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Background and Objective: Despite the proven effectiveness of organized PSA-based screening in reducing prostate cancer-related mortality, there is currently no program in Germany covered by statutory health insurance. In accordance with the EU Council Decision (2022/0290(NLE)), the German Society of Urology (DGU) has developed a concept for risk-adapted prostate cancer early detection., Materials and Methods: Based on a literature review of current screening studies, an algorithm for PSA-based prostate cancer early detection was developed., Results: Risk-adapted prostate cancer screening involves PSA testing in the age group of 45-70 years, followed by PSA-based individual risk stratification and stepwise expansion of diagnostics through magnetic resonance imaging (MRI) to biopsy. While initially up to 2.6 million men will undergo PSA testing, a reduction in these initial examinations to fewer than 200,000 men per year will occur from year four onwards., Conclusions: The presented algorithm provides clear recommendations for risk-adapted PSA-based early detection for prostate cancer for urologists and patients. The goal is to improve diagnosis of clinically significant prostate cancer, while reducing overdiagnosis and overtreatment., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Human beings with a difference in sexual development (DSD) often underwent gender reassignment surgery during early childhood. However, the medical decision was often not congruent with the gender identity that affected persons developed later on., Objectives: To represent the interests of affected persons, an interdisciplinary guideline in cooperation with support groups was written., Materials and Methods: The revision of the first version of the guideline, published in 2016, was edited by 18 professional societies and working groups as well as 3 support groups. A literature search was performed for each of the 12 chapters. Recommendations and statements created by the working groups were voted on during four consensus conferences., Results: The guideline highlights the right of self-determination of affected persons. In this context, new legal requirements are reported. Other than necessary primary diagnostics, medical procedures should be postponed. Most important is the psychological support of parents and patients. Tumor risk of the gonads and protection of fertility are analyzed and discussed in detail., Conclusion: The content of the guideline represents a paradigm shift in dealing with human beings with a difference of sexual development. Projects as DSD Care and Empower-DSD help to promote the practical implementation of the guideline's recommendations., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Renal cell carcinoma is the third most common tumor among urological tumors. In Germany more than 14,000 people are affected every year. The sex ratio is 2/3 men and 1/3 women., Objectives: The S3 guideline is intended to provide all disciplines dealing with renal cell carcinoma with the current status of diagnostics, therapy and follow-up care of the patients with this tumor., Materials and Methods: The first version of the German guideline on renal cell carcinoma was published in 2015. The development was carried out at S3 level, which means that a structured, evidence-based literature search was carried out, recommendations and statements were developed in topic-related working groups and were approved by an interdisciplinary group of officials elected by the different medical societies. The chapters were gradually revised in 2017, 2020 and 2021 to reflect new aspects. This article provides information about the most important innovations of the most recent update from 2023., Results: In the epidemiology subsection, the substance trichlorethene has been added as a risk factor for the development of renal cell carcinoma. While there were no new data on neoadjuvant therapy, the checkpoint inhibitor pembrolizumab was the first substance to demonstrate improved disease-specific and overall survival in the adjuvant situation. The combination nivolumab plus cabozantinib and lenvatinib plus pembrolizumab were included in the chapter on systemic therapy for metastatic clear cell renal cell carcinoma. New are the chapters on non-clear cell renal cell carcinoma and hereditary tumors., Conclusions: The S3 guideline provides a structured, evidence-based overview of all aspects of renal cell carcinoma., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Introduction: We report early postoperative complications (PCs) (≤90 days) of one-stage oral mucosa graft (OMG) urethroplasty in treatment of acquired anterior urethral strictures., Material and Methods: In this study, we evaluated 530 males who underwent one-stage substitution urethroplasty (SU) between September 1996 and October 2020. Medical records were reviewed to identify and classify early PCs based on the Clavien-Dindo classification (CDC). We subdivided the PCs into three groups with different kinds of complications which allowed us a more detailed analysis concerning general surgical complications (GSCs), donor site morbidity (DSM) and complications specific for free graft urethroplasty (CSUs). The influence of patient demographics, stricture characteristics and operative procedure on the occurrence of PCs was analysed., Results: Early (90-day) PCs occurred in 90 (16.98%) patients, whereas only 19 patients (3.58%) experienced serious events (CDC grades III and IV). Early complications include 4.5% GSCs, 1.7% DSM and 10.8% CSUs. Only stricture length turned out to be an independent statistically significant risk factor for the occurrence of early PCs. There was a trend towards a higher rate of complications in patients with ASA III compared to ASA I., Conclusion: The incidence of severe early complications in patients undergoing one-stage SU with OMG is low., (© 2023 S. Karger AG, Basel.)

Background: Germ-cell tumors of the testes are the most common type of malignant tumor in men aged 20 to 40. Their incidence in Germany is 10 per 100 000 men per year, with an estimated 4200 new cases annually., Methods: This selective review is based on the recommendations of the German clinical practice guideline on the diagnosis, treatment and follow-up care of testicular germ-cell tumors, as well as on pertinent original articles and reviews., Results: The treatment of germ-cell tumors requires an interdisciplinary approach comprising resection of the affected testis followed by further steps that depend on the histological type and stage of the tumor, which may include active surveillance, chemotherapy, radiotherapy, further surgery, or some combination of these measures. Two-thirds of germ-cell tumors are diagnosed in clinical stage I, when they are still confined to the testis; one-third are already metastatic when diagnosed, with organ metastases in 10-15%. Stage-based multimodal treatment approaches are associated with cure rates of more than 99% for stage I tumors and 67-95% for advanced metastatic disease, depending on the degree of progression., Conclusion: For patients with early-stage tumors, overtreatment should be avoided in order to minimize long-term sequelae. For those whose tumors are in advanced stages, it must be decided which patients should receive intensified treatment to optimize the outcome. Multimodal treatment approaches are associated with high cure rates even for patients with metastatic disease.

Guidelines can only give treatment recommendations for defined patient groups if high quality and meaningful evidence is available. However, patients included in clinical trials for the treatment of metastatic and/or locally advanced bladder cancer (mUC) are generally not representative for the spectrum of patients encountered in daily clinical practice. In particular, patients with different systemic pretreatments, variable prestudy responses or variable time to tumor progression are not sufficiently considered in trials and guideline recommendations. Accordingly, recommendations for the treatment of mUC patients with previous perioperative systemic therapy are lacking. To provide some guidance for daily uro-oncological practice despite the limited evidence, we sought to develop expert opinion-based treatment recommendations. These recommendations focus on palliative first-line therapy of mUC. Both perioperative pretreatment with classical cisplatin-based systemic therapy and/or immunotherapy, as well as the time to tumor recurrence have been considered., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Lymph node metastases are common in pelvic urological tumors, and the age-related remodeling process of the pelvic lymph nodes influences metastatic behavior. The aim of this work is to characterize age-related degenerative changes in the pelvic lymph nodes with respect to their occurrence and extent. A total of 5173 pelvic lymph nodes of 390 patients aged 44 to 79 years (median 68 years, IQR 62-71 years) were histologically examined for degenerative structural changes. Lymph node size, lipomatous atrophy, capsular fibrosis, framework fibrosis, and calcifications were recorded semi-quantitatively and evaluated by age group. Significantly more lymph nodes <10 mm were found in older patients ( p = 0.001). The incidence of framework fibrosis, capsular fibrosis, and calcifications increased significantly with increasing patient age ( p < 0.001). In lipomatous atrophy, an increase in mild to moderate lipomatous atrophy was observed with increasing age ( p < 0.001). In this, the largest study to date on this topic, age-related degenerative changes in pelvic lymph nodes were proven. Due to the consecutive decrease in hte filtration function of pelvic lymph nodes with increasing age, staging and therapy of metastatic pelvic urologic carcinomas should be reconsidered.

Background: Steep Trendelenburg position combined with capnoperitoneum can lead to pulmonary complications and prolonged affection of postoperative lung function. Changes in pulmonary function occur independent of different modes of ventilation and levels of positive end-expiratory pressure (PEEP). The effect of flow-controlled ventilation (FCV) has not been evaluated yet. We perioperatively measured spirometric lung function parameters in patients undergoing robot-assisted prostatectomy under FCV. Our primary hypothesis was that there is no significant difference in the ratio of the maximal mid expiratory and inspiratory flow (MEF50/MIF50) after surgery., Methods: In 20 patients, spirometric measurements were obtained preoperatively, 40, 120, and 240 min and 1 and 5 days postoperatively. We measured MEF50/MIF50, vital capacity (VC), forced expiratory volume in 1 s (FEV1), and intraoperative ventilation parameters., Results: MEF50/MIF50 ratio increased from 0.92 (CI 0.73-1.11) to 1.38 (CI 1.01-1.75, p < 0.0001) and returned to baseline within 24 h, while VC and FEV1 decreased postoperatively with a second nadir at 24 h and only normalized by the fifth day (p < 0.0001). Compared to patients with PCV, postoperative lung function changes similarly., Conclusion: Flow-controlled ventilation led to changes in lung function similar to those observed with pressure-controlled ventilation. While the ratio of MEF50/MIF50 normalized within 24 h, VC and FEV1 recovered within 5 days after surgery., (© 2023. The Author(s).)

Due to demographic change associated with an increase in patient numbers as well as the existing shortage of medical personnel, the German healthcare system will face a major challenge in patient care. In order to maintain high-quality patient care at a high level, the digitisation of urology should be driven forward promptly and forcefully as digital applications such as online appointment scheduling, video consultations, digital health applications (DiGAs) and others could significantly improve treatment efficiency. The long-planned introduction of the electronic patient record (ePA) will hopefully accelerate this process, and medical online platforms could also become a permanent part of new treatment methods, which could emerge from the urgently needed structural change towards more digital medicine, including questionnaire-based telemedicine. This transformation, which, already today, is urgently needed in the healthcare system, must be demanded and promoted by service providers, but also by policymakers and administration, in order to achieve the positive development of digitisation in (urological) medicine., Competing Interests: J. Huber ist Vorsitzender des Arbeitskreis "Versorgungsforschung, Qualität und Ökonomie“ der Deutschen Gesellschaft für Urologie e.V. und Initiator der Entscheidungshilfe Prostatakrebs (www.entscheidungshilfe-prostatakrebs.info). Die Entscheidungshilfe Prostatakrebs wird unterstützt von den Firmen Takeda Pharma, Janssen Cilag GmbH und Apogepha. J. Huber, A. Merseburger und S. Krege sind Mitglied des Medical Board der Urologischen Stiftung Gesundheit gGmbH. K. Miller ist medizinischer Berater der Kranus Health GmbH. A. Merseburger gibt Vortragshonorare von AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ferring Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche an sowie Beratertätigkeit für AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ferring, Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche sowie Forschungsförderung durch AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche an. C. Gratzke gibt Vortragshonorare von Amgen, Astellas Pharma, Astra Zeneca, Bayer, GSK, Ipsen, Janssen, Lilly Pharma, MSD, Novartis, Recordati, Pfizer, Rottapharm und STEBA Biotec sowie Beratertätigkeit für Astellas Pharma, Astra Zeneca, Bayer, Janssen, MSD und Novartis sowie Forschungsförderung durch Astellas Pharma, Bayer, GSK, MSD und Recordati an. H. Borgmann gibt an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: To evaluate the incidence of lymph node degeneration and its association with nodal metastatic pattern in prostate cancer., Methods: A retrospective analysis of the submitted lymph node specimen of 390 prostatectomies in 2011 was performed. All lymph nodes were histologically re-evaluated and the degree of lymph node degeneration e.g. lipomatous atrophy, capsular and framework fibrosis, and calcifications as well as the lymph node size were recorded. Lymph node degeneration was compared in the anatomic regions of the pelvis as well as in lymph nodes with and without metastases of prostatic cancer., Results: Eighty-one of 6026 lymph nodes demonstrated metastases. Complete histologic examination with analysis of a complete cross-section was possible in 5173 lymph nodes including all lymph nodes with metastases. The incidence of lymph node degeneration was different across the various landing sites. Lymph node metastases were primarily detected in less degenerative and therefore more functional lymph nodes. In metastatic versus non-metastatic lymph nodes low lipomatous atrophy was reported in 84.0% versus 66.7% (p = 0.004), capsular fibrosis in 14.8% versus 35.4% (p < 0.001), calcifications in 35.8% versus 46.1% (p = 0.072) and framework fibrosis in 69.8% versus 75.3% (p = 0.53). Metastases were also identified more frequently in larger than in smaller lymph nodes (63.0% vs. 47.5%; p = 0.007)., Conclusions: Degenerative changes in pelvic lymph nodes are commonly detectable but occur with variable frequency in the various nodal landing sites in the pelvis. The degree of lymph node degeneration of single lymph nodes has a significant influence on whether a lymph node is infiltrated by tumor cells and may harbour metastases., (© 2023. The Author(s).)

Purpose: The optimal treatment for clinical stage (CS) IIA/IIB seminomas is still controversial. We evaluated current treatment options., Methods: A systematic review was performed. Only randomized clinical trials and comparative studies published from January 2010 until February 2021 were included. Search items included: seminoma, CS IIA, CS IIB and therapy. Outcome parameters were relapse rate (RR), relapse-free (RFS), overall and cancer-specific survival (OS, CSS). Additionally, acute and long-term side effects including secondary malignancies (SMs) were analyzed., Results: Seven comparative studies (one prospective and six retrospective) were identified with a total of 5049 patients (CS IIA: 2840, CS IIB: 2209). The applied treatment modalities were radiotherapy (RT) (n = 3049; CS IIA: 1888, CSIIB: 1006, unknown: 155) and chemotherapy (CT) or no RT (n = 2000; CS IIA: 797, CS IIB: 1074, unknown: 129). In CS IIA, RRs ranged from 0% to 4.8% for RT and 0% for CT. Concerning CS IIB RRs of 9.5%-21.1% for RT and of 0%-14.2% for CT have been reported. 5-year OS ranged from 90 to 100%. Only two studies reported on treatment-related toxicities., Conclusions: RT and CT are the most commonly applied treatments in CS IIA/B seminoma. In CS IIA seminomas, RRs after RT and CT are similar. However, in CS IIB, CT seems to be more effective. Survival rates of CS IIA/B seminomas are excellent. Consequently, long-term toxicities and SMs are important survivorship issues. Alternative treatment approaches, e.g., retroperitoneal lymph node dissection (RPLND) or dose-reduced sequential CT/RT are currently under prospective investigation., (© 2021. The Author(s).)

Purpose: Testicular germ cell tumours (GCTs) represent the most common malignancy in young adult males with two thirds of all cases presenting with clinical stage I (CSI). Active surveillance is the management modality mostly favoured by current guidelines. This systematic review assesses the treatment results in CSI patients concerning recurrence rate and overall survival in non-seminoma (NS) and pure seminoma (SE) resulting from surveillance in comparison to adjuvant strategies., Methods/systematic Review: We performed a systematic literature review confining the search to most recent studies published 2010-2021 that reported direct comparisons of surveillance to adjuvant management. We searched Medline and the Cochrane Library with additional hand-searching of reference lists to identify relevant studies. Data extraction and quality assessment of included studies were performed with stratification for histology (NS vs. SE) and treatment modalities. The results were tabulated and evaluated with descriptive statistical methods., Results: Thirty-four studies met the inclusion criteria. In NS patients relapse rates were 12 to 37%, 0 to 10%, and 0 to 11.8% for surveillance, chemotherapy and for retroperitoneal lymph node dissection (RPLND) while overall survival rates were 90.7-100%, 91.7-100%, and 97-99.1%, respectively. In SE CSI, relapse rates were 0-22.3%, 0-5%, and 0-12.5% for surveillance, radiotherapy, chemotherapy, while overall survival rates were 84.1-98.7%, 83.5-100%, and 92.3-100%, respectively., Conclusion: In both histologic subgroups, active surveillance offers almost identical overall survival as adjuvant management strategies, however, at the expense of higher relapse rates. Each of the management strategies in CSI GCT patients have specific merits and shared-decision-making is advised to tailor treatment., (© 2022. The Author(s).)

