Complications; Urethral CatheterNCT03713411
Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
A study testing urethral catheter placement in people with Complications; Urethral Catheter and Ureteral Catheterization, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy
- What is being tested?
- urethral catheter placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 31 Dec 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. The purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ stent placement by evaluating the patient-reported outcomes along with laboratory tests.
Read the detailed description
Ureteral stents and foley catheters are the most commonly used disposables in urological practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons.
DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure increases during voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents.
Foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. The practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon.
The aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux and urinary tract infections.
- Conditions
- Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy, Lower Urinary Tract Symptoms, Flank Pain
- Being tested
- urethral catheter placement
- Medical subject headings
- Lower Urinary Tract Symptoms, Flank Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urethral catheter placementProcedure or surgery
urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
| Study group | Role | What they receive |
|---|---|---|
| No-catheter | No intervention | after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed |
| Catheter | Active comparator | urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones Receives: Procedure: urethral catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ureteric stent symptom questionnaire (USSQ) score
evaluation of flank pain
Measured: at the 24th hour of the operation
Secondary outcomes (2)
white blood cell count on complete blood count
evaluation of laboratory test results for infectious parameters
Measured: at the 24th hour of the operation
c-reactive protein (CRP) levels
evaluation of laboratory test results for infectious parameters
Measured: at the 24th hour of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Apr 2019
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Urethral CatheterStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarik Emre Sener, MD, Principal investigator, Marmara University Hospital, Department of UrologyYiloren Tanidir, Study chair, Marmara University Hospital, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713411
- Sponsor's protocol ID
- MAR.UAD.004
- Status last verified
- Aug 2023
- First submitted
- 18 Oct 2018
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
- ClinicalTrials.gov ID
- NCT03713411
- Acronym / sponsor ID
- MAR.UAD.004
- Conditions
- Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy, Lower Urinary Tract Symptoms, Flank Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Oct 2018 (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 semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. The purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ stent placement by evaluating the patient-reported outcomes along with laboratory tests.
Detailed description
Ureteral stents and foley catheters are the most commonly used disposables in urological practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons.
DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure increases during voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents.
Foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. The practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon.
The aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux and urinary tract infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-catheter | No intervention | –after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed |
| Catheter | Active comparator | Procedure: urethral catheter placementurethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients
- Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| urethral catheter placementurethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder | Procedure or surgery | Catheter |
Primary outcome
ureteric stent symptom questionnaire (USSQ) score
Time frame: at the 24th hour of the operation
evaluation of flank pain
2 secondary outcomes
white blood cell count on complete blood count
Time frame: at the 24th hour of the operation
c-reactive protein (CRP) levels
Time frame: at the 24th hour of the operation
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 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Tarik Emre Sener, MD principal investigator
Marmara University Hospital, Department of Urology
Yiloren Tanidir study chair
Marmara University Hospital, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urethral catheter placement in people with Complications; Urethral Catheter and Ureteral Catheterization, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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 29 Jan 2024. 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 Turkey (Türkiye). 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?
ureteric stent symptom questionnaire (USSQ) score (time frame: at the 24th hour of the operation). 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 29 Jan 2024.