Contact information
Type
Scientific
Primary contact
Dr Gregers G Hermann
ORCID ID
Contact details
Department of Urology
Frederiksberg Hospital
Ndr Fasanvej 57
Copenhagen
DK-2000
Denmark
gregershermann@frh.regionh.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UOF no 3
Study information
Scientific title
Detection rate of carcinoma in situ (CIS) after intravesical Bacille Calmette-Guérin (BCG) in fluorescence guided flexible cystoscopy in the outpatient department (OPD) compared to fluorescence guided cystoscopy in rigid cystoscopes in the operating theatre (OT).
Acronym
UOF3
Study hypothesis
Fluorescence guided cystoscopy and biopsy performed in the OPD is just as good as fluorescence guided cystoscopy and biopsy in rigid scopes in the operating theatre to evaluate the efficacy of intra vesical BCG therapy of carcinoma in situ.
Ethics approval
Not provided at time of registration
Study design
Single center study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer of the urinary bladder - carcinoma of the bladder - CIS
Intervention
Fluorescence guided cystoscopy and biopsy in rigid scopes in the operating theatre and in flexible cystoscopes in the outpatient department
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Histological diagnosis from evaluation of bladder biopsy
Secondary outcome measures
Quality of life and pain in relation to test procedures
Overall trial start date
01/12/2011
Overall trial end date
30/04/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who have had 6 weekly BCG bladder instillations as treatment of primary or secondary carcinoma in situ of the bladder.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Patients who do not understand Danish or who the investigators do not find able to fulfil the study
Recruitment start date
01/12/2011
Recruitment end date
30/04/2013
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Urology
Copenhagen
DK-2000
Denmark
Sponsor information
Organisation
Frederiksberg Hospital (Denmark)
Sponsor details
c/o Dr Gregers G Hermann
Department of Urology
Frederiksberg Hospital
University of Copenhagen
Ndr. Fasanvej 57
Frederiksberg
Copenhagen
DK-2000
Denmark
gregers.hermann@frh.regionh.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Frederiksberg Hospital, Copenhagen University (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary