None listed
Conditions
Brief summary
The implantation of double J stents is a widely used intervention in the management of patients suffering from obstructing urinary stones. Nevertheless, two main complications are frequent, namely urinary tract infection (UTI) and stent related symptoms (SRS). The reported rates for UTI range from 2% to 34%. Risk factors known to particularly increase the incidence of clinically relevant UTIs are various i.e. underlying systemic disease (e.g. diabetes mellitus, chronic renal failure), female gender or stent indwelling time. SRS such as dysuria, flank pain, hematuria and/or increased voiding frequency are common and can seriously impact daily activities, impair sexual function and even decrease work capacity. Therefore UTI and SRS can significantly reduce patient’s quality of life and consecutively lead to an increase of healthcare costs. For the prevention of UTI a periinterventional antibiotic prophylaxis during double J stent implantation is recommended by the European Association of Urology. However, there is a lack of evidence for the exact antibiotic strategy regarding the entire double J stent indwelling time. In the clinical routine it is a common and widely used practice among urologists to continue a low dose antibiotic treatment for the entire stent indwelling time with the conception to reduce the prevalence of UTI and to possibly obtain a positive effect on SRS rates. To the best of our knowledge there exists neither evidence for the benefit nor for possible disadvantages of such an established empiric prevention. We therefore compared UTI and SRS rates in patients given a continuous low-dose antibiotic treatment for the entire stent indwelling time versus periinterventional antibiotic prophylaxis only. Additionally, the impact of drug side effects, potentially limiting the use of long-term antibiotics, was analyzed.
Interventions
We compared the rates of UTI and SRS in patients with urinary stones and an indication for a temporary double J stent placement given a perioperative prophylaxis only (arm 1) versus rates in patients with a continous low dose antibiotic treatment until stent withdrawal (arm 2).
All patients received a periinterventional antibiotic prophylaxis with 1,2g amoxicillin/clavulanic acid that was given intravenously at anaesthesia induction in order to obtain a peak concentration at the time of highes
We compared the rates of UTI and SRS in patients with urinary stones and an indication for a temporary double J stent placement given a perioperative prophylaxis only (arm 1) versus rates in patients with a continous low dose antibiotic treatment until stent withdrawal (arm 2). All patients received a periinterventional antibiotic prophylaxis with 1,2g amoxicillin/clavulanic acid that was given intravenously at anaesthesia induction in order to obtain a peak concentration at the time of highest risk during the procedure. According to the local pathogen’s profile and susceptibility to different antibiotics, the antimicrobial agent of choice for continuous low dose treatment was amoxicillin/clavulanic acid (625mg once daily). Patients with allergies against penicillin received either trimethoprim/sulfamethoxazole (80mg/400mg once daily) or ciprofloxacin (250mg once daily).
Sponsors
Department of Urology, University Hospital Bern
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients with urinary stones and an indication for a temporary double J stent placement were included according to the following criteria: no previous antibiotic medication within the past two weeks, sterile urinary culture at timepoint of stent insertion.
Exclusion criteria
Patients with staghorn calculi were excluded, as were those with fever, elevated white blood cell count, urinary catheters or suprapubic tubes in situ.
Outcome results
None listed