Recurrent UtiPhase 2NCT04096820
Uromune in Treating Recurrent Urinary Tract Infections in Women
A Phase 2 study testing Uromune in people with Recurrent Uti, run by Queen's University at 1 site in Canada.
Trial summary
To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Recurrent Uti
- What is being tested?
- Uromune
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 6 Sep 2019to 1 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Advanced Urological Research
Kingston, Ontario, K7L 3J7
About this study
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.
To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.
Read the 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
- Being tested
- Uromune
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UromuneBiological
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Uromune will be taken by the participant for 90 days. Receives: Biological: Uromune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Responder
Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.
Measured: 12 months
Secondary outcomes (1)
Number of UTI in the Efficacy Period
The number of UTI in individual participants requiring antibiotics in the 9 month efficacy period following completion of vaccine therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start6 Sep 2019
- Primary completion31 Oct 2022
- Study completion1 Jan 2023
Why it stopped: Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent UtiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. J. Curtis Nickel, Queen's University
- Investigators
- J. Curtis Nickel, MD, FRCS, Principal investigator, Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096820
- Sponsor's protocol ID
- 6026618
- Status last verified
- May 2024
- First submitted
- 18 Sep 2019
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04096820
- Acronym / sponsor ID
- 6026618
- Conditions
- Recurrent Uti
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Biological: UromuneUromune will be taken by the participant for 90 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uromune2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing. | Biological | Open Label |
Primary outcome
Complete Responder
Time frame: 12 months
Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.
1 secondary outcome
Number of UTI in the Efficacy Period
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Recurrent Uti
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
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Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
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Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
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RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Curtis Nickel, MD, FRCS principal investigator
Professor of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Uromune in people with Recurrent Uti, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Responder (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.