Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy

Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Ureter Stone
• Intervention / Treatment: Other: no stent

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: uncomplicated ureteroscopic lithotripsy with DJ-US; Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care)
Active Comparator: uncomplicated ureteroscopic lithotripsy without US; Following uncomplicated uretroscopic lithotripsy no uretric stent will be placed	Other: no stent; following uretroscopy, no stent will be placed
No Intervention: uncomplicated ureteroscopic lithotripsy with DJ-US-string; Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: Sad2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No