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

NCT07535580 | Completed DMC FDA Device

• 1 other identifier: HREC/25658/Austin-2025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Single-J Stent; Double-J stent; ureteric stent; ureteroscopy; endourology

Outcome Measures

Primary Outcomes (1)

• Stent Migration Rates

  Stent migration rate of the modified Single-J ureteric stent (SJS), assessed by direct visualisation via flexible cystoscopy at the time of stent removal, approximately 14 days (±2 days) following ureteroscopy. Migration is classified into four categories: (1) stent tip freely floating within the bladder - no clinically significant migration; (2) stent tip at the ureteric orifice - partial proximal migration; (3) stent tip located in the urethra - distal migration; (4) stent tip not visualised - indeterminate. A clinically acceptable migration rate is pre-defined as 5% or less, consistent with rates reported for standard Double-J stents in the literature. This cystoscopic assessment is performed as part of the routine stent removal procedure and does not require any additional intervention beyond standard care. Migration events requiring re-intervention are recorded as adverse events and reported accordingly.

  From stent insertion to removal within 4 weeks

Secondary Outcomes (1)

• USDT (Ureteral Stent Discomfort Test) Scores

  From before stent insertion to stent removal within 4 weeks

Study Arms (1)

Single-J Stent

EXPERIMENTAL

All participants receive a modified Single-J ureteric stent (SJS) at the time of their scheduled ureteroscopy (URS) for ureteric stone disease. The device is a Cook Medical Bander Ureteral Diversion Stent, shortened to 28 cm from the proximal renal curl, eliminating the distal bladder loop of a standard Double-J stent (DJS). A 7 cm prolene suture is anchored to the distal tip to aid retrieval. The SJS is inserted under fluoroscopic guidance following stone treatment and DJS removal. It remains in situ for approximately two weeks, after which it is removed via flexible cystoscopy. Stent tip position is classified at removal to assess migration. Participants complete the validated Ureteral Stent Discomfort Test (USDT) before URS (with DJS in situ) and again at removal (with SJS in situ), enabling a direct within-subject symptom comparison.

Device: Single-J Stent

Interventions

Single-J Stent DEVICE

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

Single-J Stent

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Undergoing elective ureteroscopy (URS) and stent exchange for ureteric stone disease
• Able and willing to provide written informed consent
• Sufficient English proficiency to complete the USDT symptom questionnaire

You may not qualify if:

• Single functioning kidney or bilateral ureteric disease
• History of ureteric strictures or prior ureteric reconstruction
• Pregnancy or breastfeeding
• Active urinary tract infection at time of URS
• Immunocompromised state (e.g. ongoing chemotherapy or high-dose corticosteroids)
• Any contraindication to ureteric stenting or flexible cystoscopy
• Unwilling or unable to comply with follow-up procedures
• Complex intraoperative findings precluding safe SJS insertion, including: ureteric stone \>10mm, impacted stone, stone in the intramural ureter, difficult stent placement, or significant intraoperative haematuria

Sponsors & Collaborators

• Austin Health: lead

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Study Officials

• Joseph Ischia

  Austin Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Research Fellow

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: October 27, 2025
• Primary Completion: January 22, 2026
• Study Completion: March 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)