Ureteral Stent Related Morbidity Clinical Trial
Official title:
Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
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.
n/a