Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination

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.

Inclusion Criteria:

• Can provide written consent and willingness to comply with all aspects of study treatment and study requirements.
• Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa.
• Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception include hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception.
• Free of a urinary tract infection at the time of trial inclusion.

Exclusion Criteria:

• History of bladder tumours including uterine, cervical, vaginal or urethral cancer.
• Worrisome post-voiding residual (investigator's discretion).
• Infection related to urinary lithiasis.
• Any immunological disease requiring active therapy.
• Currently receiving Immunotherapy.
• Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit.
• Any known intolerance to the ingredients of the Uromune® Immunotherapy.
• Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results.

The study was terminated because of Covid related delay and problems with enrollment as well as cost considerations (funds ran out).

15 months

One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.