{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T18:22:49Z","timestamp":1778869369625,"version":"3.51.4"},"reference-count":47,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>To confirm the improved performance of the micro\u2010hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Male self\u2010catheterizing subjects, who used hydrophilic sleeved soft\/flexible CIC as the only bladder emptying method, were enrolled into a multi\u2010center, randomized, cross\u2010over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro\u2010holes and a CEC with two eyelets. The study consisted of four study visits (V0\u2013V3), during which endpoints related to catheter performance (urinary flow\u2010stops, bladder emptying, and intra\u2010catheter pressure) were measured and two 4\u2010week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventy\u2010three\u00a0male subjects with non\u2010neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow\u2010stops compared to \u22651 flow\u2010stops with the CEC, during both <jats:italic>HCP<\/jats:italic>\u2010 and <jats:italic>self\u2010led<\/jats:italic> catheterizations (both <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Residual urine at first flow\u2010stop was significantly reduced for the MHZC compared to CEC\u00a0(<jats:italic>p<\/jats:italic>\u2009=\u20090.001 and <jats:italic>p<\/jats:italic>\u2009=\u20090.004, for <jats:italic>HCP<\/jats:italic>\u2010 and <jats:italic>self\u2010led<\/jats:italic> catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow\u2010stop, a proxy for minimized mucosal suction (both <jats:italic>HCP<\/jats:italic>\u2010 and <jats:italic>self\u2010led<\/jats:italic> catheterizations,\u00a0<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). After home\u2010use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.25383","type":"journal-article","created":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T07:00:34Z","timestamp":1704870034000},"page":"464-478","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Improved emptying performance with a new micro\u2010hole zone catheter in adult male intermittent catheter users: A comparative multi\u2010center\u00a0randomized controlled cross\u2010over study"],"prefix":"10.1002","volume":"43","author":[{"given":"Nikesh","family":"Thiruchelvam","sequence":"first","affiliation":[{"name":"Department of Urology, NHS Foundation Trust, Addenbrooke's Hospital Cambridge University Hospital Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4479-428X","authenticated-orcid":false,"given":"Malene Hornbak","family":"Landauro","sequence":"additional","affiliation":[{"name":"Coloplast A\/S Humleb\u00e6k Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Biardeau","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Lille Lille Cedex France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecilie","family":"Rovsing","sequence":"additional","affiliation":[{"name":"Sanos Clinic Gandrup Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus","family":"Hahn","sequence":"additional","affiliation":[{"name":"ARTIMED Medical Consulting GmbH Kassel Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Omar Feix do","family":"Nascimento","sequence":"additional","affiliation":[{"name":"Coloplast A\/S Humleb\u00e6k Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharryn","family":"Gardner","sequence":"additional","affiliation":[{"name":"Hazelwood House Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00e9rard","family":"Amarenco","sequence":"additional","affiliation":[{"name":"Department of Neuro\u2010Urology Tenon Hospital Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Per","family":"Bagi","sequence":"additional","affiliation":[{"name":"Department of Urology Rigshospitalet K\u00f8benhavn \u00d8 Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,1,9]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1310\/sci2503-228"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-019-03071-4"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24914"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/bju.14514"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1155\/2019\/2757862"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24253"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.medmal.2019.02.006"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/10790268.1999.11719579"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22378"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2012.11549.x"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1965.03090110106036"},{"issue":"5","key":"e_1_2_11_13_1","first-page":"889","article-title":"Foley catheter drainage systems and bladder damage","volume":"132","author":"Isaacs JH","year":"1971","journal-title":"Surg Gynecol Obstet"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365599.1988.11690391"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365599.1988.11690392"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1159\/000253440"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-21122-6"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm12165266"},{"key":"e_1_2_11_19_1","unstructured":"Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers. 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