Recurrent Urinary Tract Infections
Conditions
Keywords
rUTI, E.coli, prophylactic, bladder lavage
Brief summary
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
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.
Interventions
BIOLOGICALABU bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
BIOLOGICALSaline bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline. 1. Patients with prophylactic bladder flushing with an ABU strain. 2. The control group with saline bladder flushing .
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of UTI events in the follow-up period | 1½ year | The number of prescriptions or hospital visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natrium and kalium | 1½ year | Measurements during treatment protocol in mmol/L |
| CRP | 1½ year | Measurements during treatment protocol in mg/L |
| Time to first UTI after the intervention | 1½ year | Symptoms and the need for medical treatment or hospitalisation |
| Quality of life by standard Questionnaires_ICIQ-OABqol 08/04 | 1½ year | 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 |
| O´Leary-Sant Voiding and Pain symptom score | 1½ year | 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. |
| Leukocytes and neutrofilocytes | 1½ year | Measurements during treatment protocol in 10E9/L |
| CRF | 1½ year | Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect |
| Hospitalization | 1½ year | Hospital visit due to UTI |
| Complications (bleeding, pain) | 1½ year | Complications due to bladder lavage |
| Microbiological diagnostics: Etiology, resistance | 1½ year | Measurements during treatment protocol |
| Creatinin | 1½ year | Measurements during treatment protocol in micromol/L |
| EQ-5D-5L | 1½ year | 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. |
Countries
Denmark
Contacts
Primary ContactKarin Andersen, MD
Backup ContactLars Lund, Prof.
Outcome results
None listed