Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Active, not recruiting
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- Other: Urodynamic examination
- Registration Number
- NCT04943094
- Lead Sponsor
- Aarhus University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- non-muscle invasive bladder tumour
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TURBT and mitomycin C Urodynamic examination Patients treated with TURBT followed by six adjuvant instillations with mitomycin C TURBT alone Urodynamic examination Patients treated with TURBT without adjuvant instillation therapy TURBT and bacillus Calmette-Guerin Urodynamic examination Patients treated with TURBT followed by six adjuvant instillations with BCG
- Primary Outcome Measures
Name Time Method Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity) examined at time 0 and after six months Obtained from the urodynamic test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark