Prevention of recurrent urinary tract infections by multi-drug resistant bacteria, by intravesical administration of gentamicin.

Completed

Conditions: Recurrent urinary tract infection
10004018
10046590

Registration Number: NL-OMON38402

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 170

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

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 <15 ml/min).
6. Patients with known hypersensitivity to gentamicin.
7. Pregnancy or lactation.
8. Inability to provide informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The primary end point is defined as the number<br /><br>of UTI per patient after initiation of the study during the first 6 months<br /><br>(prophylactic treatment) and during 12 months (total follow up). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the time to first, second and third UTI after start<br /><br>of intravesical gentamicin or oral antimicrobial prophylaxis, the<br /><br>microbiological cure rate in males with chronic bacterial prostatitis, the need<br /><br>for oral and/or intravenous antibiotic-courses for UTI in hospital/day-care<br /><br>setting during the year of the study, patients* satisfaction with the treatment<br /><br>and the development of antimicrobial resistance of uropathogens and commensal<br /><br>flora.</p><br>