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Purpose:The Optilume® Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery ...

Purpose Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to transurethral resection of bladder tumor for patients with LG IR NMIBC. Materials and methods This prospective, phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102. The primary end point was complete response (CR) rate, defined as the proportion of patients with negative endoscopic examination, negative cytology and negative for-cause biopsy 3 months after treatment initiation. Patients with CR were followed quarterly up to 12 months to assess durability of treatment effect. Safety and adverse events were monitored throughout the trial. Results A total of 63 patients (38 males and 25 females 33-96 years old) enrolled and received ≥1 instillation of UGN-102. Among the patients 41 (65%) achieved CR at 3 months, of whom 39 (95%), 30 (73%) and 25 (61%) remained disease-free at 6, 9 and 12 months after treatment initiation, respectively. A total of 13 patients had documented recurrences. The probability of durable response 9 months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis. Common adverse events (incidence ≥10%) included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection and fatigue. Conclusions Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC.

We will run a mouse-tracking study at the EADM Summer School 2018 with 5 groups of students. The studies will be pre-registered, documented and the data uploaded to this project.

To evaluate the feasibility of integrating a hereditary cancer risk assessment (HCRA) process in the community urology practice setting for patients with prostate cancer (PCa).In this prospective intervention, an HCRA process was implemented across six different community urology clinics between May 2019 and April 2020. The intervention included a process integration during which the workflow at each site was refined, a post-integration period during which HCRA was conducted in all patients with PCa, and a follow-up period during which healthcare providers and patients reported their satisfaction with the HCRA and genetic testing process.Among patients who completed a family history assessment during the post-integration period, 23.6% met guideline criteria for genetic testing. Of all patients seen at the clinic during the post-integration period, 8.7% completed genetic testing; this was a twofold increase over the period immediately preceding process integration (4.2%), and a sevenfold increase over the same period 1 year prior (1.2%). The majority of providers reported that the HCRA was as important as other regularly performed assessments (61.0%) and planned to continue using the process in their practice (68.3%). Most patients believed that the genetic test results were important for their future cancer care (84.7%) and had already shared their test results with at least one family member (63.2%).This study demonstrated that implementing an HCRA process in the community urology practice setting was feasible, generally favored by providers and patients, and resulted in an increase in the number of patients with PCa who completed genetic testing.

The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Background: The relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial. Methods: In this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months. Results: Because of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59–2.79]; P =0.53). Conclusions: PRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02663908.

Objective Different subtypes of eating disorders (ED) show dysfunctional eating behaviors such as overeating and/or restriction in response to emotions. Yet, systematic comparisons of all major EDs on emotional eating patterns are lacking. Furthermore, emotional eating correlates with body mass index (BMI), which also differs between EDs and thus confounds this comparison. Method Interview-diagnosed female ED patients (n = 204) with restrictive (AN-R) or binge-purge anorexia nervosa (AN-BP), bulimia nervosa (BN), or binge-eating disorder (BED) completed a questionnaire assessing “negative emotional eating” (sadness, anger, anxiety) and “happiness eating.” ED groups were compared to BMI-matched healthy controls (HCs; n = 172 ranging from underweight to obesity) to exclude BMI as a confound. Results Within HCs, higher BMI was associated with higher negative emotional eating and lower happiness eating. AN-R reported the lowest degree of negative emotional eating relative to other EDs and BMI-matched HCs, and the highest degree of happiness eating relative to other EDs. The BN and BED groups showed higher negative emotional eating compared to BMI-matched HCs. Patients with AN-BP occupied an intermediate position between AN-R and BN/BED and reported less happiness eating compared to BMI-matched HCs. Discussion Negative emotional and happiness eating patterns differ across EDs. BMI-independent emotional eating patterns distinguish ED subgroups and might be related to the occurrence of binge eating versus restriction. Hence, different types of emotional eating can represent fruitful targets for tailored psychotherapeutic interventions. While BN and BED might be treated with similar approaches, AN-BP and AN-R would need specific treatment modules.

