Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?

Conditions
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Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy, Lower Urinary Tract Symptoms, Flank Pain

Intervention / Treatment
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* Procedure: urethral catheter placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No-catheter<br>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<br>urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones | Procedure: urethral catheter placement<br>* urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ureteric stent symptom questionnaire (USSQ) score | evaluation of flank pain | at the 24th hour of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| white blood cell count on complete blood count | evaluation of laboratory test results for infectious parameters | at the 24th hour of the operation | 
| c-reactive protein (CRP) levels | evaluation of laboratory test results for infectious parameters | at the 24th hour of the operation |