Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
Trial Parameters
Brief Summary
The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Correspondingly, the number of surgical stone removal procedures increased by 3%, 38%, and 18%, respectively. Common treatments include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy, and percutaneous nephrolithotomy (PCNL). URS, depending on stone size, has become a preferred method due to advancements in intraoperative imaging and laser technology. Despite these improvements, small fragments often remain post-intervention, leading to recurrent stones. Complete removal of all fragments is crucial to significantly reduce recurrence rates. Current literature suggests a high recurrence rate with residual fragments, impacting healthcare costs and patient quality of life. A key objective in endourological research is optimizing the stone clearance rate. Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation. These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times. Recently, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was developed. This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust, forming a removable conglomerate. MediNiK® has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe, showing potential for optimizing stone removal. A multicenter study has assessed the safety and tolerability of mediNiK® in standard URS (Open, randomized, multicentre study to evaluate the safety, tolerability, and performance of mediNiK® compared to standard treatment in kidney stone removal - DRKS00030532). Results indicate the gel is safe and tolerable. However, further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK®.
Eligibility Criteria
Inclusion Criteria: * Male or female subjects aged ≥ 18 years * Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months * Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT. * Ability to read, write and speak German * Women of childbearing age must have a negative serum pregnancy test at the start of the study. * Submission of a personally signed and dated informed consent form stating that the subject has been informed of all relevant aspects of the study prior to any trial-related activity and that all information has been understood Exclusion Criteria: * Participation in another clinical trial for kidney stone removal in the last 6 months * Subjects with gastrointestinal cancer who have not been in remission for at least 2 years * Subjects with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject * Subjects wi