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Purpose <p>Achieving the highest possible stone-free rate is the primary goal of kidney stone surgery, yet standard flexible ureterorenoscopy often leaves small residual fragments that predispose to recurrence. The hydrogel method using mediNiK<sup>®</sup> was developed to embed and extract even the smallest fragments with conventional baskets. This study aimed to evaluate the safety and feasibility—defined as the ability to extract fragments &lt; 1&#xa0;mm—of stone extraction during flexible ureterorenoscopy with or without the hydrogel method.</p> Materials and methods <p>This prospective, randomized, multicenter proof-of-concept trial included patients &gt; 18 years with kidney stones &gt; 8&#xa0;mm and no anatomical abnormalities. Patients were randomized to flexible ureterorenoscopy + hydrogel (Group 1) or flexible ureterorenoscopy (Group 2) alone. After laser lithotripsy, fragments were retrieved either embedded in hydrogel or individually, and categorized by size (&lt; 0.5&#xa0;mm, 0.5–1.0&#xa0;mm, &gt; 1.0&#xa0;mm). Explorative statistical analyses included Mann-Whitney U, Student’s t-test, and Chi-square test. Adverse events were monitored intraoperatively and during a 6-week follow-up.</p> Results <p>Of 65 screened patients, 40 were analysed (Group 1: <i>n</i> = 23; Group 2: <i>n</i> = 17). The hydrogel method significantly retrieved more fragments &lt; 1&#xa0;mm (1716 vs. 209) and &gt; 1&#xa0;mm (310 vs. 118). On a per-patient level, more &lt; 1&#xa0;mm fragments were removed in Group 1 (median 7 [IQR 21] vs. 0 [2], <i>p</i> &lt; 0.003). Surgery duration was longer in Group 1 (80 [28] vs. 62 [20] minutes, <i>p</i> = 0.02). No serious adverse events were reported.</p> Conclusions <p>The hydrogel method was a safe and feasible addition to fURS, allowing improved retrieval of even the smallest fragments without added risk. The main limitations are the small sample size and absence of long-term stone-free and recurrence data, underscoring the need for larger confirmatory studies.</p>

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Stone extraction during flexible ureterorenoscopy with or without the hydrogel method: a randomized, multicenter safety and feasibility study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月31日

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  • T. Amiel,
  • A. Neisius,
  • C. Netsch,
  • A. Secker,
  • C. Fisang,
  • I. Grunwald,
  • L. Lunger,
  • M. Straub

摘要

Purpose

Achieving the highest possible stone-free rate is the primary goal of kidney stone surgery, yet standard flexible ureterorenoscopy often leaves small residual fragments that predispose to recurrence. The hydrogel method using mediNiK® was developed to embed and extract even the smallest fragments with conventional baskets. This study aimed to evaluate the safety and feasibility—defined as the ability to extract fragments < 1 mm—of stone extraction during flexible ureterorenoscopy with or without the hydrogel method.

Materials and methods

This prospective, randomized, multicenter proof-of-concept trial included patients > 18 years with kidney stones > 8 mm and no anatomical abnormalities. Patients were randomized to flexible ureterorenoscopy + hydrogel (Group 1) or flexible ureterorenoscopy (Group 2) alone. After laser lithotripsy, fragments were retrieved either embedded in hydrogel or individually, and categorized by size (< 0.5 mm, 0.5–1.0 mm, > 1.0 mm). Explorative statistical analyses included Mann-Whitney U, Student’s t-test, and Chi-square test. Adverse events were monitored intraoperatively and during a 6-week follow-up.

Results

Of 65 screened patients, 40 were analysed (Group 1: n = 23; Group 2: n = 17). The hydrogel method significantly retrieved more fragments < 1 mm (1716 vs. 209) and > 1 mm (310 vs. 118). On a per-patient level, more < 1 mm fragments were removed in Group 1 (median 7 [IQR 21] vs. 0 [2], p < 0.003). Surgery duration was longer in Group 1 (80 [28] vs. 62 [20] minutes, p = 0.02). No serious adverse events were reported.

Conclusions

The hydrogel method was a safe and feasible addition to fURS, allowing improved retrieval of even the smallest fragments without added risk. The main limitations are the small sample size and absence of long-term stone-free and recurrence data, underscoring the need for larger confirmatory studies.