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

  • Review
  • Intervention

Authors


Abstract

Background

There is a risk that people who have invasive urodynamic studies (cystometry) will develop urinary tract infections or bacteria in the urine or blood. However, the use of prophylactic antibiotics before or immediately after invasive cystometry or urodynamic studies is not without risks of adverse effects and emergence of resistant microbes.

Objectives

To assess the effectiveness and safety of administering prophylactic antibiotics in reducing the risk of urinary tract infections after urodynamic studies. The hypothesis was that administering prophylactic antibiotics reduces urinary tract infections after urodynamic studies.

Search methods

We searched the Cochrane Incontinence Group Specialised Trial Register, MEDLINE (January 1966 to January 2009), CINAHL (January 1982 to January 2009), 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 (searched 10 December 2009). We searched the reference lists of relevant articles, the primary trials and the proceedings of the International Urogynaecological Association International Continence Society and the American Urological Association for the years 1999 to 2009 to identify articles not captured by electronic searches. There were no language restrictions.

Selection criteria

All randomized controlled trials and quasi-randomized trials comparing the use of prophylactic antibiotics versus a placebo or no treatment in patients having urodynamic studies were selected. Two authors (PL and RF) independently performed the selection of trials for inclusion and any disagreements were resolved by discussion.

Data collection and analysis

All assessments of the quality of trials and data extraction were performed independently by two authors of the review (PL and RF) using forms designed according to Cochrane guidelines. We attempted to contact authors of the included trials for any missing data. Data were extracted on characteristics of the study participants including details of previously administered treatments, interventions used, the methods used to measure infection and adverse events.

Statistical analyses were performed according to Cochrane Collaboration guidelines. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were expressed as a risk ratio (RR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method.

The primary outcome was urinary tract infection. Heterogeneity was assessed by the P value and I2 statistic.

Main results

Nine randomized controlled trials involving the prophylactic use of antibiotics in patients having urodynamic studies were identified and these included 973 patients in total; one study was an abstract. Two further trials were excluded from the review. The methods of the included trials were poorly described.

The primary outcome in all trials was the rate of developing significant bacteriuria, defined as the presence of more than 100,000 bacteria per millilitre of a mid-stream urine sample on culture and sensitivity testing. The other outcomes included pyrexia, haematuria, dysuria and adverse reactions to antibiotics.

The administration of prophylactic antibiotics when compared to a placebo reduced the risk of significant bacteriuria (4% with antibiotics versus 12% without, risk ratio (RR) 0.35, 95% CI 0.22 to 0.56) in both men and women. The administration of prophylactic antibiotics also reduced the risk of haematuria (RR 0.46, 95% CI 0.23 to 0.91). However, there was no statistically significant difference in the primary outcome, risk of symptomatic urinary tract infection (40/201, 20% versus 59/214, 28%; RR 0.73, 95% CI 0.52 to 1.03); or in the risk of fever (RR 5.16, 95% CI 0.94 to 28.16) or dysuria (RR 0.83, 95% CI 0.5 to 1.36). Only two of 135 people had an adverse reaction to the antibiotics. The number of patients needed to treat with antibiotics to prevent bacteriuria was 12.3. Amongst women, the number needed to treat to prevent bacteriuria was 13.4; while amongst men it was 9.1 (number needed to treat = 1/ absolute risk reduction).

Authors' conclusions

Prophylactic antibiotics did reduce the risk of bacteriuria after urodynamic studies but there was not enough evidence to suggest that this effect reduced symptomatic urinary tract infections. There was no statistically significant difference in the risk of fever, dysuria or adverse reactions. Potential benefits have to be weighed against clinical and financial implications, and the risk of adverse effects.

Résumé scientifique

Les antibiotiques prophylactiques pour réduire le risque d'infections des voies urinaires après des études urodynamiques

Contexte

Il y a un risque que les personnes ayant subi des études urodynamiques invasives (cystomanométrie) développent des infections urinaires ou des bactéries dans l'urine ou le sang. Cependant, l'utilisation d'antibiotiques prophylactiques avant ou immédiatement après la cystomanométrie invasive ou les études urodynamiques n'est pas dépourvue du risque d'effets indésirables et d'émergence de microbes résistants.

Objectifs

Évaluer l'efficacité et l'innocuité de l'administration d'antibiotiques à titre prophylactique pour la réduction du risque d'infections des voies urinaires après des études urodynamiques. L'hypothèse était que l'administration d'antibiotiques prophylactiques réduit les infections des voies urinaires après des études urodynamiques.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé des essais du groupe Cochrane sur l'incontinence, ainsi que dans MEDLINE (de janvier 1966 à janvier 2009), CINAHL (de janvier 1982 à janvier 2009), EMBASE (de janvier 1966 à janvier 2009), PubMed (du 1er janvier 1980 à janvier 2009), LILACS (jusqu'à janvier 2009), la base de données TRIP (jusqu'à janvier 2009), et le UK NHS Evidence Health Information Resources (recherche effectuée le 10 décembre 2009). Nous avons cherché dans les références bibliographiques d'articles pertinents, les essais primaires et les actes de l'Association Urogynécologique Internationale, de la Société Internationale de Continence et de l'American Urological Association pour les années 1999 à 2009, afin d'identifier des articles non repérés au moyen des recherches électroniques. Il n'y avait aucune restriction concernant la langue.

Critères de sélection

Nous avons sélectionné tous les essais contrôlés randomisés et les essais quasi-randomisés comparant l'utilisation d'antibiotiques prophylactiques à un placebo ou à l'absence de traitement chez des patients subissant des études urodynamiques. Deux auteurs (PL et RF) ont effectué indépendamment la sélection des essais à inclure et les désaccords ont été résolus par la discussion.

Recueil et analyse des données

Toutes les évaluations de qualité des essais et les extractions de données ont été réalisées indépendamment par deux auteurs de la revue (PL et RF) à l'aide de formulaires conçus conformément aux directives Cochrane. Nous avons tenté de contacter les auteurs d'essais inclus à propos de données manquantes. Nous avons extrait des données sur les caractéristiques des participants à l'étude, notamment des détails sur les traitements administrés antérieurement, les interventions utilisées, les méthodes utilisées pour mesurer l'infection et les effets indésirables.

Les analyses statistiques ont été réalisées conformément aux directives de la Cochrane Collaboration. Les données provenant d'analyses en intention de traiter ont été utilisées lorsqu'elles étaient disponibles. Pour les données dichotomiques, les résultats de chaque étude ont été exprimés sous forme de risque relatif (RR) avec intervalle de confiance (IC) à 95 %, puis combinés en une méta-analyse à l'aide de la méthode de Mantel-Haenszel.

Le principal critère de jugement était l'infection des voies urinaires. L'hétérogénéité a été évaluée au moyen de la valeur P et de la statistique I2.

Résultats principaux

Neuf essais contrôlés randomisés portant sur l'utilisation prophylactique d'antibiotiques chez des patients subissant des études urodynamiques ont été identifiés, qui incluaient au total 973 patients ; une étude était un résumé. Deux autres essais ont été exclus de la revue. Les méthodes des essais inclus étaient mal décrites.

Le principal critère de jugement dans tous les essais était le taux de développement d'une bactériurie significative, définie comme la présence de plus de 100 000 bactéries par millilitre d'un échantillon d'urine à mi-jet sur un test de culture et de sensibilité. Les autres critères de jugement étaient notamment la pyrexie, l'hématurie, la dysurie et les réactions indésirables aux antibiotiques.

