Skip to main content
. 2020 Jan 8;2020(1):CD011935. doi: 10.1002/14651858.CD011935.pub2

Mangiarotti 2008.

Methods Study design: prospective, randomised clinical trial
Number of study centres: 1
Study dates: recruitment period not reported, follow‐up 12–108 months
Participants randomly assigned: 92
Participants Inclusion criteria:
  • histologically confirmed Ta‐T1 G1‐2 stage tumour


Exclusion criteria:
  • no previous intravesical treatment

Interventions Group A: MMC 40 mg in 50 mL saline
Group B: BCG Tice
Procedure:
  • therapy started 1 month after TUR;

  • MMC once a week for 8 weeks, thereafter for once a month for 1 year;

  • BCG weekly for 6 weeks, thereafter once a month for 1 year.

Outcomes Recurrence rate, recurrence‐free survival, adverse effects
Funding sources Not reported.
Declarations of interest No information on interests reported.
Notes Sample size estimation required 97 participants to allow a 5% dropout and 92 remaining participants (46 in each group). The article reported on the 92 participants and on the 46 per group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information
Allocation concealment (selection bias) Unclear risk Comment: no information
Blinding of participants and personnel (performance bias) 
 all outcomes Unclear risk Comment: no information
Blinding of outcome assessment (detection bias) 
 overall survival Unclear risk Outcome not reported.
Blinding of outcome assessment (detection bias) 
 recurrence and progression free survival High risk Comment: no information on blinding. We assumed that there was no blinding. We assumed that the absence of blinding might have had an effect on the detection and measurement of subjective outcomes.
Blinding of outcome assessment (detection bias) 
 serious and non‐serious adverse effects High risk Comment: no information on blinding. We assumed that there was no blinding. We assumed that the absence of blinding might have had an effect on the detection and measurement of subjective outcomes.
Blinding of outcome assessment (detection bias) 
 quality of life Unclear risk Outcome not reported.
Incomplete outcome data (attrition bias) 
 Survival outcomes Low risk Comment: all participants entered the analysis (46/46 in each group).
Incomplete outcome data (attrition bias) 
 Adverse effect outcomes Low risk Comment: all participants entered the analysis (46/46 in each group).
Incomplete outcome data (attrition bias) 
 Quality of life outcomes Unclear risk Outcome not reported.
Selective reporting (reporting bias) Unclear risk Comment: no study protocol available.
Other bias Low risk Comment: we assumed that there was no risk for other bias.