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Completed

NCT Number: NCT03713411

Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Hospital

Istanbul, 34890, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urethral catheter placement

Procedure

urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder

Primary outcomes

  1. ureteric stent symptom questionnaire (USSQ) score

    Time frame: at the 24th hour of the operation

    evaluation of flank pain

Secondary outcomes

  1. 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

  2. c-reactive protein (CRP) levels

    Time frame: at the 24th hour of the operation

    evaluation of laboratory test results for infectious parameters

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2018
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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