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Comparison of Two Versus Four Weeks of Ureteral Stenting Prior to Ureteroscopy After Failed Primary Ureteral Access

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study First Submitted
This study proposes a non-randomized controlled trial comparing 2 weeks versus 4 weeks of DJ ureteral stenting in patients whose primary ureteral access failed during an initial attempt at FURS. The purpose is to determine whether a longer stenting period improves subsequent ureteral access. Participants: Adults aged 18-65 years with renal/upper ureteric stones ≤20 mm and failed primary access. Sample size: 198 patients - 99 in each group. Group A: Repeat FURS after 2 weeks of DJ stenting. Group B: Repeat FURS after 4 weeks of DJ stenting. Primary outcome: Successful placement of a 10/12-Fr ureteral access sheath during repeat FURS without additional dilation. Secondary outcomes: Stone-free rate and USSQ score. Stone-free definition: No residual stone fragment ≥4 mm on NCCT at 4 weeks after FURS. Analysis: t-test/Mann-Whitney U for numerical variables and Chi-square/Fisher's exact test for categorical variables, with p \< 0.05 considered significant.
Trial Details
NCT Number NCT07868874
Lead Sponsor PAEC General Hospital, Islamabad
Conditions
(from sponsor)
Urolithiasis
Related terms Urolithiasis
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov