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1. Multidrug-resistant Uro-associated Escherichia coli Populations and Recurrent Urinary Tract Infections in Patients Performing Clean Intermittent Self-catheterisation

Author

Catherine Mowbray, Aaron Tan, Maxime Vallée, Holly Fisher, Thomas Chadwick, Catherine Brennand, Katherine E. Walton, Robert S. Pickard, Christopher Harding, Phillip D. Aldridge, and Judith Hall

Subjects
Antibiotics, Continuous intermittent single-use catheterisation, Escherichia coli, Innate immunity, Lower urinary tract infection, Multidrug resistance, Diseases of the genitourinary system. Urology, RC870-923, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: The AnTIC trial linked continuous low-dose antibiotic prophylaxis treatments to a lower incidence of symptomatic urinary tract infections (UTIs) among individuals performing clean intermittent self-catheterisation (CISC). Objective: To explore potential mechanisms underlying the protective effects of low-dose antibiotic prophylaxis treatments, blood and urine samples and uro-associated Escherichia coli isolates from AnTIC participants were analysed. Design, setting, and participants: Blood samples (n = 204) were analysed for TLR gene polymorphisms associated with UTI susceptibility and multiple urine samples (n = 558) were analysed for host urogenital responses. E.coli sequence data for 45 temporal isolates recovered from the urine samples of 16 trial participants in the prophylaxis (n = 9) and no-prophylaxis (n = 7) study arms, and characterised by multidrug resistance (MDR), were used to classify individual strains. Outcome measurements and statistical analysis: TLR polymorphism data were analysed using Poisson regression. Concentrations of urine host defence markers were analysed using linear mixed-effects models, which accounted for repeated urine samples. Results and limitations: Urine samples from CISC users, irrespective of antibiotic treatment regimens, were associated with robust urothelial innate responses. No links were identified between TLR genotype and CISC user susceptibility to recurrent UTIs. Microbiological study data were limited to the predominant MDR E. coli population; participants prescribed low-dose prophylactic antibiotics were predominantly colonised by a single uro-associated E. coli strain, while participants given acute antibiotic treatments were each colonised by more than one E. coli strain. Conclusions: Antibiotic treatments did not impact urogenital responses to infection in CISC users. Host genetics in terms of TLR polymorphisms played no role in determining CISC user susceptibility to or protection from recurrent UTIs. Prophylactic antibiotic treatments associated with MDR E. coli were associated with colonisation by stable uro-associated E. coli genotypes. Patient summary: Our findings show that the natural urogenital defences of clean intermittent self-catheterisation (CISC) users were not impacted by antibiotic treatments. For some CISC users, prophylaxis with low-dose antibiotics selected for a stable, predominantly, Esherichia coli rich uromicrobiota.

Published
2022
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2. Evasion of toll-like receptor recognition by Escherichia coli is mediated via population level regulation of flagellin production

Author

Aaron Tan, Qusai Alsenani, Marcello Lanz, Christopher Birchall, Lauren K. L. Drage, David Picton, Catherine Mowbray, Ased Ali, Christopher Harding, Robert S. Pickard, Judith Hall, and Phillip D. Aldridge

Subjects
TLR5, UPEC, flagellin, urinary tract infection, bacterial motility, Microbiology, QR1-502
Abstract

