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Prophylactic antibiotics to reduce the risk of urinary tract infections after urodynamic studies

  1. Richard Foon1,*,
  2. Philip Toozs-Hobson2,
  3. Pallavi Latthe3

Editorial Group: Cochrane Incontinence Group

Published Online: 17 OCT 2012

Assessed as up-to-date: 10 DEC 2009

DOI: 10.1002/14651858.CD008224.pub2


How to Cite

Foon R, Toozs-Hobson P, Latthe P. Prophylactic antibiotics to reduce the risk of urinary tract infections after urodynamic studies. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD008224. DOI: 10.1002/14651858.CD008224.pub2.

Author Information

  1. 1

    Royal Shrewsbury hospital, Obstetrics and Gynaecology, Shrewsbury, Shropshire, UK

  2. 2

    Birmingham Women's Hospital, Urogynaecology, Birminhgam, UK

  3. 3

    Birmingham Women's Hospital, Department of Obstetrics & Gynaecology, Birmingham, UK

*Richard Foon, Obstetrics and Gynaecology, Royal Shrewsbury hospital, Mytton Oak Road, Shrewsbury, Shropshire, SY3 8XQ, UK. rpfoon@doctors.org.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 17 OCT 2012

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

Urodynamics are used to determine any dysfunction of the lower urinary tract. Despite the use of aseptic techniques, there is a risk of bacteriuria and bacteraemia with invasive cystometry (Onur 2004). The use of prophylactic antibiotics before or immediately after invasive cystometry or urodynamic studies is controversial as it is not without risks of adverse effects and emergence of resistant microbes (Porru 1999). It is estimated that after one episode of catheterization bacteriuria occurs in 1% to 5% of patients (Schaeffer 1986). There are financial and medical consequences if a urinary tract infection develops. Urinary tract infections can increase the risk of pyelonephritis, which is associated with impairment of renal function and renal disease in paediatric patients. The estimated annual cost of community acquired urinary tract infections (UTIs) is approximately USD 1.6 billion (Foxman 2002).

 

Description of the condition

Urodynamic studies are used to detect dysfunction of the lower urinary tract in men, women or children with urinary symptoms such as frequency, urgency, incontinence, voiding difficulties etc. Urodynamic studies include spontaneous uroflowmetry, and filling and voiding phase cystometry with or without a urethral pressure profile during both resting and straining. The tests are invasive and involve the insertion of a catheter into the urethra at the least.

One of the important risks of the investigation is that of developing asymptomatic bacteriuria or a urinary tract infection (UTI).

  • Asymptomatic bacteriuria is defined as the presence of a significant number of bacteria in the urine (as defined by trialists, but normally more than 100,000 per ml of urine) without any symptoms of a UTI (such as increased frequency or burning or pain upon voiding).
  • Symptomatic UTI, or cystitis, which is the inflammatory response to bacterial invasion of the lower urinary tract, includes the clinical symptoms of urinary frequency, urgency and dysuria (pain upon voiding urine). Lower urinary tract infection may be acute, chronic or recurrent as well as being simple or complex. Infection is characterised by large numbers of microorganisms (bacteria) and leucocytes (white blood cells) in the urine. The natural history is dependent on the type and virulence of the urinary pathogen, resistance to antimicrobial agents and the host defences. 

If symptoms are mild, a dipstick test is used to guide the clinical decision on whether to prescribe oral antibiotics such as trimethoprim or nitrofurantoin. If systemically unwell, patients may need admission to hospital and intravenous followed by oral antibiotics.

It is estimated that a single catheterization episode results in a 2% incidence of symptomatic UTI (Walter 1978). The reported ranges for infection following the procedure are from 3% to 20% (Cundiff 1999b; Okorocha 2002; Sabanathan 1985). There are Cochrane Reviews available covering antibiotic use for short-term catheter bladder drainage (Niël-Weise 2005) and the use of urodynamics (Glazener 2002) in people with incontinence but not on the use of prophylactic antibiotics in people having urodynamic studies.

 

Description of the intervention

Routine prophylactic antibiotics are given for most urological surgical procedures including cystoscopy, but their use in invasive cystometry where the bladder is catheterized has been controversial. Antibiotic treatment carries risks of adverse effects including allergic reactions, questions about cost effectiveness, problems with compliance and the development of bacteria which are resistant to antibiotics.

