Title

Two single arm, multicentre unblinded first-in-human trials, including 2 phases and a qualitative sub study investigating a novel ureteric stent in Kidney stone patients and Oncology patients to determine the reduction of encrustation, biofilm deposition and complications compared to a conventional JJ stent (CASSETTE)

Description

A key problem with ureteric stents is that they can become narrowed or blocked by a build-up of calcium (like scaling in your kettle) or by bacteria (like the gunge in the plughole of your sink or bath). When this happens, patients may develop a urine infection, which needs to be treated with antibiotics. If a patient has many infections, the bacteria can become resistant to antibiotics, so that it becomes more difficult to treat the infections. If the stent is completely blocked, patients need to return to hospital for another operation to replace the stent.

Researchers in the Department of Mechanical Engineering at the University of Southampton have designed a new stent, which should be less prone to blockages. It has holes in the side with unique designs to improve the flow of urine and to prevent the build-up of calcium and bacteria. So,

• these stents should last longer before they need to be replaced. 
• patients should need to come to hospital less often to have the stent changed, which should make their lives easier.

In this study, we want to test these stents in humans for the first time. We need to prove whether they are safe and acceptable to patients, and whether they work as well as we predict.

Objectives

Primary Objectives:

• To determine rates of stent failure

Secondary Objectives:

• To assess extent of encrustation and biofilm (E&B)
• To determine whether the novel stent leads to better clinical outcomes
• To assess impact of the novel ureteric stent on quality of life
• To understand patient experience in having the novel ureteric stent inserted and reason for participation in the trial

Exploratory:

• To assess extent of encrustation and biofilm (E&B)

Trial Design