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NCT04145063 Clinical Trial

Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy

Ureter Stone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04145063
Other study ID # Sad2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2016
Est. completion date December 1, 2020

Study information
Verified date August 2021
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• no stent
following uretroscopy, no stent will be placed

Locations
Country Name City State
Jordan Jordan University Hospital Amman

Sponsors (1)
Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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