Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric … (NCT07535580) | Clinical Trial Compass
CompletedNot Applicable
Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy
Australia28 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stent Migration Rates
Timeframe: From stent insertion to removal within 4 weeks