Back to resultsUreteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
Primary Purpose
Ureter Stone
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
no stent
Sponsored by
About this trial
This is an interventional treatment trial for Ureter Stone
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- unilateral ureteric stones managed by ureteroscopy
Exclusion Criteria:
- Stone size < 2 cm
- bilateral ureteral stones
- incomplete stone removal due to impacted stones
- failed ureteroscopic access to the stone
- stone migration to the kidney
- pregnancy
- active urinary tract infection
- solitary kidney
- ureteral stent placed preoperatively
- severe mucosal injury or perforation
- suspected additional ureteral pathology such as ureteral stricture
- urothelial carcinoma or polyp.
Sites / Locations
- Jordan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
No Intervention
Arm Label
uncomplicated ureteroscopic lithotripsy with DJ-US
uncomplicated ureteroscopic lithotripsy without US
uncomplicated ureteroscopic lithotripsy with DJ-US-string
Arm Description
Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care)
Following uncomplicated uretroscopic lithotripsy no uretric stent will be placed
Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed
Outcomes
Primary Outcome Measures
Visual Analog Score (VAS)
Visual Analog Score (VAS) for flank pain and dysuria score, urgency, frequency, suprapubic pain, hematuria, analgesia requirement, operative time, re-hospitalization, and return to normal physical activity. This is a widely-used scale. It a unidimensional measure of pain intensity. It is administered as a straight horizontal line orientated from the left (worst) to the right (best) , where the patient indicates their situation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04145063
Brief Title
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
Official Title
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
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
This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uncomplicated ureteroscopic lithotripsy with DJ-US
Arm Type
No Intervention
Arm Description
Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care)
Arm Title
uncomplicated ureteroscopic lithotripsy without US
Arm Type
Active Comparator
Arm Description
Following uncomplicated uretroscopic lithotripsy no uretric stent will be placed
Arm Title
uncomplicated ureteroscopic lithotripsy with DJ-US-string
Arm Type
No Intervention
Arm Description
Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed
Intervention Type
Other
Intervention Name(s)
no stent
Intervention Description
following uretroscopy, no stent will be placed
Primary Outcome Measure Information:
Title
Visual Analog Score (VAS)
Description
Visual Analog Score (VAS) for flank pain and dysuria score, urgency, frequency, suprapubic pain, hematuria, analgesia requirement, operative time, re-hospitalization, and return to normal physical activity. This is a widely-used scale. It a unidimensional measure of pain intensity. It is administered as a straight horizontal line orientated from the left (worst) to the right (best) , where the patient indicates their situation.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
unilateral ureteric stones managed by ureteroscopy
Exclusion Criteria:
Stone size < 2 cm
bilateral ureteral stones
incomplete stone removal due to impacted stones
failed ureteroscopic access to the stone
stone migration to the kidney
pregnancy
active urinary tract infection
solitary kidney
ureteral stent placed preoperatively
severe mucosal injury or perforation
suspected additional ureteral pathology such as ureteral stricture
urothelial carcinoma or polyp.
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
We'll reach out to this number within 24 hrs