Bladder Cancer Clinical Trial
Official title:
Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?
This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.
A prospective randomized two-part clinical trial comprising patients with recurrent pTa low
grade bladder tumors.
Study objectives and purpose:
- 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode
laser in an outpatient department with similar efficacy as by TUR-BT resection in the
operating theatre.
- 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in
the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom
evaluation) and Visual Analog Scale Score (pain evaluation).
- 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor
resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD.
- 4th Objective: To evaluate the safety after laser treatment in the OPD.
Efficacy:
- 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months
and 12 months.
- 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor
removed by laser in the OPD.
General urinary problems and QOL one week after the laser treatment. The Danish validated
questionnaire (QLQ- BLS24) from EORTC will be used.
- 3rd Endpoint: Patients preference for either OPD laser treatment procedure or TUR-BT in
the OT as inpatient procedure.
- 4th Endpoint: Character and severity of adverse events in relation to the outpatient
treatment.
Study
Inclusion criteria:
1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT
Exclusion criteria:
1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients < 18 years
9. Patients who do not read or understand Danish
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