Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans. ABU can be used for preventive treatment in patients with recurrent urinary tract infections. 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.

Official Title
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Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment

Conditions
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Recurrent Urinary Tract Infections

Intervention / Treatment
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* Biological: ABU bladder lavage
* Biological: Saline bladder lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria. Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine. Failed previously treatments. Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter. Patients with neurogenic and non-neurogenic bladder dysfunction. Patients with urostomy, kidney transplantation or another complicated genesis. Written consent. Exclusion Criteria: Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline. Patients with prophylactic bladder flushing with an ABU strain. The control group with saline bladder flushing .
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients prophylatic treated with ABU<br>Patients with prophylactic bladder flushing with an ABU strain. | Biological: ABU bladder lavage<br>* Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)<br>|
| Placebo Comparator: Patients control group<br>The control group with bladder flushing with saline solution. | Biological: Saline bladder lavage<br>* Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of events (symptomatic UTIs) in the follow-up period | The number of prescriptions or hospital visits | 1½ year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first symptomatic UTI after the intervention | Symptoms and the need for medical treatment or hospitalisation | 1½ year | 
| Quality of life by standard Questionnaires_ICIQ-LUT | ICIQ-LUTSqol 08/04 questionnaire evaluating quality of life (QoL) in urinary incontinent patients (overall score with greater values indicating increased symptom severity) | 1½ year | 
| Quality of life by standard Questionnaires_SF36 | SF-36 (scored so that a high score defines a more favorable health state) | 1½ year | 
| EQ-5D-5L | Questionnaire evaluating quality of life at 5 terms (mobility, self-care, usual activities, pain, discomfort and anxiety/depression) | 1½ year | 
| CRF | Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect) | 1½ year | 
| Hospitalization | Hospital visit | 1½ year | 
| Complications (bleeding, pain) | Complications due to bladder lavage | 1½ year | 
| Microbiological diagnostics: Etiology, resistance | Measurements during treatment protocol | 1½ year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rUTI, E.coli, prophylactic, bladder lavage