OPEN Long-term follow-up
Research type
Research Study
Full title
Assessing the long-term effectiveness of urethroplasty and urethrotomy as treatments for recurrent urethral strictures in men: Long-term follow-up of the OPEN Trial
IRAS ID
322670
Contact name
Nadir Osman
Contact email
Sponsor organisation
SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Background
A urethral stricture is a narrowing in the urine pipe caused by scarring. It affects over 60,000 men in the United Kingdom. In England, 17,000 men are admitted for urethral stricture treatment per year. Men with a urethral stricture have bothersome symptoms, such as difficulty passing urine, infections and, if severe, complete inability to pass urine. The standard treatment is to cut the scar tissue using a knife through a telescope (urethrotomy). Another, bigger operation, is called urethroplasty. This involves making a cut under the testicles and reconstructing the urine pipe.
Our previous study allocated patients by chance to either receive urethrotomy or urethroplasty to make a fair comparison between the treatments for up to 2-years post procedure. We found that after 2-years, urethroplasty has a higher chance of cure but takes longer, has more risks and has a longer recovery time.
It is still unclear how urethrotomy and urethroplasty compare in the long term.
Methods
This study will be made of two parts:
Part 1 will link data routinely collected in the NHS with the data from the previous study to find out what happened to those men in the long-term. Our analysis will compare treatments in terms of the rate of further treatments required, time until new treatment is needed, need for hospital attendance as well as value for money. This will give us a fair comparison but avoid the study participants having to provide further data themselves.
Part 2 will aim to identify what difference between re-treatment rates leads patients to choose a treatment over another. To do this, we will work with patients and doctors to design a survey to identify what difference between re-treatment rates would lead them to choose one treatment over another.
This will provide currently missing information to help men and their doctors decide which treatment to have in the future.
REC name
Wales REC 4
REC reference
24/WA/0214
Date of REC Opinion
23 Jul 2024
REC opinion
Favourable Opinion