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Purpose <p>To compare the efficacy and safety of different treatment modalities, mini-percutaneous nephrolithotomy (mini-PNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (SWL), for the management of medium-sized, high-density, non-lower-pole renal stones.</p> Methods <p>Between November 2021 and March 2025, adults with single renal stones of 10–20&#xa0;mm and ≥ 1000 HU were prospectively randomized to mini-PNL, RIRS, or SWL. Procedures were performed by experienced endourologists using standardized protocols. The primary outcome was stone-free rate (SFR) at 3&#xa0;months, defined as no residual fragments &gt; 4&#xa0;mm on NCCT. Secondary outcomes included operative and fluoroscopy times, hospital stay, retreatment, perioperative complications, and treatment costs. Analyses followed the intention-to-treat principle.</p> Results <p>Of 330 enrolled patients, 304 completed the study (mini-PNL, n = 105; RIRS, n = 103; SWL, n = 96). Final SFRs were 96.2% for mini-PNL, 91.3% for RIRS, and 51.0% for SWL. Both mini-PNL and RIRS achieved significantly higher SFRs than SWL (p &lt; 0.001), with mini-PNL demonstrating superior single-session clearance. Operative time was shortest with SWL, fluoroscopy exposure was lowest with RIRS, and hospital stay was shortest with RIRS, while SWL was performed on an outpatient basis. Overall complications were 11.4% (mini-PNL), 22.3% (RIRS), and 16.7% (SWL), with no significant differences (p = 0.109) or in high-grade events (p = 0.879). Median treatment costs per stone-free patient were 24,121 EGP for mini-PNL, 57,100 EGP for RIRS, and 23,843 EGP for SWL.</p> Conclusions <p>In conclusion, mini-PNL and RIRS are more effective than SWL, with mini-PNL offering the best balance of efficacy and safety, and RIRS a less invasive but more costly option.</p> Registry <p>ClinicalTrials.gov, TRN: NCT04856722, Registration date: 21 April 2021.</p>

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Prospective randomized trial comparing mini-percutaneous nephrolithotomy, retrograde intrarenal surgery, and shock wave lithotripsy for treatment of medium-sized high-density renal stones

  • 期刊论文

  • 发表日期：

    2025年12月12日

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  • Abul-fotouh Ahmed,
  • Mohammed Raafat,
  • Hany ElDamanhory,
  • Hassan Abdelazim,
  • Ahmed Soliman,
  • Ahmed ElShazly,
  • Mohammed Hindawy,
  • Mohammed Anwar,
  • Mohamed Algammal,
  • Awatef Soliman,
  • Abdullah Daoud

摘要

Purpose

To compare the efficacy and safety of different treatment modalities, mini-percutaneous nephrolithotomy (mini-PNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (SWL), for the management of medium-sized, high-density, non-lower-pole renal stones.

Methods

Between November 2021 and March 2025, adults with single renal stones of 10–20 mm and ≥ 1000 HU were prospectively randomized to mini-PNL, RIRS, or SWL. Procedures were performed by experienced endourologists using standardized protocols. The primary outcome was stone-free rate (SFR) at 3 months, defined as no residual fragments > 4 mm on NCCT. Secondary outcomes included operative and fluoroscopy times, hospital stay, retreatment, perioperative complications, and treatment costs. Analyses followed the intention-to-treat principle.

Results

Of 330 enrolled patients, 304 completed the study (mini-PNL, n = 105; RIRS, n = 103; SWL, n = 96). Final SFRs were 96.2% for mini-PNL, 91.3% for RIRS, and 51.0% for SWL. Both mini-PNL and RIRS achieved significantly higher SFRs than SWL (p < 0.001), with mini-PNL demonstrating superior single-session clearance. Operative time was shortest with SWL, fluoroscopy exposure was lowest with RIRS, and hospital stay was shortest with RIRS, while SWL was performed on an outpatient basis. Overall complications were 11.4% (mini-PNL), 22.3% (RIRS), and 16.7% (SWL), with no significant differences (p = 0.109) or in high-grade events (p = 0.879). Median treatment costs per stone-free patient were 24,121 EGP for mini-PNL, 57,100 EGP for RIRS, and 23,843 EGP for SWL.

Conclusions

In conclusion, mini-PNL and RIRS are more effective than SWL, with mini-PNL offering the best balance of efficacy and safety, and RIRS a less invasive but more costly option.

Registry

ClinicalTrials.gov, TRN: NCT04856722, Registration date: 21 April 2021.