 

How the intervention might work

The use of antibiotics might reduce the risk of bacterial invasion of the urinary tract during catheterization and subsequent symptomatic UTI following invasive cystometry.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

The rationale for the review is that there is uncertainty as to whether prophylactic antibiotics are effective in preventing UTI and a systematic review of randomized controlled trials (RCTs) is needed to address this question. It is unclear whether antibiotics should be given to everybody or should be confined to at risk groups and what the best drug is if antibiotics are to be prescribed for prophylaxis of UTI.

The objective of this systematic review was to assess the effectiveness and safety of administering prophylactic antibiotics in reducing the risk of UTI after urodynamic studies. The following comparisons were planned.

1. Antibiotics versus placebo or no antibiotics.

2. One antibiotic versus another.

3. One dose of antibiotics versus another dose.

4. One duration of antibiotic use versus another duration.

5. One route of administration of antibiotics versus another.

6. Antibiotics versus other treatments (e.g. increased fluid intake, cranberry juice, urinary antiseptics etc).

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms
 

Criteria for considering studies for this review

 

Types of studies

All randomized and quasi-randomized controlled trials where one arm included giving a prophylactic antibiotic to a person having a urodynamic study while the other involved giving a placebo or no treatment.

 

Types of participants

Adult males, females or children undergoing urodynamic studies irrespective of whether they had spinal cord injury or a suprapubic catheter.

 

Types of interventions

One arm was allocated antibiotics and the other arm used a placebo. The arm allocated to antibiotics included any type or dose of antibiotic given prophylactically via any route, from 24 hours before to up to 72 hours after urodynamics. The antibiotic course could be for any duration, including a single dose or a course of antibiotics. The route of administration could vary as well.

 

Types of outcome measures

 

Primary outcomes

Urinary tract infection, defined as:

symptoms of frequency or dysuria; with or without dipstick urine positive for nitrites and leucocyte esterase; with or without microbiological confirmation (greater than105 colony forming units/ml)

or

asymptomatic bacteriuria (greater than 105 colony forming units/ml).

 

Secondary outcomes

Adverse events:

  1. haematuria (blood in the urine),
  2. fever (pyrexia, high temperature),
  3. dysuria (pain passing urine),
  4. adverse events as a result of or in reaction to antibiotics (e.g. allergic reaction, rash),
  5. need for analgesia (pain killers).

Health economic outcomes such as cost effectiveness.

 

Search methods for identification of studies

All prospective randomized controlled trials were identified after employing the search strategy described below. We did not apply any language or other restrictions.

 

Electronic searches

All reports which described randomized controlled trials (RCTs) of prophylactic antibiotics in patients having urodynamic studies as a sole procedure were identified. We searched the Cochrane Incontinence Group Specialised Trials Register (searched 10 December 2009), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (January 1966 to January 2009), CINAHL (January 1982 to January 2009), and handsearching of journals and conference proceedings (For more details please see the ‘Specialized Register’ section of the Group’s module in The Cochrane Library). We also searched EMBASE (January 1966 to January 2009), PubMed (1 January 1980 to January 2009), LILACS (up to January 2009), TRIP database (up to January 2009) and the UK NHS Evidence Health Information Resources (formerly known as the National Library for Health, UK). The search terms used are given in Appendix 1.

 

Searching other resources

We attempted to contact the authors of individual trials to obtain further information. We also attempted to look at the grey literature, that is conference abstracts from the last 10 years of annual meetings of the International Continence Society, International Urogynecological Association and the American Urological Association, to obtain data from trials that were published as abstracts only.

 

Data collection and analysis

All prospective randomized controlled trials comparing the use of prophylactic antibiotics versus placebo or no treatment.The data extraction and the assessment of the quality of data were done independently by the two authors (RF and PL). The data were collected and tabulated using forms designed in keeping with Cochrane Collaboration guidelines. These included data on the characteristics of the study participants including details of previously administered treatments, interventions used and methods applied to measure infection and adverse events.

Statistical analyses were performed according to the statistical guideline of The Cochrane Collaboration, the Cochrane Handbook for Systematic Reviews of Interventions. Data from intention-to-treat analyses were used where available. For the dichotomous data,results of each study were expressed as a risk ratio (RR) with 95% confidence interval (CI) and combined for meta-analysis using the Peto-modified Mantel-Haesnszel method; a fixed-effect model was used.

 

Selection of studies

Two review authors independently evaluated the titles and abstracts identified from the literature searches, without language restrictions, and assessed relevant articles for potential inclusion. The trials were critically appraised for quality using the Cochrane 'Risk of bias assessment tool'. All prospective randomized controlled trials (RCTs) comparing the use of prophylactic antibiotics versus a placebo, no treatment or another treatment in patients having urodynamics were selected.

