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Status unknownNCT02886026LaserIIIUpdated Nov 1, 2017

Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors

An interventional study of Bladder tumor resection using diathermia and Diode laser (980 nm) tumor destruction in Bladder Cancer, sponsored by University Hospital Bispebjerg and Frederiksberg. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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
02

Conditions studied

  • Bladder Cancer

Keywords

  • Laser
  • Bladder cancer
  • Treatment
  • Outpatient
  • TUR-BT
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 248 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 in GA

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
248 participants (estimated)

Study arms

  • Active comparator
    Inpatient TUR-BT

    Transurethral bladder tumor resection in operating theatre as inpatient.

    Device: Bladder tumor resection using diathermia

  • Experimental
    laser bladder tumor destruction

    Outpatient laser mediated destruction of bladder tumors (LMD-BT)

    Device: Diode laser (980 nm) tumor destruction

Interventions

  • DeviceBladder tumor resection using diathermia

    Conventional bladder tumor resection using diathermia

  • DeviceDiode laser (980 nm) tumor destruction

    Laser mediated destruction of bladder tumors (LMD-BT)

06

What researchers measure

Primary outcomes

  1. Tumor 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02886026
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Responsible party
Gregers Gautier Hermann (Consultant Urologist, University Hospital Bispebjerg and Frederiksberg) — Principal investigator
First posted
Sep 1, 2016
Start date
Jun 2016
Primary completion
Dec 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Nov 1, 2017

Study contacts

Gregers G Hermann, DM Sc
Contact
gregersgautierhermann@regionh.dk
+45 38163536
Gregers G Hermann, DM Sc
principal investigator · Department of Urology, Frederiksberg hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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