Real-world experience with the new pulsed solid-state Thulium: YAG laser (Thulio) for endoscopic enucleation of the prostate.

PURPOSE: The solid-state Thulium laser (Tm: YAG) is a novel alternative to the widely used Holmium laser for endoscopic enucleation of the prostate (EEP) due to its relatively high peak power. The aim of this study was to examine the efficacy and safety of a new pulsed Tm: YAG laser in its first application in humans. METHODS: Data were retrospectively collected for the first 103 patients who underwent EEP with a new pulsed solid-state Tm: YAG laser (Thulio®, Dornier MedTech Systems GmbH, Weßling, Germany). Peri- and postoperative data were assessed. Procedure-specific complications were graded using Clavien-Dindo Classifications (CDC). Patients were interviewed 15 months after the surgery to evaluate functional and long-term outcomes. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS®). RESULTS: The mean preoperative prostate volume was 105.6 ± 55.0 ml. Median enucleation speed was 4.1 g per minute (range 1.1-9.7). Short-term postoperative complications occurred in 21 patients (20.4%), but no high-grade complications (CDC ≥ IV) were observed. Five patients suffered gross haematuria and required reintervention (CDC IIIb; 4.9%). After 15 months, 76 patients (73.8%) participated in the follow-up interview, where seven patients (9.2%) reported complications, including two reinterventions for urethral strictures (CDC IIIb; 2.6%). Most patients reported an improvement in continence (54.0%) and urine stream (93.4%), but no difference in erectile function (81.6%). No persistent dysuria was reported. Patient satisfaction with the surgery results was very high (96.1%). CONCLUSION: Endoscopic enucleation of the prostate with the new pulsed solid-state Tm: YAG laser is a safe and effective option for surgical BPH treatment. TRIAL REGISTRATION: German Clinical Trials Register number: DRKS00031676. Registration date: 10 May 2023, retrospectively registered.

[Report template from the German Society of Urology and the German Radiological Society for standardized, structured reporting of native computed tomography scans in the diagnosis of urinary stones]. / Befundvorlage der Deutschen Gesellschaft für Urologie e. V. und der Deutschen Röntgengesellschaft zur standardisierten strukturierten Befundung von nativen Computertomographien in der Harnsteindiagnostik.

Standardized structured radiological reporting (SSRB) has been promoted in recent years. The aims of SSRB include that reports be complete, clear, understandable, and stringent. Repetitions or superfluous content should be avoided. In addition, there are advantages in the presentation of chronological sequences, tracking and correlations with structured findings from other disciplines and also the use of artificial intelligence (AI)-based methods. The development of the presented template for SSRB of native computed tomography for urinary stones followed the "process for the creation of quality-assured and consensus-based report templates as well as subsequent continuous quality control and updating" proposed by the German Radiological Society (DRG). This includes several stages of drafts, consensus meetings and further developments. The final version was published on the DRG website ( www.befundung.drg.de ). The template will be checked annually by the steering group and adjusted as necessary. The template contains 6 organ domains (e.g., right kidney) for which entries can be made for a total of 21 different items, mostly with selection windows. If "no evidence of stones" is selected for an organ in the first query, the query automatically jumps to the next organ, so that the processing can be processed very quickly despite the potentially high total number of individual queries for all organs. The German, European, and North American Radiological Societies perceive the establishment of a standardized structured diagnosis of tomographic imaging methods not only in oncological radiology as one of the current central tasks. With the present template for the description of computed tomographic findings for urinary stone diagnostics, we are presenting the first version of a urological template. Further templates for urological diseases are to follow.

[Processing of medical products in the urological practice]. / Aufbereitung von Medizinprodukten in der urologischen Praxis.

The reprocessing of medical products is an important topic both in urological practices and in hospitals. The complexity is caused by the increasing variety of medical instruments and also by the increasing demands on the legally required quality of the reprocessing. The Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) have published recommendations for the processing of MD and last updated them in 2012. This article summarizes the legal framework for the reprocessing of medical devices, how medical devices are categorized before the appropriate procedure for reprocessing can be selected and the various steps in the reprocessing. A special focus is placed on medical products that are typically found in urological practices or outpatient departments and are processed there. Furthermore, the necessity of validating the processing method and the required training (expertise) of the personnel are discussed.

Feasibility, pitfalls and results of a structured concept-development phase for a randomized controlled phase III trial on radiotherapy in primary prostate cancer patients.

OBJECTIVE: Failure rate in randomized controlled trials (RCTs) is > 50%, includes safety-problems, underpowered statistics, lack of efficacy, lack of funding or insufficient patient recruitment and is even more pronounced in oncology trials. We present results of a structured concept-development phase (CDP) for a phase III RCT on personalized radiotherapy (RT) in primary prostate cancer (PCa) patients implementing prostate specific membrane antigen targeting positron emission tomography (PSMA-PET). MATERIALS AND METHODS: The 1 yr process of the CDP contained five main working packages: (i) literature search and scoping review, (ii) involvement of individual patients, patients' representatives and patients' self-help groups addressing the patients' willingness to participate in the preparation process and the conduct of RCTs as well as the patient informed consent (PIC), (iii) involvement of national and international experts and expert panels (iv) a phase II pilot study investigating the safety of implementation of PSMA-PET for focal dose escalation RT and (v) in-silico RT planning studies assessing feasibility of envisaged dose regimens and effects of urethral sparing in focal dose escalation. RESULTS: (i) Systematic literature searches confirmed the high clinical relevance for more evidence on advanced RT approaches, in particular stereotactic body RT, in high-risk PCa patients. (ii) Involvement of patients, patient representatives and randomly selected males relevantly changed the PIC and initiated a patient empowerment project for training of bladder preparation. (iii) Discussion with national and international experts led to adaptions of inclusion and exclusion criteria. (iv) Fifty patients were treated in the pilot trial and in- and exclusion criteria as well as enrollment calculations were adapted accordingly. Parallel conduction of the pilot trial revealed pitfalls on practicability and broadened the horizon for translational projects. (v) In-silico planning studies confirmed feasibility of envisaged dose prescription. Despite large prostate- and boost-volumes of up to 66% of the prostate, adherence to stringent anorectal dose constraints was feasible. Urethral sparing increased the therapeutic ratio. CONCLUSION: The dynamic framework of interdisciplinary working programs in CDPs enhances robustness of RCT protocols and may be associated with decreased failure rates. Structured recommendations are warranted to further define the process of such CDPs in radiation oncology trials.

[Learning from coding data-surgical treatment of benign prostatic syndrome : Big data for BPS]. / Lernen aus Kodierungsdaten ­ chirurgische Behandlung des benignen Prostatasyndroms : Big Data bei N40-Diagnose.

Benign prostatic syndrome (BPS) is one of the most common urological diseases. Currently, there are numerous surgical methods to treat BPS. The digitalisation of medicine enables new study approaches in healthcare research using digital data from individual treatment pathways. In the present work, BPS-specific longitudinal trend analyses were performed. Treatment-related figures, both with regard to the therapy methods and predefined patient cohorts, could be examined after validating the datasets. This meant that information on relevant characteristics of surgical BPS treatment could be read and calculations made that reflect the overall impact of these processes. In the future, it is expected that increasingly comprehensive, higher-quality digital datasets on different clinical pictures will be available for analytical purposes. Intensification of research projects in this field is desirable. The results thus obtained enable further optimisation steps of certain treatment actions and provide important key figures for the strategy development of a medical facility.

[Minimally invasive treatment options for the management of benign prostatic hyperplasia]. / Minimal-invasive Therapieoptionen zur Behandlung des benignen Prostatasyndroms.

Benign prostatic hyperplasia is one of the most common diseases of aging men. Hyperplasia of the glandular tissue can cause distressing lower urinary tract symptoms, which can be treated with both drugs and interventions. For a long time, transurethral resection of the prostate and simple prostatectomy were considered the gold standard of surgical treatment. In order to be able to offer patients an outpatient treatment with few complications, shorter hospital stays and high efficiency, a variety of minimally invasive treatment options have been developed. While recommendations have already been made for the excision by focused waterjet, prostatic urethral lift, and prostatic artery embolization, there are several other very promising procedures for which, however, long-term data and data from comparative studies with reference procedures must still be awaited.

[Incontinence surgery-quality criteria and structured follow-up]. / Inkontinenzchirurgie ­ Qualitätskriterien und strukturiertes Follow-up.

The following article summarizes the current evidence including postoperative success rates and complications for various surgical options in the treatment of urinary incontinence. Due to different inclusion criteria and inconsistent definitions of study endpoints, the analysis of available studies is difficult. Thus, comparative studies with new devices for established treatment options should be planned. Structured processes used in certified continence centers improve the quality of care. Furthermore by documenting relevant complications, comparisons of treatment results thus become possible and provide evidence for the use of different surgical options in the treatment of urinary incontinence.

[Innovative laser technologies in the treatment of urolithiasis : A change to more gentle methods with increased patient safety]. / Innovative Lasertechnologien in der Harnsteintherapie : Ein Wandel zu schonenderen Methoden mit hoher Patientensicherheit.

Management of urolithiasis has undergone fundamental changes with the introduction of extracorporeal shock wave lithotripsy (ESWL) and percutaneous and ureterorenoscopic techniques in the 1980s. Since then, these minimally invasive techniques have been continuously optimized and specific laser techniques for stone disintegration have emerged. Besides the established holmium laser, other types of lasers are also emerging. Especially the thulium fiber laser is the subject of promising research due to its variable adjustment options. In terms of patient safety, both holmium and thulium techniques seem to be similar . While serious direct physical lesions are rare, there is increasing evidence of clinically relevant secondary thermal injury due to increased temperatures in the upper urinary tract during treatment. Our research group has recently demonstrated in both in vitro and in vivo (porcine animal model) experiments that monitoring the fluorescence spectra of calculi allows precise target differentiation between stone, tissue, and endoscope components. Consequently, pulse emissions were only emitted when stone material was detected. We believe that target monitoring will minimize the risk of laser-induced urothelial damage and decrease energy release into the upper urinary tract allowing adequate temperature management.

[Enhanced imaging in urological endoscopy]. / Erweiterte Bildgebung in der urologischen Endoskopie.

White light cystoscopy and the concise documentation of pathological findings are standard diagnostic procedures in urology. Additional imaging modalities and technical innovations may support clinicians in the detection of bladder tumors. Modern endoscopy systems provide ultra-high-resolution imaging and the option of digital contrast enhancement. Photodynamic diagnostics and narrow band imaging are well-established in clinical routine and have shown significant benefits in the detection of bladder cancer. By means of multispectral imaging, different modalities can now be combined in real-time. Probe-based procedures such as optical coherence tomography (OCT) or Raman spectroscopy can further contribute to advanced imaging through an "optical biopsy" which may primarily improve diagnostics in the upper urinary tract. The aim of all techniques is to optimize the detection rate in order to achieve a more accurate diagnosis, resection and lower recurrence rates. Current research projects aim to digitalize the documentation of endoscopy and also make it more patient- and user-friendly. In the future, the use of image processing and artificial intelligence may automatically support the surgeon during endoscopy.

[Empowerment for our patients : Innovation in everyday urology]. / Empowerment für unsere Patienten : Gelebte Innovation im urologischen Alltag.

Patient empowerment includes measures that promote their autonomy and self-determination in the physician-patient relationship. In addition to successful medical treatment, goals include long-term treatment satisfaction and the best possible quality of life for the patients and their social environment. Various initiatives and projects from German urology are already used to empower our patients. Entscheidungshilfe Prostatakrebs (decision aid for prostate cancer) and the German language decision aid for advanced bladder cancer and for the choice of urinary diversion are implemented under the umbrella of the PatientenAkademie (patient academy) of German Urologists. With more than 12,000 users, Entscheidungshilfe Prostatakrebs is very well established in urological care in Germany. The randomized evaluation study with planned 1200 participants is close to the successful completion of recruitment. Another project from the German urology sector is the project "antiCoagulation Help App for SurgERy" (CHASER). The aim is to develop a smartphone-based decision aid for the perioperative management of patients undergoing antithrombotic therapy. Online support groups can also contribute to empowerment and have been analyzed systematically for prostate cancer patients. A large randomized study on this topic is currently in preparation. Continuing advances in digitalization can thus provide us with useful support in order to provide individual information to our patients. The German Urological Association and its PatientenAkademie have been committed to this for many years.

Mixed reality for teaching catheter placement to medical students: a randomized single-blinded, prospective trial.

BACKGROUND: Cost-effective methods to facilitate practical medical education are in high demand and the "mixed-reality" (MR) technology seems suitable to provide students with instructions when learning a new practical task. To evaluate a step-by-step mixed reality (MR) guidance system for instructing a practical medical procedure, we conducted a randomized, single-blinded prospective trial on medical students learning bladder catheter placement. METHODS: We enrolled 164 medical students. Students were randomized into 2 groups and received instructions on how to perform bladder catheter placement on a male catheterization training model. One group (107 students) were given their instructions by an instructor, while the other group (57 students) were instructed via an MR guidance system using a Microsoft HoloLens. Both groups did hands on training. A standardized questionnaire covering previous knowledge, interest in modern technologies and a self-evaluation was filled out. In addition, students were asked to evaluate the system's usability. We assessed both groups's learning outcome via a standardized OSCE (objective structured clinical examination). RESULTS: Our evaluation of the learning outcome revealed an average point value of 19.96 ± 2,42 for the control group and 21.49 ± 2.27 for the MR group - the MR group's result was significantly better (p = 0.00). The self-evaluations revealed no difference between groups, however, the control group gave higher ratings when evaluating the quality of instructions. The MR system's assessment showed less usability, with a cumulative SUS (system usability scale) score of 56.6 (lower half) as well as a cumulative score of 24.2 ± 7.3 (n = 52) out of 100 in the NASA task load index. CONCLUSIONS: MR is a promising tool for instructing practical skills, and has the potential to enable superior learning outcomes. Advances in MR technology are necessary to improve the usability of current systems. TRIAL REGISTRATION: German Clinical Trial Register ID: DRKS00013186.

[Novel surgical techniques for treatment of benign prostatic hyperplasia]. / Neue operative Techniken zur Therapie des benignen Prostatasyndroms.

In recent years new surgical techniques to treat benign prostatic hyperplasia have been introduced into urological practice and evaluated in clinical studies. Complications of standard procedures, e.g. transurethral resection of the prostate (TURP), can be avoided while maintaining equivalent clinical outcomes. The main goal is preservation of erectile and ejaculatory function. Furthermore, outpatient treatment associated with a rapid patient recovery would be desirable. This article presents the course of the interventions, the mechanisms of action and current clinical evidence for novel mechanical approaches of recanalization, water-based ablation as well as prostate artery embolization. Initial study results partially indicate that in the future practically all patients can be offered an individualized surgical technique, which provides optimal symptomatic and functional improvements with a minimized risk of complications.

Adherence to the EAU guideline recommendations for systemic chemotherapy in penile cancer: results of the E-PROPS study group survey.

OBJECTIVES: To validate the adherence of urologists to chemotherapy recommendations given in the EAU guidelines on PeCa. The European Association of Urology (EAU) guidelines on penile cancer (PeCa) are predominantly based on retrospective studies with low level of evidence. MATERIALS AND METHODS: A 14-item-survey addressing general issues of PeCa treatment was developed and sent to 45 European hospitals. 557 urologists participated in the survey of which 43.5%, 19.3%, and 37.2% were in-training, certified, and in leading positions, respectively. Median response rate among participating departments was 85.7% (IQR 75-94%). Three of 14 questions addressed clinical decisions on neoadjuvant, adjuvant, and palliative chemotherapy. Survey results were analyzed by bootstrap-adjusted multivariate logistic-regression-analysis to identify predictors for chemotherapy recommendations consistent with the guidelines. RESULTS: Neoadjuvant, adjuvant, and palliative chemotherapy was recommended according to EAU guidelines in 21%, 26%, and 48%, respectively. For neoadjuvant chemotherapy, urologists holding leading positions or performing chemotherapy were more likely to recommend guideline-consistent treatment (OR 1.85 and 1.92 with p(bootstrap) = 0.007 and 0.003, respectively). Supporting resources (i.e., guidelines, textbooks) were used by 23% of survey participants and significantly improved consistency between treatment recommendations and Guideline recommendations in all chemotherapy settings (p(bootstrap) = 0.010-0.001). Department size and university center status were no significant predictors for all three endpoints. CONCLUSIONS: In this study, we found a very low rate of adherence to the EAU guidelines on systemic treatment for PeCa. Further investigations are needed to clarify whether this missing adherence is a consequence of limited individual knowledge level or of the low grade of guideline recommendations.

[Treatment of benign prostatic hyperplasia in geriatric patients-use and limitations of existing guidelines]. / Therapie des benignen Prostatasyndroms beim geriatrischen Patienten ­ Anwendung und Limitation medizinischer Leitlinien.

The demographic developments of western society and the resulting increase in the number of very old patients in urology represents a challenge for the design of clinical studies and, consequently, recommendations of guidelines. While in internal medicine there is already a subspecialization with a focus on the treatment of elderly and multimorbid patients, in urology there is hardly any subspecialization into the problems of geriatric patients. Thus, using a case study as an example, the treatment decisions for benign prostatic hyperplasia (BPH) in geriatric patients are discussed. In addition the available evidence from the literature and guidelines are presented in order to assiste in daily management of geriatric patients with lower urinary tract symptoms and to critically discuss potential fields of application and limitations of the existing guidelines. In this context, we also examine the challenges when choosing a drug therapy and in deciding which of the many surgical options should be used.

[Novel minimally invasive treatment options for male lower urinary tract symptom]. / Neue minimal-invasive Therapie des benignen Prostatasyndroms.

Novel minimally invasive treatment options strive for innovative approaches that are equally efficient to standard procedures with a superior safety profile. A true minimally invasive technique can be performed in an ambulatory setting under local anaesthesia and no need for postinterventional catheterization so that quick and problem-free return to everyday life is possible. Sexual dysfunction is a great concern of sexually active patients facing surgery. The novel techniques clearly demonstrate that relief of bothersome lower urinary tract symptoms (LUTS) is possible without compromising erectile and ejaculatory function. Urolift® is an attractive treatment option for carefully selected patients without a middle lobe who have special interest in the rapid and smooth return to daily activity and the complete preservation of sexual function. Rezum® and AquaBeam® are promising novel techniques that can be also performed in the presence of certain prostatic features like a middle lobe. iTIND® is still in its infancy of clinical evaluation and therefore, its true value still needs to be determined. According to current data the role of intraprostatic injectables for the treatment of male LUTS is still unclear.