urinary tract infections AND cystitis
Conditions
Interventions
Two transfusions of 100 ml of urine within 5 days by transurethral
catheterization after an antibiotic free interval of 3 days.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is premenopausal, aged * 18 and *45 years 2. Subject had recurrent UTI*s (*3 documented UTI*s in the last year with documented symptom-free interval of at least 2 weeks) following the definition of a urinary tract infection: the presence of significance bacteruria (103 CFU/ml or more), pyuria and fever plus one or more of the following signs and symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria 3. Subject has a documented urinary tract infection (see definition), for which oral antibiotic therapy has been initiated. 4. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby. 5. Subject is able to communicate well with the investigators and is available to attend all study visits. 6. Subject has signed informed consent. 7. Subject will remain available during the first 3 weeks of the study period
Exclusion criteria
Exclusion criteria: 1. Any history or evidence at screening of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions. 2. 2. Documented vesico-urethral reflux 3. Documented urinary retention > 100 milliliters post-void residual urine 4. Anatomic urogenital abnormalities 5. Urolithiasis 6. Nephrostomy catheters 7. Extraurogenital infections that require prolonged antibiotic therapy 8. Pregnancy 9. Use of probiotics and or cranberry juice 10. Allergy or intolerance for multiple common prescribed antibiotics 11. Carriage of multi drug resistant organisms in faeces and/or urine without regular antibiotic treatment options
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Frequency and magnitude of adverse events within 6 months of controlled human urine transfusion, including the occurrence of UTI*s that are possibly, probably or definitely related to the transfusion procedure. So concrete: total amount of adverse events, serious adverse events and suspected unexpected serieous adverse reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Urine microbiome composition and diversity by total amount of genus, percentage of genus and the Shannon diversity index before and after urine transfusion. - Time to change (in days) of urine microbiome composition and diversity - Frequency of UTI*s (in exact amounts) after urine transfusion. | — |
Countries
Netherlands
Outcome results
None listed