Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
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|ClinicalTrials.gov Identifier: NCT03713411|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Complications; Urethral Catheter Ureteral Catheterization Ureteroscopy Lower Urinary Tract Symptoms Flank Pain||Procedure: urethral catheter placement||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
No Intervention: No-catheter
after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
Active Comparator: Catheter
urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones
Procedure: urethral catheter placement
urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
- ureteric stent symptom questionnaire (USSQ) score [ Time Frame: at the 24th hour of the operation ]evaluation of flank pain
- white blood cell count on complete blood count [ Time Frame: at the 24th hour of the operation ]evaluation of laboratory test results for infectious parameters
- c-reactive protein (CRP) levels [ Time Frame: at the 24th hour of the operation ]evaluation of laboratory test results for infectious parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713411
|Contact: Yiloren Tanidir, Assc. Prof.||firstname.lastname@example.org|
|Contact: Tarik Emr Sener, M.D.||+email@example.com|
|Marmara University Hospital||Recruiting|
|Istanbul, Turkey, 34890|
|Contact: Yiloren Tanidir, Assoc. Prof. +905325694275 firstname.lastname@example.org|
|Contact: Tarik Emre Sener, M.D. +905337620712 email@example.com|
|Principal Investigator:||Tarik Emre Sener, MD||Marmara University Hospital, Department of Urology|
|Study Chair:||Yiloren Tanidir||Marmara University Hospital, Department of Urology|