En comparaison avec le placebo, l'administration d'antibiotiques prophylactiques avait réduit le risque de bactériurie importante (4 % avec des antibiotiques contre 12 % sans, risque relatif (RR) 0,35 ; IC à 95% 0,22 à 0,56) chez les hommes comme chez les femmes. L'administration d'antibiotiques prophylactiques avait également réduit le risque d'hématurie (RR 0,46 ; IC à 95% 0,23 à 0,91). Toutefois, il n'y avait pas de différence statistiquement significative pour le principal critère de jugement, le risque d'infection symptomatique des voies urinaires (40 /201, 20 % versus 59/214, 28 % ; RR 0,73 ; IC à 95% 0,52 à 1,03), ou le risque de fièvre (RR 5,16 ; IC à 95% 0,94 à 28,16) ou de dysurie (RR 0,83 ; IC à 95% 0,5 à 1,36). Seules deux personnes sur 135 avaient eu une réaction indésirable aux antibiotiques. Le nombre de patients à traiter avec des antibiotiques pour prévenir une bactériurie était de 12,3. Chez les femmes, le nombre de personnes traiter pour prévenir une bactériurie était de 13,4 , tandis que chez les hommes il était de 9,1 (nombre de sujets à traiter = 1 / réduction absolue du risque).

Conclusions des auteurs

Les antibiotiques prophylactiques avaient réduit le risque de bactériurie après des études urodynamiques mais il n'y avait pas assez de données pour mettre en évidence que cet effet ait réduit les infections symptomatiques des voies urinaires. Il n'y avait pas de différence statistiquement significative pour le risque de fièvre, la dysurie ou les réactions indésirables. Les bénéfices potentiels doivent être mis en balance avec les implications cliniques et financières et le risque d'effets indésirables.

Plain language summary

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

Urodynamics is an invasive test which involves inserting a catheter into the bladder in order to help with diagnosis of bladder symptoms. It carries the risk of causing a urinary tract infection. We need to balance the risk of a urinary tract infection and the symptoms associated with such an infection (such as fever, pain passing urine) against the risk and cost of giving prophylactic antibiotics. Some people also pick up an increased number of bacteria in the urine but do not develop the signs of an infection (asymptomatic bacteriuria). We looked at the use of prophylactic antibiotics for the prevention of urinary tract infections and bacteriuria. We identified nine trials including 973 people. We found that people were less likely to have bacteria in their urine after urodynamic studies if they had antibiotics (4% versus 12%). While they did have fewer urinary tract infections (20% compared with 28% with no antibiotics), this did not reach statistical significance. There were too few adverse effects, such as fever, pain when passing urine or a reaction to the antibiotics, for the findings to be reliable. However, people were less likely to have blood in their urine with antibiotics. There was no information about other treatments which might help reduce infections, nor about different doses or types of antibiotics.

Résumé simplifié

Les antibiotiques prophylactiques pour réduire le risque d'infections des voies urinaires après des études urodynamiques

L'examen urodynamique est une procédure invasive consistant à insérer un cathéter dans la vessie afin d'aider au diagnostic des symptômes de la vessie. Il comporte le risque de provoquer une infection des voies urinaires. Il convient de mettre en balance le risque d'infection des voies urinaires et les symptômes associés à une telle infection (tels que la fièvre et la douleur au moment d'uriner), avec le risque et le coût de l'administration d'antibiotiques à titre prophylactique. Certaines personnes aussi se retrouvent avec un nombre accru de bactéries dans l'urine mais ne développent pas de signes d'infection (bactériurie asymptomatique). Nous avons examiné l'utilisation des antibiotiques prophylactiques pour la prévention des infections urinaires et de la bactériurie. Nous avons identifié neuf essais totalisant 973 personnes. Nous avons constaté que les personnes étaient moins susceptibles d'avoir des bactéries dans l'urine après des études urodynamiques s'ils avaient reçu des antibiotiques (4 % versus 12 %). Bien que le nombre d'infections urinaires ait été réduit (20 % contre 28 % sans antibiotiques), cela n'avait pas atteint un niveau de signification statistique. Il y avait eu trop peu d'effets indésirables, tels que fièvre, douleur au moment d'uriner ou réaction aux antibiotiques, pour que les résultats soient considérés comme fiables. Avec des antibiotiques, les personnes étaient cependant moins susceptibles d'avoir du sang dans les urines. Il n'y avait pas d'information sur d'autres traitements susceptibles d'aider à réduire les infections, ni sur différentes doses ou différents types d'antibiotiques.

Notes de traduction

Traduit par: French Cochrane Centre 2nd November, 2012
Traduction financée par: Minist�re des Affaires sociales et de la Sant�

Background

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

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

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

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).

Figure 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.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figure 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

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

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

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

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 patients275Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.38, 1.26]
1.2 Antibiotics versus placebo in female patients2300Risk Ratio (M-H, Fixed, 95% CI)0.80 [0.53, 1.21]
1.3 Antibiotics versus placebo in patients with spinal injury140Risk 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 patients3176Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.06, 0.78]
2.2 Antibiotics versus placebo in female patients7757Risk Ratio (M-H, Fixed, 95% CI)0.40 [0.24, 0.67]
2.3 Antibiotics versus placebo in patients with spinal injury137Risk 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 antibiotics1 Risk 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]
Analysis 1.1.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 1 Clinical urinary tract infection following urodynamics.

Analysis 1.2.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 2 Bacteriuria following urodynamics.

Analysis 1.3.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 3 Haematuria following urodynamics.

Analysis 1.4.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 4 Fever following urodynamics.

Analysis 1.5.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 5 Dysuria following antibiotics.

Analysis 1.6.

Comparison 1 Antibiotics versus placebo (adult patients), Outcome 6 Adverse effects from prophylactic antibiotics.

Appendices

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

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

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

Contributions of authors

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

None

Sources of support

Internal sources

  • None, Not specified.

External sources

  • No sources of support supplied

Differences between protocol and review

None

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Baker 1991

Methods

124 female patients attending urodynamics clinic were randomized in two groups.

Randomization: according to hospital number

Blinding: double blinding

Intention to treat analysis: not done

Power calculation: yes

Follow up < 85%

Participants

124 patients randomized of which 22 did not complete the study

37 patients in the treatment group

33 in the placebo group

Interventions

Nitrofurantoin 50 mg four times daily and phenazopyridine hydrochloride 200mg three times daily for one day - treatment group

Phenazopyridine hydrochloride 200mg three times daily for one day - control group

OutcomesUrinary tract infections (defined as > 105 taken 2-3 days after urodynamics) was found in 4 (8.2%) in the treatment group and 10 (18.9%) in the control group.
NotesNo significant difference in the 2 groups.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskBlinding done according to hospital number
Allocation concealment (selection bias)Unclear riskNo mention of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients were not blinded but physician and laboratory technicians were blinded to the treatment patients received.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskLaboratory technicians were blinded to the treatment patients received.
Incomplete outcome data (attrition bias)
All outcomes
High riskOut of the 124 patients; 22 did not complete the study, 12 women did not provide specimens, 8 had urinary tract infections at the start of the study and did not provide specimens and had urinary tract infections. This represented a drop-out rate of 14/124.
Selective reporting (reporting bias)Low riskNo evidence of selective reporting
Other biasLow riskNone

Bergman 1983

Methods

Ninety-six patients undergoing urodynamic investigations for different complaints of the lower urinary tract complaints.

Randomization details: quasi-randomized by hospital number

Blinding: not mentioned

Intention-to-treat analysis: no

Power calculation: no

Follow up < 85%

ParticipantsNinety-six patients undergoing urodynamic investigations for different complaints of the lower urinary tract complaints.
InterventionsPatients were allocated to those receiving nitrofurantoin and phenazopyridine hydrochloride and phenazopyridine only for 3 days.
OutcomesThe number of patients with positive cultures (ie > 105 organisms/ml) for urinary tract infections
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAllocated by hospital number. Even numbers received antibiotics and odd numbers received no antibiotics.
Allocation concealment (selection bias)High riskAt risk for allocation concealment as patients selected to antibiotic group or no antibiotics based on hospital number.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding mentioned
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding mentioned
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients recruited went on to complete the study.
Selective reporting (reporting bias)Low riskNo evidence of selective reporting
Other biasLow riskNone

Coptcoat 1988

Methods

43 females and 57 males undergoing urodynamics randomized into 2 groups. All patients had a pre-urodynamics mid-stream urine specimen and a 48 hours post-procedure mid-stream urine sample taken. A questionnaire recording symptoms of frequency, dysuria and haematuria was done.

