Early Postoperative Complications of One-Stage Substitution Urethroplasty with Oral Mucosa Graft: A Monocentric Retrospective Study.

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.

Influence of lymph node degeneration on metastases in prostate cancer: or why we must look for a needle in a haystack.

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.

Single-dose carboplatin followed by involved-node radiotherapy for stage IIA and stage IIB seminoma (SAKK 01/10): a single-arm, multicentre, phase 2 trial.

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.

Testicular germ cell tumours' clinical stage I: comparison of surveillance with adjuvant treatment strategies regarding recurrence rates and overall survival-a systematic review.

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.

Therapy of clinical stage IIA and IIB seminoma: a systematic review.

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.

Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II - Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy.

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.

Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages.

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.

Consensus paper: current state of first- and second-line therapy in advanced clear-cell renal cell carcinoma.

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.

Ileal vaginoplasty as vaginal reconstruction in transgender women and patients with disorders of sex development: an international, multicentre, retrospective study on surgical characteristics and outcomes.

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.

Experience with One-Stage Repair of Urethral Strictures Using the Augmented Anastomotic Repair Technique.

INTRODUCTION: We report the results of augmented anastomotic repair (AAR) in the treatment of anterior urethral strictures. MATERIAL AND METHODS: In this retrospective study, we evaluated 71 consecutive patients who had undergone AAR between June 2004 and June 2013. Medical records were reviewed to identify early postoperative complications based on the Clavien-Dindo classification (CDC). Self-developed standardized questionnaires sent to the patients and referring urologists were used to collect data on late complications (>90) days. Stricture recurrence (SR) was defined as any postoperative endoscopic or open surgical intervention on the urethra. The influence of patient demographics, stricture characteristics, and operative procedure performed on the occurrence of SR was analyzed. RESULTS: Early postoperative complications were rare events (11.3%) with only one severe CDC complication. Late complications were reported in 46.5% cases. At a median follow-up of 17 months (range 3-114 months), however, 64 patients had no evidence of SR and required no further intervention, giving an overall success rate of 90.1%. Seven patients with SR had a higher body mass index, were older, and had been operated on by less experienced surgeon(s). Most SRs occurred within the first year after surgery. CONCLUSIONS: AAR was an effective and safe operative technique that allowed one-stage repair in our patients with anterior urethral strictures who needed resection of the scarred urethra and otherwise were not suitable for primary anastomosis or simple substitution urethroplasty.

Prospective randomized double-blind multicentre phase II study comparing gemcitabine and cisplatin plus sorafenib chemotherapy with gemcitabine and cisplatin plus placebo in locally advanced and/or metastasized urothelial cancer: SUSE (AUO-AB 31/05).

OBJECTIVE: To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer. PATIENTS AND METHODS: The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles. RESULTS: Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment. CONCLUSION: Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS.

Testicular Tumors.

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.

Perioperative lung function following flow controlled ventilation for robot-assisted prostatectomies in steep trendelenburg position: an observational study.

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.

[Urology 2030: Why it is key to promote digitisation in urology today to maintain medical care in the future - an expert consensus]. / Urologie 2030: Die dringende Notwendigkeit die Digitalisierung in der Urologie schon jetzt voranzutreiben um die medizinische Versorgung aufrecht erhalten zu können ­ ein Expertenkonsens.

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.

[Sequential therapy of advanced bladder cancer after prior perioperative systemic treatment : Recommendations from the Interdisciplinary Bladder Carcinoma Working Group (IABC) of the DKG e. V.] / Sequenztherapie des fortgeschrittenen Urothelkarzinoms der Harnblase nach vorheriger perioperativer Systembehandlung : Empfehlungen aus der Interdisziplinären Arbeitsgruppe BlasenCarcinom (IABC) der Deutschen Krebsgesellschaft e. V. (DKG).

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.

Degenerative Changes in Aging Human Pelvic Lymph Nodes-A Reason to Rethink Staging and Therapy of Regional Malignancies?

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.

Time trends in prostate cancer surgery: data from an Internet-based multicentre database.

OBJECTIVES: To report our experience with an Internet-based multicentre database that enables tumour documentation, as well as the collection of quality-related parameters and follow-up data, in surgically treated patients with prostate cancer. The system was used to assess the quality of prostate cancer surgery and to analyze possible time-dependent trends in the quality of care. PATIENTS AND METHODS: An Internet-based database system enabled a standardized collection of treatment data and clinical findings from the participating urological centres for the years 2005-2009. An analysis was performed aiming to evaluate relevant patient characteristics (age, pathological tumour stage, preoperative International Index of Erectile Function-5 score), intra-operative parameters (operating time, percentage of nerve-sparing operations, complication rate, transfusion rate, number of resected lymph nodes) and postoperative parameters (hospitalization time, re-operation rate, catheter indwelling time). Mean values were calculated and compared for each annual cohort from 2005 to 2008. The overall survival rate was also calculated for a subgroup of the Berlin patients. RESULTS: A total of 914, 1120, 1434 and 1750 patients submitted to radical prostatectomy in 2005, 2006, 2007 and 2008 were documented in the database. The mean age at the time of surgery remained constant (66 years) during the study period. More than half the patients already had erectile dysfunction before surgery (median International Index of Erectile Function-5 score of 19-20). During the observation period, there was a decrease in the percentage of pT2 tumours (1% in 2005; 64% in 2008) and a slight increase in the percentage of patients with lymph node metastases (8% in 2005; 10% in 2008). No time trend was found for the operating time (142-155 min) or the percentage of nerve-sparing operations (72-78% in patients without erectile dysfunction). A decreasing frequency was observed for the parameters: blood transfusions (1.9% in 2005; 0.5% in 2008), postoperative bleeding (2.6%; 1.2%) and re-operations (4.5%; 2.8%). The mean hospitalization time decreased accordingly (10 days in 2005; 8 days in 2008). The examined subcohort had an overall mortality of 1.5% (median follow-up of 3 years). CONCLUSIONS: An Internet-based database system for tumour documentation in patients with prostate cancer enables the collection and assessment of important parameters for the quality of care and outcomes. The participating centres show an improvement in the quality of surgical management, including a reduction of the complication rate.

[Follow-up in superficial and metastatic bladder cancer]. / Nachsorge des oberflächlichen und metastasierten Blasenkarzinoms.

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.

Long-Term Results of Surgical Treatment and Patient-Reported Outcomes in Congenital Adrenal Hyperplasia-A Multicenter European Registry Study.

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 women­24.6% 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.

LHRH sparing therapy in patients with chemotherapy-naïve, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial.

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.