RecruitingNCT07767773

Long-term Safety of UAS-assisted vs Sheathless RIRS in Non-prestented Patients

Long-Term Safety Outcomes of Ureteral Access Sheath-Assisted Versus Sheathless Retrograde Intrarenal Surgery for Renal Stones ≤20 mm in Non-Prestented Patients: A Retrospective Comparative Cohort Study With Active Follow-up

Sponsor

Al-Azhar University

Enrollment

1,200 participants

Start Date

Aug 16, 2026

Study Type

OBSERVATIONAL

Conditions

Retrograde Intrarenal Surgery Urolithiasis Hydronephrosis Ureteral Stricture Ureteral Access Sheath Renal Stone Disease

Summary

This retrospective comparative cohort study will include adult patients who underwent primary RIRS for renal stones ≤20 mm at Al-Azhar University Hospitals between January 2020 and December 2025. Patients will be classified by whether a ureteral access sheath (UAS) was used during the index RIRS, and all eligible patients will be invited for active long-term follow-up (minimum 12 months) to assess the composite outcome of delayed ipsilateral ureteral stricture or new/progressive ipsilateral hydronephrosis and other safety and efficacy outcomes. Propensity-score methods and adjusted regression analyses will be used to control confounding.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Sheathless RIRS and a procedure called Ureteral access sheath-assisted RIRS for people with hydronephrosis, renal stone disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUreteral access sheath-assisted RIRS

Retrograde intrarenal surgery (RIRS) performed with placement of a ureteral access sheath during the initial procedure. Details recorded: sheath diameter (Fr), length, manufacturer/model, insertion success, number of insertion attempts, need for ureteral dilation, intraoperative findings.

PROCEDURESheathless RIRS

RIRS performed without placement of a ureteral access sheath. Details recorded: guidewire use, ureteral dilation, access difficulty, intraoperative findings.