{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T04:41:04Z","timestamp":1793335264320,"version":"4.5.0"},"reference-count":9,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T00:00:00Z","timestamp":1596758400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002001","name":"Health Services and Delivery Research Programme","doi-asserted-by":"publisher","award":["PB-PG-1013-32017"],"award-info":[{"award-number":["PB-PG-1013-32017"]}],"id":[{"id":"10.13039\/501100002001","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Rehabil"],"published-print":{"date-parts":[[2020,12]]},"abstract":"\n Objective:<\/jats:title>\n \n To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom\n \u00ae<\/jats:sup>\n ) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction.\n <\/jats:p>\n <\/jats:sec>\n \n Design:<\/jats:title>\n A parallel-group, double-blind, randomized, placebo-controlled trial.<\/jats:p>\n <\/jats:sec>\n \n Setting:<\/jats:title>\n Patients at home, recruited through out-patient contact, social media and patient support groups.<\/jats:p>\n <\/jats:sec>\n \n Subjects:<\/jats:title>\n People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12\u2009months.<\/jats:p>\n <\/jats:sec>\n \n Interventions:<\/jats:title>\n All participants took one capsule of oral OM-89 immunotherapy (6\u2009mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3\u2009months.<\/jats:p>\n <\/jats:sec>\n \n Main measures:<\/jats:title>\n The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6\u2009months. Feasibility measures included recruitment, retention and practical difficulties.<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6\u2009months, 18\/25 active group patients had 55 infections, and 18\/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants.<\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.<\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/0269215520946065","type":"journal-article","created":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T05:53:34Z","timestamp":1596779614000},"page":"1458-1464","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Immunotherapy to reduce frequency of urinary tract infections in people with neurogenic bladder dysfunction; a pilot randomised, placebo-controlled trial"],"prefix":"10.1177","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1188-8442","authenticated-orcid":false,"given":"Derick T","family":"Wade","sequence":"first","affiliation":[{"name":"Oxford Institute of Nursing, Midwifery and Allied Health Research (OxINMAHR), Faculty of Health & Life Sciences, Oxford Brookes University, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Cooper","sequence":"additional","affiliation":[{"name":"NSIC Research Programme Manager, National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Peckham","sequence":"additional","affiliation":[{"name":"Medical Statistician, Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, (NDORMS), University of Oxford, Botnar Research Centre, Headington, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Belci","sequence":"additional","affiliation":[{"name":"Consultant in Spinal Cord Injuries, National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,8,7]]},"reference":[{"key":"bibr1-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000555"},{"key":"bibr2-0269215520946065","unstructured":"National Clinical Guideline Centre. Urinary incontinence in neurological disease: management of lower urinary tract dysfunction in neurological disease. Clinical Guideline 148. National Clinical Guideline Centre. 2012. https:\/\/www.nice.org.uk\/guidance\/cg148\/evidence\/full-guideline-pdf-188123437"},{"key":"bibr3-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3275-x"},{"key":"bibr4-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2008.08.011"},{"key":"bibr5-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(17)40084-X"},{"key":"bibr6-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkl010"},{"key":"bibr7-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)67157-1"},{"key":"bibr8-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23859"},{"key":"bibr9-0269215520946065","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2010.03.024"}],"updated-by":[{"DOI":"10.1177\/0269215521990453","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2021,1,18]],"date-time":"2021-01-18T00:00:00Z","timestamp":1610928000000}}],"container-title":["Clinical Rehabilitation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0269215520946065","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0269215520946065","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0269215520946065","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T16:54:58Z","timestamp":1777395298000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0269215520946065"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,7]]},"references-count":9,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["10.1177\/0269215520946065"],"URL":"https:\/\/doi.org\/10.1177\/0269215520946065","relation":{},"ISSN":["0269-2155","1477-0873"],"issn-type":[{"value":"0269-2155","type":"print"},{"value":"1477-0873","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,7]]}}}