Recurrent urinary tract infection
Conditions
Interventions
Intervention: The intervention group receives intravesical installations of
gentamicin during a period of 24 weeks (once daily for 2 weeks, every other day
for 10 weeks, twice weekly for 12 weeks).
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Competent patient aged 18 or above. 2. A history of recurrent cystitis, defined as: a. females: at least 2 episodes of UTI in the last 6 months or 3 in the last 12 months b. males: at least 2 episodes of UTI in the last 12 months (including recurrent cystitis likely due to chronic bacterial prostatitis). 3. At least one episode of these infections is documented by urine culture with the isolation of *10^3 CFU/mL of an identified MDR pathogen. Multidrug resistance is defined as acquired non-susceptibility to at least one agent in three or more antimicrobial classes. 4. All other episodes at least by one urinary symptom* and positive urinary nitrate test or leukocyturia (as depicted by positive leukocyte esterase test or microscopy). 5. No clinical symptoms of UTI at enrolment.
Exclusion criteria
Exclusion criteria: 1. Urinary culture in prior 6 months tested positive for high-level gentamicin resistant enterobacteriaceae or enterococci (MIC >128 mg/L). 2. Abnormalities of the upper urinary tract, including presence of urinary stones. 3. Patients with a permanent urinary catheter. 4. Complete urinary incontinence. 5. Patients with stage 5 chronic kidney disease (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The primary end point is defined as the number of UTI per patient after initiation of the study during the first 6 months (prophylactic treatment) and during 12 months (total follow up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the time to first, second and third UTI after start of intravesical gentamicin or oral antimicrobial prophylaxis, the microbiological cure rate in males with chronic bacterial prostatitis, the need for oral and/or intravenous antibiotic-courses for UTI in hospital/day-care setting during the year of the study, patients* satisfaction with the treatment and the development of antimicrobial resistance of uropathogens and commensal flora. | — |
Countries
Netherlands
Outcome results
None listed