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Antibiotic prophylaxis for short-term catheter bladder drainage in adults

  1. Gail Lusardi1,*,
  2. Allyson Lipp1,
  3. Christine Shaw2

Editorial Group: Cochrane Incontinence Group

Published Online: 3 JUL 2013

Assessed as up-to-date: 31 OCT 2012

DOI: 10.1002/14651858.CD005428.pub2


How to Cite

Lusardi G, Lipp A, Shaw C. Antibiotic prophylaxis for short-term catheter bladder drainage in adults. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD005428. DOI: 10.1002/14651858.CD005428.pub2.

Author Information

  1. 1

    Department of Care Sciences, University of South Wales, Faculty of Health, Sport and Science, Pontypridd, UK

  2. 2

    Department of Care Sciences, University of South Wales,, Faculty of Health, Sport and Science, Rhondda Cynon Taff, UK

*Gail Lusardi, Faculty of Health, Sport and Science, Department of Care Sciences, University of South Wales, Glyntaff, Pontypridd, CF37 1DL, UK. glusardi@glam.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 3 JUL 2013

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Characteristics of included studies [ordered by study ID]
Britt 1977

MethodsPlacebo-controlled RCT


Participants215 female patients entered into the study and randomised

Inclusion criteria:

Undergoing elective gynaecological surgery and who received a urinary catheter or supra-pubic catheter at the time of surgery for at least one day

Exclusion criteria:

Rapidly or ultimately fatal disease, active clinical infection, allergy to penicillins or cephalosporins

Losses post randomisation:


InterventionsGroup 1 (n = 96): Cefazolin sodium 500 mg was given at the time of operation, and each subsequent dose was given at 8-hour intervals, IV or IM, for a total of nine doses (= three days).

Group 2 (n = 100): Placebo was given at the time of operation, and each subsequent dose was given at 8-hour intervals, IV or IM, for a total of nine doses (= three days).


OutcomesBacteriuria during period of antibiotic prophylaxis (days 1-3) (102 > CFU/mL for urinary catheter and 105 > CFU/mL for MSU):
Group 1 1/96

Group 2 9/100

Secondary outcomes: febrile morbidity, catheter days, types of organisms


NotesA urine sample was obtained at the time of catheter insertion and daily from the drainage tube. A clean-voided specimen was taken on discharge when the catheter was already removed.

Remark:

Group 1: 6 supra pubic/90 urinary catheters (0.07)

Group 2: 12 supra pubic/88 urinary catheters (0.14)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskHospital pharmacy provided a randomisation schedule.

Allocation concealment (selection bias)Low riskHospital pharmacy provided a randomisation schedule.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote "Neither the attending physicians, study personnel, nor nursing personnel were aware of the treatment regime assigned by the pharmacy". Blinding by patients not stated.

Incomplete outcome data (attrition bias)
All outcomes
Low risk8.8% attrition (19 patients were excluded: 14 patients were bacteriuric at the time of catheter insertion, five patients were catheterised for less than one day).

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)High riskNo ITT analysis stated.

Timing of outcome assessment similar in all groupsLow riskAll participants assessed on third day.

Other biasUnclear riskPublic Health Service grant plus a grant for Ely Lilly & Co. Indianapolis, Ind.

Esposito 2006

MethodsPlacebo-controlled RCT


Participants82 patients enrolled and randomised

Inclusion criteria:

Male or female patients over 18 years

Planned surgical intervention requiring catheterisation

Informed consent

Catheter for 3-14 days

Exclusion criteria:

None stated


InterventionsGroup 1: Levofloxacin 250 mg orally once a day until catheter removed or for maximum of 13 days (n = 25)

Group 2: Placebo drug orally once a day until catheter removed or for maximum of 13 days (n = 25)

Group 3: Ciprofloxacin 500 mg orally twice a day until catheter removed or for maximum of 13 days (n = 21)

Follow-up : daily until end of prophylaxis (visit 3) maximum of 13 days the follow-up 4-6 weeks after end of treatment was not included in the analysis


OutcomesBacteriuria (103 > CFU/mL with one isolated pathogen for urinary catheter)

Group 1 2/25

Group 2 5/25

Group 3 0/21

Secondary outcomes: pyuria, type of organism, adverse events

Pyuria 103 > leucocytes/mL or 3 > leucocytes/microscopic field

Group 1 0/25

Group 2 3/25

Group 3 0/21


NotesM-ITT data are reported which excluded patients with bacteriuria at randomisation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "patients were randomized into three groups, according to a randomization list".

Allocation concealment (selection bias)Unclear riskRandomisation stated but no information given on method of allocation.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote " The design of the study was double blind for the LVFX and placebo group and single blind for the CPFX group".

Incomplete outcome data (attrition bias)
All outcomes
Low risk13.4% attrition. Quote "82 enrolled patients" and 71 patients were evaluable at the end of prophylaxis.

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)Unclear riskQuote "ITT: patients with at least one dose of study drug taken and Modified-ITT patients with negative bacteriuria at visit 2".

Timing of outcome assessment similar in all groupsLow riskAll participants measured at visit 3, end of prophylaxis.

Other biasHigh riskQuote "This study was supported with a financial grant by GlaxoSmithKline S.p.A."

Jaffe 1985

MethodsPlacebo-controlled RCT


Participants98 female patients enrolled and randomised

Inclusion criteria:

Patients undergoing elective abdominal hysterectomy for benign conditions

Exclusion criteria:

Patients on antibiotic therapy during the two weeks before surgery, known hypersensitivity to co-trimoxazole


InterventionsGroup 1: 200 mg sulphamethoxazole and 240 mg trimethoprim diluted in 500 mL saline in a slow intravenous infusion during the last 30 minutes before surgery (n = 50).

Group 2: 200 mg placebo diluted in 500 mL saline in a slow intravenous infusion during the last 30 minutes before surgery (n = 48).

Urine samples for culture were obtained at the time of catheter insertion, 24 hours after surgery at the time of catheter removal and on the 3rd and 6th postoperative day.


OutcomesUrinary tract infection (defined as the presence of 105 CFU/mL accompanied by urinary symptoms) on the 6th postoperative day:
Group 1: 3/48;

Group 2:13/42

Febrile morbidity (reading of > 38oC was observed on at least two occasions 4 hours or more apart excluding the first 24 postoperative hours)

Group 1: 6/48

Group 2: 16/42

Secondary outcomes: febrile morbidity, hospital stay, types of organisms


NotesA urethral catheter was inserted one hour before surgery and removed 24 hours later.

Urine samples for culture were obtained at the time of catheter insertion, at the time of catheter removal and on the 3rd and 6th postoperative day.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "Patients were randomly assigned to either the treatment or placebo group".

Allocation concealment (selection bias)Unclear riskRandomisation stated but no information given on method of allocation.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo blinding of care givers, participants or outcome assessors reported.

Incomplete outcome data (attrition bias)
All outcomes
Low risk8.1% attrition. Two patients were excluded due to positive preoperative urine cultures. In the control group 3 patients were excluded due to positive preoperative urine cultures, 2 due to malignancy found in the uterus and 1 because of a mistake in following the protocol.

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)High riskNo ITT analysis stated.

Timing of outcome assessment similar in all groupsLow riskUrine samples for culture were obtained at the time of catheter insertion, at the time of catheter removal and on the 3rd and 6th postoperative day.

Other biasLow riskNo sponsorship stated.

Mountokalakis 1985

MethodsNon-placebo RCT


Participants78 patients enrolled and randomised

Inclusion criteria:

Newly hospitalised patients (number of patients randomised not reported) with recent stroke in whom placement of an indwelling urethral catheter was used for treatment of urinary incontinence for at least seven days.

