Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy

August 17, 2021 updated by: Saddam Al Demour, University of Jordan

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 1 week
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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