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

NCT04943094 | Unknown

• 1 other identifier: URODYN
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity)

  Obtained from the urodynamic test

  examined at time 0 and after six months

Study Arms (3)

TURBT alone

Patients treated with TURBT without adjuvant instillation therapy

Other: Urodynamic examination

TURBT and mitomycin C

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

Other: Urodynamic examination

TURBT and bacillus Calmette-Guerin

Patients treated with TURBT followed by six adjuvant instillations with BCG

Other: Urodynamic examination

Interventions

Urodynamic examination 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 alone; TURBT and bacillus Calmette-Guerin; TURBT and mitomycin C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• non-muscle invasive bladder tumour

You may not qualify if:

• more than one previous bladder tumour recurrence
• utilization of urinary catheter
• have had heart valve replacement performed
• pregnant or lactating

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jørgen B. Jensen, DMSc, MD

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 29, 2021
• Study Start: September 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)