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Clinical Trial Summary

To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.


Clinical Trial Description

The proposal is for a real life clinical practice study in which female participants with a predefined history of recurrent UTIs in the previous year will be treated with 3 months of oral vaccine with a further 9 months of follow-up. The primary outcome will be no UTI in the 12 months following initiation of the vaccine (definition of a responder). A clinically significant and important outcome will be defined as a responder rate of 50% (50% of participants who had at least 3 UTIs in the previous year reporting no UTIs after therapy initiated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04096820
Study type Interventional
Source Queen's University
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 6, 2019
Completion date January 1, 2023

See also
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Recruiting NCT06149676 - A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections Early Phase 1
Not yet recruiting NCT06332781 - Intravesical Gentamicin to Prevent Recurrent UTI Phase 4