Background: Standard treatment options for patients with stage IIA or stage IIB seminoma include either para-aortic and pelvic radiotherapy or three to four cycles of cisplatin-based combination chemotherapy. These options result in 3-year progression free survival rates of at least 90%, but bear risks for acute and late toxic effects, including secondary malignancies. We tested a novel approach combining de-escalated chemotherapy with de-escalated involved node radiotherapy, with the aim of reducing toxicity while preserving efficacy., Methods: In the single-arm, multicentre, phase 2 SAKK 01/10 trial, patients with stage IIA or IIB classic seminoma (either at primary diagnosis or at relapse during active surveillance for stage I) were enrolled at ten centres of the Swiss Group for Clinical Cancer Research and ten centres of the German Testicular Cancer Study Group. WHO performance status 0-2, age 18 years or older, and adequate bone marrow and kidney function were required for eligibility. Treatment comprised one cycle of carboplatin (area under the curve 7) followed by involved-node radiotherapy (30 Gy in 15 fractions for stage IIA disease and 36 Gy in 18 fractions for stage IIB disease). The primary endpoint was 3-year progression-free survival. Efficacy analyses were done on the full analysis set, which comprised all patients who signed the informed consent, were registered in the trial, initiated trial treatment, and met all medically relevant inclusion or exclusion criteria. Safety was assessed in all patients who were treated at least once with one of the trial treatments. The study is ongoing but no longer recruiting, and is registered with Clinicaltrials.gov, NCT01593241., Findings: Between Oct 18, 2012, and June 22, 2018, 120 patients were registered in the study. 116 patients were eligible and started treatment according to the study protocol (46 patients with stage IIA disease and 70 with stage IIB disease). After a median follow-up of 4·5 years (IQR 3·9-6·0), 3-year progression-free survival was 93·7% (90% CI 88·5-96·6). With a target progression-free survival of 95% at 3 years, the primary endpoint was not met. Acute treatment-related adverse events of any grade were noted in 58 (48%) of 116 patients, and grade 3 or 4 treatment-related adverse events occurred in the form of neutropenia in five (4%) patients, thrombocytopenia in three (3%) patients, and vomiting in one (1%) patient. No treatment-related deaths and no late treatment-related adverse events were reported. Serious adverse events were reported in five (4%) of 116 patients (one transient creatinine increase and four second primary tumours)., Interpretation: Despite the fact that the primary endpoint was not met, we observed favourable 3-year progression-free survival with single-dose carboplatin area under the curve 7 and involved-node radiotherapy, with minimal toxic effects. Our findings might warrant discussion with patients about the SAKK 01/10 regimen as an alternative to standard-of-care treatment, but more research on this strategy is needed., Funding: Swiss State Secretariat for Education, Research and Innovation and Rising Tide Foundation for Clinical Cancer Research., Competing Interests: Declaration of interests AP has received honoraria from Astellas, Debiopharm, Janssen, Merck Serono, and Sanofi; and travel support from Astellas, AstraZeneca, and Bayer. MP has received consulting fees from Abbvie, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eisei, Merck Serono, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, and Takeda; honoraria from Amgen, Bayer, Janssen, Nestle, and Sanofi; and travel support from AstraZeneca, Boehringer Ingelheim, BMS, Daiichi Sankyo, Roche, Takeda, and Vifor. MH has received consulting fees from EusaPharma, Janssen, and Sanofi; honoraria from AstraZeneca, Amgen, Celgene, Janssen, Jazz Pharma, Sanofi, and Takeda; and travel support from Janssen. D-RB has received consulting fees from Astellas, Bayer, BMS, Ipsen, Janssen, MSD, and Novartis; and travel support from Ipsen and Janssen. DZ has received honoraria from BMS and travel support from Janssen; and has participated in advisory boards for BMS, Janssen, Merck-Serono, MSD, Pierre-Fabre, and Sanofi. RC has received consulting fees from Astellas, BMS, Bayer, Janssen, Sanofi, Roche, Novartis, MSD, Pfizer, Merck, Debiopharm, and AstraZeneca; and honoraria from Astellas, Roche, and Pfizer. AP, JB, MH, SK, AL, FZ, AD, A-CM, SG, and RC are members of the German Testicular Cancer Study Group. AP, SH, MP, AL, D-MA, PMP, D-RB, DZ, CS, CB, SG, and RC are members of the Swiss Group for Clinical Cancer Research. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Representatives for congenital adrenal hyperplasia (CAH) continue to desire early feminizing surgery in girls with 46,XX-CAH. The aim of this analysis, which included 174 46,XX- individuals with salt-wasting (SW) or simple-virilizing (SV) CAH, a female gender identity, and an age > 16 years participating in a multicenter cross-sectional clinical evaluation study (dsd-LIFE), was to evaluate the long-term results of surgery and patient-reported outcomes (PRO). The gynecological examination (n = 84) revealed some shortcomings concerning surgical feminization. A clitoris was absent in 9.5% of cases, while a clitoral hood was missing in 36.7% of cases. Though all women had large labia, they didn’t look normal in 22.6% of cases. Small labia were absent in 23.8% of cases. There was no introitus vaginae, and the urethra and vagina had no separate opening in 5.1% of cases. A mucosal lining was missing in 15.4% of cases. Furthermore, 86.2% of the women had scars at the region of their external genitalia. A vaginal stenosis was described in 16.5% of cases, and a meatal stenosis was described in 2.6% of cases. Additionally, PRO data showed a very-/high satisfaction rate of 21.3%/40.2% with cosmesis and 23.8%/38.1% with functionality, while 3.3%/10.7% showed a very-/low satisfaction with cosmesis as well as 5.6%/10.3% with functionality. The remaining women—24.6% and 23.8%—were indifferent. Satisfaction concerning sex life was very-/high in 9.6%/27.7%. In 12.0%/16.9% it was very-/low. Furthermore, 33.7% had no opinion. Furthermore, 27.0%/31.6% of the women reported that clitoriplasty, but not clitoridectomy, had a very-/positive influence on their lives, while 1.3%/8.9% felt it to be very-/negative, and 28.4% were indifferent. Vaginoplasty had a very-/positive influence in 25.7%/33.8% and a very-/negative effect in 3.6%/6.8%. 29.7% had no opinion. Additionally, 75.7% of the women preferred feminizing surgery during infancy/childhood, especially concerning clitoreduction. In conclusion, though the majority of the participants (76%) preferred early feminizing surgery and 60% described a positive effect on their lives, about 10% felt it to have been negative. About 15% of the women suffered from insufficient cosmesis and functionality after surgery. Sex life was even described as poor in nearly 30%. Therefore, the decision about early genital surgery in 46,XX-CAH girls should be considered carefully. Parents should get detailed information about possible complications of surgery and should receive support to understand that postponing surgery does not inevitably cause harm for their child. Importantly, genital surgery when performed in children should only be performed in expert centers with a specialized team including surgeons who are trained in feminizing surgery.

Concerning follow-up in bladder cancer, it must be distinguished between superficial, muscle-invasive, and metastatic tumors. In superficial bladder cancer, urethrocystoscopy is still standard for follow-up. Frequency depends on the risk classification. Even muscle-invasive carcinomas, which underwent a R0 resection, will metastasize in about 30% of cases. These tumors as well as primarily metastasized cancer cannot be cured. Therefore, in these cases, one should not speak about follow-up but therapeutic control. Nonetheless, even in these cases the S3 guideline recommends regular follow-up examinations because new therapeutic options can clearly improve patient survival. Possible complications of urinary diversions need consideration during follow-up., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary., Methods: In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety., Results: A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B., Conclusions: AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P., (© 2022. The Author(s).)

Introduction: Clinical stage 1 (CS1) nonseminomatous (NS) germ cell tumors involve a 30% probability of relapse upon surveillance. Adjuvant chemotherapy with one course of bleomycin, etoposide, and cisplatin (1xBEP) can reduce this risk to <5%. However, 1xBEP results are based solely on five controlled trials from high-volume centers. We analyzed the outcome in a real-life population., Patients and Methods: In a multicentric international study, 423 NS CS1 patients receiving 1xBEP were retrospectively evaluated. Median follow-up was 37 (range, 6-89) months. Primary end points were relapse-free and overall survival evaluated after 5 years. We also looked at associations of relapse with clinico-pathological factors using stratified Kaplan-Meier methods and Cox regression models. Treatment modality and outcome of recurrences were analyzed descriptively., Results: The 5-year relapse-free survival rate was 96.2%. Thirteen patients (3.1%; 95% confidence interval, 1.65-5.04%) relapsed after a median time of 13 months, of which 10 were salvaged (77%). Relapses were mostly confined to retroperitoneal nodes. Three patients succumbed, two to disease progression and one to toxicity of chemotherapy. Pathological stage >pT2 was significantly associated with relapse rate., Conclusion: The relapse rate of 3.1% found in this population of NS CS1 patients treated with 1xBEP at the routine care level was not inferior to the median rate of 2.3% reported from a meta-analysis of controlled trials. Also, the cure rate of relapses of 77% is consistent with the previously reported rate of 80%. This study clearly shows that the 1xBEP regimen represents a safe treatment for NS CS1 patients., Competing Interests: Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s), 2022.)

Background: One cycle of adjuvant chemotherapy with bleomycin, etoposide and cisplatin (BEP) has shown superiority in recurrence-free survival over retroperitoneal lymph node dissection (RPLND) in patients with clinical stage (CS) I non-seminomatous germ cell tumours (NSGCTs) of the testis in the setting of a phase III trial. We report the recurrences and late toxicities of this study after 13 years of follow-up., Methods: Questionnaires from 382 patients with CS I NSGCT treated with 1 cycle of adjuvant BEP (arm A) or RPLND + two cycles of adjuvant BEP in cases of pathological stage II disease (arm B) were evaluated regarding recurrences and late toxicity. Overall, information on recurrence status was available in 337 patients, and 170 questionnaires were evaluable for toxicity (arm A: 95; arm B: 75)., Results: With a median follow-up of 13.8 years (0-22), 3 patients (1.6%) in arm A and 16 patients (8.4%) in arm B experienced recurrence. The 15-year PFS in arm A/B was 99% (CI 96-100%)/92% (CI 89-99%) (p = 0.0049). The 15-year OS in arm A/B was 93% (CI 87-97%)/93% (CI 86-97%) (p = 0.83). Eight patients (4.2%) in arm A and four patients (2.1%) in arm B showed metachronous secondary testicular cancer (p = 0.26). Five patients (2.6%) in arm A and four patients (2.1%) in arm B developed other malignancies. Toxicities were not significantly different apart from retrograde ejaculation, which occurred more frequently after RPLND (10% versus 24%, p = 0.01)., Conclusions: With long-term observation, one cycle of BEP remains superior to RPLND in preventing recurrence and was tolerated without any clinically relevant long-term toxicities., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Clinical guidelines represent the latest standard of medical knowledge concerning diagnostics, treatment and follow up of diseases and should support doctors and patients to choose the best treatment. Depending on the prevalence of a disease there exist less or more published data. Therefore, several levels of guidelines are possible. In case of few data the expertise of the attending physicians is of greater importance (S1, S2-guidelines). In case of a huge amount of literature, especially phase III studies or metaanalyses, a S3-guideline can be written. The article describes the process of developing a guideline in Germany under the guidance of the Association of the Scientific Medical Societies in Germany (AWMF) in comparison to the process by the European Association of Urology (EAU). The aim for the future is to join resources. Another aspect of the article is to inform about different procedures how to control the implementation of the guidelines., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Testicular cancer occupies a special position in several respects. Although it belongs to the group of rare tumors, which is why extensive experience in treating this tumor can not be guaranteed, interdisciplinary experts collaboration and the consequent implementation of clinical studies have resulted in standardized treatment recommendations. Because testicular cancer is one of the most curable cancers, long-term toxicity and treatment sequelae are of special importance. In the early stages, toxicity could be reduced by minimizing therapy to the extent possible, but without decreasing treatment success. Nevertheless, treatment is still controversially discussed, especially concerning treatment of stage I disease. Finally particular focus should be paid to non-germinal tumors which are even more rare, but partly also more dangerous. Therefore known facts should be made available for the broad medical community. In penile cancer, which is also a very rare tumor entity, organ-sparing surgery and consequent invasive lymph node staging are mandatory., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Surgery is performed in many individuals with disorders/differences of sex development (DSD). Irreversibility of some surgical procedures, lack of information about the procedures, and lack of follow-up care for physical and psychological outcomes, lead to wish for more knowledge from both surgeons and patients. After the consensus conference in 2006, multidisciplinary care is provided to a higher degree with psychological support and more restricted surgical procedures. Outcome studies after genital surgery often lack of patient's perspective., Objective: To describe surgical procedures in relation to diagnosis, to evaluate the outcomes of surgery through genital examination, and through patient's and observer's satisfaction with the anatomical and functional result after genital surgery., Study Design: In a cross-sectional clinical study performed in six European countries in 2014/15, we have included 500 participants where surgery was performed, from a total of 1040 adolescents (≥16years) and adults with a DSD. Diagnoses included Turner syndrome (n = 301), mixed gonadal dysgenesis (45,XO/46,XY; n = 45), Klinefelter syndrome (n = 218), XYY (n = 1), 46, XY DSD (n = 222) and 46, XX DSD (n = 253). Study protocol included clinical report files, an optional gynecological or urological examination, patient reported outcomes including received surgical interventions, satisfaction with appearance and function after surgery, and impact of the surgical procedure on life., Results: Five hundred participants had received genital or breast surgery, with the highest rate in 46, XY DSD and the lowest in Turner syndrome. Altogether; 240 participants had feminizing surgery, 112 had masculinizing surgery, and 217 underwent gonadectomy. Physicians evaluated anatomical appearance at genital examination as poor in less than 10%. Dissatisfaction with anatomical appearance was reported by 22% of the participants, dissatisfaction with function by 20%. Being (very) dissatisfied with anatomical appearance and function was reported by 13% of the study participants. Most participants reported no impact, or positive impact, of the surgical procedures on their lives, but 29% experienced a negative effect of gonadectomy on their life., Discussion: There might be a selection bias and/or a recall bias for participating in our studies. Due to poor data quality about surgical procedures performed in the past, we also relied on participants memory about surgical procedures in their past. Ideally, patient reported outcomes should be evaluated both before and after surgical procedures., Conclusion: A vast majority are satisfied with appearance and function, but still genital or breast surgery have a long-lasting effect on patient's life. Self-reported satisfaction is usually lower than the observer's evaluation regarding both appearance and function., Competing Interests: Conflicts of interest The authors have no competing interests., (Copyright © 2020 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)

Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic's background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages., Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements., Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma., Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classification after careful diagnostic evaluation. An interdisciplinary approach as well as the referral of selected patients to centres with proven experience can help achieve favourable clinical outcomes., (© 2021 The Author(s). Published by S. Karger AG, Basel.)

Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes therecommendations for the treatment of advanced disease stages and for the management of follow-up and late effects., Materials and Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements., Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy., Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

Individuals born with a variant of gender development still have a special status in our dyadic-oriented society that even nowadays impairs their life in many ways. Thus, physicians and parents regulated the life's journey of these children until less than 30 years ago by conducting a gender assignment after birth and its implementation by surgical interventions. This approach was ensued in the hope that the child would develop the relevant gender identity, an assumption that did not hold true in many cases. Only during the last 20 years, especially due to the public relations activities of associations of affected individuals, a process of rethinking has taken place that strives to focus on the child's right to self-determination. Reforms of the Personal Statute Act have already been accomplished. Apart from the entry "female" and "male" for newborn children, the categories "open" and "diverse" also now exist. This should exonerate the parents and enable affected persons to later register a distinct term. A draft Act about the interdiction of gender-modifying interventions in the case of a child unable to consent already exists, but is controversially discussed, particularly among CAH associations that do not class themselves as variants of gender differentiation and still advocate early surgical operations. Furthermore, there is also an absolute necessity for structural reforms on the care level to ensure a competent counselling, support and/or treatment for individuals born with a variant of gender differentiation.

The therapy of advanced (clear-cell) renal cell carcinoma (RCC) has recently experienced tremendous changes. Several new treatments have been developed, with PD-1 immune-checkpoint inhibition being the backbone of therapy. Diverse immunotherapy combinations change current first-line standards. These changes also require new approaches in subsequent lines of therapy. In an expert panel, we discussed the new treatment options and how they change clinical practice. While first-line immunotherapies introduce a new level of response rates, data on second-line therapies remains poor. This scenario poses a challenge for clinicians as guideline recommendations are based on historical patient cohorts and agents may lack the appropriate label for their in guidelines recommended use. Here, we summarize relevant clinical data and consider appropriate treatment strategies.

Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial., Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management., Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference., Setting: Online Delphi survey and consensus conference., Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management., Outcome Measurements and Statistical Analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus)., Results and Limitations: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease., Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach., Patient Summary: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available., (Copyright © 2019 European Society of Medical Oncology and European Association of Urology. Published by Elsevier B.V. All rights reserved.)

In view of a considerable risk of recurrence especially in patients with a high-risk profile after organ-sparing surgery or nephrectomy, adjuvant treatment seems to make sense in renal cell carcinoma. After the failed attempts using older immunotherapeutics or vaccination therapies, new hope was put in the panel of targeted VEGF/R inhibitors. But the results from these studies published so far are also disappointing. In this context the instruments for selecting the best suitable patients for adjuvant trials have to be discussed. It remains to be seen whether using the same selection criteria as in ongoing trials with checkpoint inhibitors will show better results.

Objectives: Cisplatin-based chemotherapy represents the gold standard in the treatment of advanced bladder cancer (BC) both in the neoadjuvant and adjuvant setting. Since novel immunooncologic agents are available for cisplatin-resistant or ineligible patients, biological markers for the prediction of cisplatin resistance become more important in treatment decisions. Therefore, we aimed to assess the therapy predictive value of 8 promising tissue biomarkers with regard to cisplatin therapy., Methods: Emmprin, survivin, HMGA2, MTA1, RhoGDI, PEG10, TGM2, and TLN1 expressions were analyzed in paraffin-embedded bladder cancer tissue samples of 106 patients who underwent adjuvant or salvage cisplatin-based chemotherapy by using immunohistochemistry. Results were correlated with the clinicopathological and follow-up data by performing both univariable and multivariable survival analyses., Results: Higher HMGA2 nuclear staining intensity and positive survivin nuclear staining were associated with worse overall survival (OS) (P = 0.045 and P = 0.002, respectively). In accordance, survivin nuclear staining also significantly correlated with shorter progression free survival (PFS, P = 0.024), while HMGA2 nuclear positivity tended to correlate with shorter PFS (P = 0.069) after at least 2 cycles of chemotherapy. In the multivariable analyses only survivin remained as an independent predictor of both OS and PFS (P = 0.008 and P = 0.025). None of the other markers proved to be significant predictors of adjuvant or salvage cisplatin-based chemotherapy., Conclusions: Our results demonstrate that survivin represents a promising marker for the prediction of cisplatin resistance in BC. In addition the therapy predictive role of HMGA2 should be further investigated. Immunohistochemical analysis of BC samples provides a feasible way for the prediction of cisplatin-resistance and may therefore provide a valuable tool for optimizing treatment decisions in advanced BC., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial., Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management., Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts before voting during a consensus conference., Setting: Online Delphi survey and consensus conference., Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management., Outcome Measurements and Statistical Analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus)., Results and Limitations: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease., Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time where further evidence is available to guide our approach., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: Previous studies suggested that serum levels of microRNA (miR)-371a-3p (so-called M371 test) have a much higher sensitivity and specificity than the classic markers of testicular germ cell tumors (GCTs) and are applicable toward both seminoma and nonseminoma. We sought to confirm the usefulness of this test as a novel biomarker for GCT., Patients and Methods: In a prospective, multicentric study, serum samples of 616 patients with testicular GCTs and 258 male controls were examined for serum levels of miRNA-371a-3p (miR levels) by quantitative polymerase chain reaction. The GCT population encompassed 359 patients with seminoma and 257 with nonseminoma; 371 had clinical stage I disease, 201 had systemic disease, and 46 had relapses. Paired measurements before and after orchiectomy were performed in 424 patients; 118 with systemic disease had serial measurements during treatment. miR levels were compared with those of β-human chorionic gonadotropin, α-fetoprotein, and lactate dehydrogenase., Results: For the primary diagnosis of GCT, the M371 test showed a sensitivity of 90.1%, a specificity of 94.0%, an area under the curve of 0.966 upon receiver operating characteristic analysis, and a positive predictive value of 97.2%. α-Fetoprotein, β-human chorionic gonadotropin, and lactate dehydrogenase had sensitivities of less than 50% in seminoma and slightly higher sensitivities in nonseminomas. miR levels were significantly associated with clinical stage, primary tumor size, and response to treatment. Relapses had elevated miR levels that subsequently dropped to normal upon remission. Teratoma did not express miR-371a-3p., Conclusion: The M371 test outperforms the classic markers of GCT with both a sensitivity and a specificity greater than 90%. All histologic subgroups, except teratoma, express this marker. The test could be considered for clinical implementation after further validation.

