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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19584965

Enrollment

180

Registered

2006-01-11

Start date

2005-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral stenosis Urological and Genital Diseases Urethral stenosis

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Peak flowrate 30 3. Stenosis suitable for internal urethrotomy 4. Written consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Prevention of urethral restenosis after internal urethrotomy by radiotherapy	—

Secondary

Measure	Time frame
Toxicity	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026