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

NCT07767773 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Ureteral 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.

PROCEDURE

Sheathless RIRS

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

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Abul-fotouh Ahmed · Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-16
Primary Completion
2027-12-01
Completion
2027-12-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767773 on ClinicalTrials.gov