Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Tumour clearance
Study Overview
Brief Summary
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Detailed Description
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Study Design: Open prospective study in patients with recurrent pTa low grade bladder tumours.
All patients will have their bladder tumour removed using a diode laser. The treatment will take place in the outpatient department (OPD) without any pain treatment. Biopsy from the tumour will be obtained before the procedure. If the biopsy shows low grade non-invasive bladder tumour, flexible cystoscopy will be repeated one month later in the OPD. At both procedures biopsy will be taken from the laser treated area.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrence of pTa low grade urothelial bladder tumor
- •Tumor < 1.5 cm
- •< 6 tumors
Exclusion Criteria
- •Patients with porphyria
- •Known hypersensitivity to Hexvix® or porphyrins
- •Use of any anticoagulants
- •Macroscopic hematuria
- •Pregnant or breast feeding women
- •Expected poor compliance
- •Patients < 18 years
- •Patients who do not read or understand Danish
Outcomes
Primary Outcomes
Tumour clearance
Time Frame: 1 month
No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gregers Gautier Hermann
consultant urologist
University Hospital Bispebjerg and Frederiksberg