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Recruiting NCT07767773

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1200
Sponsor: Al-Azhar University

Location: Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University Cairo

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 Criteria

Inclusion Criteria: * Age ≥18 years at time of index RIRS. * Primary RIRS performed at Al-Azhar University Hospitals between Jan 1, 2020 and Dec 31, 2025. * Renal stone(s) with maximum diameter ≤20 mm on preoperative imaging. * No ipsilateral ureteral stent or nephrostomy before index RIRS. * Documented operative record specifying whether a UAS was used. * At least 12 months elapsed since index RIRS. * Available contact information allowing invitation for active follow-up. Exclusion Criteria: * Primary ureteral stone treated during the same procedure. * Staghorn or \>20 mm stone burden. * Prior ipsilateral ureteral stricture or reconstructive surgery. * Congenital renal/ureteral anomalies affecting outcome (e.g., horseshoe kidney, duplicated system). * Incomplete operative or preoperative imaging records that preclude determination of eligibility or exposure (UAS use). * Additional ipsilateral ureteral procedure during follow-up that independently causes ureteral narrowing. * Refusal to participate in active follow-up or failure to attend after repeated attempts.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07767773). StuddyBuddy aggregates publicly available trial information.