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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
92
Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally
Urological Department, Cantonal Hospital of St. Gallen
Sankt Gallen, Switzerland
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
Difference in the USSQ subscores ("Pain-Symptoms" and "Urinary-Symptoms") between standard stent and Suture-Stent (symptoms assessed one week after insertion and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal)
Time frame: One week after stent insertion and 2-6 weeks after removal
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
Difference in the USSQ subscores ("Pain-Symptoms" and "Urinary-Symptoms") between standard stent and Suture-Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal).
Time frame: 2-6 weeks after stent insertion and 2-6 weeks after removal
Difference in total morbidity as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire)
Difference in the USSQ total score between standard ureteral stent and Suture- Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal).
Time frame: 2-6 weeks after stent insertion and 2-6 weeks after removal
Difference in type of morbidity as assessed by USSQ sub-scores and single-items (e.g. equal function, work incapacity, hematuria and others) between standard ureteral stent and Suture-Stent
Difference in the USSQ sub scores and items (i.e. general health, work performance, sexual matters, items, additional problems, GQ, assessment of haematuria: items U8 and U9) between standard ureteral stent and Suture-Stent (symptoms assessed before removal (i.e. 2-6 weeks after insertion) and corrected for "baseline symptoms" by assessing symptom subscores 2-6 weeks after stent removal).
Time frame: 2-6 weeks after stent insertion and 2-6 weeks after removal
Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention
Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention (measured by a retrograde ureterography) at three locations of the ureter (i.e. proximal, middle and distal ureter).
Time frame: 2-6 weeks after stent insertion
Differences of ureteral access with a 9.5 F ureterorenoscopy device after stenting with the new Suture-Stent or the standard ureteral stent at the time of secondary intervention (URS)
Differences of ureteral access with a 9.5 F ureterorenoscopy device after stenting with the new Suture-Stent or the standard ureteral stent at the time of secondary intervention (URS) measured by the success of: Entering the whole ureter or Insertion of an access sheath 14/12F; Complete stone removal.
Time frame: 2-6 weeks after stent insertion
Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention
Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention (measured by a grading: no, light, heavy irritation) at two locations (periostial and ureteral).
Time frame: 2-6 weeks after stent insertion
Comparison of practicability of Suture-Stent and standard ureteral stent
Comparison of practicability of Suture-Stent and standard ureteral stent (i.e. insertion time, problems with insertion or removal)
Time frame: 2-6 weeks after stent insertion
Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent
Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent measured at time of stent removal (2-6 weeks after insertion)
Time frame: At the time of stent insertion and 2-6 weeks after insertion
Microbiological investigation of the suture-part of the Suture-stent
Microbiological investigation of the suture-part of the Suture-stent: total biofilmmass, number of bacteria
Time frame: 2-6 weeks after stent insertion
Assessment of complications not assessed by USSQ during intervention and indwelling time (i.e. intraoperative complications, additional hospitalizations, prolongation of hospitalization, ureteral injuries)
Assessment of complications not assessed by USSQ during intervention and indwelling time (e.g. perioperative adverse events according to Clavien-Dindo classification, stent dislocation or dysfunction during indwelling time).
Time frame: At the time of stent insertion until 2-6 weeks after stent removal
Assessment of medication that had to be taken in both groups
Assessment of medication that had to be taken in both groups
Time frame: At the time of stent insertion until 2-6 weeks after stent removal
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