Exposure of plastic surgery and urology registrars in the United Kingdom to gender affirming care of transgender patients: A cross-sectional survey of training programme directors.

Objectives: To assess the expected duration of exposure of United Kingdom urology and plastic surgery trainees to the provision of gender affirming healthcare to transgender patients. This observational, cross-sectional survey asked UK training programme directors (TPDs) to report the volume of training in gender affirming care of transgender patients that urology and plastic surgery trainees are expected to receive.

Methods: A Google Form online questionnaire was distributed to each regional TPD in the UK both for plastic surgery and urology.

Design, implementation and assessment of a novel, introductory curriculum into female, neurological and urodynamic urology: a 7-year experience of urology simulation bootcamp course.

Purpose: To present the seven-year experience of a multi-component and interactive module on female, neurological and urodynamic urology (FNUU) training at the UK National Urology Simulation Bootcamp Course (USBC) and demonstrate trainee satisfaction and competency progression.

Methods: During the week-long USBC, a four-hour module on FNUU was designed which consisted of short interactive presentations with an emphasis on practical stations in urodynamics, intravesical botulinum toxin injection, urethral bulking injection, female pelvic examination and, initially, mid-urethral tapes (subsequently replaced with percutaneous sacral nerve evaluation). The trainee's level of knowledge, operative experience and confidence were assessed pre- and post-course.

Urological and Gynaecological Considerations for the Use of Gonadotropin-releasing Hormone Analogues in Transgender and Nonbinary Adolescents: A Narrative Review.

Context: Gonadotropin-releasing hormone analogues (GnRHAs) delay the progression of puberty in transgender and nonbinary (TGNB) adolescents and reduce the impact of dysphoria due to ongoing physical development. The intervention remains contentious despite growing evidence to support this practice.

Objective: To stimulate discussion on this topical issue in the urological and gynaecological community given potential ramifications for future fertility, physical development, and options for gender affirmation surgery (GAS).

Pre-Clinical Evaluation of Tenofovir and Tenofovir Alafenamide for HIV-1 Pre-Exposure Prophylaxis in Foreskin Tissue.

Background: HIV-1 pre-exposure prophylaxis (PrEP) has focused predominantly on protective efficacy in receptive sex, with limited research on the dosing requirements for insertive sex. We pre-clinically assessed the ex vivo pharmacokinetic-pharmacodynamic (PK-PD) profile of tenofovir (TFV) and tenofovir alafenamide (TAF) in foreskin tissue.

Methods: Inner and outer foreskin explants were exposed to serial dilutions of TFV or TAF prior to addition of HIV-1 at a high (HVT) or a low viral titer (LVT).

Burnout in Surgical Trainees: a Narrative Review of Trends, Contributors, Consequences and Possible Interventions.

Surgical disciplines are popular and training places are competitive to obtain, but trainees report higher levels of burnout than either their non-surgical peers or attending or consultant surgeons. In this review, we critically summarise evidence on trends and changes in burnout over the past decade, contributors to surgical trainee burnout, the personal and professional consequences of burnout and consider the evidence for interventions. There is no evidence for a linear increase in burnout levels in surgeons over the past decade but the impact of the COVID-19 pandemic has yet to be established and is likely to be significant.

GDC-0810 Pharmacokinetics and Transporter-Mediated Drug Interaction Evaluation with an Endogenous Biomarker in the First-in-Human, Dose Escalation Study.

GDC-0810 (Cheeti et al., 2018) is an orally bioavailable, selective estrogen receptor (ER) degrader developed to treat ER-positive breast cancer. A first-in-human (FIH) dose escalation phase I study ( = 41) was conducted to characterize the pharmacokinetics (PK) of GDC-0810 and its two major metabolites.

Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

Background: Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies).

Objective: To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

Investigation of the absolute bioavailability and human mass balance of navoximod, a novel IDO1 inhibitor.

Aims: Navoximod (GDC-0919, NLG-919) is a small molecule inhibitor of indoleamine-2,3-dioxygenase 1 (IDO1), developed to treat the acquired immune tolerance associated with cancer. The primary objectives of this study were to assess navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ C]-navoximod, and characterize navoximod's metabolite profile.

Methods: A phase 1, open-label, two-part study was conducted in healthy volunteers.

Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors.

Purpose: IDO1 induces immune suppression in T cells through l-tryptophan (Trp) depletion and kynurenine (Kyn) accumulation in the local tumor microenvironment, suppressing effector T cells and hyperactivating regulatory T cells (Treg). Navoximod is an investigational small-molecule inhibitor of IDO1. This phase I study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of navoximod in combination with atezolizumab, a PD-L1 inhibitor, in patients with advanced cancer.

Association of Cancer Immunotherapy With Acute Macular Neuroretinopathy and Diffuse Retinal Venulitis.

Importance: Checkpoint inhibition in cancer immunotherapy related to T-cell-driven mechanisms of action associated with acute macular neuroretinopathy (AMN) and diffuse retinal venulitis, an adverse event not previously described, is reported here.

Objective: To describe 2 patients who developed ophthalmologic events after treatment with the programmed death 1 axis inhibitor, atezolizumab.

Design, Setting, And Participants: Retrospective review of 2 patients treated with atezolizumab for metastatic breast cancer and colon cancer, respectively, who presented with AMN and diffuse retinal venulitis conducted at 2 tertiary medical centers.

Correction to: Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects.

The Publisher regrets the typesetting mistake of retaining incorrect text in the Figure 1 caption. The correct text for the caption is "Molecular Structure of GDC-0810 NMG Salt". The original article has been corrected.

Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects.

Purpose: GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers. It contains N-methyl-D-glucamine (NMG) salt of GDC-0810 with 10% sodium lauryl sulfate (SLS) as a surfactant and 15% sodium bicarbonate (NaHCO) as an alkalizing agent to aid dissolution. To improve the processability of the formulation and reduce potential mucosal irritation in future Phase III clinical studies, the salt form and the amount of excipient required further optimization.

Results of the British Association of Urological Surgeons female stress urinary incontinence procedures outcomes audit 2014-2017.

Objectives: To analyse the results of the stress urinary incontinence (SUI) audit conducted by the British Association of Urological Surgeons (BAUS), and to present UK urologists' contemporary management of SUI.

Patients And Methods: The BAUS audit tool is an online resource, to which all UK urologists performing procedures for SUI are invited to submit data. The data entries for procedures performed during 2014-2016 were collated and analysed.

A Method to Evaluate Trainee Progression During Simulation Training at the Urology Simulation Boot Camp (USBC) Course.

Objectives: To evaluate skills progression at the Urology Simulation Boot Camp (USBC), a course intended to provide urology trainees with 32 hours of 1:1 training on low and high-fidelity simulators.

Design: In this single-group cohort study, trainees rotated through modules based on aspects of the United Kingdom urology residency curriculum and undertook a pre and postcourse MCQ. Specific procedural skill was evaluated by an expert and graded as either: "A"-Good (≥4 on a 5-point Likert Scale) or "B"-Poor (Likert scale of 1-3).

Effect of OATP1B1/1B3 Inhibitor GDC-0810 on the Pharmacokinetics of Pravastatin and Coproporphyrin I/III in Healthy Female Subjects.

Developed as an oral anticancer drug to treat estrogen receptor-positive breast cancer, GDC-0810 was shown to be a potent inhibitor of organic anion-transporting polypeptide 1B1 and 1B3 (OATP1B1/1B3) from an in vitro assay. A clinical study was conducted to assess the drug-drug interaction potential between GDC-0810 and pravastatin, which is a relatively selective and sensitive OATP1B1/1B3 substrate. Fifteen healthy female subjects of non-childbearing potential were enrolled in the study.

Mesh removal after vaginal surgery: what happens in the UK?

Introduction And Hypothesis: There is little objective evidence regarding complication rates for mesh procedures outside clinical trials. Current coding poorly collects complications of prolapse and continence surgery using mesh. This survey was designed to identify surgeons performing mesh removal and reporting patterns in the UK.

Safety of Onartuzumab in Patients with Solid Tumors: Experience to Date from the Onartuzumab Clinical Trial Program.

Background: Onartuzumab, a recombinant humanized monovalent monoclonal antibody directed against MET, the receptor for the hepatocyte growth factor, has been investigated for the treatment of solid tumors. This publication describes the safety profile of onartuzumab in patients with solid tumors using data from the global onartuzumab clinical development program.

Methods: Adverse event (AE) and laboratory data from onartuzumab phase II/III studies were analyzed and coded into standardized terms according to industry standards.

Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women.

Objective: To compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI).

Patients And Methods: A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol.

What patients think: patient-reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence--a multi-centre randomised controlled trial.

Introduction And Hypothesis: The purpose of this study is to determine if the trans-obturator tape (TOT; Monarc, American Medical Systems (AMS)), which has been claimed to have similar or improved outcomes to retropubic mid-urethral slings, was equivalent (but not inferior) to the trans-vaginal tape (TVT; Gynecare) by using patient-reported outcomes for the treatment of urodynamic stress incontinence.

Methods: The primary outcome was the percentage cured of the symptom of stress urinary incontinence at 12 months on the International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms question, 'does urine leak when you are physically active, exert yourself, cough or sneeze?'. Secondary outcomes included: quality of life, pain scores, global impression of improvement, patient satisfaction and complications.

Pharmacokinetics of plasma lopinavir/ritonavir following the administration of 400/100 mg, 200/150 mg and 200/50 mg twice daily in HIV-negative volunteers.

Objectives: Data suggest that some licensed antiretroviral doses could be reduced. We assessed the safety, tolerability and pharmacokinetics of lopinavir/ritonavir at doses of 400/100, 200/150 and 200/50 mg twice daily in HIV-negative volunteers (http://clinicaltrials.gov/ct2/show/NCT00985543).

British Association of Urological Surgeons' suprapubic catheter practice guidelines.

Unlabelled: What's known on the subject? and What does the study add? The suprapubic catheter (SPC) is a useful and widely used tool in urological practice. However, complications can arise from its insertion or ongoing care. Currently there are no guidelines relating to SPC usage.

Biomaterials in urinary incontinence and treatment of their complications.

Biomaterials integrate with the anatomy and provide support to the weakened area. They are generally synthetic, but natural substances are also used. These substances are being increasingly used in stress urinary incontinence.

The central urology multidisciplinary team - is it time to change the referral criteria? An audit of practice in a district general hospital in London.

Introduction: All cancer patients are discussed in multidisciplinary team meetings (MDTs). Certain patients are referred to the Central MDT based on specific national criteria. We wanted to see whether the Central MDT aided in the decision-making process above that of the Local MDT alone.