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Clinical Trials/NCT02886026
NCT02886026UnknownNot Applicable

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?

University Hospital Bispebjerg and Frederiksberg2 sites in 1 country248 target enrollmentStarted: June 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
248
Locations
2
Primary Endpoint
Tumor recurrence histological identified in biopsy obtained during cystoscopy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Ta low grade bladder tumor recurrences
  • •Up to a tumor size of 1,5 cm
  • •Up to 6 tumors
  • •Eligible patients for TUR-BT in GA

Exclusion Criteria

  • •Patients with porphyria
  • •Known hypersensitivity to Hexvix® or porfhyrins
  • •Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
  • •Macroscopic hematuria
  • •Pregnant or breast feeding women
  • •Expected poor compliance estimated by the investigators
  • •Patients < 18 years
  • •Patients who do not read or understand Danish

Outcomes

Primary Outcomes

Tumor recurrence histological identified in biopsy obtained during cystoscopy

Time Frame: 4 months

Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months

Secondary Outcomes

  • Pain during laser treatment(Evaluated immediately after laser treatment)
  • Side effects to laser treatment.(2 weeks)
  • Lower urinary symptoms caused by laser treatment.(2 weeks)

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gregers Gautier Hermann

Consultant Urologist

University Hospital Bispebjerg and Frederiksberg

Study Sites (2)

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