1. Baseline characteristics of included studies.
| Study name | Trial period (year to year) | Setting | Participants | Intervention(s) and comparator(s) | Description of intervention | Median age (years, interquartile range) | Disease characteristics (n) | Median follow‐up (months, interquartile range) |
| Di Stasi 2003 | June 1994 to March 2001 | Multicentre/Italy | People with histologically confirmed multifocal CIS of the bladder and most had concurrent pT1 papillary transitional‐cell carcinoma (all primary disease). | MMC‐EMDA induction after TURBT | 6 intravesical instillation at weekly intervals. | 64.5 (not reported) | Ta/T1: 0/32 Grade: not reported CIS: 36 |
43 (not reported) |
| MMC‐PD induction after TURBT | 68.5 (not reported) | Ta/T1: 0/33 Grade: not reported CIS: 36 |
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| BCG induction after TURBT | 66.5 (not reported) | Ta/T1: 0/33 Grade: not reported CIS: 36 |
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| Di Stasi 2006 | 1 January 1994 to 30 June 2002 | Multicentre/Italy | People with histologically confirmed stage pT1 transitional‐cell carcinoma of the bladder were regarded as being at high risk for tumour recurrence and at moderate to high risk for progression because of: multifocal pT1, primary or recurrent, grade 2 transitional‐cell carcinoma; primary or recurrent pT1, multifocal or solitary, grade 3 transitional‐cell carcinoma; or pT1 with CIS. | MMC‐EMDA with sequential BCG induction and maintenance after TURBT | Induction: 3 cycles of treatment per week for 9 weeks for which 1 cycle consisted of 2 BCG infusions and 1 MMC infusion Maintenance: 1 infusion per month for 9 months: 3 cycles of MMC, MMC and BCG. |
66.0 (56.0‐73.0) | Ta/T1: all T1 disease Grade: 0/65/42 CIS: 29 |
88 (63‐110) |
| BCG induction and maintenance after TURBT | Induction: 6 intravesical treatments at weekly intervals Maintenance: monthly infusion of BCG for 10 months. |
67.0 (61.0‐73.0) | Ta/T1: all T1 disease Grade: 0/64/41 CIS: 28 |
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| Di Stasi 2011 | 1 January 1994 to 31 December 2003 | Multicentre/Italy | People with pTa and pT1 urothelial carcinoma. | Single‐dose, MMC‐EMDA before TURBT | Single intravesical instillation about 30 minutes before spinal or general anaesthesia. | 67.0 (63.0‐74.0) | Ta/T1: 63/54 Grade: 22/62/33 CIS: not reported |
86 (57‐125) |
| Single‐dose, MMC‐PD immediately after TURBT | Single intravesical instillation within 6 hours of TURBT. | 67.0 (61.0‐72.0) | Ta/T1: 64/55 Grade: 23/64/32 CIS: not reported |
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| TURBT alone | No intravesical instillation. | 66.5 (60.0‐73.0) | Ta/T1: 63/53 Grade: 21/63/32 CIS: not reported |
BCG: Bacillus Calmette‐Guérin; CIS: carcinoma in situ; MMC‐EMDA: electromotive drug administration of mitomycin C; MMC‐PD: passive diffusion of mitomycin C; TURBT: transurethral resection of bladder tumour.