Clinical trial NCT04096820: Uromune in Treating Recurrent Urinary Tract Infections in Women
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Uti
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Responder
timeFrame: 12 months
Secondary outcomes:
measure: Number of UTI in the Efficacy Period
timeFrame: 12 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Centre for Advanced Urological Research
state: Ontario
Study officials:
affiliation: Professor of Urology
name: J. Curtis Nickel, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: