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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prophylatic treated with ABU | Experimental | Patients with prophylactic bladder flushing with an ABU strain. |
|
| Patients control group | Placebo Comparator | The control group with bladder flushing with saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABU bladder lavage | Biological | Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of UTI events in the follow-up period | The number of prescriptions or hospital visits | 1½ year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first UTI after the intervention | Symptoms and the need for medical treatment or hospitalisation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Andersen, MD | Contact | +45 21570468 | karin.andersen@rsyd.dk | |
| Lars Lund, Prof. | Contact | lars.lund@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karin Andersen | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline.
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| Saline bladder lavage | Biological | Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline |
|
| 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. | 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. | 1½ year |
| CRF | Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect | 1½ year |
| Hospitalization | Hospital visit due to UTI | 1½ year |
| Complications (bleeding, pain) | Complications due to bladder lavage | 1½ year |
| Microbiological diagnostics: Etiology, resistance | Measurements during treatment protocol | 1½ year |
| Creatinin | Measurements during treatment protocol in micromol/L | 1½ year |
| Leukocytes and neutrofilocytes | Measurements during treatment protocol in 10E9/L | 1½ year |
| Natrium and kalium | Measurements during treatment protocol in mmol/L | 1½ year |
| CRP | Measurements during treatment protocol in mg/L | 1½ year |
| Odense University Hospital | Recruiting | Odense C | 5000 | Denmark |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |