A Prospective Randomized Double-Blind Study on Prevention of Urethral Restenosis by Radiotherapy

ISRCTN	ISRCTN19584965
DOI	https://doi.org/10.1186/ISRCTN19584965
Secondary identifying numbers	N/A

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 Stephan Gripp
Scientific

Klinik für Strahlentherapie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
Düsseldorf
40225
Germany

Phone	+49 (0)2118118992
Email	Gripp@uni-duesseldorf.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study acronym	RADIUS
Study objectives	Postoperative endourethral radiotherapy after urethrotomy may reduce rate of restenosis
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Prevention of urethral restenosis after internal urethrotomy by radiotherapy
Secondary outcome measures	Toxicity
Overall study start date	01/02/2005
Completion date	01/02/2006

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	180
Key inclusion criteria	1. Peak flowrate <15 ml/s 2. Age >30 3. Stenosis suitable for internal urethrotomy 4. Written consent
Key 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
Date of first enrolment	01/02/2005
Date of final enrolment	01/02/2006

Klinik für Strahlentherapie

Düsseldorf
40225
Germany

University of Düsseldorf (Germany)
University/education

Klinik für Strahlentherapie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
Duesseldorf
40225
Germany

University/education

University of Düsseldorf (Germany)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan