Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study (mm millimeter)

January 15, 2026 updated by: Mohammad Saad Abdulbaki Hafez Attaby, Ain Shams University
This study aims to assess the efficacy and safety of antegrade flexible ureteroscopic lithotripsy in treating upper ureteric stones >10 mm in maximum dimension and impacted upper ureteric stones irrespective of size in comparison to retrograde ureteroscopic lithotripsy and evaluate feasibility, adverse events, hospital stay and cost benefit of both techniques

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study included 100 patients meeting the inclusion criteria for having an upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years. Stones were deemed impacted in case of lack of movement for 1 month on 2 computed tomography scans of urinary tract (CTUT) or non passage of guide wire and / or dye intraoperatively. Exclusion criteria were unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors. All patients signed an informed consent and were randomized by closed envelop method into 2 groups: group A included 50 patients treated by antegrade flexible URSL and group B included 50 patients treated by retrograde flexible URSL.

Preoperatively, all patients underwent evaluation by medical history, physical examination, laboratory work up including complete blood count (CBC), kidney functions test, liver functions test, hepatitis markers, coagulation profile, completer urine analysis and urine culture with sensitivity. All patients were subjected to imaging studies including pelvi-abdominal ultrasound, plain X-ray of urinary tract and CTUT. Postoperatively, all patient had CBC done a few hours after the procedure, monitored for vital signs and urine color. All patients were assessed for residual stone presence 3 weeks after procedure by CTUT. Stone free status was defined by absence of stone fragment of 4 mm or more in maximum diameter. The primary endpoint was stone free rate. Secondary endpoints were complications, operative time, fluoroscopy time, mean hemoglobin drop, hospital stay and need for auxiliary procedures.

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

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Ain shams university hospitals

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years

Exclusion Criteria:

  • unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors

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
Active Comparator: group A
Antegrade flexible ureteroscopy
Procedure: antegrade flexible ureteroscopy for group A
The antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile
Active Comparator: group B
retrograde flexible ureteroscopy
Procedure: retrograde flexible ureteroscopy For group B
he antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rate
Time Frame: 3 weeks after the intervention
stone free rate was compared between the 2 arms
3 weeks after the intervention

Collaborators and Investigators

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

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 15, 2022

Primary Completion (Actual)

August 10, 2025

Study Completion (Actual)

September 14, 2025

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAMSU M D 23/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

for 6 months after publication

IPD Sharing Access Criteria

access for all requesting urologists via Email of central contact person

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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