Contact information
Type
Scientific
Primary contact
Dr Stephan Gripp
ORCID ID
Contact details
Klinik für Strahlentherapie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
Düsseldorf
40225
Germany
+49 (0)2118118992
Gripp@uni-duesseldorf.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
RADIUS
Study hypothesis
Postoperative endourethral radiotherapy after urethrotomy may reduce rate of restenosis
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Urethral stenosis
Intervention
Internal urethrotomy followed by postoperative single shot endourethral Ir-192- High Dose Rate (HDR)-brachytherapy within 24 hours. The prescribed dose is 15 Gy/2 mm depth. The control group receives sham brachytherapy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Prevention of urethral restenosis after internal urethrotomy by radiotherapy
Secondary outcome measures
Toxicity
Overall trial start date
01/02/2005
Overall trial end date
01/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Peak flowrate <15 ml/s
2. Age >30
3. Stenosis suitable for internal urethrotomy
4. Written consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
180
Participant exclusion criteria
1. Prior radiotherapy in this area (penis, prostate, bladder)
2. Cancer of the prostate or urethra or bladder
3. Congenital stenosis
4. Greater than three prior urethrotomies
5. Traumatic genesis
6. Stenosis >2 cm
Recruitment start date
01/02/2005
Recruitment end date
01/02/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Strahlentherapie
Düsseldorf
40225
Germany
Sponsor information
Organisation
University of Düsseldorf (Germany)
Sponsor details
Klinik für Strahlentherapie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
Duesseldorf
40225
Germany
+49 (0)2118118992
Gripp@uni-duesseldorf.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Düsseldorf (Germany)
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