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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Conventional bladder tumor resection using diathermia
Laser mediated destruction of bladder tumors (LMD-BT)
Urological department, Frederiksberg Hospital
Copenhagen, Denmark
RECRUITINGTumor recurrence histological identified in biopsy obtained during cystoscopy
Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months
Time frame: 4 months
Lower urinary symptoms caused by laser treatment.
Using the EORTC questionnaire QLQ-BLS24 the extent of symptoms are given on a unique score from 0-100, with 0 being no symptoms and 100 are worst symptoms. Mean and range score in the two arms will be compared statistically.
Time frame: 2 weeks
Side effects to laser treatment.
Symptoms measured by one unique score according to the Clavien-Dindo grading system. Mean and range score in the two arms will be compared statistically.
Time frame: 2 weeks
Pain during laser treatment
The patients record pain on a visual analogue scale of 0-10. Zero corresponds to no pain. Ten correspond to the worst possible pain.
Time frame: Evaluated immediately after laser treatment
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