Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713411
• Other study ID #: MAR.UAD.004
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications; Urethral Catheter
• Flank Pain
• Lower Urinary Tract Symptoms
• Ureteral Catheterization
• Ureteroscopy

Intervention

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

Locations

Country	Name	City	State
Turkey	Marmara University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ureteric stent symptom questionnaire (USSQ) score	evaluation of flank pain	at the 24th hour of the operation
Secondary	white blood cell count on complete blood count	evaluation of laboratory test results for infectious parameters	at the 24th hour of the operation
Secondary	c-reactive protein (CRP) levels	evaluation of laboratory test results for infectious parameters	at the 24th hour of the operation