Uromune in Treating Recurrent Urinary Tract Infections in Women

NCT ID: NCT04096820

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-06
• Study Completion Date: 2023-01-01

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.

Conditions

Recurrent Uti

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Open Label

Uromune will be taken by the participant for 90 days.

Group Type: EXPERIMENTAL

Uromune

Intervention Type: BIOLOGICAL

2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.

Interventions

Uromune

2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. J. Curtis Nickel

Professor or Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Curtis Nickel, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Professor of Urology

Locations

Centre for Advanced Urological Research

Kingston, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

6026618

Identifier Type: -

Identifier Source: org_study_id