Ureteral Stent Related MorbidityNCT03217318
Reduction of Stent Associated Morbidity by Minimizing Stent Material.
A study testing ureteral stenting with standard or modified ureteral stent in people with Ureteral Stent Related Morbidity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent Related Morbidity
- What is being tested?
- ureteral stenting with standard or modified ureteral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2017to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Urological Department, Cantonal Hospital of St. Gallen
Sankt Gallen
About this study
Official title: 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.
Read more
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.
- Conditions
- Ureteral Stent Related Morbidity
- Being tested
- ureteral stenting with standard or modified ureteral stent
- Keywords
- ureteral stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteral stenting with standard or modified ureteral stentDevice
Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally
| Study group | Role | What they receive |
|---|---|---|
| ureteral stenting with standard ureteral stent | Active comparator | Group 1 will receive a standard ureteral stent. Diameter: 6F, length according to surgeons' estimation and patient's height. Receives: Device: ureteral stenting with standard or modified ureteral stent |
| ureteral stenting with suture-stent | Active comparator | 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. Receives: Device: ureteral stenting with standard or modified ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
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)
Measured: One week after stent insertion and 2-6 weeks after removal
Secondary outcomes (11)
Difference in Pain-Symptoms and Urinary-Symptoms as assessed by the validated questionnaire USSQ (ureteral stent symptoms questionnaire) between standard stent and Suture-Stent
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).
Measured: 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)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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)
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.
Measured: 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
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).
Measured: 2-6 weeks after stent insertion
Comparison of practicability of Suture-Stent and standard ureteral stent
Comparison of practicability of Suture-Stent and standard ureteral stent (i.e. insertion time, problems with insertion or removal)
Measured: 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
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)
Measured: At the time of stent insertion and 2-6 weeks after insertion
Microbiological investigation of the suture-part of the Suture-stent
Microbiological investigation of the suture-part of the Suture-stent: total biofilmmass, number of bacteria
Measured: 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)
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).
Measured: At the time of stent insertion until 2-6 weeks after stent removal
Assessment of medication that had to be taken in both groups
Assessment of medication that had to be taken in both groups
Measured: At the time of stent insertion until 2-6 weeks after stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start15 Jul 2017
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent Related MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Abt, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217318
- Sponsor's protocol ID
- CTU 16.028 EKOS 17-00496
- Status last verified
- Feb 2019
- First submitted
- 3 Jul 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
- ClinicalTrials.gov ID
- NCT03217318
- Acronym / sponsor ID
- CTU 16.028 EKOS 17-00496
- Conditions
- Ureteral Stent Related Morbidity
- Keywords
- ureteral stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ureteral stenting with standard ureteral stent | Active comparator | Device: ureteral stenting with standard or modified ureteral stentGroup 1 will receive a standard ureteral stent. Diameter: 6F, length according to surgeons' estimation and patient's height. |
| ureteral stenting with suture-stent | Active comparator | Device: ureteral stenting with standard or modified ureteral stentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- Bilateral ureteral stenting
- Stenting because of malignant obstruction
- Mentally retarded patients
- Obstructive pyelonephritis at the time of stent insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ureteral stenting with standard or modified ureteral stentUreteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally | Device | ureteral stenting with standard ureteral stent, ureteral stenting with suture-stent |
Primary outcome
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)
11 secondary outcomes
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 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 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 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
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
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 practicability of Suture-Stent and standard ureteral stent
Time frame: 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
Microbiological investigation of the suture-part of the Suture-stent
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ureteral stenting with standard or modified ureteral stent in people with Ureteral Stent Related Morbidity, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: One week after stent insertion and 2-6 weeks after removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.