Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

Not Applicable

Completed

• Conditions: Complications; Urethral Catheter; Ureteral Catheterization; Ureteroscopy; Lower Urinary Tract Symptoms; Flank Pain
• Interventions: Procedure: urethral catheter placement

• Registration Number: NCT03713411
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-04-01
• Status Verified: 2023-08
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter	urethral catheter placement	urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones

Primary Outcome Measures

Name	Time	Method
ureteric stent symptom questionnaire (USSQ) score	at the 24th hour of the operation	evaluation of flank pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marmara University Hospital; 🇹🇷 Istanbul, Turkey