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. 2021 Jun 14;2021(6):CD009294. doi: 10.1002/14651858.CD009294.pub3

Bendary 2011.

Study characteristics
Methods Study design: randomized trial
Setting/country: single center in Egypt
Dates when study was conducted: January 2006 to June 2008
Participants Ethnicity: NA
Inclusion criteria
  • Primary Ta‐T1 TCC of the bladder without CIS


Exclusion criteria
  • NA


Total number of participants randomly assigned
  • Screened: NA

  • Eligible: 80


Disease type: primary disease
Intervention: gemcitabine
  • Number of all participants randomly assigned: 40

  • Age: overall mean 56.2 (SD 11.18) years

  • Gender (men/women): NA

  • Tumor T stage: NA

  • Tumor grade (G1/G2/G3) or tumor grade (low/high): NA

  • Tumor size (< 3 cm/≥ 3 cm): NA

  • Number of tumors (1/> 1): NA

  • Prior intravesical therapy: 0


Comparator: BCG
  • Number of all participants randomly assigned: 40

  • Age: overall mean 56.2 (SD 11.18) years

  • Gender (men/women): NA

  • Tumor T stage: NA

  • Tumor grade (G1/G2/G3) or tumor grade (low/high): NA

  • Tumor size (< 3 cm/≥ 3 cm): NA

  • Number of tumors (1/> 1): NA

  • Prior intravesical therapy: 0

Interventions Intervention: gemcitabine
  • Gemcitabine 2000 mg/50 mL saline

  • 6 weekly intravesical instillation after 2 weeks from TURBT


Comparator: BCG
  • BCG 6 × 108 CFU (strain: NA)/50 mL saline

  • 6 weekly intravesical instillation after 2 weeks from TURBT


Follow‐up: 3–18 months (mean 10.8 (SD 27) months)
Outcomes Study did not separate the outcomes as primary and secondary.
Efficacy
  • Recurrence

  • Progression

  • How measured: NA

  • Time point measured: NA

  • Time point reported: NA


Safety
  • How measured: NA

  • Time point measured: NA

  • Time point reported: NA


Subgroup analysis: NA
Funding Sources None
Declarations of interest NA
Notes Protocol: NA
Language of publication: English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "Random" only; abstract only.
Comment: randomization stated, but no information on method used; therefore, unclear risk of selection bias.
Allocation concealment (selection bias) Unclear risk Comment: no information given; abstract only.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: no information given; abstract only.
Blinding of outcome assessment (detection bias)
Subjective outcomes Unclear risk Comment: no information given; abstract only.
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Comment: no information given; abstract only, but objective outcomes not likely affected by lack of blinding.
Incomplete outcome data (attrition bias)
Time to recurrence Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Time to progression Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Grade III–V adverse events Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Time to death from bladder cancer Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Time to death from any cause Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Grade I or II adverse events Unclear risk Comment: no information given; abstract only.
Incomplete outcome data (attrition bias)
Disease‐specific quality of life Unclear risk Comment: no information given; abstract only.
Selective reporting (reporting bias) Unclear risk Comment: no information given; abstract only.
Other bias Unclear risk Comment: no information given; abstract only