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

Aarhus University Hospital

Status: Active, not recruiting

Conditions: Non-muscle Invasive Bladder Cancer

Treatments: Other: Urodynamic examination

Study type: Observational

Funder types: Other

Identifiers

NCT04943094

URODYN

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

TURBT alone

Description:

Patients treated with TURBT without adjuvant instillation therapy

Treatment:

Other: Urodynamic examination

TURBT and mitomycin C

Description:

Patients treated with TURBT followed by six adjuvant instillations with mitomycin C

Treatment:

Other: Urodynamic examination

TURBT and bacillus Calmette-Guerin

Description:

Patients treated with TURBT followed by six adjuvant instillations with BCG

Treatment:

Other: Urodynamic examination