Reduction of Stent Associated Morbidity by Minimizing Stent Material.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03217318
• Date of registration: 03/07/2017
• Prospective Registration: Yes
• Primary sponsor: Cantonal Hospital of St. Gallen
• Public title: Reduction of Stent Associated Morbidity by Minimizing Stent Material.
• Scientific title: Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
• Date of first enrolment: July 15, 2017
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03217318
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ureteral Stent Related Morbidity

Intervention(s)

Device: ureteral stenting with standard or modified ureteral stent

Primary Outcome(s)

Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent [Time Frame: One week after stent insertion and 2-6 weeks after removal]

Secondary Outcome(s)

Comparison of practicability of Suture-Stent and standard ureteral stent [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 [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) [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 [Time Frame: At the time of stent insertion until 2-6 weeks after stent removal]

Difference in total morbidity as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) [Time Frame: 2-6 weeks after stent insertion and 2-6 weeks after removal]

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) [Time Frame: 2-6 weeks after stent insertion]

Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent [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 [Time Frame: 2-6 weeks after stent insertion]

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 [Time Frame: 2-6 weeks after stent insertion and 2-6 weeks after removal]

Comparison of the total biofilmmass and number of bacteria on stent surface between the Suture-Stent and standard ureteral stent [Time Frame: At the time of stent insertion and 2-6 weeks after insertion]

Microbiological investigation of the suture-part of the Suture-stent [Time Frame: 2-6 weeks after stent insertion]

Secondary ID(s)

CTU 16.028 EKOS 17-00496

Source(s) of Monetary Support

Please refer to primary and secondary sponsors