Medico-economic impact of onco-urological robot-assisted minimally invasive surgery in a high-volume centre.

BACKGROUND: We lack data regarding the economic cost of robot-assisted surgical procedures in urology. We aimed to assess the medico-economic impact of onco-urological robot-assisted surgery. METHODS: All patients who underwent robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) in 2019 were included. Cost assessment included the costs of surgery, hospital stay, and complications. Global cost was calculated and compared with open and laparoscopic procedures. RESULTS: Overall, 126 (48%) RAPN and 135 (52%) RARP were included. Total cost per patient was 6857€ for RARP and 6034€ for RAPN. Costs of surgery, hospital stay, and complications represented 76.2%, 21.5%, and 2.3%, respectively, of the total cost per patient for RAPN, and 74.1%, 25.9%, and 0% for RARP. Compared to the open approach, RAPN was 6% cheaper and RARP was 10% more expensive per patient. Standard laparoscopic procedures were cheaper. CONCLUSIONS: Robotic procedures were associated with increased costs of surgical procedures, but with reduction in morbidity and hospital stay costs.

Postoperative assessment of nosocomial transmission of COVID-19 after robotic surgical procedures during the pandemic.

OBJECTIVES: To assess potential nosocomial coronavirus disease-2019 (COVID-19) transmission in patients who underwent robot-assisted laparoscopic procedures during the pandemic. MATERIAL AND METHODS: Prospective study in patients undergoing robot-assisted laparoscopy in urology or gynaecology within 2 academic hospitals. Patients underwent local preoperative COVID-19 screening using a symptoms questionnaire. Patients with suspicious screening underwent coronavirus real time-polymerase chain reaction (RT-PCR) and were excluded from robotic surgery if positive. Patients with symptoms postsurgery were systematically tested for coronavirus by RT-PCR. One-month postsurgery, all patients had a telephone consultation to evaluate COVID-19 symptoms. RESULTS: Sixty-eight patients underwent robotic surgery during the study period (median age: 63-years [IQR: 53-70], 1.8 male: female ratio). Oncology was the main indication for robotic surgery (n = 62, 91.2%) and 26 patients (38.2%) received a chest CT-scan prior to surgery. Eleven patients (16.2%) were symptomatic after surgery of whom only 1 tested positive for coronavirus by RT-PCR (1.5%) and was transferred to COVID-19 unit with no life-threatening condition. No attending surgeon was diagnosed with COVID-19 during the study. CONCLUSIONS: Robot-assisted laparoscopic surgery seemed safe in the era of COVID-19 as long as all recommended precautions are followed. The rate of nosocomial COVID-19 transmission was extremely low despite the fact that we only used RT-PCR testing in symptomatic patients during the preoperative work-up. Larger cohort is needed to validate these results.

Preliminary assessment of patient and physician satisfaction with the use of teleconsultation in urology during the COVID-19 pandemic.

PURPOSE: Lockdown during the COVID-19 pandemic compelled urologists to change access to healthcare, especially for oncology patients. Teleconsultation is a safe way to receive medical advice without a risk of infection, and was implemented urgently in our academic centres. Our purpose was to evaluate patient and physician satisfaction with teleconsultation set up during the COVID-19 pandemic. METHODS: From March 16th 2020, all face-to-face consultations were cancelled in France, except for emergencies. Teleconsultation was started immediately by five senior urologists in two academic hospitals. All patients received an email survey including the validated Teleconsultation Satisfaction Questionnaire (TSQ) and demographic questions. Data were collected prospectively. Physicians also responded to the TSQ. Patient satisfaction was measured objectively with the validated 14-item TSQ. Each item was scored on a 5-point Likert scale. Factors associated with positive satisfaction with teleconsultation were assessed by multivariable logistic regression. RESULTS: Overall, 105 patients replied to the survey (91.3%). Median age was 66 years (IQR: 55‒71) and 95 were men (90.5%). Median overall TSQ score was 67 (IQR: 60‒69); teleconsultation was judged to be a good experience by 88 patients (83.8%) and four physicians (80%). Patients who met their surgeon for the first time were more likely to have a good experience (OR = 1.2 [95% CI 1.1‒1.5], p = 0.03). CONCLUSION: Introduced rapidly during the COVID-19 lockdown, urology teleconsultation attained a high level of satisfaction among both patients and physicians. A major change in telemedicine use is foreseen in the post COVID-19 era.

Multicriteria Decision Analysis Applied to the Clinical Use of Pharmacotherapy for Overactive Bladder Symptom Complex.

