Condition category
Urological and Genital Diseases
Date applied
07/09/2005
Date assigned
11/01/2006
Last edited
12/01/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes