Uromune in Treating Recurrent Urinary Tract Infections in Women
Uromune in Treating Recurrent Urinary Tract Infections in Women
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
 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.
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.