A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent
Two Single Arm, Multicentre Unblinded First-in-human Trials Investigating a Novel Ureteric Stent to Determine the Reduction of Encrustation, Biofilm Deposition and Complications Compared to a Conventional JJ Stent
University of Southampton
50 participants
Aug 6, 2025
INTERVENTIONAL
Conditions
Summary
Urological stents and catheters often lead to inflammation, causing pain and infection in the urinary tract. Moreover, 80% of stents are associated with pain, negatively impacting on QoL and mental health. Offering novel designs with significantly lower E\&B leads to a reduction in UTIs and improves QoL. Reducing hospital admissions (from 3 to 1 per patient, annually) would free \>100,000 bed-nights, allowing the elderly to regain independence. Our proposed research could have a significant impact towards fulfilling the 'healthy-ageing' Grand Challenge. Additionally, the novel stent reduces prevalence of infections and therefore, of antibiotic prescriptions contributing to the Global AMR challenge.
Eligibility
Inclusion Criteria7
- Aged 18 years or over
- Ureteric stents clinically indicated either due to kidney stones or abdominal/pelvic cancers compressing ureters
- Previous experience with ureteric stents
- Awaiting insersion/replacement of stents
- Ability to give consent
- Ability to interact with study documentation
- Sufficient English to complete study documentations and questionnaires
Exclusion Criteria3
- Expected survival <4months
- Unfit for stent insertion
- Unable to comply with study processes Pregnancy
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Interventions
Kidney stone patients and Oncology patients admitted to either the University Hospital Southampton (UHS) or University College London Hospital (UCLH) for management of kidney stones or for the management of urine drainage in ureter will have a novel ureteric stent instead of their planned conventional stent. The novel stent will be removed after 4 weeks (kidney stone patients) or 25 weeks (oncology patients). Recruitment to the cohort of oncology patients will only commence once the results for kidney stones patients have been reviewed.
Kidney stone patients, Oncology patients and doctors will be interviewed about their experience of having a stent, or their experience in managing patients with a stent.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06815120