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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urinary tract infection (UTI)

Ureteral stent related symptoms (SRS)

Condition category

Condition code

Renal and Urogenital

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]

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]

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]

During the entire stent indwelling time

Primary outcome [2]

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]

During the entire stent indwelling time

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2005

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]

Switzerland

State/province [1]

Bern

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Urology, University Hospital Bern

Address [1]

Department of Urology
University Hospital Bern
Inselspital
Anna-Seiler-Haus
3010 Bern

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Kantonale Ethikkommission Bern

Ethics committee address [1]

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]

Switzerland

Date submitted for ethics approval [1]

01/02/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Felix Moltzahn

Address

Department of Urology
University Hospital of Bern
Inselspital
3010 Bern, Switzerland

Country

Switzerland

Phone

+41 31 632 0797

Fax

+41 31 632 2180

Felix.Moltzahn@insel.ch

Contact person for scientific queries

Name

Felix Moltzahn

Address

Department of Urology
University Hospital of Bern
Inselspital
3010 Bern, Switzerland

Country

Switzerland

Phone

+41 31 632 0797

Fax

+41 31 632 2180

Felix.Moltzahn@insel.ch

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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