{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T02:23:44Z","timestamp":1793759024127,"version":"4.6.1"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,8,3]],"date-time":"2022-08-03T00:00:00Z","timestamp":1659484800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,8,3]],"date-time":"2022-08-03T00:00:00Z","timestamp":1659484800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients\u2019 and clinicians\u2019 views and experiences of the interventions.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition<jats:bold>.<\/jats:bold><\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-022-06546-9","type":"journal-article","created":{"date-parts":[[2022,8,3]],"date-time":"2022-08-03T07:04:02Z","timestamp":1659510242000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment"],"prefix":"10.1186","volume":"23","author":[{"given":"L.","family":"Clark","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Fitzgerald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Noble","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"MacNeill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Paramasivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Cotterill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Hashim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Jha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Toozs-Hobson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Greenwell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Thiruchelvam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Agur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"White","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Garner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Cobos-Arrivabene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Clement","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Cochrane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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Health Research Authority (HRA) and Heath and Care Research Wales (HCRW) approval was obtained on 19 December 2019 and applies to all participating sites in England and Wales. Any amendments to study documents, including the study protocol, after receiving initial study approvals will be submitted to the REC\/HRA for approval prior to implementation. A copy of the current study protocol (v4.0) is available from the NIHR Journals Library [].Written informed consent (including electronic (e)consent) will be obtained, according to ICH GCP guidelines, from all patients who are deemed eligible and agree to take part before entering the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"This manuscript does not contain any details or personal data relating to individual persons. Informed consent materials for the trial are available from the corresponding author on request.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"<i>Authors<\/i>TG is a personal consultant for Boston Scientific and Contura; is a speaker for Allergan, Boston Scientific, Contura, Ferring, Olympus and Medtronic; is a GURS board member (AUA), ESGURS board member (EAU), and member of the EAU Urethral Stricture Guidelines Committee; has received institutional grants\/ sponsorship to run the annual Female Urology and Urogynaecology Masterclass at UCLH from Allergan, Astellas, Axonics, Boston Scientific, Contura, Ferring, June Medical, Laborie, Mediplus, Medtronic, Olympus and Vesica Urology; has received sponsorship from Medtronic for a Neuromodulation Fellow at UCLH (now replaced by the Medipoints system); has received an education grant from Laborie for an ICS-approved UDS course at UCLH; and has received equipment and a staff loan from Olympus, Storz, Cook and Mediplus.WA has received trainer and speaker fees from CR Bard, Contura, NHS Ayrshire and Arran, and the London Medical Education Academy; sponsorship from Boston Scientific and Neomedic; expert fees from NHS Scotland and various law firms in the UK, Ireland, the USA and Australia in relation to mesh litigation; and institutional research support as principal investigator for the SIMS Pilot, PROSPECT and VUE studies, and as co-chief investigator for PURSUIT study. Wael Agur is also a member of an All Party Parliamentary Group on surgical mesh.HH is speaker for Boston Scientific, Allergan, Medtronic and Ferring; is a committee member of ESSFU and BAUS FNUU; and is associate editor of Neurourology and Urodynamics and BJUI Compass journals. He has received institutional grants to run Medtronic courses on sacral neuromodulation and has received speaker fees from Medtronic for mentorship and lecturing. HH is chair of the ICS mesh complications working group and CI for NIHR UNBLOCS trial, co-applicant on PURSUIT, CATHETER II, TRIUMPH and FUTURE.<i>Principal Investigators at study sites<\/i>Magda Kujawa is a site PI. MK has been a previous speaker for and carried out consultancy work for Contura, manufacturers of Bulkamid (Axonics).Aethele Khunda is a site PI. AK has not received any sponsorship in the last 2 years. AK has previously received an educational grant and\/or speaker fees from Medtronic, Axonic, Astellas and Specialty European Pharma and has received travel and accommodation expenses from conference organising committees when invited as a speaker.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"628"}}