Flexible suction sheath outperforms conventional sheath in renal stone surgery
This randomized controlled trial enrolled 217 adult patients with renal stones measuring 14-27 mm who were undergoing retrograde intrarenal surgery (RIRS). Participants were assigned to drainage with a flexible navigable suction ureteral access sheath (FANS), percutaneous nephrostomy (PCN), or a conventional ureteral access sheath (UAS).
The primary outcome was stone-free rate (SFR). SFR was 97.2% with PCN (n=72), 98.6% with FANS (n=73), and 81.9% with UAS (n=72). The odds ratio for PCN was 7.756 (95% CI 1.655-36.346) and for FANS was 17.25 (95% CI 2.156-138.024) compared to UAS (p < 0.001). Operative time was shorter with PCN (48 ± 14 min) versus UAS (58 ± 13 min) and FANS (58 ± 11 min) (p < 0.001).
Safety data showed loin/suprapubic pain and hematuria were more frequent with UAS; infectious and major complications were infrequent and similar across groups. Serious adverse events and discontinuations were not reported.
Key limitations include a single RCT with no reported follow-up duration and no funding or conflict disclosures. The practice relevance is that PCN and FANS are effective and safe drainage strategies during RIRS and outperform conventional UAS in SFR; FANS provides a minimally invasive, entirely endoscopic alternative to PCN. Results are limited to the reported population and outcomes.