Uromune in Treating Recurrent Urinary Tract Infections in Women

• ClinicalTrials.gov Identifier: NCT04096820
• Recruitment Status: Active, not recruiting
• First Posted: September 20, 2019
• Last Update Posted: July 29, 2022
• Sponsor: Queen's University
• Information provided by (Responsible Party): Dr. J. Curtis Nickel, Queen's University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Recurrent Uti	Biological: Uromune	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open label
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: September 6, 2019
• Estimated Primary Completion Date: October 31, 2022
• Estimated Study Completion Date: January 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Complete Responder [ Time Frame: 12 months ]
   Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy.

Secondary Outcome Measures :

1. Responder Rate [ Time Frame: 12 months ]
   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).

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Canada, Ontario

Centre for Advanced Urological Research

Kingston, Ontario, Canada, K7L 3J7

Sponsors and Collaborators

Queen's University

Investigators

• Principal Investigator: J. Curtis Nickel, MD, FRCS; Professor of Urology

  Study Documents (Full-Text)

Documents provided by Dr. J. Curtis Nickel, Queen's University:

Study Protocol and Statistical Analysis Plan  [PDF] August 20, 2019

Informed Consent Form  [PDF] August 15, 2019

More Information

• Responsible Party: Dr. J. Curtis Nickel, Professor or Urology, Queen's University
• ClinicalTrials.gov Identifier: NCT04096820
• Other Study ID Numbers: 6026618
• First Posted: September 20, 2019
• Last Update Posted: July 29, 2022
• Last Verified: July 2022

• 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

Additional relevant MeSH terms:

Urinary Tract Infections; Recurrence; Infections; Disease Attributes; Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases