Palleschi 2017.

Study characteristics
Methods	Study design Parallel, open‐label RCT Study duration and follow‐up 15 days from treatment start (February to September 2015) Study type Prevention study (perioperative prophylaxis)
Participants	General information Country: Italy Setting: single centre Inclusion criteria: ≥ 18 years having a mini‐invasive urological diagnostic procedure; negative urine examination and negative urine culture Exclusion criteria: history of recent haematuria (within 3 months); presence of indwelling catheter or nephrostomy or suprapubic catheter or ureteral stent; recent urological, gynaecological or pelvic surgery (within 3 months); neoplastic disease; evidence or suspicious of fistula; diagnosis of interstitial cystitis; pathological findings at physical examination (e.g. digital rectal exploration suspicious for prostate cancer or suggestive for prostatitis) Baseline characteristics Number (randomised/analysed): treatment group (40/37); control group (40/38) Mean age ± SD (years): treatment group (65.4 ± 1.09); control group (65.4 ± 1.03) Sex (M/F): treatment group (18/19); control group (21/17) Definition of UTI:positive urine culture Relevant health status: diabetes (11%); menopausal status for females (29%); hypertension/heart disease (9%); dysthyroidism (4%); natural childbirth (9%); urological surgery (5%); urogynaecological surgery (10%); other co‐morbidities (8%) Differences between groups at baseline: "The results obtained from the anamnestic assessments between the two groups did not show significant difference in relation to the age, sex, body mass index, menopausal status, co‐morbidities and pharmacotherapy (p‐value > 0.05). The population enrolled in the study was stratified according to the age, benign prostatic hyperplasia (BPH), menopausal status, different birthing modalities, hypertension/heart diseases, diabetes, dysthyroidism, gynaecological and urological surgery or other pathologies, called “Other” (such as osteoporosis, dyslipidaemia, depressive illness, etc.) as indicated in Table 2."
Interventions	Treatment group D‐mannose 500 mg + N‐acetylcysteine 100 mg + Morinda citrifolia fruit extract 300 mg Daily, starting 5 days before procedure, continued for 10 days post‐procedure Control group Prulifloxacin 400 mg (antibiotics) oral capsules Daily, starting 5 days before procedure, continued for 10 days post‐procedure Co‐interventions or additional treatments Antibiotic rescue medication Follow‐up details At 10 days post‐procedure, 15 days from start of treatment
Outcomes	Outcomes reported at 15 days from treatment start UTI incidence (symptomatic or asymptomatic) via urine cultures Side effects
Notes	At 10 days post urodynamic test, a second laboratory assessment based on urine examination and urine culture was performed in all patients Trial registration: not reported A priori protocol publication: not reported Conflicts of interest: not reported Funding declared: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a randomized procedure was used for the random allocation of the enrolled patients into two groups of 40 in equal proportions to ensure a uniform allocation ratio (1:1)"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided regarding the concealment of allocation to groups within the abstract
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: open‐label study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: open‐label study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: all participants were accounted for from start to end of study; attrition 6.25%
Selective reporting (reporting bias)	Unclear risk	Trial registration: not reported A priori published protocol: not reported
Other bias	Unclear risk	Funding: not reported Conflicts of interest: not reported