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

May 30, 2023 updated by: Jørgen Bjerggaard Jensen, Aarhus University Hospital
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with primary non-muscle invasive bladder cancer or who are diagnosed with their first or second recurrence.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TURBT alone
Patients treated with TURBT without adjuvant instillation therapy
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.
TURBT and mitomycin C
Patients treated with TURBT followed by six adjuvant instillations with mitomycin C
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.
TURBT and bacillus Calmette-Guerin
Patients treated with TURBT followed by six adjuvant instillations with BCG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
examined at time 0 and after six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Study Chair: Jørgen B. Jensen, DMSc, MD, Aarhus Universitetshospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URODYN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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