 

Data extraction and management

All data extraction was performed independently by two authors of the review (PL and RF) using standardised extraction forms designed according to Cochrane guidelines. Data on characteristics of the study participants, including details of previously administered treatments, adverse events from the interventions and methods used to measure infection, were extracted. There were no disagreements between the two review authors.

The following methodological parameters were recorded:
1) identification of study as randomized or quasi-randomized;
2) description of inclusion and exclusion criteria.

 

Assessment of risk of bias in included studies

The trials were critically appraised. The following were assessed and reported in the Cochrane 'Risk of bias' tables.

  • Was the allocation sequence adequately generated?
  • Was allocation adequately concealed?
  • Was knowledge of the allocated interventions adequately prevented during the study (blinding of researchers, participants, outcome assessors)?
  • Were incomplete outcome data adequately addressed?
  • Are reports of the study free of suggestion of selective outcome reporting?
  • Was the study apparently free of other problems that could put it at a high risk of bias?

 

Measures of treatment effect

In the protocol stage, it was decided that where there were any continuous data results from the same method of measurement, the mean difference would be derived with the 95% confidence interval and summarised using a fixed effect model. Any continuous data that were the product of a number of different scales (for example scales used to assess a symptom such as pain or quality of life) were to be summarised as the standardised mean difference using a fixed-effect model. Details of other outcomes such as quality of life were reported as described in the individual trials. The outcome of UTI was to considered a negative consequence and a lower risk ratio (RR) would represent a benefit.

 

Dealing with missing data

We intended to only include the data of participants as they were reported and not to impute missing values but, if appropriate, we had planned to do sensitivity analyses, particularly if there was a differential drop-out from the randomized groups.

 

Assessment of heterogeneity

Heterogeneity was assessed by visual inspection of the forest plots and using the Chi2 test for heterogeneity and the I2 statistic (Higgins 2008). If data were heterogeneous, then we planned to use a random-effects model and consider the following possible explanations.

1. Antibiotic prescription: frequency, dose, route, duration.

2. Timing of antibiotic treatment in relation to the invasive cystometry.

3. Populations (men, women, children).

 

Assessment of reporting biases

Publication bias was not assessed due to the limited number of trials.

 

Data synthesis

Included data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008).

 

Subgroup analysis and investigation of heterogeneity

Within each comparison, we planned to carry out subgroup analysis by sample characteristics such as neurogenic and non-neurogenic groups, males and females, and adults versus children. If the data allowed, we had planned to look at people at high risk versus routine risk of UTI, different types of urodynamic studies separately (for example standard, ambulatory) and different routes of catheterization (suprapubic versus standard); however, there were no data available.

 

Sensitivity analysis

We planned to carry out a sensitivity analysis based on eligibility criteria (such as including and excluding results from abstract-only publications) (Deeks 2008).

 

Results

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms
 

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies.

A total of 276 records were screened for this review. Eleven randomised controlled trials involving the prophylactic use of antibiotics in patients having urodynamics were identified as potentially relevant. Two trials were excluded from the review, one because the author could not be contacted for the details of the study (Bhatia 1985) and the other because it included patients who underwent combined cystourethroscopy and urodynamics rather than urodynamics alone (Cundiff 1999b). Nine randomised controlled trials involving 973 patients in total were included in the review (Baker 1991; Bergman 1983; Coptcoat 1988; Darouiche 1994; Kartal 2006; Peschers 2001; Siracusano 2008; Tosto 1989; Yip 2006); one was reported in an abstract only (Yip 2006). The flow of literature through the assessment process is shown in the PRISMA diagram (Figure 1).

 FigureFigure 1. PRISMA study flow diagram showing the flow of literature through the assessment process.

The methods of the included trials were poorly described. Two trials were double blinded and two were single blind. The allocation concealment was adequate only in one study. The trials were conducted in seven countries (Canada, Germany, Hong Kong, Italy, Turkey, UK and USA). The trials involved a total of 963 patients of which 479 received antibiotics.

The nine randomized controlled trials in this review used a wide range of antibiotics (amoxicillin and clavulanate (Augmentin), nitrofurantoin, ciprofloxacin, trimethoprim and norfloxacin) at different doses and for different durations.

 

Results of the search

Eleven randomized controlled trials were identified but two were excluded.

 

Included studies

The nine included trials involved 973 patients between the ages of 18 and 82 years, of which 230 patients were male. The trials took place in Canada (Baker 1991), Germany (Peschers 2001), Hong Kong (Yip 2006), Italy (Siracusano 2008; Tosto 1989), Turkey (Kartal 2006), the United Kingdom ( Coptcoat 1988) and the United States (Bergman 1983; Darouiche 1994). Antibiotics were given as a single dose in six trials (Bergman 1983; Coptcoat 1988; Kartal 2006; Peschers 2001; Siracusano 2008; Yip 2006) and multiple doses in three trials (Baker 1991; Darouiche 1994; Tosto 1989). The antibiotics used were amoxicillin and clavulanate (Yip 2006), ciprofloxacin (Darouiche 1994; Kartal 2006), cotrimoxazole (Peschers 2001), norfloxacin (Siracusano 2008), nitrofurantoin (Baker 1991; Bergman 1983), ciprofloxacin (Tosto 1989) and trimethoprim (Coptcoat 1988).

The urodynamics were performed using standard techniques. The primary outcome in all trials was symptoms of frequency or dysuria, with or without dipstick urine positive for nitrites and leucocyte esterase, with or without microbiological confirmation (greater than105 colony factor units/ml). Significant bacteriuria was defined the presence of more than 100,000 bacteria per millilitre of a mid-stream urine sample on culture and sensitivity testing. Four trials reported the incidence of symptomatic urinary tract infections (Coptcoat 1988; Darouiche 1994; Siracusano 2008; Tosto 1989). The outcomes that some trials assessed were pyrexia, haematuria, dysuria and adverse reactions to the treatment. Outcomes were assessed at various times, ranging from one day to one week following urodynamic studies. All trials were carried out in a hospital or outpatient setting.

In four of the trials the drop-out or withdrawal patients were adequately reported (Baker 1991; Darouiche 1994; Peschers 2001; Siracusano 2008). In the remaining trials, there were no drop-outs in four trials (Bergman 1983; Coptcoat 1988; Kartal 2006; Yip 2006) and in one study the drop-outs were not accounted for adequately (Tosto 1989).

 

Excluded studies

Two studies were excluded from the review: one that combined instrumentation of the urinary bladder and urodynamics, and the author could not be contacted for further details of the study (Bhatia 1985); and a second because it included patients who underwent combined cystourethroscopy and urodynamics rather than urodynamics alone (Cundiff 1999b).

 

Risk of bias in included studies

Summaries of the risk of bias assessments for each trial and for the trials together are given in Figure 2 and Figure 3, respectively.

 FigureFigure 2. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
 FigureFigure 3. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

 

Allocation

Two out of the nine trials were at low risk of selection bias in terms of random sequence generation (Peschers 2001; Siracusano 2008), while in another four trials the risk was unclear (Coptcoat 1988; Darouiche 1994; Tosto 1989; Yip 2006). Three trials used a quasi-randomized method of sequence generation and were thus at high risk of bias (Baker 1991; Bergman 1983; Kartal 2006). Only one study reported a low risk of bias from allocation concealment (Siracusano 2008) (Figure 2). For this study, a computer generated double blind randomized controlled trial was conducted. Two were at high risk of bias (Bergman 1983; Kartal 2006) and the remainder were unclear in their risk of bias.

 

Blinding

Two out of the nine trials showed a low risk of performance bias, by blinding both participants and personnel (Darouiche 1994; Siracusano 2008). In four trials the risk was unclear based on the data provided in the manuscripts (Coptcoat 1988; Kartal 2006; Tosto 1989; Yip 2006) (Figure 2). As far as detection bias was concerned, only two trials showed a low risk (Baker 1991; Siracusano 2008) while for most of the trials the risks were unclear; but in one study there was a high risk of detection bias (Bergman 1983) (Figure 2).

 

Incomplete outcome data

Three trials were assessed as having a high risk of attrition bias (Darouiche 1994; Tosto 1989; Yip 2006) while in two trials the risk was unclear due to lack of information (Kartal 2006; Peschers 2001) (Figure 2). One possible reason for the relatively low number of trials having a high risk of attrition bias is the short follow-up time associated with the trials.

 

Selective reporting

it is possible that trials showing a positive result are more likely to be reported and hence there was likely to be a risk of reporting bias in this systematic review.

 

Other potential sources of bias

Some of the trials had a small number of participants (Darouiche 1994; Peschers 2001; Tosto 1989).

 

Effects of interventions

The intention was to include as comparators no treatment, placebo, any type of urinary antiseptic, cranberry juice or changes in fluid intake (such as advice to increase fluid intake). We did not find any trials that compared different types of antibiotics, different routes of administration or different interventions. There were also no trials that compared different durations of antibiotic administration. There was, therefore, no information for Comparisons 2 to 6.

 

1. Antibiotics versus placebo or no antibiotics

 

Symptomatic urinary tract infections

Five trials reported this outcome. When compared to no treatment, patients receiving prophylactic antibiotics had fewer UTIs (40/201, 20%) than those receiving control or placebo interventions (59/214, 28%). This difference in the risk of symptomatic urinary tract infections following urodynamics did not reach statistical significance (RR 0.73, 95% CI 0.52 to 1.03; 4 trials) ( Analysis 1.1).

 

Bacteriuria

All nine trials reported this outcome. When compared to no treatment, the administration of prophylactic antibiotics reduced the overall risk of significant bacteriuria in all participant groups combined (RR 0.35, 95% CI 0.22 to 0.56; 8 trials) ( Analysis 1.2). In the subgroup with male patients only (3 trials), there was also a reduction in the risk of significant bacteriuria (RR 0.21, 95% CI 0.06 to 0.78) ( Analysis 1.2) as was the case in the subgroup of female patients (RR 0.40, 95% CI 0.24 to 0.67; 7 trials) ( Analysis 1.2). There were too few participants with spinal cord injury to provide reliable results in this subgroup (RR 0.17, 95% CI 0.01 to 3.14) ( Analysis 1.1).

 

Adverse effects

When compared to no treatment, the administration of prophylactic antibiotics reduced the risk of haematuria (RR 0.46, 95% CI 0.23 to 0.91; 2 trials) ( Analysis 1.3). However, there were too few data to assess the risk of fever (RR 5.16, 95% CI 0.94 to 28.16; 2 trials) ( Analysis 1.4) or dysuria (RR 0.83, 95% CI 0.5 to 1.36; 2 trials) ( Analysis 1.5).

Only two trials reported any adverse reactions to antibiotics (Kartal 2006; Peschers 2001). Only two of 135 (2%) participants had an adverse reaction to the antibiotics (RR 4.47, 95% CI 0.22 to 89.94; 2 trials) ( Analysis 1.6).

 

Number needed to treat

The number needed to treat with antibiotics to prevent bacteriuria and haematuria was 12.3 and 13.4 respectively. Amongst the female patients, the number needed to treat to prevent bacteriuria was 13.4 while amongst the male patients it was 9.1.

 

Sensitivity analysis

When we excluded the abstract (Yip 2006) the results still favoured the use of prophylactic antibiotics in all patients (male and female combined) (RR 0.42, 95% CI 0.22 to 0.80). The same was true for the use of prophylactic antibiotics in female patients (RR 0.48, 95% CI 0.26 to 0.90) when we excluded the abstract (Yip 2006) (RR 0.54, 95% CI 0.34 to 0.88).

Fixed-effect model analyses were performed on all subgroups and there was no significant difference in the results. When compared to no treatment, the administration of prophylactic antibiotics reduced the risk of significant bacteriuria in patients (male and female combined) with a fixed-effect model analysis (RR 0.46, 95% CI 0.32 to 0.66) ( Analysis 1.1). When the data from the abstract-only publication were removed, the data still supported the original findings (RR 0.50, 95% CI 0.34 to 0.72).

 

2. One antibiotic versus another

No trials addressed this comparison.

 

3. One dose of antibiotics versus another dose

No trials addressed this comparison.

 

4. One duration of antibiotic use versus another duration

No trials addressed this comparison.

 

5. One route of administration of antibiotics versus another

No trials addressed this comparison.

 

6. Antibiotics versus other treatments (for example increased fluid intake, cranberry juice, urinary antiseptics etc)

No trials addressed this comparison.

 

Discussion

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

This review considers whether prophylactic antibiotic is better than no treatment for the prevention of urinary tract infections (UTIs) in patients undergoing urodynamic studies. Nine randomized controlled trials were identified. These trials were conducted in seven countries (Canada, Germany, Hong Kong, Italy, Turkey, UK and USA). The trials involved a total of 963 patients of which 479 received antibiotics.

 

Summary of main results

Prophylactic antibiotics reduce the risk of significant bacteriuria following the procedure, however their effectiveness in reducing the symptoms of UTIs is unclear. The review did not find any data to address other issues such as different types of antibiotic, different doses or duration of use of antibiotics, different routes of administration of antibiotics or the use of other interventions such as increasing fluid intake or cranberry juice.

 

Overall completeness and applicability of evidence

There were a limited number of trials suitable for inclusion.

There are several strengths of this review. The search was thorough and systematic without language restrictions. Two review authors independently did the study selection and data extraction to minimize errors. We attempted to contact authors of published and unpublished trials to obtain further details. We adhered to the PRISMA checklist while reporting the meta-analyses (Moher 1999).

The existing trials have focused on objective evidence of significant bacteriuria rather than clinically significant irritative symptoms suggestive of a UTI which might prompt consultation and antibiotic treatment. The significance of asymptomatic significant bacteriuria has been studied in various high risk groups like children and people with neurogenic bladders. The evidence from these trials suggests that antibiotic cover is not necessary unless there are co-existent risk factors like vesico-ureteric reflux (Jayawardena 2004; Ottolini 1995). There is no robust information on progression of bacteriuria to UTI in low risk individuals.

Assessment of antimicrobial prophylaxis entails a thorough cost–benefit analysis. The intended benefit is the prevention of infectious complications, which can lead to morbidity ranging from trivial to substantial as well as significant healthcare costs. The cost in the cost-benefit analysis is the risk of adverse patient effects, cost of antibiotic administration and the risk of promoting the emergence of resistant strains of microbes, which can have serious implications from a public health standpoint (Kraklau 1999). With the use of a decision analysis model, it has been shown that prophylactic antibiotics after urodynamic studies in women are beneficial if the baseline rate of UTIs for that clinic or institution is greater than 10% (Lowder 2007). Each institution could audit their UTI rates de novo following urodynamics and then, after discussions with microbiologists, draw up a policy for antibiotic prophylaxis if the urinary tract infection rates are high. Ideally, rates higher than 5% should prompt an infection control review. The choice of prophylactic antibiotic should be based on the local sensitivity data and after discussion with a microbiologist.

Therefore, due to the poor quality of the included trials, it is suggested that each institute should audit their UTI rates following urodynamic studies. Using this data, and in conjunction with the evidence provided by this meta-analysis and the opinion of the microbiologist, each institution should formulate a local policy for the use of prophylactic antibiotics following urodynamics.

 

Quality of the evidence

The nine randomized controlled trials in this review used a wide range of antibiotics (amoxicillin and clavulanate, nitrofurantoin, ciprofloxacin, trimethoprim and norfloxacin), different doses and durations of treatment. The quality of the randomized controlled trials was moderate or poor and this can reduce the reliability of the results.

The issue of small sample sizes of the individual trials has partly been overcome with meta-analysis though the quality of the included randomized controlled trials was generally moderate to poor. Compared to trials which report adequate concealment, failure to prevent foreknowledge of treatment allocation is associated with exaggeration of treatment effects by 30 to 40% (Schulz 1995). The trials included a wide range of antibiotic regimens as well as end points of interest. The evidence from observational studies with respect to male urodynamics is controversial (Logadotirr 2001; Klingler 1998). 

 

Potential biases in the review process

The quality of the randomized controlled trials was moderate to poor and this can reduce the reliability of the estimates of the effectiveness of treatment. Publication bias can distort findings because trials with statistically significant results are more likely to be published (Egger M 2001). Therefore, selective reporting of the outcome might account for reporting bias. Only one trial (Siracusano 2008) was at low risk of bias on all the criteria considered.

It should be noted that attempts were made to contact authors for additional information but in the case of one study we were unsuccessful (Yip 2006).

 

Agreements and disagreements with other studies or reviews

One study showed no improvement following the use of a one-day course of nitrofurantoin as the prophylactic antibiotic (Cundiff 1999b). In this study patients had both urodynamic studies and cystourethroscopy and it for this reason the authors decided not to include this study in the systematic review. There are no other published systematic reviews that address this topic.

 

Authors' conclusions

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

 

Implications for practice

There is limited evidence available to guide clinicians in the use of prophylactic antibiotics in patients undergoing urodynamic studies. Prophylactic antibiotics can be used to reduce the risk of significant bacteriuria after urodynamics but their use in reducing symptomatic urinary tract infections and the clinical importance of reducing significant bacteriuria are still unclear. Amongst the various antibiotics used, there were very few side effects with an adverse reaction to the antibiotics in only two people (2%). However, only two trials reported adverse effects and hence there is limited information to base comments about adverse effects on. The number needed to treat with antibiotics to prevent bacteriuria was 10.9.

 
Implications for research

This review shows a lack of good quality studies and the need for robustly conducted and sufficiently powered randomized controlled trials comparing different antibiotics, different routes of administration and different interventions on outcomes such as symptomatic urinary tract infections and cost effectiveness. Further research on the effectiveness of antibiotics in children should also be considered.

Outcomes should include those that are of clinical importance (such as symptomatic urinary tract infections) and economic outcomes such as cost effectiveness as well as adverse effects.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

We thank June Cody for help with technical support. We would also like to thank Muhammad Imran Omar for methodological advice and help.

