SPRINGStudy of Prevention of Recurrent urinary tract infections by Intravesical iNstilment of Gentamici
Completed
- Conditions
- recurrent urinary tract infectionsmulti-drug resistant bacteriacystitisprophylaxisrecidiverende urineweginfectiesmulti resistente bacterieen
- Registration Number
- NL-OMON23211
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
van Nieuwkoop C, den Exter PL, Elzevier HW, den Hartigh J, van Dissel JT. Intravesical gentamicin for recurrent urinary tract infection in patients with intermittent bladder catheterisation. Int J Antimicrob Agents. 2010 Dec;36(6):485-90
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
Inclusion Criteria
Competent patient aged 18 or above.
- A history of recurrent cystitis, defined as:
Exclusion Criteria
- Urinary culture in prior 6 months tested positive for high-level gentamicin resistant enterobacteriaceae or enterococci (MIC >128 mg/L).
- Abnormalities of the upper urinary tract, including presence of urinary stones.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of UTI per patient after start of intravesical gentamicin or oral antibiotic prophylaxis during 6 months (period of prophylactic treatment) and 12 months (total follow up)
- Secondary Outcome Measures
Name Time Method The time to first, second and third symptomatic UTI after start of intravesical gentamicin or oral antibiotic prophylaxis; the proportion of patients with at least 1 UTI during 6 months of prophylactic treatment; the microbiological cure rate in male patients with chronic bacterial prostatitis; the need for oral/iv antibiotic-courses for UTI given in the hospital/daycare during the year of the study; antimicrobial resistance of urethral, perineal and vaginal flora before, during and after treatment; the rate of side effects and adverse events.<br /> Patients’ satisfaction with the treatment will be evaluated after 2, 12 and 24 weeks, and occurrence of urinary symptoms will be assessed every visit.