Viewing Study NCT03713411



Ignite Creation Date: 2024-05-06 @ 12:16 PM
Last Modification Date: 2024-10-26 @ 12:56 PM
Study NCT ID: NCT03713411
Status: COMPLETED
Last Update Posted: 2024-01-29
First Post: 2018-10-18

Brief Title: Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement
Sponsor: Marmara University
Organization: Marmara University

Study Overview

Official Title: Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement
Status: COMPLETED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 doesnt 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 doesnt 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None