Longterm Indwelling Ureteral StentNCT02871609
Assessment of Longterm Ureteral Stenting
An observational study of Longterm Indwelling Ureteral Stent, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Longterm Indwelling Ureteral Stent
- What is being tested?
- Stent examination, urinary analysis, USSQ questionnaire
- How many people
- 91 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Nov 2018
- Phase
- Observational
- 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
Study population: Patients with longterm indwelling ureteral stent undergoing regular changes in an inpatient or outpatient setting at the department of urology of KSSG.
Who may be able to join
- Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
- Informed consent
- responsible patients
Who cannot join
- ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
- insufficient language skills
- cognitive limitation
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: Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms
This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.
Read the detailed description
The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting.
In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.
The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.
- Conditions
- Longterm Indwelling Ureteral Stent
- Being tested
- Stent examination, urinary analysis, USSQ questionnaire
- Keywords
- Biofilm, Morbidity, Ureteral Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent examination, urinary analysis, USSQ questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with longterm ureteral stent | Not described Receives: Other: Stent examination, urinary analysis, USSQ questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total biofilm mass on ureteral stents
Measured: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Measured: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Secondary outcomes (4)
Urine Culture
Measured: 2-6 months after stent insertion
Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents
Measured: 2-6 months after stent insertion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2-6 months after stent insertion
Assessment of costs arising from complications
complications assessed by CTCAE v4.0
Measured: 2-6 months after stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Longterm Indwelling Ureteral StentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Betschart, Cantonal Hospital of St. Gallen
- Investigators
- Patrick Betschart, Dr. med., Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871609
- Sponsor's protocol ID
- CTU 16.011
- Status last verified
- Jan 2019
- First submitted
- 5 Aug 2016
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms
- ClinicalTrials.gov ID
- NCT02871609
- Acronym / sponsor ID
- CTU 16.011
- Conditions
- Longterm Indwelling Ureteral Stent
- Keywords
- Biofilm, Morbidity, Ureteral Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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.
This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.
Detailed description
The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting.
In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.
The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with longterm ureteral stent | – | Other: Stent examination, urinary analysis, USSQ questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with longterm indwelling ureteral stent undergoing regular changes in an inpatient or outpatient setting at the department of urology of KSSG.
Key inclusion criteria (3 listed)
- Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
- Informed consent
- responsible patients
Key exclusion criteria (3 listed)
- ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
- insufficient language skills
- cognitive limitation
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 |
|---|---|---|
| Stent examination, urinary analysis, USSQ questionnaire | Other | Patients with longterm ureteral stent |
Primary outcome
Total biofilm mass on ureteral stents
Time frame: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change
4 secondary outcomes
Urine Culture
Time frame: 2-6 months after stent insertion
Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents
Time frame: 2-6 months after stent insertion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2-6 months after stent insertion
Assessment of costs arising from complications
Time frame: 2-6 months after stent insertion
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 31 Jan 2019.
- 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.
Patrick Betschart, Dr. med. principal investigator
Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Longterm Indwelling Ureteral Stent, 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 3 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 31 Jan 2019. 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?
Total biofilm mass on ureteral stents (time frame: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change). The study lists 2 primary outcomes in all. 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 31 Jan 2019.