A Prospective Randomized Double-Blind Study on Prevention of Urethral Restenosis by Radiotherapy
| ISRCTN | ISRCTN19584965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19584965 |
| Protocol serial number | N/A |
| Sponsor | University of Düsseldorf (Germany) |
| Funder | University of Düsseldorf (Germany) |
- Submission date
- 07/09/2005
- Registration date
- 11/01/2006
- Last edited
- 12/01/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 Stephan Gripp
Scientific
Scientific
Klinik für Strahlentherapie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
Düsseldorf
40225
Germany
| Phone | +49 (0)2118118992 |
|---|---|
| Gripp@uni-duesseldorf.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Prevention of urethral restenosis after internal urethrotomy by radiotherapy |
| Key secondary outcome measure(s) |
Toxicity |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Strahlentherapie
Düsseldorf
40225
Germany
40225
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
