• Hexvix®;
  • bladder cancer;
  • fluorescence cystoscopy;
  • recurrence;
  • non-muscle-invasive;
  • residual tumour

Study Type – Therapy (RCT)

Level of Evidence 1b

What’s known on the subject? and What does the study add?

Photodynamic diagnosis (PDD) improves the diagnostic sensitivity of non-invasive bladder cancer as compared to TURB without PDD.

TURB in white light leaves residual tumour in the bladder in up to 49% of the patients. PDD-guided TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced tumour recurrence rate.


• To compare the bladder tumour recurrence rate in stage Ta and T1 tumours after conventional transurethral resection of the bladder in white light (WL TURB) and after fluorescence-guided TURB (HAL TURB) using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.

• As secondary objectives, to relate the tumour recurrence rate to fluorescence-detected residual tumour after WL TURB and to assess the false positive rate.


• This was a prospective, comparative, randomized, open-label study carried out in hospital outpatient urology clinics and the operating theatre. A total of 233 patients presenting with suspected superficial bladder tumour were recruited. Both patients with new tumours and patients with recurrent tumours were included.

• The study duration was 2.5 years with follow-up cystoscopic investigations at 4, 8 and 12 months.

• Patients were randomized to cystoscopy and WL TURB (118 patients) or WL TURB followed immediately by HAL TURB (115 patients). Cystoscopy/TURB and bladder biopsies were performed under general anaesthesia. No patients had intravesical chemotherapy immediately after TURB.

• Recurrences were verified histologically.


• The two groups were similar regarding age and previous bladder cancer history.

• In all, 90 patients from the HAL TURB group had bladder tumour. Fluorescence-guided cystoscopy after complete WL TURB identified residual tumour tissue in 44 of 90 patients (49%). In 37 of 83 (45%) residual Ta tumour was found; in three of seven residual T1 was found and in four cases carcinoma in situ.

• True (and false) positive detection rate of photodynamic diagnosis was 64% (25%) and of white light 83% (16%).

• In all, 145 patients were eligible for analysis of tumour recurrence. Twelve patients had their last follow-up after 4 months. The recurrence rate in patients followed for 12 months was 47.3% (35/74) after WL TURB and 30.5% (18/59) after HAL TURB (P= 0.05).

• Kaplan–Meier analyses comprising data from all 145 patients showed that the recurrence-free period was significantly longer in the HAL TURB group than in the WL TURB group (P= 0.02).


• WL TURB often leaves residual tumour in the bladder. HAL TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced recurrence rate.