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Clinical Trials/NCT03713411
NCT03713411
Completed
Not Applicable

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

Marmara University1 site in 1 country112 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complications; Urethral Catheter
Sponsor
Marmara University
Enrollment
112
Locations
1
Primary Endpoint
ureteric stent symptom questionnaire (USSQ) score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

ureteric stent symptom questionnaire (USSQ) score

Time Frame: at the 24th hour of the operation

evaluation of flank pain

Secondary Outcomes

  • c-reactive protein (CRP) levels(at the 24th hour of the operation)
  • white blood cell count on complete blood count(at the 24th hour of the operation)

Study Sites (1)

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