{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T15:50:16Z","timestamp":1789746616493,"version":"4.0.1"},"reference-count":34,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T00:00:00Z","timestamp":1693180800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>Since formal evidence demonstrating the value of urodynamic studies (UDS) in functional urology remains elusive, we aimed to consider how best to design robust research for this purpose in female urinary incontinence.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An expert group was convened to debate the following considerations: (a) precedents for formally proving the value of a gold standard diagnostic test, (b) key research principles, (c) defining a study population, (d) selecting endpoints, (e) defining interventional and controls arms, (f) blinding, (g) powering the study, and (h) duration of follow\u2010up. In each case, we considered the strengths and weaknesses of different approaches in terms of scientific validity, ethical acceptability, practicality, and likelihood of bias.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We agreed that unlike evaluating therapies, attempting to judge the value of a diagnostic test based on eventual treatment success is conceptually flawed. Nonetheless, we explored the design of a hypothetical randomized controlled trial for this purpose, agreeing that: (1) the study population must sufficiently reflect its real\u2010world counterpart; (2) clinical endpoints should include not only continence status but also other lower urinary tract symptoms and risks of management; (3) participants in the interventional arm should receive individualized management based on their UDS findings; (4) the most scientifically valid approach to the control arm\u2014empiric treatment\u2014is ethically problematic; (5) sufficient statistical power is imperative; and (6)\u2009\u2265\u20092 years' follow\u2010up is needed to assess the long\u2010term impact of management.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Although a perfect protocol does not exist, we recommend careful consideration of our observations when reflecting on past studies or planning new prospective research.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.25273","type":"journal-article","created":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T09:04:55Z","timestamp":1693213495000},"page":"1639-1646","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["How should prospective research be designed to legitimately assess the value of urodynamic studies in female urinary incontinence?"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3387-3524","authenticated-orcid":false,"given":"Tufan","family":"Tarcan","sequence":"first","affiliation":[{"name":"Department of Urology Marmara University School of Medicine and Ko\u00e7 University School of Medicine Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0308-8824","authenticated-orcid":false,"given":"Enrico","family":"Finazzi\u2010Agr\u00f2","sequence":"additional","affiliation":[{"name":"Department of Surgical Sciences, University of Rome Tor Vergata and UOSD Urologia Policlinico Tor Vergata Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1991-5919","authenticated-orcid":false,"given":"Thomas M.","family":"Kessler","sequence":"additional","affiliation":[{"name":"Department of Neuro\u2010Urology, Balgrist University Hospital University of Z\u00fcrich Z\u00fcrich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8534-646X","authenticated-orcid":false,"given":"Maurizio","family":"Serati","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of Insubria Varese Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4382-0394","authenticated-orcid":false,"given":"Eskinder","family":"Solomon","sequence":"additional","affiliation":[{"name":"Urology Centre Guy's and St Thomas' NHS Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0445-4563","authenticated-orcid":false,"given":"Peter F. W. M.","family":"Rosier","sequence":"additional","affiliation":[{"name":"Department of Urology University Medical Center Utrecht Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,8,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.1970.tb06796.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1520-6777(1996)15:5<443::AID-NAU1>3.0.CO;2-F"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2011.03.010"},{"key":"e_1_2_9_5_1","first-page":"487","volume-title":"Incontinence","author":"De Wachter S","year":"2023"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00070-8"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23501"},{"key":"e_1_2_9_8_1","unstructured":"https:\/\/uroweb.org\/guidelines\/neuro-urology"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1113595"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31828c68e3"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22324"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-013-2163-2"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.12102"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-014-2404-z"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.13457"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22804"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euf.2018.07.031"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2019.10.046"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euros.2022.08.013"},{"issue":"10","key":"e_1_2_9_20_1","article-title":"Urodynamic studies for management of urinary incontinence in children and adults","volume":"2013","author":"Clement KD","year":"2013","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2017.02.049"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2019.01.004"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2012.09.050"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2016.03.024"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euf.2015.10.006"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2020.09.025"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22338"},{"key":"e_1_2_9_28_1","unstructured":"https:\/\/www.cebm.net\/2009\/06\/oxford-centre-evidence-based-medicine-levels-evidence-march-2009"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrurol.2015.207"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05661-3"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta19150"},{"issue":"8","key":"e_1_2_9_32_1","first-page":"691","article-title":"Urodynamics before surgery for stress urinary incontinence in female patients: an open debate","volume":"70","author":"Finazzi Agro E","year":"2017","journal-title":"Arch Esp Urol"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22323"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-020-04393-3"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2017.03.048"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.25273","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T10:15:49Z","timestamp":1703672149000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.25273"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,28]]},"references-count":34,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1002\/nau.25273"],"URL":"https:\/\/doi.org\/10.1002\/nau.25273","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,28]]},"assertion":[{"value":"2023-08-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}