Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
This briefing summarises 2 conference abstracts including a total of 157 patients. Both studies used non-comparative prospective designs. Table 1 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
The available evidence is limited in both quantity and quality, and comprises only abstracts of non-comparative studies reporting technical success. Only 1 of the studies used the Urethrotech UCD for second-line catheterisation, and only 9 patients in this study were catheterised with it. Both studies were done in the UK in men having cardiac or urological surgery, so the results are generalisable to the current NHS pathway.
To determine the clinical effectiveness of the Urethrotech UCD, studies comparing it with standard care in men who need second-line catheterisation would be useful. Important outcome measures would include the rate of successful catheterisations, adverse events (such as rates of urethral trauma including false passages and infections), patient satisfaction and healthcare resource use.
Table 1 Published evidence
|
Study size, design and location |
57 men having bulbar and posterior urethroplasty. Only 9 had catheterisation using the Urethrotech UCD. Prospective non-comparative design. UK-based. |
|
Intervention and comparator(s) |
Intervention was the Urethrotech UCD. No comparator. |
|
Key outcomes |
Of 57 patients, 9 needed second-line catheterisation. The Urethrotech UCD was used successfully without any adverse events in all 9. |
|
Strengths and limitations |
Only a small number of patients had the intervention. It was a non-comparative study and reported only limited outcomes. |
|
Study size, design and location |
100 men having cardiac surgery. Prospective non-comparative design to test safety and efficacy. UK-based. |
|
Intervention and comparator(s) |
Intervention was the Urethrotech UCD. No comparator. |
|
Key outcomes |
All 100 patients had successful first-line catheterisations using the Urethrotech UCD, with no adverse events. |
|
Strengths and limitations |
The study had a large sample size but the device was used for first-line catheterisation, not second line as is intended for general NHS use. |