Uropathogenic Escherichia coli is a major cause of urinary tract infections. Analysis of the innate immune response in immortalized urothelial cells suggests that the bacterial flagellar subunit, flagellin, is key in inducing host defenses. A panel of 48 clinical uro-associated E. coli isolates recovered from either cystitis, pyelonephritis asymptomatic bacteriuria (ABU) or UTI-associated bacteraemia infections were characterized for motility and their ability to induce an innate response in urothelial cells stably transfected with a NF-κB luciferase reporter. Thirty-two isolates (67%) were identified as motile with strains recovered from cystitis patients exhibiting an uneven motility distribution pattern; seven of the cystitis isolates were associated with a > 5-fold increase in NF-κB signaling. To explore whether the NF-κB signaling response reflected antigenic variation, flagellin was purified from 14 different isolates. Purified flagellin filaments generated comparable NF-κB signaling responses, irrespective of either the source of the isolate or H-serotype. These data argued against any variability between isolates being related to flagellin itself. Investigations also argued that neither TLR4 dependent recognition of bacterial lipopolysaccharide nor growth fitness of the isolates played key roles in leading to the variable host response. To determine the roles, if any, of flagellar abundance in inducing these variable responses, flagellar hook numbers of a range of cystitis and ABU isolates were quantified. Images suggested that up to 60% of the isolate population exhibited flagella with the numbers averaging between 1 and 2 flagella per bacterial cell. These data suggest that selective pressures exist in the urinary tract that allow uro-associated E. coli strains to maintain motility, but exploit population heterogeneity, which together function to prevent host TLR5 recognition and bacterial killing.

Published
2023
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5. Acupuncture for treating overactive bladder in adults

Author

Emma, Hargreaves, Katherine, Baker, Gill, Barry, Christopher, Harding, Yingying, Zhang, Ngianga-Bakwin, Kandala, Xiaowen, Zhang, Ashleigh, Kernohan, and Carl E, Clarkson

Subjects
Adult, Urinary Incontinence, Urinary Bladder, Overactive, Acupuncture Therapy, Urinary Bladder Diseases, Humans, Nocturia, Pharmacology (medical), Randomized Controlled Trials as Topic
Abstract

Overactive bladder is a common, long-term symptom complex, which includes frequency of micturition, urgency with or without associated incontinence and nocturia. Around 11% of the population have symptoms, with this figure increasing with age. Symptoms can be linked to social anxiety and adaptive behavioural change. The cost of treating overactive bladder is considerable, with current treatments varying in effectiveness and being associated with side effects. Acupuncture has been suggested as an alternative treatment.To assess the effects of acupuncture for treating overactive bladder in adults, and to summarise the principal findings of relevant economic evaluations.We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (including In-Process, Epub Ahead of Print, Daily), ClinicalTrials.gov and WHO ICTRP (searched 14 May 2022). We also searched the Allied and Complementary Medicine database (AMED) and bibliographic databases where knowledge of the Chinese language was necessary: China National Knowledge Infrastructure (CNKI); Chinese Science and Technology Periodical Database (VIP) and WANFANG (China Online Journals), as well as the reference lists of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs and cross-over RCTs assessing the effects of acupuncture for treating overactive bladder in adults.Four review authors formed pairs to assess study eligibility and extract data. Both pairs used Covidence software to perform screening and data extraction. We assessed risk of bias using Cochrane's risk of bias tool and assessed heterogeneity using the ChiWe included 15 studies involving 1395 participants in this review (14 RCTs and one quasi-RCT). All included studies raised some concerns regarding risk of bias. Blinding of participants to treatment group was only achieved in 20% of studies, we considered blinding of outcome assessors and allocation concealment to be low risk in only 25% of the studies, and random sequence generation to be either unclear or high risk in more than 50% of the studies. Acupuncture versus no treatment One study compared acupuncture to no treatment. The evidence is very uncertain regarding the effect of acupuncture compared to no treatment in curing or improving overactive bladder symptoms and on the number of minor adverse events (both very low-certainty evidence). The study report explicitly stated that no major adverse events occurred. The study did not report on the presence or absence of urinary urgency, episodes of urinary incontinence, daytime urinary frequency or episodes of nocturia. Acupuncture versus sham acupuncture Five studies compared acupuncture with sham acupuncture. The evidence is very uncertain about the effect of acupuncture on curing or improving overactive bladder symptoms compared to sham acupuncture (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -1.03 to 0.31; 3 studies; 151 participants; IThe evidence is very uncertain about the effect acupuncture has on cure or improvement of overactive bladder symptoms compared to no treatment. It is uncertain if there is any difference between acupuncture and sham acupuncture in cure or improvement of overactive bladder symptoms. This review provides low-certainty evidence that acupuncture may result in a slight increase in cure or improvement of overactive bladder symptoms when compared with medication and may reduce the incidence of minor adverse events. These conclusions must remain tentative until the completion of larger, higher-quality studies that use relevant, comparable outcomes. Timing and frequency of treatment, point selection, application and long-term follow-up are other areas relevant for research.

