Evaluation of treatment of local bladder cancer with Bacille Calmette-Guérin (BCG). Is treatment follow up in the outpatient department just as good as follow up in the operating theatre?

ISRCTN	ISRCTN48222814
DOI	https://doi.org/10.1186/ISRCTN48222814
Protocol serial number	UOF no 3
Sponsor	Frederiksberg Hospital (Denmark)
Funder	Frederiksberg Hospital, Copenhagen University (Denmark)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Gregers G Hermann
Scientific

Department of Urology
Frederiksberg Hospital
Ndr Fasanvej 57
Copenhagen
DK-2000
Denmark

Email	gregershermann@frh.regionh.dk

Primary study design	Observational
Study design	Single center study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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).
Study acronym	UOF3
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Histological diagnosis from evaluation of bladder biopsy
Key secondary outcome measure(s)	Quality of life and pain in relation to test procedures
Completion date	30/04/2013

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key inclusion criteria	Patients who have had 6 weekly BCG bladder instillations as treatment of primary or secondary carcinoma in situ of the bladder.
Key exclusion criteria	Patients who do not understand Danish or who the investigators do not find able to fulfil the study
Date of first enrolment	01/12/2011
Date of final enrolment	30/04/2013

Department of Urology

Copenhagen
DK-2000
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes