Actively Recruiting
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Led by Odense University Hospital · Updated on 2025-09-18
80
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Urinary tract infection (UTI) is a common bacterial infection affecting millions worldwide, with recurrent cases leading to high antibiotic use and health costs. This trial investigates alternative treatments by studying the ability of a non-pathogenic E.coli strain (ABU) to prevent recurrent UTIs by outcompeting the harmful bacteria. The study is a placebo-controlled, double-blind clinical trial aimed at strengthening evidence for this approach. Participants will be randomly assigned to one of two groups: one receiving bladder flushing with the non-pathogenic ABU bacterial strain as a preventive treatment, and the other receiving bladder flushing with a saline solution as a placebo. This study uses a quadruple-blind design to ensure unbiased results and focuses on evaluating the clinical effect of these interventions in preventing recurrent cystitis. During the 1½-year follow-up, participants will undergo various assessments including monitoring the number of UTI events, time to first UTI after intervention, quality of life questionnaires, symptom scoring, and microbiological and laboratory tests. Safety aspects such as complications and hospitalizations will also be tracked. The study includes patients with different bladder conditions and requires regular clinical and microbiological evaluations throughout the trial period.
CONDITIONS
Brief Title
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with recurrent cystitis including 2 times of recurrent urinary tract infection within the last 6 months or 3 times in the last 12 months, with at least 2 cultures showing the same bacteria
- Normal investigations for lower urinary tract diseases including voiding diary, symptom scores, flexible cystoscopy, voiding diagram, and residual urine test
- Previously failed treatments for recurrent urinary tract infections
- Patients with native bladder, including those with spontaneous voiding, clean intermittent catheterization, or indwelling catheter
- Patients with neurogenic and non-neurogenic bladder dysfunction
- Patients with urostomy, kidney transplantation, or other complicated causes
- Able to provide written consent
You will not qualify if you...
- Malignancy in the urinary tract
- Presence of kidney, ureteral, or bladder stones
- Age under 18 years
- Pregnancy or breastfeeding
- Ongoing oral antibiotic treatment
- Unable to speak or understand Danish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment duration not explicitly specified
Participants receive prophylactic bladder lavage with either the non-pathogenic bacterial strain (ABU) or saline as a preventive treatment for recurrent urinary tract infections.
Visit schedule not specified
Duration - 1½ years
Participants are monitored for 1½ years to evaluate the number of urinary tract infection events, time to first UTI after intervention, quality of life, symptom scores, microbiological diagnostics, and other health outcomes.
Visit schedule not specified
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Odense University Hospital
Odense C, Denmark, 5000
Actively Recruiting
Research Team
K
Karin Andersen, MD
L
Lars Lund, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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