[Onabotulium toxin A detrusor injection: The "real world" of users, the "real world" of patients - Update BOTUROLOGY 2022]. / OnabotuliumtoxinA Detrusorinjektion: Die "Real World" der Anwender, die "Real World" der Patienten ­ Update BOTUROLOGY 2022.

BACKGROUND: OnabotulinumtoxinA (Botox) has been approved in Germany since 2013 for the second-line treatment of idiopathic overactive bladder in the form of a detrusor injection (OnabotA DI) after failure of anticholinergic therapy. Until 2018, however, its application lagged far behind the demand due to billing hurdles. Since the beginning of 2018, there has been an EBM (German Uniform Evaluation Standard) approval number in Germany for the transurethral application of Botox in urology. QUESTION: The aim of a survey performed in 2019 among course participants of regular injection workshops (WS-P) in our institution was to evaluate whether billability has changed user behaviour in Germany in line with the demand. A similar survey was carried out in 2021 to show the developments over the past two years. MATERIAL AND METHODS: In 2019, 88 consecutive participants in a user workshop that had been held regularly since 2013 were asked about their OnabotA DI practice anonymously via questionnaire. The survey was repeated in 2021 in an anonymous online survey of 55 course participants in order to evaluate changes in user behaviour over the past two years. RESULTS: Evaluation 2019: Response rate 35/88 of the questionnaires (39.8%); a large majority (82%) of the WS-P attended the workshop AFTER the establishment of the EBM code. Only 54.5% of the WS-P performed two or more (12% more than 10) OnabotA DIs per quarter after the workshop. Most users (85%) always or predominantly performed the procedure on an outpatient basis, 63% always or predominantly under local anesthesia. The majority (84%) administered no or only a perioperative antibiotic treatment, 13% for one week. 89% stated that at least 70% of their patients had no or only mild symptoms under the LA. In the 2021 evaluation, the users tended to perform the procedure more often on an outpatient basis and in LA, and more often without any antibiotics. CONCLUSIONS: The results of our user survey indicate that the implementation of the OnabotA DI has gained significant impetus since the EBM approval in Germany in January 2018. In most cases, the procedure can be performed easily on an outpatient basis under local anesthesia.

Circulating tumor cells in patients with testicular germ cell tumors.

PURPOSE: Germ cell tumors (GCTs) represent the most frequent malignancies among young men, but little is known about circulating tumor cells (CTCs) in these tumors. Considering their heterogeneity, CTCs were investigated using two independent assays targeting germ cell tumor and epithelial cell-specific markers, and results were correlated with disease stage, histology, and serum tumor markers. EXPERIMENTAL DESIGN: CTCs were enriched from peripheral blood (n = 143 patients) and testicular vein blood (TVB, n = 19 patients) using Ficoll density gradient centrifugation. For CTC detection, a combination of germ cell tumor (anti-SALL4, anti-OCT3/4) and epithelial cell-specific (anti-keratin, anti-EpCAM) antibodies was used. In parallel, 122 corresponding peripheral blood samples were analyzed using the CellSearch system. RESULTS: In total, CTCs were detected in 25 of 143 (17.5%) peripheral blood samples, whereas only 11.5% of patients were CTC-positive when considering exclusively the CellSearch assay. The presence of CTCs in peripheral blood correlated with clinical stage (P < 0.001) with 41% of CTC positivity in patients with metastasized tumors and 100% in patients with relapsed and chemotherapy-refractory disease. Histologically, CTC-positive patients suffered more frequently from nonseminomatous primary tumors (P < 0.001), with higher percentage of yolk sac (P < 0.001) and teratoma (P = 0.004) components. Furthermore, CTC detection was associated with elevated serum levels of α-fetoprotein (AFP; P = 0.025), ß-human chorionic gonadotropin (ßHCG; P = 0.002), and lactate dehydrogenase (LDH; P = 0.002). Incidence and numbers of CTCs in TVB were much higher than in peripheral blood. CONCLUSIONS: The inclusion of germ cell tumor-specific markers improves CTC detection in GCTs. CTCs occur frequently in patients with more aggressive disease, and there is a gradient of CTCs with decreasing numbers from the tumor-draining vein to the periphery.