CompletedNot Applicable

Reduction of Stent Associated Morbidity by Minimizing Stent Material.

Switzerland92 participantsStarted 2017-07-15

Plain-language summary

After providing informed consent, patients will be randomized into one of two groups (single-blinded): Group 1 will receive a standard Percuflex® (Boston scientific) ureteral stent. Diameter: 6F, length according to surgeons' estimation. Patients in Group 2 will receive a Suture-Stent adjusted to the individual stone location. All participant receive standardized patient information, using a validated leaflet on ureteral stenting and associated morbidity. In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1 week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of "baseline symptoms". During secondary stone removal, stents are removed and ureteral dilatation / access is assessed. The removed stents will be assessed for biofilm formation within the framework of an approved and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential complications and adverse events are assessed at all scheduled and unscheduled patient visits.

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: * Kidney stone(s) and/or ureteral stone(s) at the iliacal vessel crossing of the ureter or proximally * Indication for ureteral stenting for the preparation of a secondary intervention * Informed consent Exclusion Criteria: * Patients younger than 18 years * Bilateral ureteral stenting * Stenting because of malignant obstruction * Mentally retarded patients * Obstructive pyelonephritis at the time of stent insertion * Additional operations performed during the stent indwelling time

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

Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent

Timeframe: One week after stent insertion and 2-6 weeks after removal

Trial details

NCT IDNCT03217318

SponsorCantonal Hospital of St. Gallen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-22

View on ClinicalTrials.gov More Ureteral Stent Related Morbidity trials