CONTEXT: The nonspecific storage symptom complex overactive bladder (OAB) is an important clinical condition in functional urology. Until recently, pharmacological therapy comprised antimuscarinic drugs, but more recently beta 3 agonists have added to the available agents. Traditional reporting of efficacy and safety of these agents relies upon regulatory placebo-controlled studies. There remains no head-to-head comparison of existing agents in the contemporary literature. Contemporary conclusions on comparative efficacy and safety drawn from the use of these agents are based on systematic reviews of the literature and associated meta-analyses. OBJECTIVE: In this study, we used the analytical model of multicriteria decision analysis (MCDA) to compare contemporary pharmacotherapy for OAB. EVIDENCE ACQUISITION: Efficacy and safety data from published, randomised, placebo-controlled trials of antimuscarinic antagonists, the beta 3 agonist, and the combination of an antimuscarinic and beta 3 agonist were used to populate the MCDA model. EVIDENCE SYNTHESIS: Experts assessed weights of the relative importance of favourable and unfavourable effects, which provided a common measure of benefits and safety that were combined in the MCDA model to give an overall ranking of the OAB drugs. RESULTS: When benefits are judged as more important than safety, fesoterodine 4 or 8mg used in a flexible dosing pattern provides the most favourable therapeutic option, over a wide sensitivity analysis relating to benefits and harms. CONCLUSIONS: In our analysis using an MCDA model, in both the flexible dosing pattern of fesoterodine and the solifenacin combination with mirabegron, the benefit-safety balance is better in terms of benefits and/or safety than any of the other available OAB drugs. Caution in interpretation of the data has to be expressed as the fesoterodine data are based on a flexible dosing regimen, which adds an additional dimension of personalising therapy. PATIENT SUMMARY: Overactive bladder (OAB) is a common condition with a significant impact on the quality of life. Possible symptoms include the following: (1) urgency-a compelling desire to urinate, which is difficult to defer; (2) urgency urinary incontinence-urgency leading to incontinence episodes; (3) frequency-increased frequency of wanting to pass urine; and (4) nocturia-increase in instances of getting up at night to urinate. To date, the mainstay of therapy for OAB has been antimuscarinic drugs and, more recently, the beta 3 agonist mirabegron. Ten international experts in urology, obstetrics, gynaecology, healthy ageing, and data analysis compared the benefit-risk balance of 14 OAB drugs licensed in Europe. The experts considered the importance of a favourable effect on the above four symptoms and also potential for side effects, but only three of these side effects, constipation, dry mouth, and dizziness, showed clinically relevant differences among the six drugs they considered. The observations recorded here suggest interesting differences between drugs across a wide range of possible trade-offs between benefit and safety. The different recruitment criteria used for each study may influence the results seen, so they need to be treated with caution. Comparison of flexibly dosed fesoterodine studies with fixed-dose fesoterodine studies introduces an additional potential bias; definitive conclusions can be drawn only if enough comparable placebo-controlled flexible dosing studies with other drugs were available.

Prevalence, management, and prognosis of bladder cancer in patients with neurogenic bladder: A systematic review.

AIM: To perform a systematic review of the literature regarding epidemiology, diagnosis, management and prognosis of bladder cancer in the neuro-urological patient population, in order to serve as a basis for future recommendations and research. METHODS: A systematic review was performed according to the PRISMA-Preferred Reporting Items for Systematic Reviews and Meta-Analyzes Statement. Embase was searched for studies providing data on epidemiology, diagnosis, management and prognosis of bladder cancer in neuro-urological patients. RESULTS: After screening 637 abstracts, 15 studies (13 retrospective and 2 prospective studies) were included in this study. We identified 332 patients (0.3%) who were diagnosed with bladder cancer. This mostly affected mostly men (59.3%) and spinal cord injured patients (98.8%). Mean age at diagnosis was 56.1 years. Bladder cancer occurred after a long period of evolution of the neurological disease (24.9 years). Gross hematuria was the predominating presenting symptom (31.6% of cases). Indwelling urethral or supra-pubic catheters were used in 44.5% of patients. The most frequent histological subtype of bladder cancer was transitional cell carcinoma (53.1%), followed by squamous cell carcinoma (33.5%). Muscle-invasive bladder cancer was reported in 67.7% of patients. The mean cancer-specific mortality rate was of 47.1%. CONCLUSIONS: The prevalence and high mortality rate of bladder cancer in neuro-urological patients underlines the importance of long-term follow-up in this specific population. This highlights the necessity of further studies in this field.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

First-line urological evaluation in multiple sclerosis: validation of a specific decision-making algorithm.

