| Eligibility |
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.
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