Uromune in Treating Recurrent Urinary Tract Infections in Women

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

Detailed Description
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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.

Official Title
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Protocol 19-01: Canadian, Single Centre, Pilot, Open Label Study to Evaluate the Efficacy and Safety of the Bacterial Vaccine Uromune in Treating Recurrent Urinary Tract Infections in Women.

Conditions
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Recurrent Uti

Intervention / Treatment
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* Biological: Uromune


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Uromune will be taken by the participant for 90 days. | Biological: Uromune<br>* 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Responder | Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate | The number of UTI in individual participants requiring antibiotics in the 12 months after starting therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated (number over previous 12 months or 2 X the number over the preceding 6 months). | 12 months |