NCT07362784

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Upper Ureteric Stones

Keywords

flexible ureteroscopyproximal ureteric stoneslaser

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    stone free rate was compared between the 2 arms

    3 weeks after the intervention

Study Arms (2)

group A

ACTIVE COMPARATOR

Antegrade flexible ureteroscopy

Procedure: antegrade flexible ureteroscopy for group A

group B

ACTIVE COMPARATOR

retrograde flexible ureteroscopy

Procedure: retrograde flexible ureteroscopy For group B

Interventions

antegrade flexible ureteroscopy for group APROCEDURE

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

group A
retrograde flexible ureteroscopy For group BPROCEDURE

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

group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Cairo Governorate, Egypt

Location

Related Publications (3)

  • Gokce MI, Akpinar C, Obaid K, Suer E, Gulpinar O, Beduk Y. Comparison of retrograde ureterorenoscopy (URS) and percutaneous anterograde ureteroscopy for removal of impacted upper ureteral stones >10mm in the elderly population. Int Braz J Urol. 2021 Jan-Feb;47(1):64-70. doi: 10.1590/S1677-5538.IBJU.2019.0638.

    PMID: 32840338BACKGROUND

  • Elgebaly O, Abdeldayem H, Idris F, Elrifai A, Fahmy A. Antegrade mini-percutaneous flexible ureteroscopy versus retrograde ureteroscopy for treating impacted proximal ureteric stones of 1-2 cm: A prospective randomised study. Arab J Urol. 2020 Aug 23;18(3):176-180. doi: 10.1080/2090598X.2020.1769385.

    PMID: 33029428BACKGROUND

  • Mohey A, Abdelfattah AA, Mohammed AE, Marzouk A, El-Dakhakhny AS. Comparative study between antegrade flexible ureteroscopy and reterograde intrarenal surgery in the management of impacted upper ureteric stones 1.5 cm or larger. World J Urol. 2023 Dec;41(12):3731-3736. doi: 10.1007/s00345-023-04672-w. Epub 2023 Nov 3.

    PMID: 37921933BACKGROUND

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
MD candidate

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

March 15, 2022

Primary Completion

August 10, 2025

Study Completion

September 14, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
for 6 months after publication
Access Criteria
access for all requesting urologists via Email of central contact person

Locations

EG(1)