Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 18, 2021
August 1, 2021
3.3 years
October 28, 2019
August 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 week
Study Arms (3)
uncomplicated ureteroscopic lithotripsy with DJ-US
NO INTERVENTIONFollowing uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care)
uncomplicated ureteroscopic lithotripsy without US
ACTIVE COMPARATORFollowing uncomplicated uretroscopic lithotripsy no uretric stent will be placed
uncomplicated ureteroscopic lithotripsy with DJ-US-string
NO INTERVENTIONFollowing uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed
Interventions
following uretroscopy, no stent will be placed
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- unilateral ureteric stones managed by ureteroscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jordan University Hospital
Amman, 11942, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
February 2, 2016
Primary Completion
June 1, 2019
Study Completion
December 1, 2020
Last Updated
August 18, 2021
Record last verified: 2021-08