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

ConditionsCatheter Blockage Oncology Kidney Stone

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-99

SponsorUniversity of Southampton

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Expected survival <4months

Unfit for stent insertion

Unable to comply with study processes Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental ureteric stent with specially shaped side-holes that prevent stagnation points (i.e., areas of low flow that cause particles to settle and E&B)
Device
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.
Qualitative interview
Other intervention
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Kidney Stone cohortExperimental treatment 2 interventions

Group B: Oncology cohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

To determine rates of stent failure

Outcome measure: Stent failure, defined as any of: a): a stent change earlier than planned (oncology only); b) need for additional surgical or radiological intervention; c): kidney failure (evidenced by acute kidney injury (AKI) on blood tests (eGFR or creatinine kidney function tests) and/or worsening hydronephrosis on imaging Summary method: Frequency and percentage of people experiencing any stent failure

Time frame

From enrolment to stent removal (4 weeks for Kidney cohort), (25 weeks for Oncology cohort)

Secondary outcomes

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

Outcome measure: * Cell culturing (CFU counts per ml per bacterial microorganism) * Flow study (pressure value): A section of the retrieved stent will be used for flow study. The part will be placed into a larger diameter tube. DI water/Saline is injected using a pump into the inlet of the external tube and pressure sensor is connected to the inlet tube. Pressure readings will be captured per stent. * Dwell time Summary method: * Imaging (selected samples of stents will be examined using non-contact, non-destructive SEM (scanning-electron-microscopy) and/or episcopic-differential-interference-contrast (EDIC) microscopy allowing imaging of the surface with the biofilm in-situ and colonisation by bacteria - when needed) * Mean and standard deviation or median and quartiles of pressure readings

Time frame

From enrolment to stent removal (4 weeks for Kidney cohort), (25 weeks for Oncology cohort)

To determine whether the novel stent leads to better clinical outcomes

Outcome measure: * Individual component of the primary outcome * Urinary symptoms * Infections Summary method: * As per primary outcome * Frequency and percentage of participants experiencing each symptom * Frequency and percentage of people with antibiotic * use, readmission, urosepsis, ITU, death; number of infections per unit of time stent is in use

Time frame

From enrolment to completion of patient questionnaires 2-3 weeks post surgery 2 (4 weeks for Kidney cohort), 2-3 weeks post surgery 2 (~25 weeks for Oncology cohort)

To assess impact of the novel stent on quality of life

Outcome measure: Questionnaires at: * Baseline * While stent is in situ * Post-surgery Summary method: Appropriate descriptive summaries (e.g., median and quartiles) per timepoint

Time frame

Within first month of stent removal for participants (4 weeks for Kidney cohort), (25 weeks for Oncology cohort)

To understand patient experience in having the novel ureteric stent inserted and reason for participation in the trial

Outcome measure: 30-45-minute Qualitative interviews with Oncology and Kidney stone cohorts Summary method: An inductive thematic analysis of interview transcripts

Time frame

From enrolment to stent removal (4 weeks for Kidney cohort), (25 weeks for Oncology cohort)

Other outcomes

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

Outcome measure: Weight: Weighing stents after being removed from body, at the site (theatre room) and prior to packaging for delivery to the University laboratory Summary method: Mean and standard deviation or median and quartiles of weights pre- and post-insertion

Time frame

After surgery 2 for Kidney Stone cohort (4 weeks) and surgery 2 for Oncology patients (25 weeks)