Introduction:Low grade, intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC) is notable for a high rate of disease recurrence yet low risk of disease progression. Patients with LG IR-...

278 Background: Professional guidelines recommend hereditary cancer risk assessment (HCRA) for men with prostate cancer to inform both risk of cancer (primary or subsequent) and treatment decisions. The objectives of the study were to evaluate the feasibility of integrating a HCRA protocol in urology practice for patients with prostate cancer and determine the response of providers and patients to the HCRA protocol. Methods: This prospective study was divided into 4 segments: process integration (4 wks.), practice (4 wks.), post-integration (8 wks.), and follow up (10 wks.). Study site staff were trained to perform HCRA for men with prostate cancer (integration). The sites then incorporated recommendations from the integration process into their normal practice workflow (practice). During the post-integration period, the HCRA process was implemented with eligible patients consented to participate. Eligible patients were ≥18 years old, had a personal history of prostate cancer, and met National Comprehensive Cancer Network guidelines for genetic testing (2.2018). Patients and providers completed surveys regarding testing ≥ 8 weeks of test delivery or 1 week of end of data collection period, respectively (follow up). Results: In the 8 weeks prior to the study, 4.2% of patients completed testing at the study sites. During the study, 8.4% of patients completed testing, about 1/2 of eligible patients screened. Of all patients who completed testing and consented for their results to be summarized (N = 182), 10.4% (N = 19) tested positive for a single pathogenic variant (PV; monoallelic MUTYH N = 4; BRCA2 N = 3; ATM, BRCA1, BRIP1, CHEK2, HOXB13 N = 2 each; RAD51C, RAD51D N = 1 each). Not all men who tested positive or a PV reported a family history of cancer and not all PVs detected were in known prostate cancer risk genes. During follow up, most providers (61.0%) felt HCRA was as important as other assessments regularly performed and 68.3% planned to continue to use the HCRA process. In contrast, only 9.8% of providers did not believe HCRA was as important and 12.2% did not plan to continue to use the process. Of the patients that responded to the survey (N = 166), most had shared (62.0%) or planned to share (25.3%) their results with family members post-testing. Conclusions: Urologists and patients responded favorably to HCRA protocol integration. Based on this study, education around and incorporation of an HCRA process in a community urology practice setting for men with prostate cancer appears effective at increasing appropriate uptake of genetic testing. Clinical trial information: NCT04015102.

Cet ouvrage comprend la traduction française du rapport "The cost of perinatal mental health problems" édité par le Care Policy and Evaluation Centre (CPEC) de la London School of Economics (LSE); International audience; Cet ouvrage prend le pari que des connaissances rigoureuses sur le bébé et son environnement peuvent éclairer des pratiques professionnelles respectueuses du bébé et de ses parents. Il veut contribuer au développement de la psypérinatalité dont l'ambition est de soigner les parents souffrant de troubles psychiques pour prendre soin des bébés, et inversement. Pour cela, il s'appuie sur le socle fondamental qui consiste à reconnaître que les soins corporels au bébé, chargés d'émotions, sont ainsi des soins psychiques (Myriam David), que le corps est le berceau du langage (André Bullinger), qu'il y a co-naissance du langage dans l'interaction parents-bébé dès les proto-conversations (Colwyn Trevarthen). Favoriser la construction d'une relation indissociablement corporelle et langagière entre le bébé et ses parents, entre le bébé et ses soignants, entre les parents et les soignants exige une éthique de la considération qui promeut le respect du bébé et des parents dans leurs corps, leurs rythmes, leur intégrité et la parole qui leur est adressée. Le déploiement de ces questions convoque les pratiques des professionnels des métiers de la périnatalité et leur ambition de prodiguer des soins suffisamment bons. L'alliance entre des disciplines aussi différentes que la psychanalyse, la sensori-motricité, l'histoire, l'anthropologie, la psychologie du développement et une clinique rigoureuse irrigue les réflexions et les pratiques de ces professionnels des mille et un jours, de la conception aux deux ans de l'enfant. (4e de couverture)

Reduced perception of bodily signals and low levels of intuitive eating have been reported in patients with anorexia nervosa (AN) compared with normalweight individuals. However, findings have been inconsistent and treatment progress might account for some of these inconsistencies. Thirtyseven inpatients with AN and 39 normalweight controls completed a heartbeat perception task and the Intuitive Eating Scale2. Patients with AN reported lower intuitive eating than controls, whereas interoceptive sensitivity did not differ between groups. Higher interoceptive sensitivity was related to higher intuitive eating across both groups. In patients with AN, both higher interoceptive sensitivity and intuitive eating correlated with the number of days in the hospital and with higher body mass index (BMI), when controlling for BMI at admission. These relationships suggest that interoceptive sensitivity and intuitive eating improve during treatment. Future research should determine whether these improvements promote weight gain or follow it. ERCStG2014 639445 (VLID)3568897

Objective: Conventional weight loss programs that induce a calorie deficit mostly fail in long-term weight reduction and disadvantageous eating styles often remain unchanged. Mindfulness interventions therefore redirect the focus away from the weight loss goal and toward the process of eating itself. By eating more mindfully, at a slower pace, and with an enhanced focus on bodily sensations, participants might not only indirectly reduce their daily calorie intake but also eat less craving- and stress-driven. Method: This study randomized participants to either intervention (n=23) or waitlist group (n=23) to investigate the effectiveness of a four-session mindfulness and prolonged chewing intervention. Dependent variables were body mass index (BMI), food craving, as well as emotional, external, and intuitive eating. Results: Across the eight weeks of intervention, significant group×measurement time interactions pointed to decreases in BMI and disadvantageous eating styles (food cravings, emotional, and external eating) and an increase in intuitive eating in the intervention group. Weight loss in the intervention group was maintained after a 4-week follow up. Conclusion: A combination of mindfulness and a specific chewing training that increases awareness of satiety strongly impacted energy intake and related eating styles. Such interventions obviate loss-oriented calorie reduction and foster enjoyment and focused tasting of foods. Conventional weight loss diets might incorporate such brief interventions in more long-term dieting trials.

Diet failures are often attributed to an increase in cravings for attractive foods. However, accumulating evidence shows that food cravings actually decrease during energy-restricting weight-loss interventions. The current study aimed at elucidating possible mechanisms that may explain how and under which circumstances food cravings in- or decrease during dieting. Specifically, decreases in food cravings during weight-loss diets may be due to effects of energy restriction (homeostatic changes) and to effects of avoiding specific foods (hedonic changes). Thus, we used a selective, hedonic deprivation (i.e., restricting intake of a specific food in the absence of an energy deficit) that precludes homeostatic changes due to energy restriction. Furthermore, interindividual differences in food craving experiences might affect why some individuals are more prone to experience cravings during dieting than others. Thus, we investigated whether a selective deprivation of chocolate would in- or decrease craving and implicit preference for chocolate as a function of trait-level differences in chocolate craving. Participants with high and low trait chocolate craving (HC, LC) refrained from consuming chocolate for 2 weeks but otherwise maintained their usual food intake. Both groups underwent laboratory assessments before and after deprivation, each including explicit (i.e., state chocolate craving) and implicit measures (i.e., Single Category Implicit Association Test, SC-IAT; Affect Misattribution Procedure, AMP). Results showed that hedonic deprivation increased state chocolate craving in HCs only. HCs also showed more positive implicit attitudes toward chocolate than LCs on the SC-IAT and the AMP irrespective of deprivation. Results help to disambiguate previous studies on the effects of dieting on food cravings. Specifically, while previous studies showed that energy-restricting diets appear to decrease food cravings, the current study showed that a selective, hedonic deprivation in the absence of an energy deficit increases food cravings. However, this effect can only be observed for individuals with high trait craving levels. Thus, if attractive foods are strictly avoided through a selective deprivation, HCs are at risk to experience craving bouts in the absence of an energy deficit. As implicit preference was unaffected by chocolate deprivation, strong implicit preference for chocolate likely characterize a stable mechanism that drives consumption in HCs.