Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
Primary Purpose
Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
urethral catheter placement
Sponsored by
About this trial
This is an interventional treatment trial for Complications; Urethral Catheter
Eligibility 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
Sites / Locations
- Marmara University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No-catheter
Catheter
Arm Description
after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones
Outcomes
Primary Outcome Measures
ureteric stent symptom questionnaire (USSQ) score
evaluation of flank pain
Secondary Outcome Measures
white blood cell count on complete blood count
evaluation of laboratory test results for infectious parameters
c-reactive protein (CRP) levels
evaluation of laboratory test results for infectious parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03713411
Brief Title
Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
Official Title
Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Urethral Catheter, Ureteral Catheterization, Ureteroscopy, Lower Urinary Tract Symptoms, Flank Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No-catheter
Arm Type
No Intervention
Arm Description
after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
Arm Title
Catheter
Arm Type
Active Comparator
Arm Description
urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones
Intervention Type
Procedure
Intervention Name(s)
urethral catheter placement
Intervention Description
urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
Primary Outcome Measure Information:
Title
ureteric stent symptom questionnaire (USSQ) score
Description
evaluation of flank pain
Time Frame
at the 24th hour of the operation
Secondary Outcome Measure Information:
Title
white blood cell count on complete blood count
Description
evaluation of laboratory test results for infectious parameters
Time Frame
at the 24th hour of the operation
Title
c-reactive protein (CRP) levels
Description
evaluation of laboratory test results for infectious parameters
Time Frame
at the 24th hour of the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiloren Tanidir, Assc. Prof.
Phone
905325694275
Email
yiloren@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarik Emr Sener, M.D.
Phone
+5337620712
Email
dr.emresener@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarik Emre Sener, MD
Organizational Affiliation
Marmara University Hospital, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yiloren Tanidir
Organizational Affiliation
Marmara University Hospital, Department of Urology
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiloren Tanidir, Assoc. Prof.
Phone
+905325694275
Email
yiloren@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tarik Emre Sener, M.D.
Phone
+905337620712
Email
dr.emresener@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
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