Risk of Urinary Tract Infection in Patients with Positive Urine Culture and Antibiotic Therapy Undergoing Cystoscopy in a Third

Le Infezioni in Medicina, n. 4, 336-342, 2015 336 Articolo originale / Original article

Risk of urinary tract infection in patients with positive urine culture and antibiotic therapy undergoing cystoscopy in a third-level hospital Rischio di infezione urinaria in pazienti con urinocoltura positiva e in terapia antibiotica sottoposti a cistoscopia in un ospedale di terzo livello

Kevin Escandón-Vargas1, Herney Andrés García-Perdomo2, Fernando Echeverría2, José Daniel Osorio2 1School of Medicine, Faculty of Health, Universidad del Valle, Cali, Colombia; 2Urology service, Hospital Universitario del Valle, Universidad del Valle, Cali, Colombia

n INTRODUCTION screening and treatment of asymptomatic bacteriuria before performing urological procedures ystoscopy is a common procedure used in other than transurethral prostatic resection (TURP) Cthe urological practice for various indications in which mucosal bleeding is anticipated (level of such as the study of patients with hematuria, re- evidence A-III), but cystoscopy does not seem to current urinary tract infection (UTI), lower urinary be enough traumatic or unsafe and therefore even tract symptoms (LUTS), urinary incontinence and the routine prophylaxis use is not recommended in bladder cancer [1, 2]. This procedure is minimally standard cases [2, 6, 7]. traumatic with little-incidence complications, such Moreover, cystoscopies are increasingly per- as UTI, urinary sepsis, and bladder perforation [3]. formed in elderly patients; some of them cathe- It is required that patients provide a negative pre- terized or with anatomical or functional urinary cystoscopy urine-culture report for medical ap- tract alterations. These factors could lead to per- proval and performance of the cystoscopy. sistent asymptomatic bacteriuria. The main ob- Culture-proven incidence of UTI vary between jective of the present study was to determine the 0.36% and 1.1% in patients undergoing cystoscopy risk of UTI following rigid cystoscopy in outpa- with preoperatively sterile urine and without anti- tients with positive urine culture and antibiotic biotic prophylaxis [3-6]. Due to larger incidences of treatment compared to outpatients with negative bacteriuria (up to 21.3%) reported in non-prophy- urine culture and without antibiotic prophylaxis. laxis subjects, several clinical trials have been performed in patient populations undergoing cystoscopy, most having a prior negative urine culture, to n PATIENTS AND METHODS examine the efficacy of prophylactic antibiotics in reducing bacteriuria or UTI [2]. However, studies Study design and setting We conducted a prospec- addressing patients with positive urine culture pri- tive pilot study in the urology service of a third- or to cystoscopy and under antibiotic therapy have level hospital in Cali, Colombia, the Hospital been scarcely performed. Currently, the Infectious Universitario del Valle, between July 30, 2013 and Diseases Society of America (IDSA) recommends June 5, 2014. Inclusion criteria. Patients of 18 years or older un- Corresponding author dergoing rigid cystoscopy on an outpatient basis Herney Andrés García-Perdomo were asked to participate. Informed consent was E-mail: [email protected] obtained through a written document and par- Risk of urinary tract infection 337

ticipants were initially classified in one of two to cystoscopy. After procedure, the patients were groups according to the results of a urine culture discharged and requested to provide a post-pro- performed in the last two weeks before the proce- cedure urine culture report between the fifth and dure. Group 1 comprised asymptomatic patients 10th day after cystoscopy and telephonic follow- with positive urine culture and group 2 were as- up was made at seventh and 30th day for docu- ymptomatic patients with sterile urine. menting urinary tract symptoms, hematuria, UTI Exclusion criteria. Patients with immunosuppres- and urosepsis. sive conditions (e.g., HIV/AIDS) and diabetes, UTI was deemed as the presence of irritative uri- and patients who did not agree to sign the consent nary tract symptoms and a urine culture with form were excluded. We also excluded patients more than 105 colony-forming units (CFU)/mL who additionally underwent bladder biopsy or for one microorganism in a midstream urine urethral dilation. sample. Suspicion of urosepsis was made if the Sample size We calculated a sample size of 55 pa- patient developed signs or symptoms of systemic tients per arm based on an estimated risk of uro- inflammatory response syndrome. A pure growth sepsis of 15% in group 1 and of 1% in group 2 (al- of more than 105 CFU/mL with no symptoms was pha 5%, power 80%). However, due to administra- regarded as asymptomatic bacteriuria. tive and technical problems, we could not afford Statistical analysis. We conducted database pro- the sample and decided to stop recruiting patients. cessing and analysis in Stata software version Recruitment. Outpatients scheduled to cystoscopy 13. We first performed an exploratory analysis by the nursing personnel were communicated to using relative frequencies and percentages for the researchers of the study for consecutive selec- categorical variables, and central tendency and tion of participants. Group 1 patients were pre- dispersion measures for numerical variables. A scribed antibiotic therapy by the urologists of the bivariate analysis was made using chi-square test service, basing the decision on the antibiogram (χ2) for proportions and Student t test for means, pattern reported. Antibiotic was initiated 72 hours if following a normal distribution. Relative risks before the cystoscopy and was continued for four (RRs) with their corresponding 95% confidence days after the procedure. Group 2 did not receive intervals (CIs) were calculated. Variables with P antibiotics. A urological trainee (supervised by an value <0.2 were included in a multivariate logistic experienced urologist/professor) performed all regression modeling to identify risk factors. Mul- cystoscopies in an endoscopy room of the urol- tivariate regression modeling was used to iden- ogy service. For each procedure, a 17 to 21 French tify risk factors associated with the outcome vari- rigid endoscope was disinfected by immersion ables. A P value <0.05 was considered significant. in 10% chlorhexidine for five to 10 minutes, then Ethical standard statement. The approval of this was washed off with sterile water and was dried study was gained from the Institutional Ethics with a sterile compress. The external genitalia Committee of the Universidad del Valle accord- were cleaned with povidone-iodine solution and ing with the Colombian normativity stated in the the examination area was isolated with surgical resolution 8430/1993. All patients were told about towels. Procedures were performed with urethral the justification, objectives, procedures, risks and instillation of 2% lidocaine hydrochloride jelly as benefits of the study. Informed consent was ob- topical anesthesia and lubrication before insert- tained prior to cystoscopy. ing the cystoscope. Surgeon and assistant wore gloves, gowns and masks. Sterile 0.9% NaCl solution was used for irrigation. n RESULTS We collected the data for the study in a form by interview with the participant and review of the Eighty-nine patients (69 men and 20 women) met medical record after procedure performance. We selection criteria and were followed-up. We ex- kept confidentiality using consecutive numbers, cluded two patients of the initial cohort because instead of the patients’ names, to differentiate the they failed in providing a post-cystoscopy urine records. All patients were told about the justifica- culture report. Group 1 (asymptomatic bacteri- tion, objectives, procedures, risks and benefits of uria group) were 13 patients. Six (46.2%) of these the study. Informed consent was obtained prior patients before cystoscopy provided a urine cul- 338 K. Escandón-Vargas, et al.

Table 1 - Comparison of groups regarding sociodemographic characteristics, medical history and clinical variables. Variable Group 1 Group 2 Total P value (n=13) (n=76) (n=89) Age (years) 0.30 18-64 5 (38.5%) 41 (54%) 46 ≥65 8 (61.5%) 35 (46%) 43 Median (range) 70 (36-83) 63 (18-88) 64 (18-88) Sex 0.96 Male 10 (76.9%) 59 (77.6%) 69 Female 3 (23.1%) 17 (22.4%) 20 Medical history (not mutually exclusive) None 2 (15.4%) 25 (32.9%) 27 0.20 Benign prostatic hyperplasia 5 (38.5%) 12 (15.8%) 17 0.06 Cancer 4 (30.8%) 17 (22.4%) 21 0.51 Arterial hypertension 3 (23.1%) 26 (34.2%) 29 0.43 Heart disease 1 (7.7%) 5 (6.6%) 6 0.88 Chronic obstructive pulmonary disease 2 (15.4%) 2 (2.6%) 4 0.04 Nephropathy 0 8 (10.5%) 8 0.22 Urological disease 7 (53.9%) 33 (43.4%) 40 0.49 Indication of cystoscopy (not mutually exclusive) Lower urinary tract symptoms 8 (61.5%) 49 (64.5%) 57 (64%) 0.84 Hematuria 1 (7.7%) 9 (11.8%) 10 0.66 Recurrent urinary tract infection 6 (46.2%) 5 (6.6%) 11 <0.001 Urinary incontinence 0 12 (15.8%) 12 0.12 Chronic pelvic pain 0 4 (5.3%) 4 0.4 Urinary retention 0 2 (2.6%) 2 0.55 Suspicion of urethral stricture 1 (7.7%) 11 (14.5%) 12 0.51 Suspicion of vesical, renal or ovarian tumor 0 2 (2.6%) 2 0.55 Suspicion of bladder fistula 1 (7.7%) 0 1 0.02 Control cancer 1 (7.7%) 7 (9.2%) 8 0.86 Indwelling urethral catheter (last 30 days prior to cystoscopy) 0.001 Yes 6 (46.2%) 8 (10.5%) 14 No 7 (53.9%) 68 (89.5%) 75 Cystostomy catheter (last 30 days prior to cystoscopy) 0.10 Yes 2 (15.4%) 3 (4%) 5 No 11 (84.6%) 73 (96.1%) 84 Previous use of antibiotics (last 30 days prior to cystoscopy) <0.001 Yes 10 (76.9%) 4 (5.3%) 14 No 3 (23.1%) 72 (94.7%) 75 Diagnosis by cystoscopy 0.30 Normal 4 (30.8%) 15 (19.7%) 19 (21.4%) Benign prostatic hyperplasia 5 (38.5%) 34 (44.7%) 39 Urethral stricture 2 (15.4%) 5 (6.6%) 7 Urinary incontinence 0 2 (2.6%) 2 Cystitis 0 3 (4%) 3 Lower urinary tract obstructive uropathy 0 1 (1.3%) 1 Cystourethrocele 0 2 (2.6%) 2 Trigonitis 0 2 (2.6%) 2 Fistula 1 (7.7%) 0 1 Residual adenoma 0 1 (1.3%) 1 Bladder tumor 0 6 (7.9%) 6 Prostate cancer 0 1 (1.3%) 1 Chronic prostatitis 0 1 (1.3%) 1 Overactive bladder 0 2 (2.6%) 2 Urethral trauma 0 1 (1.3%) 1 Recurrent urinary tract infection 1 (7.7%) 0 1 Risk of urinary tract infection 339

ture report with Escherichia coli, while the other both groups. Cystoscopic findings were abnormal seven were colonized each one (7.7%) by one of for 70 (78.7%) patients. Benign prostatic hyperpla- the following bacteria: Enterococcus faecalis, Klebsi- sia (55.7%) was the most frequent of all abnormal ella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, diagnosis made by cystoscopy. Cystoscopy indi- Stenotrophomonas maltophilia, Morganella morganii cation because of recurrent UTI and the presence and Enterobacter sp. Antibiotics initiated prior to of indwelling urethral catheter in the last month cystoscopy were diverse: six (46.2%) patients re- prior to cystoscopy, as well as previous use of an- ceived nitrofurantoin, two (15.4%) trimethoprim/ tibiotics, presented statistically significant differ- sulfamethoxazole, two (15.4%) ciprofloxacin, two ences in group 1 compared to group 2. (15.4%) amikacin and one (7.7%) meropenem. Results for outcomes after follow-up are shown in Group 2 (sterile urine group) were 76 patients. Table 2. 12 (13.5%) patients had bacteriuria after Both groups were compared regarding sociode- cystoscopy. The most common post-cystoscopy mographic characteristics, medical history and organism cultured was E. coli in eight (66.7%) pa- clinical variables (Table 1). Mean age of all par- tients. Regarding asymptomatic bacteriuria, inci- ticipants was 64 years old (range 18-88) and over- dence in group 1 (61.5%) was significantly higher all the most common indication of cystoscopy than in group 2 (0%) (P<0.001). Overall incidence was LUTS (64%). There were few statistically of UTI at seventh or 30th day was 4.5% (4/89). Two significant differences regarding the distribution (15.4%) patients of group 1 developed UTI com- of medical history and clinical variables between pared to two (2.6%) patients of group 2 (P=0.04;

Table 2 - Comparison of groups regarding follow-up variables. Variable Group 1 Group 2 Total P value (n=13) (n=76) (n=89) Bacteriuria <0.001 Yes 10 (76.9%) 2 (2.6%) 12 No 3 (23.1%) 74 (97.4%) 77 Microorganism 0.22 Escherichia coli 7 (70%) 1 (50%) 8 Enterococcus faecalis 1 (10%) 0 1 Klebsiella oxytoca 1 (10%) 0 1 Proteus mirabilis 1 (10%) 0 1 Pseudomonas aeruginosa 0 1 (50%) 1 Asymptomatic bacteriuria <0.001 Yes 8 (61.5%) 0 8 No 5 (38.5%) 76 (93.8%) 81 Storage urinary tract symptoms at seventh or 30th day 0.17 Yes 3 (23.1%) 33 (43.4%) 36 No 10 (76.9%) 43 (56.6%) 53 Urinary tract infection at seventh or 30th day 0.04 Yes 2 (15.4%) 2 (2.6%) 4 No 11 (84.6%) 74 (97.4%) 85 Suspicion of urinary sepsis at seventh or 30th day 0.55 Yes 0 2 (2.6%) 2 No 13 (100%) 74 (97.4%) 87 Gross hematuria at seventh or 30th day 0.47 Yes 0 3 (4%) 3 No 13 (100%) 73 (96.1%) 86 Hospital admission * Yes 0 0 0 No 13 (100%) 76 (100%) 89 Death 0.68 Yes 0 1 (1.3%) 1 No 13 (100%) 75 (98.7%) 88 *Non-calculable P value. 340 K. Escandón-Vargas, et al.

RR 5.85; 95% CI 0.90-37.92). There was no statisti- urinary retention) and bladder perforation, only cally significant difference in risk of urosepsis at three cases of gross hematuria were present, ac- seventh or 30th day between the groups (P=0.55) counting for 3.4% of all patients, which is in ac- either. None patient presented complications sec- cord with the reported in the literature (around ondary to cystoscopy except for transient gross 3%) [2]. Pain after cystoscopy and adverse events hematuria which was recorded in three (3.4%) of to antibiotics were not studied. A relevant limita- all patients at seventh or 30th days after cystosco- tion of this study was the low number of patients py; all belonged to group 2. Multivariate analysis of group 1 as we had a considerable problem re- did not show significant differences in risk of UTI cruiting patients with asymptomatic bacteriuria at seventh or 30th day between groups. who were candidates for cystoscopy because most of them preferred being first treated than undergoing the procedure under antibiotic treatment. n DISCUSSION We also recognize as another weakness the fact of relying on telephone calls for follow-up of the This is a prospective pilot study, which aimed to es- study participants beyond the date of cystoscopy. tablish the post-cystoscopy risk of UTI in an outpa- Nonetheless, in the present study we could esti- tient clinical setting in a group of patients who had mate an overall risk of UTI of 4.5%, similar as re- asymptomatic bacteriuria and initiated treatment 72 ported in world literature [6, 10, 11]. One factor hours prior to cystoscopy, and another group with which was statistically associated (P=0.001) with sterile urine and without antibiotic prophylaxis. the presence of asymptomatic bacteriuria prior to Participants, whether or not experiencing bacteri- cystoscopy was the presence of an indwelling ure- uria following cystoscopy, were compared accord- thral catheter in the last 30 days before procedure. ing to sociodemographic and clinical variables (Tab. Bacteriuria incidence associated with indwelling 1) and there were only significant associations of catheterization is 3%-8% per day, consequently al- pre-cystoscopy asymptomatic bacteriuria with in- most all patients with an indwelling catheter are dwelling urethral catheter in the last 30 days before bacteriuric by one month [12, 13]. Patients attend- cystoscopy, previous antibiotic use in the last 30 ing urology services and undergoing cystoscopy days and cystoscopy indication by recurrent UTI. are frequently catheterized and hence colonized All these factors reasonably fit with the fact that the without necessarily having repercussion in their patients included in group 1 were colonized. health. However, being colonized is a contrain- The most frequent microorganisms causing UTI dication to performing cystoscopy and treatment worldwide are E. coli, Enterococcus spp, Proteus sometimes does not guarantee obtaining a nega- spp. and Klebsiella spp [8, 9]. In our study, these tive urine culture. Patients may not be allowed to four bacteria, remarkably E. coli, accounted for the undergo cystoscopy due to persistent asymptom- 77% of the urine culture reports before cystoscopy atic bacteriuria in the context of unknowing the and the 92% after cystoscopy. Antibiotic suscepti- real risk of UTI or urinary sepsis. To our knowledge bility profiles of theses microorganisms were not this is the first Colombian study which assesses the assessed since the urine culture reports were from UTI risk in asymptomatic colonized patients un- different laboratories. It was found that the group dergoing cystoscopy at the time of antibiotic treat- of patients with initial asymptomatic bacteriuria ment. Most studies addressing the infectious risk was at a higher risk for persisting with it than the of asymptomatic bacteriuric patients under antibi- risk of the group of patients with sterile urine of otics before endourological procedures have been developing it following cystoscopy. With regard carried out in patients undergoing TURP, and does to UTI risk, group 1 was not statistically different not exist clarity in relation with other urological when compared with group 2. For urosepsis we procedures, such as cystoscopy [7]. did not found statistically significant associations On the other hand, most studies aimed to determine either. We could not determine if patients who the risk of bacteriuria or UTI in patient populations were with suspicion of urosepsis presented to a undergoing cystoscopy, have been performed in hospital elsewhere and were assessed and treated. patients with sterile urine. Some of them have es- Despite the complications secondary to cystos- tablished significant differences in decreasing the copy, such as hematuria, storage LUTS (mainly incidence of post-procedure UTI under antibiotic Risk of urinary tract infection 341

prophylaxis, whereas others have demonstrated tial impact that antibiotic overuse has on emerg- that routine antibiotic prophylaxis is not needed in ing antibiotic resistance, it is reasonable to recom- terms of reducing UTI [2, 3, 5, 11, 14]. While on this mend against routine prophylaxis for cystosco- subject, several articles have included asymptomat- pies [6, 19, 20]. Antibiotic prophylaxis for cystos- ic bacteriuria as the main outcome, ones reporting a copy should only be advised in the presence of decrease in the incidence of asymptomatic bacteri- risk factors, such as indwelling urethral catheters uria in the intervention group compared to control or history of urogenital infections including UTI, or placebo group, others reporting no statistically or additional procedures performed, due to an in- significant differences [2, 3, 11, 14-18]. Although creased probability of an infection [19-23]. sample size for group 1 was not reached due to the In conclusion, the risk of UTI following rigid cys- problems mentioned above affecting confidence of toscopy in outpatients with positive urine culture our results, this pilot study included participants and antibiotic treatment did not differ significant- rightly classified in two groups and intended to ly from the risk in outpatients with negative urine focus on two outcomes: UTI and urosepsis. As ex- culture without antibiotic prophylaxis at seventh pressed recently by García-Perdomo et al., UTI and and 30th day. These findings support the need of sepsis as final outcomes are definitely what matters further studies elsewhere. in terms of clinical implication, contrary to asymptomatic bacteriuria which does not justify prophy- Acknowledgements: None. laxis prior cystoscopy unless the patient has risk Conflict of interest: We all declare that we have factors for infection [2]. no conflicts of interest. As reported in this study, UTI after cystoscopy is Financial support: None not common. Given the low infectious risk following cystoscopy, the large number of procedures Keywords: antibiotic, bacterial infections, cystos- performed worldwide and the consequent poten- copy, urinary tract infection.

SummaRY The aim of the study was to determine the risk of uri- and 30 days. Eighty-nine patients, 13 from group 1 and nary tract infection (UTI) following rigid cystoscopy in 76 from group 2, were followed up in this pilot study. outpatients with positive urine culture and antibiotic General incidence of UTI at the seventh or 30th day was treatment compared to outpatients with negative urine 4.5% (4/89). There were no statistically significant dif- culture and without antibiotic prophylaxis. A prospec- ferences in risk of UTI or urosepsis at the seventh or 30th tive pilot study in two groups of patients was conducted day between the two groups. The risk of UTI following in a third-level hospital in Cali, Colombia. Group 1 com- rigid cystoscopy in outpatients with positive urine cul- prised asymptomatic patients with positive urine culture and antibiotic treatment did not differ significantly ture and group 2 were asymptomatic patients with ster- from the risk in outpatients with negative urine culture ile urine. UTI and urosepsis were assessed after seven without antibiotic prophylaxis at day 7 and 30.

RIASSUNTO Lo studio è stato condotto al fine di determinare il rischio di Complessivamente, in questo studio pilota sono stati studia- infezione delle vie urinarie (IVU) conseguente a cistoscopia ti 89 pazienti, 13 del gruppo 1 e 76 del gruppo 2. L’incidenza transuretrale rigida in pazienti ambulatoriali con urinocol- complessiva di IVU al settimo o al trentesimo giorno è stata tura positiva e in trattamento antibiotico rispetto a pazienti del 4,5% (4/89). Non sono state osservate differenze statisti- ospedalizzati con urinocoltura negativa e non sottoposti a camente significative nel rischio di IVU o urosepsi dopo 7 o profilassi antibiotica. Lo studio, pilota e prospettico, è stato 30 giorni tra i due gruppi. Il rischio di IVU conseguente a effettuato su due gruppi di pazienti in un ospedale di terzo cistoscopia rigida in pazienti ambulatoriali con urinocoltura livello a Cali, Colombia. Il gruppo I comprendeva pazienti positiva e in trattamento antibiotico non è risultato signifi- asintomatici con urinocoltura positiva e il gruppo 2 com- cativamente differente rispetto a quello osservato in pazienti prendeva pazienti asintomatici con urine sterili. La presenza ambulatoriali con urinocoltura negativa e senza profilassi di IVU e urosepsi è stata valutata a distanza di 7 e 30 giorni. antibiotica ai giorni 7 e 30. 342 K. Escandón-Vargas, et al.

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