Jimenez‐Pacheco 2012.
Methods |
Study design: unblinded, randomized, controlled study Study dates: March–August 2011 Setting: Urology Department, Santa Ana Hospital de Motril Country: Spain |
|
Participants |
Inclusion criteria: diagnostic flexible cystoscopy indication, aged ≥ 18 years Exclusion criteria: antibiotic administration for any reason during the previous month; urethral catheterization during previous month or at the moment of intervention; history of UTI during previous month; positive culture; pregnancy; ≥ 2 UTI episodes during last 3 months; obstructive uropathy diagnosis with residual urine > 100 mL; unilateral or bilateral vesicoureteral reflux; neurogenic bladder or any lower urinary system malformation; intermittent or urethral permanent catheterization; risk of endocarditis (participants with prosthetic cardiac or vascular valves, etc); and hypersensitivity to fosfomycin Sample size: 60 participants Age (years): mean: control group: 65.4; treatment group: 64.6 Sex: 27 men and 3 women in control group; 25 men and 5 women in treatment group |
|
Interventions |
Group 1 (n = 30): no antibiotics after flexible cystoscopy Group 2 (n = 30): oral single dose of fosfomycin trometamol 3 g during 2 hours prior to test |
|
Outcomes |
Symptomatic UTI How measured: 10 days after cystoscopy, urine culture and urinalysis performed, bacteriuria considered when > 105 CFU/mL were recorded in urinalysis. 1 month later, a telephonic questionnaire performed to evaluate lower urinary tract symptoms regardless of bacteriuria Time points measured: urine culture performed 10 days after cystoscopy, symptoms evaluated 1 month after cystoscopy Time points reported: not reported Outcomes: 2/30 participants in control group and 3/30 in treatment group had symptomatic bacteriuria Asymptomatic bacteriuria How measured: 10 days after cystoscopy, urine culture and urinalysis performed, bacteriuria considered when > 105 CFU/mL were recorded in urinalysis. 1 month later, a telephonic questionnaire performed to evaluate lower urinary tract symptoms regardless of bacteriuria Time points measured: urine culture performed 10 days after cystoscopy, symptoms evaluated 1 month after cystoscopy Time points reported: not reported Outcomes: 1/30 participants in control group and 0/30 in treatment group had asymptomatic bacteriuria |
|
Funding sources | No information about funding | |
Declarations of interest | No information about conflict and interest | |
Notes | We tried to contact corresponding author regarding random sequence generation method, but received no response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Sixty patients were distributed in two groups by random assignment." Comment: method for generation of random sequence not given. |
Allocation concealment (selection bias) | Low risk | Quote: "Sequence was kept hidden to the responsible conductor of assignments just before the moment of intervention." Comment: allocation concealment performed adequately. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Control did not receive any dose of antibiotics after the test, treatment was given antibiotic prophylaxis: three grams as oral single‐dose of fosfomycin trometamol, during the first two hours previous to the test." Comment: participants in control group did not receive antibiotics before cystoscopy, while participants in the treatment group receive oral single dose of fosfomycin trometamol 3 g. Unlikely that participants and personnel were blinded to intervention. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote: "Control did not receive any dose of antibiotics after the test, treatment was given antibiotic prophylaxis: three grams as oral single‐dose of fosfomycin trometamol, during the first two hours previous to the test." Comment: participants not blinded to their intervention. Risk of detection bias for symptomatic UTI and asymptomatic bacteriuria was high. |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: not applicable, since the objective outcome of drug resistance was not reported. |
Incomplete outcome data (attrition bias) Systemic UTI | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Symptomatic UTI | Low risk | Quote: "No statistically significant differences were observed regarding the distribution of most baseline variables between both groups." Comment: 60/60 randomized participants (30 participants in each group) were included for analysis of this outcome, 5 participants were lost to follow‐up 1 month later for evaluation of lower urinary tract symptoms, intention‐to‐treat analysis performed for symptom analysis. |
Incomplete outcome data (attrition bias) Serious adverse events | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Minor adverse events | Unclear risk | .Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Localized UTI | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Asymptomatic bacteriuria | Low risk | Quote: "No statistically significant differences were observed regarding the distribution of most baseline variables between both groups." Comment: 60/60 randomized participants (30 participants in each group) were included for analysis of this outcome, 5 participants were lost to follow‐up 1 month later for evaluation of lower urinary tract symptoms, intention‐to‐treat analysis performed for symptom analysis |
Incomplete outcome data (attrition bias) Bacterial resistance | Unclear risk | Comment: outcome not reported. |
Selective reporting (reporting bias) | Unclear risk | Comment: data reported on all outcomes specified in methods section, but there was no access to trial protocol/registration to further assess selective reporting. |
Other bias | Low risk | Comment: no other bias detected. |