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Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy

NCT07535580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-17

No results posted yet for this study

Summary

This study investigates whether a modified Single-J ureteric stent (SJS) is a safe and better-tolerated alternative to the standard Double-J stent (DJS) following ureteroscopy (URS) for kidney and ureteric stone disease. Standard DJS are routinely placed after URS but frequently cause significant patient discomfort, including urinary urgency, frequency, pain, and haematuria. The SJS is created by modifying a commercially available Bander Ureteral Diversion Stent - retaining the proximal renal coil but removing the distal bladder loop - with the aim of reducing these lower urinary tract symptoms while maintaining adequate ureteric drainage and positional stability.

Eligible participants are adults aged 18 or older who are already pre-stented with a DJS and are scheduled for elective URS at Austin Health (Austin Hospital or Heidelberg Repatriation Hospital, Melbourne, Australia). At the time of URS, the existing DJS is replaced with the modified SJS. Participants complete a validated symptom questionnaire - the Ureteral Stent Discomfort Test (USDT) - both before URS (with DJS in situ) and at the time of stent removal approximately two weeks later (with SJS in situ), enabling a direct within-patient comparison. Stent migration is assessed cystoscopically at removal. The study aims to enrol 40 participants over approximately six months.

Conditions

  • Ureter Calculi

Interventions

DEVICE

Single-J Stent

All participants receive a modified Single-J ureteric stent (SJS) at the time of their scheduled ureteroscopy (URS) for ureteric stone disease. Uniquely, the device is fashioned intraoperatively from a Cook Medical Bander Ureteral Diversion Stent - a stent not conventionally used in this clinical context - by shortening it to exactly 28 cm from the proximal renal curl, eliminating the distal bladder loop present in standard Double-J stents (DJS). A 7 cm non-absorbable prolene suture is anchored to the distal tip to facilitate cystoscopic retrieval. The SJS is inserted under fluoroscopic guidance immediately following laser lithotripsy and DJS removal, within the same operative episode. This study is, to our knowledge, the first Australian prospective feasibility study employing this specific device modification post-URS. Unlike prior SJS studies conducted in transplant or conduit diversion settings, this intervention targets pre-stented stone patients, enabling a controlled within-subj

Sponsors & Collaborators

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Joseph Ischia · Austin Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-01-22
Completion
2026-03-01
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535580 on ClinicalTrials.gov