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CompletedNCT07362784mm millimeterUpdated Jan 23, 2026

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

An interventional study of antegrade flexible ureteroscopy for group A and retrograde flexible ureteroscopy For group B in Upper Ureteric Stones, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Mar 2022, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Upper Ureteric Stones

Keywords

  • flexible ureteroscopy
  • proximal ureteric stones
  • laser
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    group A

    Antegrade flexible ureteroscopy

    Procedure: antegrade flexible ureteroscopy for group A

  • Active comparator
    group B

    retrograde flexible ureteroscopy

    Procedure: retrograde flexible ureteroscopy For group B

Interventions

  • Procedureantegrade 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

  • Procedureretrograde 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

06

What researchers measure

Primary outcomes

  1. stone free rate

    stone free rate was compared between the 2 arms

    Time frame: 3 weeks after the intervention

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Study locations

1 site
  • Ain Shams University hospitals
    Cairo, Cairo Governorate, Egypt
08

References and documents

Publications

  • 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. PubMed 32840338 ↗
  • 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. PubMed 33029428 ↗
  • 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. PubMed 37921933 ↗
  • Wishahi M, Attaby M, El Halaby R, Elbaz AG, Hasan M. Efficacy and safety of antegrade ureteroscopic lithotripsy versus retrograde ureteroscopic lithotripsy in the treatment of upper ureteric stones measuring > 10 mm in maximum dimension and/or impacted stones: randomized comparative study. World J Urol. 2026 May 5;44(1):340. doi: 10.1007/s00345-026-06445-7. PubMed 42086948 ↗

Study documents

  • Protocol, analysis plan and consent form · Jan 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07362784
Lead sponsor
Ain Shams University
Responsible party
Mohammad Saad Abdulbaki Hafez Attaby (MD candidate, Ain Shams University) — Principal investigator
First posted
Jan 23, 2026
Start date
Mar 15, 2022
Primary completion
Aug 10, 2025
Completion
Sep 14, 2025
Last update
Jan 23, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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