Ureteric stent in kidney stone patients and oncology patients Urological and Genital Diseases
Conditions
Interventions
To test these new stents, we will run 'First-in-Human' trials to assess safety, performance, and patient acceptability, providing data for analysis and development of wider clinical trials. We have id
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Ureteric stents clinically indicated either due to kidney stones or abdominal/pelvic cancers compressing ureters 3. Previous experience with ureteric stents 4. Awaiting insertion/replacement of stents 5. Ability to give consent 6. Ability to interact with the study documentation 7. Sufficient English to complete study documentation and questionnaires
Exclusion criteria
Exclusion criteria: 1. Expected survival <4 months 2. Unfit for stent insertion 3. Unable to comply with study processes 4. Pregnancy occurring prior to stent insertion 5. Planned stent removal is not at the same hospital as the stent insertion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent failure, defined as any of: 1. A stent change earlier than planned (oncology only) 2. Need for additional surgical or radiological intervention 3. 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
| Measure | Time frame |
|---|---|
| 1. Extent of encrustation and biofilm (E&B) measured using: 1.1. Cell culturing (CFU counts per ml per bacterial microorganism) 1.2. Dwell time 1.3. Imaging (selected samples of stents will be examined using non-contact, non-destructive episcopic-differential-interference-contrast (EDIC) microscopy allowing imaging of the surface with the biofilm in-situ and colonisation by bacteria – when needed) Time frame: from enrolment to stent removal (~4 weeks for the kidney cohort, ~25 weeks for the oncology cohort) 2. Clinical outcomes: 2.1. Individual components of the primary outcome 2.2. Urinary symptoms 2.3. Infections Time frame: from enrolment to completion of patient questionnaires 2-3 weeks post-surgery 2 (~4 weeks for the kidney cohort), 2-3 weeks post-surgery 2 (~25 weeks for the oncology cohort) 3. Quality of life measured using study-specific baseline (pre-stent insertion/implantation), in situ (stent inserted/implanted) and post-surgery (post-stent removal) questionnaires. Time frame: within first month of stent removal for participants (~4 weeks for the kidney cohort, ~25 weeks for the oncology cohort) 4. Patient experience in having the novel ureteric stent inserted and reason for participation in the trial, assessed using 30–45-minute qualitative interviews with oncology and kidney stone cohorts and an inductive thematic analysis of interview transcripts. Time frame: from enrolment to stent removal (~4 weeks for the kidney cohort, ~25 weeks for the oncology cohort) Other pre-specified outcomes: 1. Extent of encrustation and biofilm (E&B) measured using: 1.1. Weight: Stents will be weighed post-removal upon arrival at the microbiology lab 1.2. 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. I | — |
Countries
England, United Kingdom
Outcome results
None listed