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Trial registered on ANZCTR


Registration number
ACTRN12612000002886
Ethics application status
Not yet submitted
Date submitted
7/12/2011
Date registered
3/01/2012
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a continuous low-dose antibiotic treatment lower the rates of urinary tract infections and stent related symptoms in patients with ureteral stents compared to a periinterventionel prophylaxis only?
Scientific title
For patients with ureteral stents does the use of a continuous low-dose antibiotic treatment reduce the risk of urinary tract infections and stent related symptoms compared with periinterventional antibiotic prophylaxis only?
Secondary ID [1] 273555 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection (UTI) 279353 0
Ureteral stent related symptoms (SRS) 279354 0
Condition category
Condition code
Renal and Urogenital 279539 279539 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 283861 0
Treatment: Drugs
Comparator / control treatment
Control treatment: Perioperative antibiotic prophylaxis only (arm 1) in patients with urinary stones and an indication for a temporary double J stent placement.
Control group
Active

Outcomes
Primary outcome [1] 286106 0
Overall rate of urinary tract infection.

Evaluations for UTI were performed prior to stent insertion and consecutively after one, two and four weeks and/or at stent withdrawal.
In women urine was obtained via sterile single use catheter while it was a midstream urine sample in men. Samples were promptly analyzed automatically (dipstick test) and manually (urinary sediment) and consecutively cultured on agars. In case of bacterial growth antibiotic susceptibility and resistance was determined. Trained clinical laboratory assistants in the institute of microbiology, University Hospital Bern, conducted all tests according to the guidelines of laboratory diagnosis.
Significant bacterial count was defined as >10'000 colony forming units (cfu) per /ml (single organism) in the culture.
Timepoint [1] 286106 0
During the entire stent indwelling time
Primary outcome [2] 286107 0
Overall rate of stent related symptoms

Evaluations for SRS were performed prior to stent insertion and consecutively after one, two and four weeks and/or at stent withdrawal.
SRS including urinary symptoms (dysuria, hematuria as well as frequency (day- and nighttime separately)) and body pain (flank/suprapubic) were quantified according to the validated ureteric stent symptom questionnaire (USSQ).
Timepoint [2] 286107 0
During the entire stent indwelling time
Secondary outcome [1] 295164 0
Drug side effects

Evaluations for drug side effects were performed prior to stent insertion and consecutively after one, two and four weeks and/or at stent withdrawal.
General health symptoms including possible drug side effects such as fatigue, gastrointestinal symptoms and skin erythema were quantified according to the validated ureteric stent symptom questionnaire (USSQ)
Timepoint [1] 295164 0
During the entire stent indwelling time

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After informed consent was obtained, patients were randomized to the two arms with no further stratification.

Simple randomisation using a randomisation table created by computer software (arm 1: periinterventional antibiotic prophylaxis only, arm 2: periinterventional antibiotic prophylaxis followed by a continuous low-dose antibiotic treatment).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3999 0
Switzerland
State/province [1] 3999 0
Bern

Funding & Sponsors
Funding source category [1] 284338 0
Hospital
Name [1] 284338 0
Department of Urology, University Hospital Bern
Address [1] 284338 0
Department of Urology
University Hospital Bern
Inselspital
Anna-Seiler-Haus
3010 Bern
Country [1] 284338 0
Switzerland
Primary sponsor type
Hospital
Name
Department of Urology, University Hospital Bern
Address
Department of Urology
University Hospital Bern
Inselspital
Anna-Seiler-Haus
3010 Bern
Country
Switzerland
Secondary sponsor category [1] 283280 0
None
Name [1] 283280 0
Address [1] 283280 0
Country [1] 283280 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286297 0
Kantonale Ethikkommission Bern
Ethics committee address [1] 286297 0
Kantonale Ethikkommission Bern
Postfach 56
3010 Bern
Switerzland

The reason we mentioned a date at all was because without it we were unable to submit the online registration form for evaluation.

The study compared two clinically established and accredited approaches regarding the antibiotic treatment of patients with long-erm indwelling ureteral catheters. Our data collection was part of an internal quality control at our hospital. Therefore, ethics approval was not required
Ethics committee country [1] 286297 0
Switzerland
Date submitted for ethics approval [1] 286297 0
01/02/2012
Approval date [1] 286297 0
Ethics approval number [1] 286297 0

Summary
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.
Trial website
none
Trial related presentations / publications
1. Akay AF, Aflay U, Gedik A, Sahin H, Bircan MK. Risk factors for lower urinary tract infection and bacterial stent colonization in patients with a double J ureteral stent. Int Urol Nephrol. 2007;39(1):95-8. Epub 2006/12/16.
2. Klis R, Korczak-Kozakiewicz E, Denys A, Sosnowski M, Rozanski W. Relationship between urinary tract infection and self-retaining Double-J catheter colonization. J Endourol. 2009;23(6):1015-9. Epub 2009/06/06.
3. Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX, Jr., Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003;169(3):1065-9; discussion 9. Epub 2003/02/11.
4. Irani J, Siquier J, Pires C, Lefebvre O, Dore B, Aubert J. Symptom characteristics and the development of tolerance with time in patients with indwelling double-pigtail ureteric stents. BJU Int. 1999;84(3):276-9. Epub 1999/09/01.
5. EAU Guidelines, edition presented at the 25th EAU Annual Congress, Barcelona 2010. ISBN 978-90-79754-70-0.
Public notes

Contacts
Principal investigator
Name 33511 0
Address 33511 0
Country 33511 0
Phone 33511 0
Fax 33511 0
Email 33511 0
Contact person for public queries
Name 16758 0
Felix Moltzahn
Address 16758 0
Department of Urology
University Hospital of Bern
Inselspital
3010 Bern, Switzerland
Country 16758 0
Switzerland
Phone 16758 0
+41 31 632 0797
Fax 16758 0
+41 31 632 2180
Email 16758 0
Felix.Moltzahn@insel.ch
Contact person for scientific queries
Name 7686 0
Felix Moltzahn
Address 7686 0
Department of Urology
University Hospital of Bern
Inselspital
3010 Bern, Switzerland
Country 7686 0
Switzerland
Phone 7686 0
+41 31 632 0797
Fax 7686 0
+41 31 632 2180
Email 7686 0
Felix.Moltzahn@insel.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary