Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06815120

Two Single Arm, Multicentre Unblinded Trials Investigating a Novel Ureteric Stent to Reduce Encrustation, Biofilm Deposition, and Complications Compared to a Conventional JJ Stent

Led by University of Southampton · Updated on 2026-05-11

50

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Southampton

Lead Sponsor

U

University Hospital Southampton NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Ureteric stents and catheters are commonly used to restore urinary drainage in patients with kidney stones or cancers pressing on the ureters. These devices often cause complications like inflammation, pain, and infections, which negatively affect quality of life and increase antibiotic use. Device-associated encrustation and biofilm formation lead to urinary tract infections in more than 90% of cases, causing stent blockages and contributing to antibiotic resistance. This research aims to study a novel ureteric stent designed to reduce these complications and improve patient outcomes, particularly in elderly and oncology patients. The trial evaluates an experimental ureteric stent with specially shaped side-holes that prevent low-flow areas where particles settle, reducing encrustation and biofilm formation. Patients with kidney stones or abdominal/pelvic cancers requiring stents will receive this novel stent instead of a conventional JJ stent. The stent will be removed after 4 weeks for kidney stone patients and after 25 weeks for oncology patients. Recruitment for the oncology group starts after reviewing kidney stone patient results. Additionally, qualitative interviews will be conducted with patients and doctors about their stent experiences. Participants will be monitored from enrolment until stent removal, with assessments of stent failure rates, extent of encrustation and biofilm, clinical outcomes, quality of life, and patient experiences. Questionnaires will be completed 2-3 weeks after stent removal. The study includes multiple visits and data collection to understand the impact of the novel stent. Researchers aim to reduce hospital admissions, improve quality of life, and decrease antibiotic use through this innovative device, with follow-up lasting up to 25 weeks for oncology patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or over
  • Ureteric stents clinically indicated due to kidney stones or abdominal/pelvic cancers compressing ureters
  • Previous experience with ureteric stents
  • Awaiting insertion or replacement of stents
  • Ability to give consent
  • Ability to interact with study documentation
  • Sufficient English to complete study documentations and questionnaires
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 4 weeks for Kidney Stone cohort, 25 weeks for Oncology cohort

Participants receive a novel ureteric stent inserted to manage kidney stones or urine drainage caused by abdominal or pelvic cancers.

1 stent insertion visit

Post-operative Follow-up

Duration - 2 to 3 weeks after stent removal

Participants have their novel ureteric stent removed after the treatment period and complete follow-up assessments including patient questionnaires to evaluate stent performance, encrustation, biofilm formation, clinical outcomes, and quality of life.

1 to 2 visits depending on cohort

Trial Site Locations

Total: 2 locations

1

University Hospital Southampton

Southampton, England, United Kingdom, SO16 6YD

Actively Recruiting

2

University College Hospital London

London, London, United Kingdom, W1G 8PH

Actively Recruiting

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Research Team

A

Ali Mosayyebi

S

Sophie Varkonyi-Clifford

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Ureteroscopy and stone treatment in the elderly (≥70 years): prospective outcomes over 5- years with a review of literature.

Sarah Prattley, James Voss, Stephanie Cheung...

https://pubmed.ncbi.nlm.nih.gov/29522293

Strategies to Improve Patient Outcomes and QOL: Current Complications of the Design and Placements of Ureteric Stents.

Meghana Ramachandra, Ali Mosayyebi, Dario Carugo...

https://pubmed.ncbi.nlm.nih.gov/32802807

Metallic double pigtail ureteral stent usage during extracorporeal shock wave lithotripsy in the swine model: is there any effect on the ureter?

Evangelos N Liatsikos, Panagiotis Kallidonis, Iason Kyriazis...

https://pubmed.ncbi.nlm.nih.gov/19335328