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

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: Non-muscle Invasive Bladder Cancer
• Intervention / Treatment: Other: Urodynamic examination

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

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)	Obtained from the urodynamic test	examined at time 0 and after six months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Chair: Jørgen B. Jensen, DMSc, MD, Aarhus Universitetshospital

Study record dates

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: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• 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