Clinical trial NCT03713411: Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
Official title: Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Urethral Catheter
Ureteral Catheterization
Ureteroscopy
Lower Urinary Tract Symptoms
Flank Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: ureteric stent symptom questionnaire (USSQ) score
timeFrame: at the 24th hour of the operation
Secondary outcomes:
measure: white blood cell count on complete blood count
timeFrame: at the 24th hour of the operation
measure: c-reactive protein (CRP) levels
timeFrame: at the 24th hour of the operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
affiliation: Marmara University Hospital, Department of Urology
name: Tarik Emre Sener, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Hospital, Department of Urology
name: Yiloren Tanidir
role: STUDY_CHAIR
References: