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Completed

NCT Number: NCT07362784

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antegrade flexible ureteroscopy for group A

Procedure

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

retrograde flexible ureteroscopy For group B

Procedure

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

Primary outcomes

  1. stone free rate

    Time frame: 3 weeks after the intervention

    stone free rate was compared between the 2 arms

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: mm millimeter

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.