- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217318
Reduction of Stent Associated Morbidity by Minimizing Stent Material.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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St. Gallen, Switzerland
- Urological Department, Cantonal Hospital of St. Gallen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ureteral stenting with standard ureteral stent
Group 1 will receive a standard ureteral stent.
Diameter: 6F, length according to surgeons' estimation and patient's height.
|
Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally
|
ACTIVE_COMPARATOR: ureteral stenting with suture-stent
In Group 2, a modification of the standard ureteral stent will be inserted.
The stent will be cut through obliquely according to the position of the ureteral calculus.
The extend to be removed can be easily measured by the retrograde probing catheter and is replaced by a monofilament, non-absorbable suture as described previously by Vogt et al. (W J Urol, 2015).
This suture can be easily attached by puncturing the bevelled stent end.
|
Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
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One week after stent insertion and 2-6 weeks after removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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).
|
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)
Time Frame: 2-6 weeks after stent insertion and 2-6 weeks after removal
|
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).
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2-6 weeks after stent insertion and 2-6 weeks after removal
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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
|
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).
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2-6 weeks after stent insertion and 2-6 weeks after removal
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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
|
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).
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2-6 weeks after stent insertion
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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
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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.
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2-6 weeks after stent insertion
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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
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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).
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2-6 weeks after stent insertion
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Comparison of practicability of Suture-Stent and standard ureteral stent
Time Frame: 2-6 weeks after stent insertion
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Comparison of practicability of Suture-Stent and standard ureteral stent (i.e.
insertion time, problems with insertion or removal)
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2-6 weeks after stent insertion
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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
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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)
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At the time of stent insertion and 2-6 weeks after insertion
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Microbiological investigation of the suture-part of the Suture-stent
Time Frame: 2-6 weeks after stent insertion
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Microbiological investigation of the suture-part of the Suture-stent: total biofilmmass, number of bacteria
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2-6 weeks after stent insertion
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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
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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).
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At the time of stent insertion until 2-6 weeks after stent removal
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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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Assessment of medication that had to be taken in both groups
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At the time of stent insertion until 2-6 weeks after stent removal
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CTU 16.028 EKOS 17-00496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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