Clinical trial NCT03217318: Reduction of Stent Associated Morbidity by Minimizing Stent Material.
Official title: Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Stent Related Morbidity
Keywords: ureteral stent
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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: 2-6 weeks after stent insertion and 2-6 weeks after removal
measure: Difference in total morbidity as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire)
timeFrame: 2-6 weeks after stent insertion and 2-6 weeks after removal
measure: 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
timeFrame: 2-6 weeks after stent insertion and 2-6 weeks after removal
measure: Comparison of the ureteral expanse after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention
timeFrame: 2-6 weeks after stent insertion
measure: 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)
timeFrame: 2-6 weeks after stent insertion
measure: Comparison of the mucosal irritation after stenting with the new Suture-Stent and the standard ureteral stent at the time of secondary intervention
timeFrame: 2-6 weeks after stent insertion
measure: Comparison of practicability of Suture-Stent and standard ureteral stent
timeFrame: 2-6 weeks after stent insertion
measure: Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent
timeFrame: At the time of stent insertion and 2-6 weeks after insertion
measure: Microbiological investigation of the suture-part of the Suture-stent
timeFrame: 2-6 weeks after stent insertion
measure: Assessment of complications not assessed by USSQ during intervention and indwelling time (i.e. intraoperative complications, additional hospitalizations, prolongation of hospitalization, ureteral injuries)
timeFrame: At the time of stent insertion until 2-6 weeks after stent removal
measure: Assessment of medication that had to be taken in both groups
timeFrame: At the time of stent insertion until 2-6 weeks after stent removal
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Urological Department, Cantonal Hospital of St. Gallen
Study officials:
References: