Three-year cost utility analysis of mini versus standard slings : A trial based economic evaluation

Funding Information: This work was funded by the National Institute of Health Research, Health Technology Assessment programme: project number HTA‐12/127/157. Funding information Dr. Dwayne Boyers reports grants from UK NIHR during the conduct of the study. Ms. Mary Kilonzo reports grants from UK NIHR during the conduct of the study. Kiron Bhal: I have been a speaker and trainer for the following companies in the past Astellas, Pfizer, AMS, Contura, Allergan and others, where I have received honorariums and sponsorship towards attending scientific conferences. Professor James N'Dow reports HTA General Committee 2016–2018. Professor Graeme MacLennan reports grants from UK NIHR during the conduct of the study. Professor John Norrie reports grants from the University of Edinburgh, outside the submitted work; and past and present member of the following: HTA Commissioning Sub‐Board (EOI), NIHR CTU Standing Advisory Committee, NIHR HTA & EME Editorial Board, Pre‐Exposure Prophylaxis Impact Review Panel, EME Strategy Advisory Committee, EME—Funding Committee Members, EME Funding Committee Sub‐Group Remit & Comp Check, HTA General Committee, HTA Funding Committee Policy Group (formerly CSG) and HTA Commissioning Committee. HTA post‐funding committee teleconference 2016–2019; COVID‐19 reviewing 2020. Professor Mohamed Abdel‐Fattah: None in the last 5 years. Before 2015, I have been a speaker, consultant and/or surgical trainer for a number of industrial companies (Astellas, Ethicon, Bard, Pfizer, AMS, Coloplast and others): I have been reimbursed my travel expenses; and on occasions received personal honorariums; proctorship fees and sponsorship towards attending scientific conferences. Research grant from Coloplast managed by the University of Aberdeen. A limited number of my trainees attended pharmaceutical‐sponsored educational/leadership workshops and/or received assistance in presenting their research work at scientific conferences. Was Chairman of the Scottish Pelvic Floor Network (SPFN), which at the time received financial sponsorship from various industrial companies (including all those mentioned above) and non‐profit organisations for its annual meetings and surgical workshops. The SPFN provided an educational grant funding the PI at the highest recruiting site to attend the International Continence Society annual scientific conference in Brazil in 2014. Ongoing: I receive travel sponsorship and occasionally speaker‘s fees from numerous national and international conferences and non‐profit organisations when invited as a guest speaker and/or expert surgeon. In 2019, and at request from NHS Grampian, I attended 2 educational meetings for setting up sacral nerve stimulation service partially funded by Medtronic. I am the Chief Investigator for four NIHR—HTA‐funded studies. I do not hold (and never held) any shares (or similar) in any of the industrial companies (medical or non‐medical). To the best of my knowledge, none of the above have influenced my research or clinical practice. Publisher Copyright: © 2023 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.Peer reviewedPublisher PD

Patient preferences for stress urinary incontinence treatments : a discrete choice experiment

Funding: The study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number: 12/127/157). The full project report is available from the funder’s website: https://www.journalslibrary.nihr.ac.uk/hta/BTSA6148%23/abstract. The full citation for the funder report is: Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, et al. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess 2022;26(47). The Health Economics Research Unit and Health Services Research Unit are both funded by the Chief Scientist’s Office (CSO) of the Scottish government health directorates. The SIMS trial was registered as: ISRCTN93264234.Peer reviewedPublisher PD

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

Supported by the NIHR (NIHR Evaluation, Health Technology Assessment Programme; funder number, 12/127/157). We thank all the SIMS trial patients without whom this trial would not have been possible; the members of the independent trial steering committee (Chris Mayne [chair], Isobel Montgomery, Dudley Robinson, Lynda Harper, Eleanor Mitchell, and Khaled Ismail) for their supervision of the trial and their guidance and support; the members of the independent data monitoring committee (Peter Brocklehurst [chair], Lee Middleton, Christian Phillips, and Doug Tincello) for their work in assessing all serious adverse events reported to the trial office in real time; Phil Assassa for his substantive role in the trial, including the obtaining of funding, the design of the protocol, and the recruitment of patients; Athele Khunda for his role in patient recruitment and for his contribution to the trial; and Ahmed Mansor and Katie Gillespie for their contribution with the systematic review.Peer reviewedPostprin

Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women:The SIMS RCT

BACKGROUND: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. OBJECTIVE: The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. DESIGN: This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). SETTING: The trial was set in 21 UK hospitals. PARTICIPANTS: Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. INTERVENTIONS: Single-incision mini-slings, compared with standard mid-urethral slings. MAIN OUTCOME MEASURES: The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. RESULTS: A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; pnon-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; pnon-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-£6, 95% confidence interval -£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year. LIMITATIONS: Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. CONCLUSIONS: Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. TRIAL REGISTRATION: This trial was registered as ISRCTN93264234. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information

Falling Caesarean section rate and improving intra-partum outcomes: A prospective cohort study

Objective: To evaluate caesarean section (CS) rates and moderate to severe hypoxaemic ischaemic encephalopathy (HIE) rates with other core intra-partum outcomes following reconfiguration of maternity services in Cardiff, South Wales, UK. Design: Cohort study of births from 2006 to 2015. Settings: A University tertiary referral centre for foetal and maternal medicine with 6000 births/year, University Hospital of Wales, United Kingdom. Method: Data relating to births from 1 January 2006 to 31 December 2015 were extracted from the computerized maternity database on a yearly basis. Case notes of all mothers and babies for the same duration were hand searched for documentation of HIE. HIE data was also collected prospectively by neonatologist (SC) and obstetrician (PA). Main outcome measures: Incidence of caesarean section births, babies with moderate to severe HIE, instrumental vaginal births, obstetric anal sphincter injuries (OASIS) associated with instrumental delivery, and major post-partum haemorrhage (MPPH) of 2500 mL or more. Results: During this 10-year period, a downward trend in emergency CS rate was seen from 15.6% in 2006 to 10.5% in 2015, reducing total CS rate from 25.5% in 2006 to 21.2% in 2015. A downward trend in the incidence of moderate and severe HIE was seen over the same period. There was an increase in operative vaginal births (OVB) from 12.8% to 15%. The rate of spontaneous vaginal births (SVB) remained stable. The incidence of OASIS remained constant and MPPH rate has fallen. Conclusions: Following amalgamation of two medium sized obstetric units and the opening of a Midwifery Led Unit (MLU), core intrapartum outcomes have improved. Contributing factors are the introduction of regular multidisciplinary training with enhanced team working, compulsory education for obstetricians and midwives on cardiotocograph (CTG) interpretation, increased consultant presence on delivery suite, robust risk management systems and broad multidisciplinary agreement on clinical guidelines promoting vaginal birth