Two Single Arm, Multicentre Unblinded Trials Investigating a Novel Ureteric Stent to Reduce Encrustation, Biofilm Deposition, and Complications Compared to a Conventional JJ Stent

What this Trial Is About

Ureteric stents and catheters are commonly used to restore urinary drainage in patients with kidney stones or cancers pressing on the ureters. These devices often cause complications like inflammation, pain, and infections, which negatively affect quality of life and increase antibiotic use. Device-associated encrustation and biofilm formation lead to urinary tract infections in more than 90 of cases, causing stent blockages and contributing to antibiotic resistance. This research aims to study a novel ureteric stent designed to reduce these complications and improve patient outcomes, particularly in elderly and oncology patients. The trial evaluates an experimental ureteric stent with specially shaped side-holes that prevent low-flow areas where particles settle, reducing encrustation and biofilm formation. Patients with kidney stones or abdominalpelvic cancers requiring stents will receive this novel stent instead of a conventional JJ stent. The stent will be removed after 4 weeks for kidney stone patients and after 25 weeks for oncology patients. Recruitment for the oncology group starts after reviewing kidney stone patient results. Additionally, qualitative interviews will be conducted with patients and doctors about their stent experiences. Participants will be monitored from enrolment until stent removal, with assessments of stent failure rates, extent of encrustation and biofilm, clinical outcomes, quality of life, and patient experiences. Questionnaires will be completed 2-3 weeks after stent removal. The study includes multiple visits and data collection to understand the impact of the novel stent. Researchers aim to reduce hospital admissions, improve quality of life, and decrease antibiotic use through this innovative device, with follow-up lasting up to 25 weeks for oncology patients.

A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent