PhotoDynamic Diagnosis (PDD) and results of biopsies in flexible cystoscopy of bladder tumour patients in an Out-Patient Department set up

ISRCTN	ISRCTN88551578
DOI	https://doi.org/10.1186/ISRCTN88551578
Protocol serial number	Method development II
Sponsor	Frederiksberg Hospital (Denmark)
Funders	The Foundation Juchum (Denmark) - provided financial support, Boemske Foundation (Denmark) - provided financial support, Karl Storz, Tuttlingen (Germany) - kindly delivered flexible cystoscope systems, Richard Wolf GmbH (Germany) - kindly delivered flexible cystoscope systems

Submission date: 02/07/2009
Registration date: 30/11/2009
Last edited: 30/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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

Contact information

Dr Gregers G Hermann
Scientific

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

Study information

Primary study design	Interventional
Study design	Quality assurance, non-randomised single arm pilot study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	PhotoDynamic Diagnosis (PDD) and results of biopsies in flexible cystoscopy of bladder tumour patients in an Out-Patient Department set up: a quality assurance study
Study acronym	PDD in OPD
Study objectives	The study was carried out to develop a method for photodynamic diagnosis (PDD) and bladder biopsies in flexible cystoscopes in the out-patient department (OPD). PDD in the operating theatre and cystoscopy and biopsy using flexible cystoscopes are routine methods in urology departments. The issue was to evaluate them for use in the OPD and to see the quality of biopsies obtained through the scopes. The examinations were performed to see whether we got a usable procedure for a subsequent study comparing the method in OPD and in the operating theatre during admittance to the ward.
Ethics approval(s)	The Danish Medicines Agency (Danish FDA) and the Ethical Committee in Copenhagen feel that there isn't a need to evaulate this study as the methods are commonly used.
Health condition(s) or problem(s) studied	Non-muscle invasive bladder tumour
Intervention	Instillation of 50 cc fluorescent material in to the bladder 1 hour before cystoscopy. The instillation gives no side effects. Each treatment last for 15 - 30 minutes and there is no follow-up.
Intervention type	Other
Primary outcome measure(s)	Acceptable view in the bladder, measured immediately during the cystoscopy
Key secondary outcome measure(s)	Sufficient biopsy information for a valid diagnosis, assessed a few days after cystoscopy where the pathologist give the histological description of the biopsy
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	37
Key inclusion criteria	1. Patients booked for flexible cystoscopy due to follow up of recurrent bladder tumour according to the guidelines of the ward 2. Aged 54 - 91 years, either sex
Key exclusion criteria	1. Patients refuse 2. Non-recurrent bladder tumour disease 3. Pregnancy 4. Aged less than 18 years
Date of first enrolment	09/04/2008
Date of final enrolment	01/04/2009

Locations

Countries of recruitment

Denmark

Study participating centre

Department of Urology

Copenhagen
DK-2000
Denmark

Results and Publications

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

Study outputs

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