{"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":1793335264122,"version":"4.5.0"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,10,1]],"date-time":"2022-10-01T00:00:00Z","timestamp":1664582400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,10,1]],"date-time":"2022-10-01T00:00:00Z","timestamp":1664582400000},"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":["Int Urol Nephrol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>To evaluate efficacy and safety of vaccination with StroVac compared to placebo in patients with recurrent urinary tract infections (rUTI).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Material and methods<\/jats:title>\n                <jats:p>We performed a prospective, double-blinded, placebo-controlled study in patients with uncomplicated rUTI. Patients received three single intramuscular injections with StroVac every two weeks. Primary endpoint was the number of bacterial urinary tract infections (UTI) over 13.5\u00a0months after randomization and adjusted by the respective \u201cbaseline\u201d value when comparing verum and placebo group. Secondary endpoints were the number of patients with non-recurrence, time to first recurrence, frequency of recurrences, and patients' self-assessment of quality of life using a validated questionnaire.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>376 patients were randomized to both groups between January 2012 and March 2015. Mean age was 44.4\u00a0years. Patients were mainly female (98.4%). In the StroVac group (<jats:italic>n<\/jats:italic>\u2009=\u2009188), the number of UTIs was reduced from 5.5 to 1.2, in the placebo group (<jats:italic>n<\/jats:italic>\u2009=\u2009188) from 5.4 to 1.3 (<jats:italic>p<\/jats:italic>\u2009=\u20090.63). In patients with\u2009\u2265\u20097 UTIs prior to study inclusion, StroVac was statistically significantly superior to placebo (<jats:italic>p<\/jats:italic>\u2009=\u20090.048). However, in all other secondary endpoints, no statistical differences between the two groups could be seen (all <jats:italic>p<\/jats:italic>\u2009&gt;\u20090.3).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>StroVac reduced the number of clinically relevant UTIs like in former studies but did not show statistically significant better results than the chosen placebo. Most likely, that was due to a, since confirmed, prophylactic effect of the chosen placebo itself. Therefore, placebo-controlled and double-blinded studies using a different ineffective placebo preparation are needed to determine the importance of StroVac in prophylaxis of rUTI.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11255-022-03379-y","type":"journal-article","created":{"date-parts":[[2022,10,1]],"date-time":"2022-10-01T07:11:37Z","timestamp":1664608297000},"page":"9-16","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Prospective multicentre randomized double-blind placebo-controlled parallel group study on the efficacy and tolerability of StroVac\u00ae in patients with recurrent symptomatic uncomplicated bacterial urinary tract infections"],"prefix":"10.1007","volume":"55","author":[{"given":"S.","family":"Nestler","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Peschel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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S Peschel and AH Horstmann are employees of Strathmann GmbH & Co. KG. W Vahlensieck works as advisor\/author for Apogepha, Bene, Bionorica, Strathmann, Fresenius, Infectopharm, Medice, Perrigo, Repha. W Fabry have no conflicts of interest. A Neisius works as an advisor\/author for MSD, Janssen, AstraZeneca, Ispen, Amgen, Roche, GlaxoSmithKline, Optimed, Boston Scientific.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted in compliance with the ICH Guideline E6 (R1) on Good Clinical Practice and registered under EudraCT no. 2010-020882-25. Several ethic committees were involved, including a leading committee in Berlin and local ethic committees in regions with participating centres. Informed consent was obtained by all patients.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}