Inclusion Criteria:

- Primary papillary bladder cancer at high risk for further recurrence as defined as
follows:

Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent
papillary tumors

- Histologically proven Ta bladder cancer

- Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of
low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder
cancer

- Written informed consent is required from every eligible patient

Exclusion Criteria:

- Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading
system)

- CIS (carcinoma in situ)

- Suspicion or evidence of papillary tumors or CIS of the upper urinary tract

- Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer

- Suspicion or previous history of the patient not tolerating intravesical
instillations

- Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)

- Urethral stricture, stone disease, chronic urinary tract infection or any other
urological condition that may compromise study participation (as judged by treating
physician)

- Pregnancy or lactating patient

- Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix
uteri or any other malignancy in remission ≥5 years)

- Age < 18 years

- Expected survival time less than one year

- Expected poor compliance (e.g. some severe psychiatric disorders, antisocial
behaviour, or dementia)