Uromune in Treating Recurrent Urinary Tract Infections in Women

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Uti
• Intervention / Treatment: Biological: Uromune

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 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre for Advanced Urological Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: J. Curtis Nickel, MD, FRCS, Professor of Urology

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Recurrence; Urinary Tract Infections
• Other Study ID Numbers: 6026618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No