Exclusion criteria:

Known urological disease, any urinary tract instrumentation in the previous year, history of urinary tract infection, antimicrobial treatment in the previous 15 days, bacteriuric at the time of catheter insertion


InterventionsGroup 1: 3 g ampicillin IM, divided in three equal doses: 1 hour before, at the time of, and 6 hours after insertion of the catheter (n = 24)

Group 2: 3 x 1 g ampicillin IM daily (n = 28)

Group 3: Control (No prophylactic antibiotics) (n = 26)

Follow-up : CSU day 1-7 or until significant bacteriuria


OutcomesSignificant bacteriuria was defined as 105 > CFU/mL:
Group 1: 3/24;

Group 2: 12/28;

Group 3:12/26


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "assigned randomly to 3 treatment groups"

Allocation concealment (selection bias)Unclear riskNo information on allocation concealment given.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo blinding of care givers, participants or outcome assessors reported.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop outs reported.

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)Unclear riskNo ITT analysis stated, but no drop outs reported.

Timing of outcome assessment similar in all groupsLow riskQuote "The study was completed in each patient at the end of an observation period of 7 days or when a urine culture revealed significant bacteria".

Other biasLow riskSponsorship not stated.

Romanelli 1990

MethodsPlacebo-controlled RCT


Participants169 patients enrolled and randomised

Inclusion criteria:

Elderly hospitalised patients who needed indwelling urethral catheterisation for at least seven days (mainly neurological disorders associated with bladder dysfunction)

Exclusion criteria:

None stated


InterventionsGroup 1: A single dose of Aztreonam IM (2 g in 4 mL lidocaine 2%) three hours before catheterisation (n = 80)

Group 2: A single dose of placebo (4 mL lidocaine 2%) three hours before catheterisation (n = 82)

Follow-up : Urine culture on days 1, 3 and 7


OutcomesBacteriuria was defined as 105 > CFT/mL:

At the first day of catheterisation:
Group 1: 0/80;

Group 2:19/82

Bacteriuria at the third day of catheterisation:
Group 1: 8/80;

Group 2: 44/82

Bacteriuria at the seventh day of catheterisation:
Group 1: 9/80;

Group2: 44/82

Secondary outcomes: Types of organisms, results in diabetic patients


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "patients were randomly allocated".

Allocation concealment (selection bias)Unclear riskNo information on allocation concealment given.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote "double blind" but not stated whether blinding applies to participants, care givers or outcome. assessors

Incomplete outcome data (attrition bias)
All outcomes
Low risk4% attrition. Seven were excluded due to positive urine culture prior to catheterisation.

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)High riskNo ITT analysis stated.

Timing of outcome assessment similar in all groupsLow riskAll participants urine culture measurement on 1st, 3rd and 7th day.

Other biasUnclear riskQuote " The authors are grateful to Prof. G Patrizi and Dr L Ventriglia (Squibb, Italy) for their helpful technical assistance".

van der Wall 1992

MethodsPlacebo-controlled RCT


Participants202 patients enrolled

Inclusion criteria:

Surgical patients from two hospitals who had postoperative bladder drainage scheduled to last for 3 to 14 days (vaginal repair, total hip replacement, rectal surgery); at least 18 years old; had given informed consent

Exclusion criteria:

Pregnancy, impaired renal or hepatic function, symptomatic UTI, fever, antibiotic use within 48 hours before study inclusion


InterventionsGroup 1: 250 mg ciprofloxacin per day from 2nd postoperative until catheter removal (n = 59)

Group 2: 500 mg ciprofloxacin twice daily from 2nd postoperative until catheter removal (n = 64)

Group 3: Placebo from 2nd postoperative until catheter removal (n = 61)

Follow-up :CSU within 24 hours of insertion, CSU just before removal if requested by a physician, clean catch at 6-week follow-up


OutcomesSignificant bacteriuria was defined as 103 > CFU/mL of CSU and 105 > CFT/mL in clean-catch urine

Bacteriuria 103 > CFU/mL at the time of catheter removal:
Group 1 (250 mg):10/54;

Group 2 (1000 mg):8/59;

Group 3: 43/57;

Group 1 & 2 (250 mg or 1000 mg):18/113;

Bacteriuria 105 > CFU/mL at the time of catheter removal

Group 1 (250 mg):4/54;