 

Data and analyses

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms
Download statistical data

 
Comparison 1. Antibiotics versus placebo (adult patients)

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

 1 Clinical urinary tract infection following urodynamics4415Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.52, 1.03]

    1.1 Antibiotics versus placebo in male patients
275Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.38, 1.26]

    1.2 Antibiotics versus placebo in female patients
2300Risk Ratio (M-H, Fixed, 95% CI)0.80 [0.53, 1.21]

    1.3 Antibiotics versus placebo in patients with spinal injury
140Risk Ratio (M-H, Fixed, 95% CI)0.17 [0.01, 3.14]

 2 Bacteriuria following urodynamics9970Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.22, 0.56]

    2.1 Antibiotics versus placebo in male patients
3176Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.06, 0.78]

    2.2 Antibiotics versus placebo in female patients
7757Risk Ratio (M-H, Fixed, 95% CI)0.40 [0.24, 0.67]

    2.3 Antibiotics versus placebo in patients with spinal injury
137Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.72]

 3 Haematuria following urodynamics2344Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.23, 0.91]

 4 Fever following urodynamics2299Risk Ratio (M-H, Fixed, 95% CI)5.16 [0.94, 28.16]

 5 Dysuria following antibiotics1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 6 Adverse effects from prophylactic antibiotics2262Risk Ratio (M-H, Fixed, 95% CI)4.47 [0.22, 89.94]

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms
 

Appendix 1. Search strategies used for this review

The Trials Search Co-ordinator used the following terms to search the Incontinence Group Specialised Register:

({design.cct*} or {design.rct*})
AND
{topic.urine*}
AND
{intvent.invest.urodyn*}
AND
{intvent.prevent.*}
(All searches will be of the keyword field of Reference Manager 12, Thomson Reuters). The date of the last search was: 10 December 2009.

For an earlier version of this review (not Cochrane) the review authors searched: CENTRAL (The Cochrane Library Issue 4,2006), MEDLINE (1966 to January 2009), PubMed, CINAHL, TRIP (up to January 2009), LILACS (up to January 2009) and the UK NHS Evidence Health Information Resources (formerly known as the National Library for Health, UK). The searches were conducted in April 2007. The review authors consulted a medical librarian who suggested the following terms be used for the search as text words (as well as subject headings when using OVID software):

Urinary tract infections AND prophylaxis,

Antibiotics AND Urodynamics AND placebo AND trials AND Male/ Female/ Children

 

What's new

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

Last assessed as up-to-date: 10 December 2009.


DateEventDescription

5 September 2012New citation required and conclusions have changedNew review comparing the use of prophylactic antibiotics versus placebo in patients undergoing urodynamics



 

History

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

Protocol first published: Issue 1, 2010
Review first published: Issue 10, 2012

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

PL conceived the idea for the review. PL and RF drafted the protocol, did the data extraction and edited the manuscript. In the case of disagreement PT was involved to give his advice. All authors contributed to the final text of the review.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

None

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms
 

Internal sources

  • None, Not specified.

 

External sources

  • No sources of support supplied

 

Differences between protocol and review

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Differences between protocol and review
  17. Index terms

None

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. AbstractRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Characteristics of studies
  19. References to studies included in this review
  20. References to studies excluded from this review
  21. Additional references
  22. References to other published versions of this review
Baker 1991 {published data only}
  • Baker KR, Drutz HP, Barnes MD. Effectiveness of antibiotic prophylaxis in preventing bacteriuria after multichannel urodynamic investigations: a blind, randomized study in 124 female patients. American Journal of Obstetrics and Gynecology 1991;165(3):679-81.
Bergman 1983 {published data only}
Coptcoat 1988 {published data only}
Darouiche 1994 {published data only}
Kartal 2006 {published data only}
  • Kartal ED, Yenilmez A, Kiremitchi A, Meric H, Kale M, Usluer G. Effectiveness of ciprofloxacin prophylaxis in preventing bacteriuria caused by urodynamic study: a blind, randomized study of 192 patients. Urology 2006;67(6):1149-53.
Peschers 2001 {published data only}
  • Peschers UM, Kempf V, Jundt K, Autenrieth I, Dimpfl T. Antibiotic treatment to prevent urinary tract infections after urodynamic evaluation. International Urogynecology Journal and Pelvic Floor Dysfunction 2001;12(4):254-7.
  • Peschers UM, Kempf V, Leib B, Wasmeier C, Autenrieth I, Dimpfl T. Incidence of urinary tract infections in women with urogynecological symptoms and efficacy of routine antibiotic treatment for the prophylaxis of urinary tract infections after urodynamic evaluation (Abstract number 330). Proceedings of the International Continence Society (ICS), 29th Annual Meeting, 1999 Aug 23-26, Denver, Colorado 1999:409-10.
Siracusano 2008 {published data only}
  • Siracusano S, Knez R, Tiberio A, Alfano V, Giannantoni A, Pappagallo G. The usefulness of antibiotic prophylaxis in invasive urodynamics in postmenopausal female subjects. International Urogynecology Journal and Pelvic Floor Dysfunction 2008;19(7):939-42.
Tosto 1989 {published data only}
  • Tosto A, Dattolo E, Brigadini R, Pironti M, Di Cello V, Rizzo M. Early antibiotic therapy following urodynamic examination. Results of a randomized, controlled study. [Italian]. Minerva Urologica e Nefrologica 1989;41(4):271-3.
Yip 2006 {published data only}
  • Yip S, Cheon C, Wong T, Pang M, Lee L, Yuen C, et al. A randomised double-blind placebo-controlled trial of prophylactic antibiotics in preventing female urinary tract infection after urodynamic study (Abstract number 99). Neurourology and Urodynamics 2006;25(6):627-8.

References to studies excluded from this review

  1. Top of page
  2. AbstractRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Characteristics of studies
  19. References to studies included in this review
  20. References to studies excluded from this review
  21. Additional references
  22. References to other published versions of this review
Bhatia 1985 {published data only}
  • Bhatia N. Comparison of antibiotic (cefadroxil) versus placebo before lower urinary tract instrumentation, including urethrocystometry as prophylaxis for UTI. American Urogynecology Society meeting. 1985.
Cundiff 1999a {published data only}

Additional references

  1. Top of page
  2. AbstractRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Characteristics of studies
  19. References to studies included in this review
  20. References to studies excluded from this review
  21. Additional references
  22. References to other published versions of this review
Cundiff 1999b
Deeks 2008
  • Deeks JJ, Higgins JPT, Altman DG. Analysing data and presenting results. In: Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. Wiley & Sons, Ltd, 2008.
Egger M 2001
  • Egger M, Dickersin K, Davey-Smith G. Problems and limitations in conducting systematic reviews. In: Egger M, Davey-Smith G, Altman D editor(s). Systematic Reviews in Health Care: Meta-analysis in Context. first. London: BMJ Publications, 2001:43-66.
Foxman 2002
Glazener 2002
  • Glazener CMA, Lapitan MCM. Urodynamic investigations for management of urinary incontinence in children and adults. Cochrane Database of Systematic Reviews 2002, Issue 3. [DOI: 10.1002/14651858.CD003195; : CD003195]
Higgins 2008
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.
Jayawardena 2004
Klingler 1998
  • Klingler HC, Madersbacher S, Djavan B, Schatzl G, Marberger M, Schmidbauer CP. Morbidity of the evaluation of the lower urinary tract with transurethral multichannel pressure-flow studies. Journal of Urology 1998;159(1):191-4.
Kraklau 1999
  • Kraklau DM, Wolf JS, Jr. Review of antibiotic prophylaxis recommendations for office-based urologic procedures. Techniques in Urology 1999;5(3):123-8.
Logadotirr 2001
  • Logadottir Y, Dahlstrand C, Fall M, Knutson T, Peeker R. Invasive urodynamic studies are well tolerated by the patients and associated with a low risk of urinary tract infection. Scandinavian Journal of Urology and Nephrology 2001;35(6):459-62.
Lowder 2007
  • Lowder JL, Burrows LJ, Howden NL, Weber AM. Prophylactic antibiotics after urodynamics in women: a decision analysis. International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18(2):159-64.
Moher 1999
  • Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999;354(9193):1896-900.
Niël-Weise 2005
  • Niël-Weise BS, van den Broek PJ. Antibiotic policies for short-term catheter bladder drainage in adults. Cochrane Database of Systematic Reviews 2005, Issue 3. [DOI: 10.1002/14651858.CD005428; : CD005428]
Okorocha 2002
Onur 2004
Ottolini 1995
  • Ottolini MC, Shaer CM, Rushton HG, Majd M, Gonzales EC, Patel KM. Relationship of asymptomatic bacteriuria and renal scarring in children with neuropathic bladders who are practicing clean intermittent catheterization. Journal of Pediatrics 1995;127(3):368-72.
Porru 1999
Sabanathan 1985
Schaeffer 1986
Schulz 1995
  • Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408-12.
Walter 1978