An interventional study of ABU bladder lavage and Saline bladder lavage in Recurrent Urinary Tract Infections, sponsored by Odense University Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Claim to be investigated:
Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's planned enrollment of 80 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with prophylactic bladder flushing with an ABU strain.
Biological: ABU bladder lavage
The control group with bladder flushing with saline solution.
Biological: Saline bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
The number of UTI events in the follow-up period
The number of prescriptions or hospital visits
Time frame: 1½ year
Time to first UTI after the intervention
Symptoms and the need for medical treatment or hospitalisation
Time frame: 1½ year
Quality of life by standard Questionnaires_ICIQ-OABqol 08/04
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol). ICIQ-OABqol is a patient-completed questionnaire evaluating the quality of life (QoL) in patients with overactive bladder. It is translated into Danish and chosen because UTI symptoms often resemble OAB symptoms. Scoring: 25-160 overall score with greater values indicating increased impact on quality of life
Time frame: 1½ year
O´Leary-Sant Voiding and Pain symptom score
The O'Leary-Sant Interstitial Cystitis Symptom Index is translated into Danish and chosen because UTI symptoms often resemble the bladder pain symptoms. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. Overall score with greater values indicating increased symptom severity.
Time frame: 1½ year
EQ-5D-5L
Questionnaire evaluating quality of life at 5 terms (mobility, self-care, usual activities, pain, discomfort and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value. The index values, presented in country-specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions.
Time frame: 1½ year
CRF
Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect
Time frame: 1½ year
Hospitalization
Hospital visit due to UTI
Time frame: 1½ year
Complications (bleeding, pain)
Complications due to bladder lavage
Time frame: 1½ year
Microbiological diagnostics: Etiology, resistance
Measurements during treatment protocol
Time frame: 1½ year
Creatinin
Measurements during treatment protocol in micromol/L
Time frame: 1½ year
Leukocytes and neutrofilocytes
Measurements during treatment protocol in 10E9/L
Time frame: 1½ year
Natrium and kalium
Measurements during treatment protocol in mmol/L
Time frame: 1½ year
CRP
Measurements during treatment protocol in mg/L
Time frame: 1½ year
Plan to share: No
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Odense University Hospital