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NCT04943094 Clinical Trial

Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy

Non-muscle Invasive Bladder Cancer Clinical Trial

— URODYN  

Official title:
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04943094
Other study ID # URODYN
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2025

Study information
Verified date May 2023
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

  • Non-muscle Invasive Bladder Cancer

Intervention

Other:
• Urodynamic examination
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.

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity) Obtained from the urodynamic test examined at time 0 and after six months
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