BACKGROUND: Urinary disorders that lead to urological complications are frequent in multiple sclerosis, resulting in diminished quality of life. Urinary management guidelines are scarce and targeted to neuro-urology specialists. OBJECTIVE: This study aimed to construct and validate an algorithm dedicated to neurologists and general practitioners to facilitate first-line evaluation and treatment of urinary disorders associated with multiple sclerosis. METHODS: 49 items concerning urological symptom evaluation and therapeutic strategies were derived from literature analysis and evaluated by an expert panel. The Delphi method established consensus between the experts and allowed development of the First-Line Urological Evaluation in Multiple Sclerosis (FLUE-MS) algorithm. Two questions from the Urinary Bothersome Questionnaire in Multiple Sclerosis were included and their validation to verify comprehensiveness and acceptability was also conducted. RESULTS: Three rounds of expert review obtained consensus of all 49 items and allowed finalisation of the algorithm. Comprehension and acceptability of two Urinary Bothersome Questionnaire in Multiple Sclerosis questions were verified (mean comprehensiveness score: 1.99/2 [99.7% total comprehensiveness], mean acceptability score: 1.99/2 [99.1% complete acceptability]). CONCLUSION: The FLUE-MS algorithm was designed for neurologists and general practitioners, enabling identification of 'red flags', timely patient referral to specialist neuro-urology units, and appropriate first-line therapy.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Mapping of transrectal ultrasonographic prostate biopsies: quality control and learning curve assessment by image processing.

OBJECTIVE: Mapping of transrectal ultrasonographic (TRUS) prostate biopsies is of fundamental importance for either diagnostic purposes or the management and treatment of prostate cancer, but the localization of the cores seems inaccurate. Our objective was to evaluate the capacities of an operator to plan transrectal prostate biopsies under 2-dimensional TRUS guidance using a registration algorithm to represent the localization of biopsies in a reference 3-dimensional ultrasonographic volume. METHODS: Thirty-two patients underwent a series of 12 prostate biopsies under local anesthesia performed by 1 operator using a TRUS probe combined with specific third-party software to verify that the biopsies were indeed conducted within the planned targets. RESULTS: The operator reached 71% of the planned targets with substantial variability that depended on their localization (100% success rate for targets in the middle and right parasagittal parts versus 53% for targets in the left lateral base). Feedback from this system after each series of biopsies enabled the operator to significantly improve his dexterity over the course of time (first 16 patients: median score, 7 of 10 and cumulated median biopsy length in targets of 90 mm; last 16 patients, median score, 9 of 10 and a cumulated median length of 121 mm; P = .046). CONCLUSIONS: In addition to being a useful tool to improve the distribution of prostate biopsies, the potential of this system is above all the preparation of a detailed "map" of each patient showing biopsy zones without substantial changes in routine clinical practices.

A description of health care provision and access to treatment for women with urinary incontinence in Europe -- a five-country comparison.

BACKGROUND: Female urinary incontinence is a prevalent condition, but only about one-third of women seek treatment. OBJECTIVES: To describe the health care provision for women with urinary incontinence from a European perspective, selecting France, Germany, Spain, Sweden, and the United Kingdom as examples, and to investigate whether specific barriers for treatment exist. METHODS: Available health care system information, a literature review and clinical expert information identified patterns of treatment provision. RESULTS: In Spain, Sweden, and the UK, access to medical care in general is primarily through the general practitioners. However, in Spain and Sweden, women with urinary incontinence can directly visit specialists. In France and Germany, women have equal access to either general practitioners or specialists. Aside from general practitioners, gynaecologists play a major role in urinary incontinence care in all countries except the UK. In Germany, urologists are also involved in initial female urinary incontinence care; however, only in about 16% of women. There are no waiting lists in France and Germany for appointments with physicians or procedures, contrary to Spain, which has long waiting lists. Access to general practitioners in the UK is unrestricted whereas advanced diagnosis and treatment in secondary care requires long waits. A specific Swedish policy mandates that no woman is required to wait longer than 3 months for incontinence visits and related surgery. In Sweden and the UK, specialist nurses and other health care workers provide incontinence services. Almost all treatment options for urinary incontinence are at least in part reimbursed. However, various co-payments and fees in France, Germany, Spain and Sweden exist and constitute out-of-pocket expenses for women if no complementary additional private health insurance is available. In some countries, financial incentives for physicians to provide incontinence services are low, raising concerns about their interest to engage in continued patient care. CONCLUSIONS: Information about service provision in Europe for women with urinary incontinence is limited and makes it difficult to understand barriers to treatment seeking. A broad European perspective may promote optimised treatment access in the future for this widespread and under-recognised condition.