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