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Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

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ClinicalTrials.gov Identifier: NCT03713411
Recruitment Status : Unknown
Verified April 2019 by Marmara University.
Recruitment status was:  Recruiting
First Posted : October 19, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Marmara University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Complications; Urethral Catheter Ureteral Catheterization Ureteroscopy Lower Urinary Tract Symptoms Flank Pain Procedure: urethral catheter placement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : June 1, 2020
Arms and Interventions
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Arm Intervention/treatment
No Intervention: No-catheter
after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
Active Comparator: Catheter
urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones
 Procedure: urethral catheter placement
urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder


Outcome Measures
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Primary Outcome Measures :
  1. ureteric stent symptom questionnaire (USSQ) score [ Time Frame: at the 24th hour of the operation ]
    evaluation of flank pain


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713411


Contacts
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Contact: Yiloren Tanidir, Assc. Prof. 905325694275 yiloren@yahoo.com
Contact: Tarik Emr Sener, M.D. +5337620712 dr.emresener@gmail.com

Locations
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Turkey
Marmara University Hospital Recruiting
Istanbul, Turkey, 34890
Contact: Yiloren Tanidir, Assoc. Prof.    +905325694275    yiloren@yahoo.com   
Contact: Tarik Emre Sener, M.D.    +905337620712    dr.emresener@gmail.com   
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Tarik Emre Sener, MD Marmara University Hospital, Department of Urology
Study Chair: Yiloren Tanidir Marmara University Hospital, Department of Urology
More Information
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03713411    
Other Study ID Numbers: MAR.UAD.004
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Flank Pain
Urological Manifestations
Pain
Neurologic Manifestations