{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:10:29Z","timestamp":1786119029384,"version":"build-2736575974"},"reference-count":41,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["10390032310057"],"award-info":[{"award-number":["10390032310057"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Acute urinary retention (AUR) is a burdensome urological emergency, often caused by benign prostatic obstruction. Standard management includes transurethral catheterization, alpha-blocker therapy, and a trial without catheter (TWOC) to assess spontaneous voiding. Despite the high incidence of AUR, the optimal catheter duration prior to TWOC remains uncertain. Evidence is limited, guideline recommendations are largely expert-based, and catheter duration varies widely in practice. Prolonged catheterization may increase morbidity and discomfort, whereas earlier removal may raise concerns regarding recurrent retention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>RELIEF is a pragmatic, multicenter, randomized non-inferiority trial comparing TWOC on day 3 versus TWOC on day 14 in men with AUR. All participants undergo transurethral catheterization and receive alpha-blocker therapy prior to randomization. Primary outcome is TWOC success, defined as a voided volume \u2265100 mL and post-void residual \u2264200 mL. The primary analysis follows a per-protocol approach, with a complementary intention-to-treat analysis to confirm non-inferiority. Secondary outcomes include recurrent retention, catheter-related complications, patient-reported symptoms and quality of life, and cost-effectiveness from healthcare and societal perspectives over 18 months. In parallel, a qualitative substudy using semi-structured interviews with healthcare professionals aims to explore the determinants underlying current practice variation, as well as the perceived barriers and facilitators for the sustainable implementation of a standardized TWOC strategy in future clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>By comparing two catheterization intervals already applied in routine care and combining clinical, patient-reported, economic, and implementation outcomes, RELIEF is designed to generate directly applicable evidence on TWOC timing after AUR. The results are expected to support guideline refinement and improve consistency of care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>WHO ICTRP primary registry, identifier NL-OMON57836. Registered on February 7, 2025.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0354879","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T17:23:53Z","timestamp":1786037033000},"page":"e0354879","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Early versus delayed trial without catheter in men with Acute urinary retention - Study Protocol for a dutch national randomized trial"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-4268-7095","authenticated-orcid":true,"given":"Liselot L.A.","family":"Ribbert","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9209-8030","authenticated-orcid":true,"given":"Nadine A.M.","family":"van Merode","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1086-8730","authenticated-orcid":true,"given":"Marco H.","family":"Blanker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6405-6789","authenticated-orcid":true,"given":"Michelle M.A.","family":"Kip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4820-7505","authenticated-orcid":true,"given":"Ingrid M.","family":"Nijholt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1567-4847","authenticated-orcid":true,"given":"Lambertus P.W.","family":"Witte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the RELIEF Study 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Association","year":"2018"},{"issue":"2","key":"pone.0354879.ref010","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1016\/j.prnil.2022.12.002","article-title":"Comparing effects of alpha-blocker management on acute urinary retention secondary to benign prostatic hyperplasia: A systematic review and network meta-analysis","volume":"11","author":"YN Gwon","year":"2023","journal-title":"Prostate Int"},{"issue":"5","key":"pone.0354879.ref011","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1016\/j.eururo.2019.01.046","article-title":"Management of Urinary Retention in Patients with Benign Prostatic Obstruction: A Systematic Review and Meta-analysis","volume":"75","author":"M Karavitakis","year":"2019","journal-title":"Eur Urol"},{"issue":"6","key":"pone.0354879.ref012","article-title":"The role of alpha blockers prior to removal of urethral catheter for acute urinary retention in men","volume":"2014","author":"E Fisher","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"pone.0354879.ref013","year":"2025"},{"issue":"3","key":"pone.0354879.ref014","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1177\/102490790901600302","article-title":"Acute Urinary Retention: How Useful is an Ambulatory Care Protocol?","volume":"16","author":"Y Li","year":"2009","journal-title":"Hong Kong j emerg med"},{"issue":"2","key":"pone.0354879.ref015","doi-asserted-by":"crossref","first-page":"180","DOI":"10.1111\/j.1464-410X.1989.tb05160.x","article-title":"Trial without catheter following acute retention of urine","volume":"63","author":"M Taube","year":"1989","journal-title":"Br J Urol"},{"key":"pone.0354879.ref016","first-page":"110","article-title":"Does prolonged catheter drainage improve the chance of recovering voluntary voiding after acute urinary retention (AUR","volume":"33","author":"B Djavan","year":"1998","journal-title":")? European Urology"},{"issue":"1","key":"pone.0354879.ref017","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1177\/03915603231215936","article-title":"Does the duration of catheterization have an impact on the outcome of trial without catheter in patients with acute urine retention (AUR) due to benign prostatic hyperplasia (BPH)? A prospective randomized study","volume":"91","author":"M Abuelnaga","year":"2024","journal-title":"Urologia"},{"issue":"6","key":"pone.0354879.ref018","doi-asserted-by":"crossref","first-page":"288","DOI":"10.4103\/UROS.UROS_12_18","article-title":"Early Versus Late Trail of Catheter Removal in Patients with Urinary Retention Secondary to Benign Prostatic Hyperplasia under Tamsulosin Treatment","volume":"29","author":"SH Salem Mohamed","year":"2018","journal-title":"Urological Science"},{"issue":"8","key":"pone.0354879.ref019","doi-asserted-by":"crossref","first-page":"732","DOI":"10.1002\/bco2.369","article-title":"Immediate or delayed trial without catheter in acute urinary retention in males: A systematic review","volume":"5","author":"VS Christensen","year":"2024","journal-title":"BJUI Compass"},{"issue":"4","key":"pone.0354879.ref020","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1038\/pcan.2015.15","article-title":"Systematic review and meta-analysis on management of acute urinary retention","volume":"18","author":"PD Yoon","year":"2015","journal-title":"Prostate Cancer Prostatic Dis"},{"key":"pone.0354879.ref021","doi-asserted-by":"crossref","first-page":"102295","DOI":"10.1016\/j.cont.2025.102295","article-title":"Variation in catheter management and predictors of trial without catheter success in men with AUR: results from the AUR-SNAPSHOT study","volume":"16","author":"NAM van Merode","year":"2025","journal-title":"Continence"},{"issue":"2","key":"pone.0354879.ref022","article-title":"Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals","volume":"9","author":"AS Letica-Kriegel","year":"2019","journal-title":"BMJ Open"},{"issue":"4","key":"pone.0354879.ref023","first-page":"727","article-title":"The management of acute urinary retention in France: a cross-sectional survey","volume":"97","author":"F Desgrandchamps","year":"2006","journal-title":"BJU International"},{"issue":"1","key":"pone.0354879.ref024","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1111\/j.1464-410X.2011.10430.x","article-title":"Management of acute urinary retention: a worldwide survey of 6074 men with benign prostatic hyperplasia","volume":"109","author":"JM Fitzpatrick","year":"2012","journal-title":"BJU Int"},{"key":"pone.0354879.ref025","first-page":"2020"},{"key":"pone.0354879.ref026","article-title":"SPIRIT 2025 statement: updated guideline for protocols of randomised trials","volume":"389","author":"A-W Chan","year":"2025","journal-title":"BMJ"},{"issue":"2","key":"pone.0354879.ref027","first-page":"205","article-title":"Classification of surgical complications: a new proposal","volume":"240","author":"D Dindo","year":"2004","journal-title":"Annals of Surgery"},{"issue":"2","key":"pone.0354879.ref028","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1159\/000474438","article-title":"Ten-language translation and harmonization of the International Prostate Symptom Score","volume":"31","author":"X Bad\u00eda","year":"1997","journal-title":"European Urology"},{"issue":"3","key":"pone.0354879.ref029","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1002\/nau.22729","article-title":"Development and psychometric evaluation of the ICIQ-LTCqoL","volume":"35","author":"N Cotterill","year":"2016","journal-title":"Neurourology and Urodynamics"},{"issue":"10","key":"pone.0354879.ref030","doi-asserted-by":"crossref","first-page":"1727","DOI":"10.1007\/s11136-011-9903-x","article-title":"Development and preliminary testing of the EQ-5D-5L","volume":"20","author":"M Herdman","year":"2011","journal-title":"Quality of Life Research"},{"key":"pone.0354879.ref031","unstructured":"iMTA Productivity and Health Research Group. Manual iMTA Medical Cost Questionnaire (iMCQ). Rotterdam: iMTA, Erasmus University Rotterdam, 2018."},{"key":"pone.0354879.ref032","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1016\/j.jval.2015.05.009","article-title":"The IMTA Productivity Cost Questionnaire","volume":"18","author":"C Bouwmans","year":"2015","journal-title":"Value in Health"},{"key":"pone.0354879.ref033","doi-asserted-by":"crossref","first-page":"114523","DOI":"10.1016\/j.socscimed.2021.114523","article-title":"Sample sizes for saturation in qualitative research: A systematic review of empirical tests","volume":"292","author":"M Hennink","year":"2022","journal-title":"Soc Sci Med"},{"key":"pone.0354879.ref034","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1186\/1748-5908-4-50","article-title":"Fostering implementation of health services research findings into practice","volume":"4","author":"LJ Damschroder","year":"2009","journal-title":"Implementation Science"},{"issue":"6","key":"pone.0354879.ref035","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","article-title":"Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist","volume":"19","author":"A Tong","year":"2007","journal-title":"International Journal for Quality in Health Care"},{"issue":"10489","key":"pone.0354879.ref036","first-page":"1633","article-title":"CONSORT 2025 statement. The","volume":"405","author":"S Hopewell","year":"2025","journal-title":"Lancet"},{"issue":"11","key":"pone.0354879.ref037","doi-asserted-by":"crossref","first-page":"1403","DOI":"10.1007\/s40273-023-01301-7","article-title":"Conducting Trial-Based Economic Evaluations Using R: A Tutorial","volume":"41","author":"\u00c2J Ben","year":"2023","journal-title":"Pharmacoeconomics"},{"key":"pone.0354879.ref038","unstructured":"Netherlands Care Institute. Guideline for conducting economic evaluations in healthcare (Richtlijn voor het uitvoeren van economische evaluaties in de gezondheidszorg). Diemen; 2024."},{"issue":"4","key":"pone.0354879.ref039","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1016\/j.jval.2016.01.003","article-title":"Dutch Tariff for the Five-Level Version of EQ-5D","volume":"19","author":"M M Versteegh","year":"2016","journal-title":"Value Health"},{"issue":"3","key":"pone.0354879.ref040","article-title":"mice: Multivariate Imputation by Chained Equations inR","volume":"45","author":"van Buuren S","year":"2011","journal-title":"J Stat Soft"},{"key":"pone.0354879.ref041","doi-asserted-by":"crossref","DOI":"10.1002\/9780470316696","volume-title":"Multiple imputation for nonresponse in surveys","author":"DB Rubin","year":"1987"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354879","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T17:23:58Z","timestamp":1786037038000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354879"}},"subtitle":[],"editor":[{"given":"Stanis\u0142aw Jacek","family":"Wro\u0144ski","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,6]]},"references-count":41,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,6]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0354879","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,6]]}}}