Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

Urol Int. 2017;99(3):358-366. doi: 10.1159/000477973. Epub 2017 Aug 9.


Objective: The Hexvix® Observational Patients Evaluation (HOPE) study was designed to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non-muscle invasive bladder cancer (NMIBC) and assess patient and treatment characteristics associated with different endoscopic modalities and to address the French authorities' request for information on routine practices for NMIBC diagnosis and surveillance.

Patients and methods: A prospective, observational study in 30 centres in France with fluorescence endoscopy equipment available. All candidates for endoscopy with transurethral resection who gave their consent were eligible. The primary endpoint was the proportion of patients with an NMIBC diagnosis performed with hexaminolevulinate.

Results: 506 patients were included: 252 (49.8%) diagnosed with hexaminolevulinate and 254 (50.2%) with white-light endoscopy alone. There were more patients with tumour recurrence, multiple lesions, lesions with a diameter <3 cm, stage Ta disease, and grade 1 lesions in the hexaminolevulinate group. The first quartile median recurrence-free survival time was 310 days in the hexaminolevulinate group and 144 days in the standard-endoscopy group (p = 0.0015).

Conclusion: Hexaminolevulinate was in frequent use in France with specific patient and disease characteristics associated with its use. HOPE illustrates the type of data that can be gained in post-authorisation studies to address requests from European health authorities.

Keywords: European Union regulation; Hexaminolevulinate; Non-muscle invasive bladder cancer; Observational studies.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Aminolevulinic Acid / administration & dosage
  • Aminolevulinic Acid / analogs & derivatives*
  • Cystectomy
  • Cystoscopy / methods*
  • Cystoscopy / trends
  • Disease Progression
  • Disease-Free Survival
  • Evidence-Based Medicine* / trends
  • Female
  • France
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Recurrence, Local
  • Photosensitizing Agents / administration & dosage*
  • Practice Patterns, Physicians'* / trends
  • Predictive Value of Tests
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Urinary Bladder Neoplasms / pathology*
  • Urinary Bladder Neoplasms / therapy
  • Urology / trends*
  • Young Adult


  • Photosensitizing Agents
  • Aminolevulinic Acid
  • 5-aminolevulinic acid hexyl ester