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Trial record 1 of 1 for:    NCT04943094
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Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy (URODYN)

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ClinicalTrials.gov Identifier: NCT04943094
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

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.

Condition or disease Intervention/treatment
Non-muscle Invasive Bladder Cancer Other: Urodynamic examination

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943094


Contacts
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Contact: Linea Blichert-Refsgaard, MD 004530915431 lineblic@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Jørgen Bjerggaard Jensen, MD    +45 30915682    bjerggaard@clin.au.dk   
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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Study Chair: Jørgen B. Jensen, DMSc, MD Aarhus Universitetshospital
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Responsible Party: Jørgen Bjerggaard Jensen, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04943094    
Other Study ID Numbers: URODYN
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases