Reduction of Stent Associated Morbidity by Minimizing Stent Material.

January 23, 2020 updated by: Dominik Abt, Cantonal Hospital of St. Gallen

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

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • St. Gallen, Switzerland
        • Urological Department, Cantonal Hospital of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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).
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
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).
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
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).
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)
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) measured by the success of: Entering the whole ureter or Insertion of an access sheath 14/12F; Complete stone removal.
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
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).
2-6 weeks after stent insertion
Comparison of practicability of Suture-Stent and standard ureteral stent
Time Frame: 2-6 weeks after stent insertion
Comparison of practicability of Suture-Stent and standard ureteral stent (i.e. insertion time, problems with insertion or removal)
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
Time Frame: At the time of stent insertion and 2-6 weeks after insertion
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)
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
Microbiological investigation of the suture-part of the Suture-stent: total biofilmmass, number of bacteria
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 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).
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
Assessment of medication that had to be taken in both groups
At the time of stent insertion until 2-6 weeks after stent removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2017

Primary Completion (ACTUAL)

January 22, 2020

Study Completion (ACTUAL)

January 22, 2020

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (ACTUAL)

July 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

February 1, 2019

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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