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

NCT06815120 | Not Yet Recruiting DMC

• 1 other identifier: 63246
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Catheter Blockage; Oncology; Kidney Stone

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

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

  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

  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

  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

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

Other Outcomes (1)

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

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

Study Arms (2)

Kidney Stone cohort

EXPERIMENTAL

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: 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

Oncology cohort

EXPERIMENTAL

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: 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

Interventions

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.

Kidney Stone cohort; Oncology cohort

Qualitative interview OTHER

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.

Kidney Stone cohort; Oncology cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Expected survival \<4months
• Unfit for stent insertion
• Unable to comply with study processes Pregnancy

Sponsors & Collaborators

• University of Southampton: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• University College London Hospitals: collaborator

Related Publications (19)

• Prattley 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 BACKGROUND

• Heers 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 BACKGROUND

• Z. 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

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• C. R. UK, "Cancer incidence by age," 2020. https://www.cancerresearchuk.org/health-professional/cancer-statistics/incidence/age#heading-Zero (accessed Apr. 11, 2021)

  BACKGROUND

• Kehinde 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 BACKGROUND

• S. 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)

  BACKGROUND

• Zumstein 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 BACKGROUND

• Feneley 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.

  PMID: 26383168 BACKGROUND

• Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.

  PMID: 12576847 BACKGROUND

• Ramachandra M, Mosayyebi A, Carugo D, Somani BK. Strategies to Improve Patient Outcomes and QOL: Current Complications of the Design and Placements of Ureteric Stents. Res Rep Urol. 2020 Jul 31;12:303-314. doi: 10.2147/RRU.S233981. eCollection 2020.

  PMID: 32802807 BACKGROUND

• Mosayyebi A, Manes C, Carugo D, Somani BK. Advances in Ureteral Stent Design and Materials. Curr Urol Rep. 2018 Apr 10;19(5):35. doi: 10.1007/s11934-018-0779-y.

  PMID: 29637309 BACKGROUND

• Mosayyebi A, Vijayakumar A, Yue QY, Bres-Niewada E, Manes C, Carugo D, Somani BK. Engineering solutions to ureteral stents: material, coating and design. Cent European J Urol. 2017;70(3):270-274. doi: 10.5173/ceju.2017.1520. Epub 2017 Aug 28.

  PMID: 29104790 BACKGROUND

• Liatsikos EN, Kallidonis P, Kyriazis I, Karnabatidis D, Tsamandas A, Sakellaropoulos G, Flaris N, Rigopoulos C, Toronidis C, Efthimiou I, Filos K, Siablis D, Perimenis P. Metallic double pigtail ureteral stent usage during extracorporeal shock wave lithotripsy in the swine model: is there any effect on the ureter? J Endourol. 2009 Apr;23(4):685-91. doi: 10.1089/end.2008.0569.

  PMID: 19335328 BACKGROUND

• S. Zheng et al., "Quantitative Evaluation of Encrustations in Double-J Ureteral Stents With Micro-Computed Tomography and Semantic Segmentation," Frontiers in Urology, vol. 2, 2022, [Online]. Available: https://www.frontiersin.org/articles/10.3389/fruro.2022.836563

  BACKGROUND

• Tomer N, Garden E, Small A, Palese M. Ureteral Stent Encrustation: Epidemiology, Pathophysiology, Management and Current Technology. J Urol. 2021 Jan;205(1):68-77. doi: 10.1097/JU.0000000000001343. Epub 2020 Aug 28.

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• Mosayyebi A, Lange D, Yann Yue Q, Somani BK, Zhang X, Manes C, Carugo D. Reducing deposition of encrustation in ureteric stents by changing the stent architecture: A microfluidic-based investigation. Biomicrofluidics. 2019 Jan 4;13(1):014101. doi: 10.1063/1.5059370. eCollection 2019 Jan.

  PMID: 30867872 BACKGROUND

• Mosayyebi A, Yue QY, Somani BK, Zhang X, Manes C, Carugo D. Particle Accumulation in Ureteral Stents Is Governed by Fluid Dynamics: In Vitro Study Using a "Stent-on-Chip" Model. J Endourol. 2018 Jul;32(7):639-646. doi: 10.1089/end.2017.0946. Epub 2018 Jun 12.

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Related Links

• NHS, "Overview - Hydronephrosis," NHS website, 2018

MeSH Terms

Conditions

Neoplasms; Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Mosayyebi

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Mosayyebi

CONTACT

02380594767; a.mosayyebi@soton.ac.uk

Sophie Varkonyi-Clifford

CONTACT

02381203866; cassette@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two single arm, multicentre unblinded first-in-human trials, including 2 phases and a qualitative substudy

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: February 7, 2025
• Study Start: February 28, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02