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

NCT ID: NCT04943094

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Non-muscle Invasive Bladder Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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TURBT alone

Patients treated with TURBT without adjuvant instillation therapy

Urodynamic examination

Intervention Type OTHER

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.

TURBT and mitomycin C

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

Urodynamic examination

Intervention Type OTHER

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.

TURBT and bacillus Calmette-Guerin

Patients treated with TURBT followed by six adjuvant instillations with BCG

Urodynamic examination

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jørgen Bjerggaard Jensen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jørgen B. Jensen, DMSc, MD

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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URODYN

Identifier Type: -

Identifier Source: org_study_id

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