To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.
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 9 month efficacy period following completion 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
67
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Centre for Advanced Urological Research
Kingston, Ontario, Canada
Complete Responder
Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.
Time frame: 12 months
Number of UTI in the Efficacy Period
The number of UTI in individual participants requiring antibiotics in the 9 month efficacy period following completion of vaccine therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.