Group 2 (1000 mg): 2/59;

Group 3: 40/57;

Secondary outcomes: types of organisms, pyuria, febrile illness, hospital acquired infection, symptomatic UTI

Pyuria was defined as more than 8 leucocytes/µL

Pyuria at the time of catheter removal:
Group 1 & 2 (250 mg or 1000 mg):12/113;

Group 3: 24/57


NotesSuprapubic vs urethral bladder drainage:
Group 1: 16/50 (0.3)
Group 2:12/56 (0.2)
Group 3: 17/51 (0.3)

Different 24-hour perioperative antibiotic prophylactic regimens were given.

3 patients had side effects of ciprofloxacin (moderate gastrointestinal symptoms).

two hospitals

Remark: Of the 170 patients evaluated for bacteriuria, 11% or less in each group were bacteriuric at the time of catheter insertion (data not shown).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "Randomisation was achieved with separate lists with permuted blocks of 12 random numbers for each of the two hospitals and for each hospital service (gynaecology, surgery, orthopaedics) participating in the study".

Allocation concealment (selection bias)Low riskQuote "All tablets were identical and contained either 250mg ciprofloxacin or no active drug".

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote "Patients and the doctors and nurses involved in their care were all unaware of the nature of the medication being given". Blinding by outcome assessors not stated.

Incomplete outcome data (attrition bias)
All outcomes
Low risk16% attrition 18 excluded prior to randomisation because of protocol errors (16) or because they refused further participation (2) and "14 patients were not evaluable at the time of catheter removal" because a urine specimen was not obtained at the time of catheter removal. The excluded patients were evenly distributed over the three study arms.

Selective reporting (reporting bias)Unclear riskReports all prespecified outcomes but we were unable to access the trial protocol.

Incomplete outcome data (ITT analysis)High riskNo ITT analysis stated.

Timing of outcome assessment similar in all groupsLow riskUntil catheter removal: Median (range) days:
Group 1 (250 mg):7.0 (3-18);

Group 2 (1000 mg):7.0 (3-15);

Group 3 (placebo): 8.0 (3-16)

Other biasUnclear riskQuote " a clinical research grant from Bayer AG, Leverkussen, Germany"

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Gasser 1996Primary purpose of antibiotic administration was to prevent surgical site infection.

Little 1974Not randomised trial.

Meyer 1975Another question was answered.

Ragnaud 1983Another question was answered.

Shohet 1983Not randomised trial.

Stricker 1988Another question was answered.

Verbrugh 1988Not randomised trial.

 
Comparison 1. Antibiotic prophylaxis versus no prophylaxis

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of people with asymptomatic bacteriuria (surgical patients)3437Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.13, 0.31]

 2 Number of people with asymptomatic bacteriuria (Non-surgical patients)2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

 3 Number of people with symptomatic bacteriuria / UTI1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Surgical patients
190Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.06, 0.66]

 4 Febrile morbidity2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Surgical patients
2286Risk Ratio (M-H, Fixed, 95% CI)0.53 [0.31, 0.89]

 5 Pyuria2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Surgical patients
2241Risk Ratio (M-H, Fixed, 95% CI)0.23 [0.13, 0.42]

 6 Number of gram-negative strains / total number of strains1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 Before catheter removal
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 Six weeks after discharge
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. CG: Antibiotic prophylaxis with antibiotic A versus Antibiotic prophylaxis with antibiotic B

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of people with asymptomatic bacteriuria2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Prophylactic levofloxacin vs prophylactic ciprofloxacin
146Risk Ratio (M-H, Fixed, 95% CI)4.23 [0.21, 83.53]

    1.2 Ciprofloxacin 250 mg versus ciprofloxacin 1000 mg
1113Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.58, 3.21]

 
Comparison 3. CG: Antibiotic prophylaxis at catheterisation only versus antibiotic prophylaxis throughout catheterisation period

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of people with asymptomatic bacteriuria1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Ampicillin 3 g once versus ampicillin 3 g daily
152Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.09, 0.91]