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Completed

NCT Number: NCT03217318

Reduction of Stent Associated Morbidity by Minimizing Stent Material.

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.

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Key information

Conditions

Ureteral Stent Related Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ureteral stenting with standard or modified ureteral stent

Device

Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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).

  7. 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)

  8. 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)

  9. 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

  10. 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).

  11. 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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.