Full title
Stents In Ureteric Stricture (SInUS) – Randomised Controlled Trial
Background
Certain conditions can block the ureter and cause damage to the kidney. Patients will need an emergency surgery to help relieve the blockage. This involves putting a flexible J-shaped tube called a Polymeric Short-term Stent (PSS).
This type of emergency surgery is commonly performed in the NHS. The PSS has coils at both ends of the stent. One of the coils of the PSS sits in the kidney and the other in the bladder.
This helps to keep the JJ in place and drain urine. The PSS provides patients with immediate relief of the blockage, but needs to be replaced every 3-6 months under anaesthesia. The coil in the bladder can cause several bothersome stent-related symptoms and can greatly impact their quality-of-life (QoL).
Another option is to use a different type of stent called a Segmental Intra-ureteric Stent (SIS) at the time the PSS needs replacing.
Unlike the PSS, the SIS sits entirely in the ureter without the coils at either end and does not need to be changed as often. This can reduce the number of hospital visits and number of surgeries, which can then reduce NHS costs. However, SIS is not commonly used in the NHS due to limited research on how well it works compared to PSS.
What we are doing
In this study, we will evaluate whether the SIS is better than the PSS to relieve ureter blockages.
To do this, we will see if the SIS reduces stent-related symptoms, the number of surgeries needed, NHS costs and whether it can improve a patient’s QoL.
We will be recruiting 334 adults from NHS hospitals in the UK who already have a PSS and due a stent change to take part. They will be randomised to receive either the SIS or continue with PSS changes.
We will conduct an eight month internal pilot of 9 NHS sites with a further 8 NHS sites set-up for the main trial. Recruitment will be conducted over a 24-month period.
We will be measuring stent-related symptoms including urinary symptoms, body pain, general health and work performance. We will also collect further information on quality-of-life, renal function, urinary infections, complications, healthcare resource implications and cost-effectiveness.
Chief Investigator
Mr Chandrasekharan Badrakumar
Sponsor
South Tees Hospitals NHS Foundation Trust
Funder
National Institute for Health and Care Research Health Technology Assessment (NIHR HTA)
Current status
In set-up