Bladder CancerLaserIIINCT02886026
Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
A study testing Bladder tumor resection using diathermia and Diode laser (980 nm) tumor destruction in people with Bladder Cancer, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Bladder tumor resection using diathermia and Diode laser (980 nm) tumor destruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porfhyrins
- Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- Dementia
- Macroscopic hematuria
- Pregnant or breast feeding women
Show all 9Show fewer
- Expected poor compliance estimated by the investigators
- Patients < 18 years
- Patients who do not read or understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Urological department, Frederiksberg Hospital
Copenhagen, 2000
Gregers G Hermann, MD, + 45 38163536, gregers.gautier.hermann@regionh.dk
About this study
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.
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:
- Ta low grade bladder tumor recurrences
- Up to a tumor size of 1,5 cm
- Up to 6 tumors
- Eligible patients for TUR-BT
Exclusion criteria:
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porfhyrins
- Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- Dementia
- 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
- Conditions
- Bladder Cancer
- Being tested
- Bladder tumor resection using diathermia, Diode laser (980 nm) tumor destruction
- Keywords
- Laser, Bladder cancer, Treatment, Outpatient, TUR-BT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder tumor resection using diathermiaDevice
Conventional bladder tumor resection using diathermia
Diode laser (980 nm) tumor destructionDevice
Laser mediated destruction of bladder tumors (LMD-BT)
| Study group | Role | What they receive |
|---|---|---|
| Inpatient TUR-BT | Active comparator | Transurethral bladder tumor resection in operating theatre as inpatient. Receives: Device: Bladder tumor resection using diathermia |
| laser bladder tumor destruction | Experimental | Outpatient laser mediated destruction of bladder tumors (LMD-BT) Receives: Device: Diode laser (980 nm) tumor destruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence histological identified in biopsy obtained during cystoscopy
Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Evaluated immediately after laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregers Gautier Hermann, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Gregers G Hermann, DM Sc, Principal investigator, Department of Urology, Frederiksberg hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886026
- Sponsor's protocol ID
- URU06
- Acronym
- LaserIII
- Status last verified
- Oct 2017
- First submitted
- 21 Jun 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pedersen GL, Mogensen K, Rosthoj S, Erikson MS, Fode M, Hermann GG. In-Office Laser Coagulation of Ta Bladder Tumor Compared With Transurethral Resection of Bladder Tumor: 12 Months Follow-Up Randomized Clinical Trial. J Urol. 2026 May;215(5):535-543. doi: 10.1097/JU.0000000000004918. Epub 2025 Dec 29.
PubMed 41461083
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02886026
- Acronym / sponsor ID
- LaserIII / URU06
- Conditions
- Bladder Cancer
- Keywords
- Laser, Bladder cancer, Treatment, Outpatient, TUR-BT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Ta low grade bladder tumor recurrences
- Up to a tumor size of 1,5 cm
- Up to 6 tumors
- Eligible patients for TUR-BT
Exclusion criteria:
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porfhyrins
- Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- Dementia
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient TUR-BT | Active comparator | Device: Bladder tumor resection using diathermiaTransurethral bladder tumor resection in operating theatre as inpatient. |
| laser bladder tumor destruction | Experimental | Device: Diode laser (980 nm) tumor destructionOutpatient laser mediated destruction of bladder tumors (LMD-BT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porfhyrins
- Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- Dementia
- Macroscopic hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder tumor resection using diathermiaConventional bladder tumor resection using diathermia | Device | Inpatient TUR-BT |
| Diode laser (980 nm) tumor destructionLaser mediated destruction of bladder tumors (LMD-BT) | Device | laser bladder tumor destruction |
Primary outcome
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
3 secondary outcomes
Lower urinary symptoms caused by laser treatment.
Time frame: 2 weeks
Side effects to laser treatment.
Time frame: 2 weeks
Pain during laser treatment
Time frame: Evaluated immediately after laser treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Derived from this study: PubMed 41461083Pedersen GL, Mogensen K, Rosthoj S, Erikson MS, Fode M, Hermann GG. In-Office Laser Coagulation of Ta Bladder Tumor Compared With Transurethral Resection of Bladder Tumor: 12 Months Follow-Up Randomized Clinical Trial. J Urol. 2026 May;215(5):535-543. doi: 10.1097/JU.0000000000004918. Epub 2025 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregers G Hermann, DM Sc principal investigator
Department of Urology, Frederiksberg hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder tumor resection using diathermia and Diode laser (980 nm) tumor destruction in people with Bladder Cancer, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregers G Hermann, DM Sc (+45 38163536, gregersgautierhermann@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence histological identified in biopsy obtained during cystoscopy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.