Published
2022
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19. Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation

Author

Dean Elterman, Jodi Michaels, Eric Margolis, Janet Harris‐Hicks, Kimberly Burgess, Christopher Betts, Christopher Harding, Geoffrey Towers, Hashim Hashim, Akin Ojo‐Carons, Amanda White, Tracy Cannon‐Smith, Nathan Grunow, Katie Bittner, and Keith Xavier

Subjects
Treatment Outcome, Urinary Bladder, Overactive, Urology, Humans, Electric Stimulation Therapy, Urinary Incontinence, Urge, Neurology (clinical), Prospective Studies
Abstract

The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle.Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit).One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae.The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.

Published
2022

33. Renegotiating Westphalia : Essays and Commentary on the European and Conceptual Foundations of Modern International Law

Author

C.L. Lim, Christopher Harding, C.L. Lim, and Christopher Harding

Subjects
International law, International law--Europe
Abstract

This collection of papers addresses two main themes: firstly, whether there is a distinctively European contribution to or even leadership in the contemporary formation and evolution of international law; secondly, the extent to which non-governmental actors (e.g. NGOs, international organizations, companies, individuals) contribute decisively to the formation of international law at the present time. These issues are explored within a number of different contexts of contemporary significance, in particular: the protection of human and minority rights; protection of the environment; control of transnational organized crime; prosecution of war crimes and crimes against humanity; the definition of statehood and the right to self-determination; transnational commercial and economic activity. The discussion is firmly located within the theory of international law and relations and also the continuum of international history.Comparisons are drawn with both global and other regional developments to test the hypothesis of a'European international law'. The work will be of interest to teachers, students and practitioners (legal and otherwise) in the field of international law and relations.

Published
2024

34. Criminal and Quasi-criminal Enforcement Mechanisms in Europe : Origins, Concepts, Future

Author

Vanessa Franssen, Christopher Harding, Vanessa Franssen, and Christopher Harding

Subjects
Criminal law--Europe, Criminal justice, Administration of--Europe, Law enforcement--Europe, Public law--Europe
Abstract

This book looks at the interplay between criminal and other branches of public law pursuing similar objectives (referred to as'quasi-criminal law'). The need for clarifying the concepts and the interlink between criminal and quasi-criminal enforcement is a topic attracting a lot of discussion and debate both in academia and practice across Europe (and beyond). This volume adds to this debate by bringing to light the substantive and procedural problems stemming from the current parallel or dual use of the different enforcement systems. The collection draws on expertise from academia, practice and policy; its high-quality analysis will appeal to scholars, practitioners and policymakers alike.

Published
2022

35. Bad Business Practice : Criminal Law, Regulation and the Reconfiguration of the Business Model

Author

Christopher Harding, Alison Cronin, Christopher Harding, and Alison Cronin

Subjects
Business enterprises--Corrupt practices, Business enterprises--Law and legislation, Criminal law, Competition, Unfair, Corporation law--Criminal provisions
Abstract

This cutting-edge book critically reviews the field of attempted legal control and regulation of delinquent conduct by business actors in the form of exploitative, collusive and corrupt behaviour. It explores key topics including victimhood, accountability, theories of trading and shared responsibility. Christopher Harding and Alison Cronin reflect on the attempts that have been made globally to use criminal law and other methods of formal legal control, as well as more flexible and innovative approaches under the heading of'regulation', to address the problem of bad business practice. The book argues for a return to first principles and that the possibility of a reconfiguration of economic ordering and market and trading culture should be considered; as business malpractice is largely inherent in the dominant capitalist model, that model is in need of repurposing and reform. Taking an interdisciplinary approach, this book will be a valuable resource for scholars and students of law with a focus on business, commercial law and criminal law, in addition to researchers of corporate governance and public administration and management. Its critical arguments will also benefit NGOs, business professionals and campaign groups.

Published
2022

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