Non-muscle Invasive Bladder CancerURODYNNCT04943094
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
An observational study of Non-muscle Invasive Bladder Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- Urodynamic examination
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with primary non-muscle invasive bladder cancer or who are diagnosed with their first or second recurrence.
Who may be able to join
- non-muscle invasive bladder tumour
Who cannot join
- more than one previous bladder tumour recurrence
- muscle invasive bladder cancer (at baseline or prior to inclusion)
- utilization of urinary catheter
- have had heart valve replacement performed
- pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- Urodynamic examination
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic examinationOther
A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.
| Study group | Role | What they receive |
|---|---|---|
| TURBT alone | Patients treated with TURBT without adjuvant instillation therapy Receives: Other: Urodynamic examination | |
| TURBT and mitomycin C | Patients treated with TURBT followed by six adjuvant instillations with mitomycin C Receives: Other: Urodynamic examination | |
| TURBT and bacillus Calmette-Guerin | Patients treated with TURBT followed by six adjuvant instillations with BCG Receives: Other: Urodynamic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity)
Obtained from the urodynamic test
Measured: examined at time 0 and after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Sep 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
- Investigators
- Jørgen B. Jensen, DMSc, MD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943094
- Sponsor's protocol ID
- URODYN
- Acronym
- URODYN
- Status last verified
- May 2023
- First submitted
- 18 Jun 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
- ClinicalTrials.gov ID
- NCT04943094
- Acronym / sponsor ID
- URODYN / URODYN
- Conditions
- Non-muscle Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jun 2021 (actual)
- 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.
The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TURBT alone | – | Other: Urodynamic examinationPatients treated with TURBT without adjuvant instillation therapy |
| TURBT and mitomycin C | – | Other: Urodynamic examinationPatients treated with TURBT followed by six adjuvant instillations with mitomycin C |
| TURBT and bacillus Calmette-Guerin | – | Other: Urodynamic examinationPatients treated with TURBT followed by six adjuvant instillations with BCG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with primary non-muscle invasive bladder cancer or who are diagnosed with their first or second recurrence.
Key inclusion criteria (1 listed)
- non-muscle invasive bladder tumour
Key exclusion criteria (5 listed)
- more than one previous bladder tumour recurrence
- muscle invasive bladder cancer (at baseline or prior to inclusion)
- utilization of urinary catheter
- have had heart valve replacement performed
- pregnant or lactating
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 |
|---|---|---|
| Urodynamic examinationA urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes. | Other | TURBT alone, TURBT and bacillus Calmette-Guerin, TURBT and mitomycin C |
Primary outcome
Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity)
Time frame: examined at time 0 and after six months
Obtained from the urodynamic test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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.
Jørgen B. Jensen, DMSc, MD study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-muscle Invasive Bladder Cancer, run by Aarhus University Hospital 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 1 inclusion and 5 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 31 May 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity) (time frame: examined at time 0 and after six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.