Prospective Randomized Controlled Trial Comparing Traditional Access Sheath and Novel Tip-Flexible Suctioning Ureteral Access Sheath Combined with Flexible Ureteroscope in the Treatment of Renal Calculi

This randomized controlled study aims to evaluate the efficacy and safety of the flexible and navigable suction ureteral access sheath (NTFS-UAS) compared to the traditional access sheath (T-UAS) in patients undergoing retrograde intrarenal surgery (RIRS). Patients presenting to the Urology OPD and scheduled for RIRS will be randomized into two groups using software. One group will use the traditional access sheath, while the other will use the NTFS-UAS.

Study Parameters

Stone Clearance Rate

Duration of Surgery

Stone-Free Rate: Assessed at Day 1, 1 month, and 3 months postoperatively.

Need for Ancillary Procedures

Complication Rates: Including infection rates.

Imaging and Measurement

Radiopaque Calculi: Patients with stones having a Hounsfield Unit (HU) of more than 1000 will have their residual stone bulk and clearance rates compared using X-ray imaging.

Radiolucent Calculi: Patients with stones having a HU of less than 1000 will undergo CT scans to compare stone bulk in the preoperative and postoperative periods.

This study will provide comprehensive data to determine which access sheath is superior in terms of surgical duration, stone clearance, ancillary procedure requirements, and infection rates.