Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial

What this Trial Is About

This research aims to compare two types of ureteral access sheaths used during flexible ureteroscopy to treat kidney stones, known as nephrolithiasis. The study focuses on a novel bendable suction ureteral access sheath with a flexible tip that can reach the renal calyces, compared to a conventional ureteral access sheath. The goal is to evaluate their effectiveness and safety in removing stones, especially for patients with stones smaller than 20 mm, where flexible ureteroscopy is considered a first-line surgical option. Participants will be randomly assigned to one of two groups: one group will receive flexible ureteroscopy using the bendable suction ureteral access sheath, while the other group will receive the same procedure with the conventional ureteral access sheath. Both groups undergo minimally invasive surgery with flexible ureteroscopes, and the new device aims to improve surgical vision, reduce pressure inside the kidney, and lower infection risks during treatment. During the study, participants will be monitored for stone-free status immediately after surgery and again at three months postoperatively. Researchers will also track hospital stay duration, need for additional interventions, complications, and costs over three months. The total participation period includes surgery and follow-up assessments up to three months to measure the outcomes and safety of the two devices in treating renal stones.

Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy