Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Catheter Blockage | — | UNRESOLVED | — |
| Kidney Stone | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
| Qualitative interview | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Kidney Stone cohort
- description
- 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)
- interventionNames
- Device: 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)
- Other: Qualitative interview
- type
- EXPERIMENTAL
- label
- Oncology cohort
- description
- 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)
- interventionNames
- Device: 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)
- Other: Qualitative interview
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 insersion/replacement of stents 5. Ability to give consent 6. Ability to interact with study documentation 7. Sufficient English to complete study documentations and questionnaires Exclusion Criteria: 1. Expected survival \<4months 2. Unfit for stent insertion 3. Unable to comply with study processes Pregnancy
References
Publications (19)
- BACKGROUNDPrattley S, Voss J, Cheung S, Geraghty R, Jones P, Somani BK. Ureteroscopy and stone treatment in the elderly (>/=70 years): prospective outcomes over 5- years with a review of literature. Int Braz J Urol. 2018 Jul-Aug;44(4):750-757. doi: 10.1590/S1677-5538.IBJU.2017.0516. PMID 29522293
- BACKGROUNDHeers H, Turney BW. Trends in urological stone disease: a 5-year update of hospital episode statistics. BJU Int. 2016 Nov;118(5):785-789. doi: 10.1111/bju.13520. Epub 2016 May 26. PMID 27128735
- BACKGROUNDZ. Chen, M. Prosperi, and V. Y. Bird, "Prevalence of kidney stones in the USA: The National Health and Nutrition Evaluation Survey," J Clin Urol, vol. 12, no. 4, pp. 296-302, Jul. 2019, doi: 10.1177/2051415818813820
- BACKGROUNDC. R. UK, "Cancer incidence by age," 2020. https://www.cancerresearchuk.org/health-professional/cancer-statistics/incidence/age#heading-Zero (accessed Apr. 11, 2021)
- BACKGROUNDKehinde EO, Rotimi VO, Al-Hunayan A, Abdul-Halim H, Boland F, Al-Awadi KA. Bacteriology of urinary tract infection associated with indwelling J ureteral stents. J Endourol. 2004 Nov;18(9):891-6. doi: 10.1089/end.2004.18.891. PMID 15659928
- BACKGROUNDS. T. Thomas, C. Heneghan, C. P. Price, A. van den Bruel, and A. Plüddemann, "Point-of-care testing for urinary tract infections - NIHR Community Healthcare MIC," NIHR, Jun. 2016. https://www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/point-of-care-testing-for-urinary-tract-infections (accessed Feb. 01, 2023)
- BACKGROUNDZumstein V, Betschart P, Albrich WC, Buhmann MT, Ren Q, Schmid HP, Abt D. Biofilm formation on ureteral stents - Incidence, clinical impact, and prevention. Swiss Med Wkly. 2017 Feb 3;147:w14408. doi: 10.4414/smw.2017.14408. eCollection 2017. PMID 28165539
- BACKGROUNDFeneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18.