Ureteral CatheterizationNCT02845726
Biofilms on Short-term Indwelling Ureteral Stents
An observational study of Ureteral Catheterization and Biofilm, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Catheterization, Biofilm, Morbidity
- What is being tested?
- Stent examination, urinary analysis, USSQ questionnaire
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Dec 2017
- 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 undergoing ureteral stenting for the preparation of a secondary intervention in an inpatient setting at the department of urology of KSSG.
Who may be able to join
- Patients temporarily undergoing ureteral stenting
- Informed consent
Who cannot join
- Bilateral stenting
- Ureteral obstruction due to malignancies
- Additionally performed procedures/operations during stent indwelling time -Cognitively impaired patients
- UTI at the time of stent insertion (>10 to the power of 2 cfu/ml)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Urological Department, Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: Biofilms on Short-term Indwelling Ureteral Stents: Influence on Associated Symptoms and Complications; Prediction by Urine Analysis; Current Bacterial Spectrum and Antibiotic Resistance
This study is performed to analyze various aspects of biofilms on ureteral stents.
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.
Moreover, it could provide more detailed knowledge about the correlation of the occurrence of biofilms on ureteral stents and findings in urinary analysis, which could serve as a decision support whether patients with ureteral stents undergoing further interventions (for example ESWL or simple secondary URS) should receive antibiotic prophylaxis.
Correlation of results of urinary bacteriologies (assessed pre- and intraoperatively) and biofilm analysis on stents could provide information if "targeted antibiotic treatment" based on urinary bacteriology only is possible at all.
Correlation of urinary analysis and conventional urinary bacteriology could provide a valuable contribution regarding the prediction of bacteriuria and the necessity of postponing operations.
Additionally, the study is intended to provide an overview over the recent bacterial species that are involved into biofilms on ureteral stents and their resistance to antibiotics. This could provide valuable information about the choice of antibiotics in cases were treatment has to be performed empirically.
- Conditions
- Ureteral Catheterization, Biofilm, Morbidity
- Being tested
- Stent examination, urinary analysis, USSQ questionnaire
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 temporary ureteral stent | Assessment of patients transiently undergoing ureteral stenting. 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: Four weeks (range 2-6 weeks) after stent insertion
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Measured: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Secondary outcomes (7)
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Measured: One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
Urinary analysis (pH, nitrite, leucocyturia, hematuria).
Measured: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Urine Culture
Measured: Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)
Rapid immunoassay test for bacteriuria
Measured: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Next generation sequencing of biofilms
To identify bacterial species that are involved into biofilms on ureteral stents.
Measured: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)
Measured: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Number of bacteria on stent surface (determined via quantitative PCR)
Measured: Day of stent removal: Four weeks (range 2-6 weeks) 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 posted27 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion23 Sep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral CatheterizationStudies 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
- 85 participants (estimated)
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
- Investigators
- Dominik Abt, Dr. med., Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845726
- Sponsor's protocol ID
- CTU 15.010
- Status last verified
- Jan 2018
- First submitted
- 8 Jul 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buhmann MT, Abt D, Nolte O, Neu TR, Strempel S, Albrich WC, Betschart P, Zumstein V, Neels A, Maniura-Weber K, Ren Q. Encrustations on ureteral stents from patients without urinary tract infection reveal distinct urotypes and a low bacterial load. Microbiome. 2019 Apr 13;7(1):60. doi: 10.1186/s40168-019-0674-x.
PubMed 30981280
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilms on Short-term Indwelling Ureteral Stents: Influence on Associated Symptoms and Complications; Prediction by Urine Analysis; Current Bacterial Spectrum and Antibiotic Resistance
- ClinicalTrials.gov ID
- NCT02845726
- Acronym / sponsor ID
- CTU 15.010
- Conditions
- Ureteral Catheterization, Biofilm, Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 23 Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Jul 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.
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.
Moreover, it could provide more detailed knowledge about the correlation of the occurrence of biofilms on ureteral stents and findings in urinary analysis, which could serve as a decision support whether patients with ureteral stents undergoing further interventions (for example ESWL or simple secondary URS) should receive antibiotic prophylaxis.
Correlation of results of urinary bacteriologies (assessed pre- and intraoperatively) and biofilm analysis on stents could provide information if "targeted antibiotic treatment" based on urinary bacteriology only is possible at all.
Correlation of urinary analysis and conventional urinary bacteriology could provide a valuable contribution regarding the prediction of bacteriuria and the necessity of postponing operations.
Additionally, the study is intended to provide an overview over the recent bacterial species that are involved into biofilms on ureteral stents and their resistance to antibiotics. This could provide valuable information about the choice of antibiotics in cases were treatment has to be performed empirically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with temporary ureteral stent | – | Other: Stent examination, urinary analysis, USSQ questionnaireAssessment of patients transiently undergoing ureteral stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ureteral stenting for the preparation of a secondary intervention in an inpatient setting at the department of urology of KSSG.
Key inclusion criteria (2 listed)
- Patients temporarily undergoing ureteral stenting
- Informed consent
Key exclusion criteria (4 listed)
- Bilateral stenting
- Ureteral obstruction due to malignancies
- Additionally performed procedures/operations during stent indwelling time -Cognitively impaired patients
- UTI at the time of stent insertion (>10 to the power of 2 cfu/ml)
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 temporary ureteral stent |
Primary outcome
Total biofilm mass on ureteral stents.
Time frame: Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
7 secondary outcomes
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
Urinary analysis (pH, nitrite, leucocyturia, hematuria).
Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Urine Culture
Time frame: Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)
Rapid immunoassay test for bacteriuria
Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Next generation sequencing of biofilms
Time frame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)
Time frame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Number of bacteria on stent surface (determined via quantitative PCR)
Time frame: Day of stent removal: Four weeks (range 2-6 weeks) 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 25 Jan 2018.
- Derived from this study: PubMed 30981280Buhmann MT, Abt D, Nolte O, Neu TR, Strempel S, Albrich WC, Betschart P, Zumstein V, Neels A, Maniura-Weber K, Ren Q. Encrustations on ureteral stents from patients without urinary tract infection reveal distinct urotypes and a low bacterial load. Microbiome. 2019 Apr 13;7(1):60. doi: 10.1186/s40168-019-0674-x.
- Individual participant dataSharing planned: No
Related trials for Ureteral Catheterization
RecruitingObservational study
Ureteral Stent Exchange Abstention in Urinary Tract Infections
Urinary Tract Infections, Urinary Catheterization
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.
Dominik Abt, 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 Ureteral Catheterization and Biofilm, 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 2 inclusion and 4 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 25 Jan 2018. 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: Four weeks (range 2-6 weeks) after stent insertion). 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?
On the ClinicalTrials.gov record for NCT02845726, which also lists 1 linked publication.
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 25 Jan 2018.