Comparing Standard Ureterorenoscopy With and Without Hydrogel to Improve Kidney Stone Removal

What this Trial Is About

Kidney stones, known as urolithiasis, have become more common worldwide, affecting about 15% of people. Diagnoses and surgical removals have increased notably in countries like Germany, France, and England over recent years. Ureterorenoscopy URS, a procedure using laser technology to break up stones, is often preferred but can leave small fragments behind, which may cause new stones to form. Reducing these residual fragments is important to lower recurrence rates and improve patient quality of life while managing healthcare costs. This study compares two treatment approaches for kidney stone removal the standard URS with lithotripsy alone and URS combined with a new two-component hydrogel called mediNiK. The hydrogel is applied after stone fragmentation to embed and capture smaller stone fragments, enabling easier removal. Both procedures involve positioning the patient, sterile preparations, cystoscopy, guidewire placement, and laser fragmentation of stones, followed by stent and catheter placement. The study aims to assess how well mediNiK improves stone clearance compared to standard care. Participants will undergo treatment and be followed up for several months to monitor stone clearance rates, surgery duration, complications, and costs. Assessments include postoperative imaging at two months, tracking stone-related events up to three months, and cost analysis up to twelve months. Researchers will also gather feedback from surgeons about the procedures. The studys results are intended to provide valuable information for improving kidney stone treatment practices and outcomes.

Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal