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. 2022 Aug 30;2022(8):CD013608. doi: 10.1002/14651858.CD013608.pub2

De Leo 2017.

Study characteristics
Methods Study design
  • Parallel, open‐label RCT


Study duration and follow‐up
  • 3 months treatment; duration of study not reported


Study type
  • Prevention and treatment study

Participants General information
  • Country: Italy

  • Setting: multicentre

  • Inclusion criteria: women aged 40 to 50 years with recurrent episodes of cystitis; at least one positive urine culture during 6 months preceding recruitment

  • Exclusion criteria: chronic diseases; neoplasms; endocrine pathologies; urinary stones


Baseline characteristics
  • Number: treatment group (100); control group (50)

  • Mean age ± SD (years): treatment group (47.3 ± 4.1); control group (47.9 ± 4)

  • Sex: 100% women

  • Definition of UTI: recurrent episodes of cystitis ‐ at least one positive urine culture during 6 months preceding recruitment

  • Co‐morbidities: not reported in abstract

Interventions Treatment group
  • D‐mannose 500 mg + noxamicina 100 mg + cranberry 90 mg + PACs‐A 72 mg

    • 1 oral sachet/day, for the first 10 days of the month, for 3 months


Control group
  • No treatment


Co‐interventions or additional treatments
  • None


Follow‐up details
  • None

Outcomes All outcomes reported at 3 months
  • Complete remission of urinary symptoms

  • Slight decrease in urinary symptoms

  • Side effects

Notes
  • Full text available in Italian; translated prior to assessment

  • Trial registration: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the subjects were randomly assigned to two groups"
Allocation concealment (selection bias) High risk Comment: open‐label study so it is unlikely that allocation to treatment groups was concealed
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 Unclear risk Comment: insufficient information within the abstract
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