Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study
Technical University of Munich
120 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria10
- 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 with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
- Subjects with known impaired renal function from stage IV or known dialysis
- Subjects with chronic hydronephrosis not associated with nephrolithiasis
- Subjects with the following known or suspected diseases: Coagulation disorders, untreated urinary tract infections, renal disease sepsis and marked prostatic hyperplasia
- Subjects with any other disease or condition that, in the opinion of the investigator, could interfere with the purpose of the study (e.g. bleeding that restricts vision in the kidney, problems in the renal tubular system)
- Breastfeeding or pregnant women
- Subjects who may be part of a vulnerable group (e.g. prisoners or developmentally delayed adults)
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Interventions
The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Finally, a double-J or mono-J stent and a transurethral catheter are placed.
The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Application of MediNiK to embbed the residual stones in the hydrogel and extract it with a basket. Finally, a double-J or mono-J stent and a transurethral catheter are placed.
Locations(1)
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NCT06469736