Randomization details: not mentioned

Blinding: not mentioned

Intention-to-treat analysis: no

Power calculation: no

Follow up < 85%

Participants43 females ( mean age 46 years), 57 males ( mean age 55 years)
InterventionsGroup 1 - control , Group 2 - 200mg of trimethoprim 2 hours before catheterization.
OutcomesPositive cultures were found in 3 post-procedure in Group 1 and one in group 2.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnable to comment due to the lack of information on the randomization process.
Allocation concealment (selection bias)Unclear riskUnable to comment due to the lack of information.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskUnable to comment due to the lack of information.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnable to comment due to the lack of information.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients accounted for in the study.
Selective reporting (reporting bias)Unclear riskUnable to comment due to the lack of information.
Other biasLow riskNone

Darouiche 1994

MethodsPatients were prospectively randomized double blindly into a treatment group and a placebo. The treatment and placebo were given 2 days prior to undergoing urodynamics testing. Pre and post-procedure urine samples were taken and screened for infection and patients screened for symptoms.
Participants46 patients undergoing urodynamics over an 18 month period. Six patients were not available for re-evaluation and were excluded.
Interventions

18 patients received prophylactic antibiotics (3 day course of ciprofloxacin).

22 patients received a placebo.

OutcomesNone of the 18 patients who received ciprofloxacin developed symptomatic UTI after urodynamic studies and 3 out of 22 patients in the placebo group.
NotesThis study showed a 14% incidence of symptomatic UTI in the group who received a placebo prior to the urodynamics.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo mention of method used for randomization
Allocation concealment (selection bias)Unclear riskNo information given
Blinding of participants and personnel (performance bias)
All outcomes
Low riskBoth participants and personnel were blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information given
Incomplete outcome data (attrition bias)
All outcomes
High riskSix patients were not available for re-evaluation and were excluded. In the remaining 40 patients all 40 were followed up.
Selective reporting (reporting bias)Low riskUnable to detect reporting bias
Other biasUnclear riskSmall numbers used therefore an unclear risk of bias

Kartal 2006

Methods

192 patients for urodynamics had a mid-stream urine sample taken 24 hours and 48 to 72 hours after the procedure.

Randomization details: not mentioned

Blinding: not mentioned

Intention-to-treat analysis: yes

Power calculation: no

Follow up > 85%

Participants192 patients for urodynamics were randomly assigned to 2 groups
Interventions98 patients were given a single dose of 500mg of ciprofloxacin 1 hour before urodynamics and 94 were given no antibiotics.
OutcomesThe rate of significant bacteriuria in urine culture following urodynamics was 1% in the prophylactic group and 14% in the controls.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskRandomized according to hospital registration numbers
Allocation concealment (selection bias)High riskRandomized according to hospital registration numbers
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo mentioned method of blinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo data given
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo data given
Selective reporting (reporting bias)Low riskAll the patients were accounted for in the study
Other biasLow riskNo other bias detected

Peschers 2001

Methods

The patients included in the study had a clean catch specimen prior to urodynamics. If the urine tested positive for leukocytes and nitrites, these patients were excluded. The treatment group was given antibiotics while the control group received a placebo and the number of newly acquired urinary tract infections was obtained.

Randomization details: envelope

Blinding: single blinding

Intention-to-treat analysis: not done

Power calculation: done

Follow up < 85%

ParticipantsA single blinded randomized controlled study in which 94 women undergoing urodynamic testing were included: treatment group (n=37), control group (n= 33)
InterventionsThe treatment group received two tablets of cotrimoxazole and the control group receive two tablets of a placebo.
Outcomes

Newly acquired infection in treatment group = 2/37

Newly acquired infection in the control group = 2/33

NotesThe power of the sample size was unfortunately too small to draw a conclusions to the efficacy of prophylactic antibiotics.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskOpaque envelopes used to randomise patients however randomization took place at the end the urodynamics examination.
Allocation concealment (selection bias)Low riskSealed opaque envelopes used to randomise patients
Blinding of participants and personnel (performance bias)
All outcomes
High riskOnly single blinding was performed, as the placebo tablets were not identical in shape and colour to the antibiotics.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information given.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskTen patients failed to provide specimens of urine and hence were excluded, and 8 provided samples with evidence of contamination.
Selective reporting (reporting bias)Low riskNo evidence of reporting bias
Other biasUnclear riskTwo relatively small groups of patients

Siracusano 2008

Methods

262 postmenopausal women underwent urodynamics. Prior to having urodynamics they were double blindly randomised into group 1 who received prophylactic antibiotics and group 2 received a control.

Randomization details: yes

Blinding: double

Intention-to-treat analysis: no

Power calculation: no

Follow up > 85%

Participants262 postmenopausal women undergoing urodynamics
InterventionsTreatment group (n=130) received a single dose of 400mg norfloxacin and group 2, the control, received a placebo.
OutcomesUrinary tract infection occurred in 24/130 patients receiving prophylactic antibiotics and 30/132 patients reviving the placebo.
NotesThere was not significant difference in the incidence of urinary tract infection between those receiving the prophylactic antibiotics and the placebo.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization done by a computer, generated in a double blinding fashion.
Allocation concealment (selection bias)Low riskLow risk due to the method of randomization
Blinding of participants and personnel (performance bias)
All outcomes
Low riskBoth participants and personnel were blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of personnel performing the analysis of the urine was also performed
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants were accounted for in the study
Selective reporting (reporting bias)Low riskNo evidence given
Other biasLow riskNo other bias detected

Tosto 1989

Methods

37 male patients undergoing urodynamics were randomized into a treatment group and placebo group. A catheter specimen was taken before urodynamics and 3-7 days after.

Randomization: unclear

Blinding: unclear

Intention-to-treat analysis: no

Power calculation: done

Follow up > 85%

Participants37 male patients undergoing urodynamics
InterventionsTreatment group received prophylactic cinoxacin 500mg twice a day for 5 days. The control group received no treatment.
OutcomesIrritative symptoms occurred in 12/15 in the treatment group while it occurred in 14/16 in the no treatment group.
NotesUrinary tract infection was defined as > 105 bacteriuria on MSU taken 1 week post-urodynamics.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details of the method of randomization given
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskUnclear from the manuscript whether blinding was performed
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details given
Incomplete outcome data (attrition bias)
All outcomes
High riskNot all participants were accounted for in the study
Selective reporting (reporting bias)Unclear riskNo details given
Other biasUnclear riskTwo small groups of patients used

Yip 2006

Methods

130 consecutive women attending were randomized into two groups, one receiving prophylactic antibiotics and the other group receiving a placebo.

Randomization method: not mentioned

Intention to treat analysis: yes

Power calculation: not mentioned

Follow up > 85%

Participants130 female patients undergoing urodynamics
Interventions65 in each group. One group receiving Augmentin 375 mg stat, 30 minutes before urodynamics and the other group receiving a placebo.
OutcomesPatients developing newly acquired infection: 1/65 in the treatment group and 8/65 in the control group.
NotesSingle dose of 375 mg Augmentin offers effective prophylaxis against bacteriuria following urodynamics.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo mention of the method of randomization
Allocation concealment (selection bias)Unclear riskNo mention in the manuscript
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given on blinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo data given
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients were accounted for in the study
Selective reporting (reporting bias)Unclear riskNo data given
Other biasLow riskNo other bias detected

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bhatia 1985The population studied included patients undergoing urethrocystoscopy, cytometry and simultaneous urethrocystometry. Unable to contact authors to clarify.
Cundiff 1999aThe population studied included were those undergoing both urodynamics and cystourethroscopy hence this study was excluded after discussion between the three review authors.

Ancillary