Introduction: The term variations of sex development subsumes a large number of congenital conditions including chromosomal mosaics and variations of chromosomal, gonadal, and phenotypic sex. A situation of this nature may cause severe distress to both, parents and affected persons. One of the reasons for this is the binary form of gender classification in the society. In the past, because of a fear of possible stigmatization and an inability to cope with complex situations, it has been medical policy and practice for newborns to undergo early, mostly 'feminizing' elective surgery with the aim of achieving an outer genital appearance that is unambiguously male or female. Protests by advocacy groups for the most part as well as the results of outcome studies have shown that the development of affected persons may be very different to what has been expected and often does not result in the intended clear female or male gender identity as had been intended. It, therefore, seemed a matter of urgency to implement this new awareness as well as the ethical and personal human rights perspectives in the recommendations for the medical and psychosocial management of diverse sex development (DSD) in the future., Study Design: In 2012, an interdisciplinary group of German academics engaged in the field of DSD decided to work on a consensus paper for this topic. It involved the participation of all faculties and non-scientific groups dealing with DSD, in particular advocacy and service-user groups. In a structured consensus, process recommendations were developed based on scientific literature as well as personal experiences of clinicians and affected individuals., Results: Finally, 37 recommendations were agreed on. The strength of consensus is reflected in the degree of agreement as expressed in percentages., Conclusion: The introduction of the consensus paper reflects on the emerging paradigm shift and the necessity for a more open view of gender within society. The paper is intended to aid the performance of appropriate diagnostics in DSD-affected newborns and especially to help parents and affected persons cope with the biological and social consequences of DSD. With regard to medical or surgical therapy, it gives information about the most recent treatment trends., (Copyright © 2018 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)

Background:  In 2016, the first German guideline for bladder cancer was introduced. This survey evaluates current management of bladder cancer in Germany, focusing on systemic therapies and compares this to the guidelines., Material and Methods:  More than 4000 urologists and oncologists in Germany received a questionnaire assessing surgical and systemic therapeutic management of bladder cancer. We received 278 evaluable responses., Results:  This is the largest nationwide survey evaluating current bladder cancer management in Germany. Management can be optimised of non-muscle invasive bladder cancer including intravesical instillation therapies, as well as of muscle invasive bladder cancer including (neo)adjuvant chemotherapies, particularly with respect to the numbers of chemotherapy courses. Management of metastasised bladder cancer is predominantly performed according to the guidelines., Conclusions:  Adherence to bladder cancer guidelines in Germany can be optimised and could possibly decrease cancer-specific mortality, supported by the development of novel diagnostic and therapeutic options., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: To describe the surgical outcomes of ileal vaginoplasty in transgender women and patients with disorders of sex development (DSD)., Patients and Methods: Transgender women and patients with DSD, who underwent ileal vaginoplasty at the VU University Medical Center Amsterdam, University Hospital Trieste, University Hospital Essen, and Belgrade University Hospital, were retrospectively identified. A chart review was performed, recording surgical technique, intraoperative characteristics, complications, and re-operations., Results: We identified a total of 32 patients (27 transgender and five non-transgender), with a median (range) age of 35 (6-63) years. Ileal vaginoplasty was performed as the primary procedure in three and as a revision procedure in the remaining 29. The mean (sd) operative time was 288 (103) min. The procedure was performed laparoscopically (seven patients) or open (25). An ileal 'U-pouch' was created in five patients and a single lumen in 27. Intraoperative complications occurred in two patients (one iatrogenic bladder damage and one intraoperative blood loss necessitating transfusion). The median (range) hospitalisation was 12 (6-30) days. Successful neovaginal reconstruction was achieved in all. The mean (sd) achieved neovaginal depth was 13.2 (3.1) cm. The median (range) clinical follow-up was 35 (3-159) months. In one patient a recto-neovaginal fistula occurred, which lead to temporary ileostomy. Introital stenosis occurred in four patients (12.5%)., Conclusion: Ileal vaginoplasty can be performed with few intra- and postoperative complications. It appears to have similar complication rates when compared to sigmoid vaginoplasty. It now seems to be used predominantly for revision procedures., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

In November 2016, the results of a phase III clinical trial with the protein cell death (PD)-1 inhibitor pembrolizumab for second-line treatment of metastatic urothelial carcinoma were published and showed an overall survival benefit in comparison with conventional chemotherapy with vinflunine, docetaxel, or paclitaxel. In a similar trial the PD-L1 antibody atezolizumab showed no significant benefit in comparison to chemotherapy in the subgroup of PD-L1-positive patients and, thus, missed its primary endpoint. For other PD-1/PD-L1 directed substances, large phase I/II trials reported data concerning response rates and overall survival. This substance class will most likely become the new treatment standard in second-line treatment of metastatic urothelial cancer. Currently, PD-1/PD-L1 inhibitors are also being tested within randomized phase III trials for first-line treatment using different approaches either as a monotherapy or a combination with conventional chemotherapy or cytotoxic T‑lymphocyte-associated protein (CTLA)-4 inhibitors. Whereas data from single-arm phase II clinical trials have already been published, preliminary phase III data are expected in 2018.