are discussed. Surgical treatment is based on its size, location and coexisting pathology (prostatic hyperplasia, calculus, bladder tumor, etc.).

[Trigeminal neuralgia. First manifestation of adenocarcinoma of the prostate]. / Neuralgia del trigémino. Primera manifestación de un adenocarcinoma de próstata.

We report a case of adenocarcinoma of the prostate that had been incidentally discovered during patient evaluation for trigeminal nerve neuralgia refractory to treatment. Analysis revealed the underlying cause of neuralgia was tumor metastasis to the mandible, which had caused irritation of the fifth nerve. The patient was treated with complete androgenic block and his symptoms improved simultaneously with partial remission of metastasis.