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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAl-Azhar University

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Ureteral access sheath-assisted RIRS
  • Sheathless RIRS

Treatment groups

1,200 Participants
are divided into 2 treatment groups

Sponsors and collaborators