Research AppraisalSystematic Review

Complications of thulium fiber laser lithotripsy: a systematic review and meta-analysis by the EAU-YAU endourology and urolithiasis working group

World journal of urologyKatsimperis, Stamatios, Tzelves, Lazaros, Juliebø-Jones, Patrick et al.11 May 2026DOI

Clinical Snapshot

75CEBM
Evidence: ModerateSystematic Review

PICO Framework

P — PopulationAdult patients with urolithiasis undergoing lithotripsy
I — InterventionThulium Fiber Laser (TFL) lithotripsy
C — ComparatorNo specific comparator (descriptive meta-analysis of complication rates)
O — OutcomesPrimary: overall complication rate; Secondary: Clavien-Dindo grading, specific adverse events (fever, sepsis, injury), stone-free rate

Bottom Line

This meta-analysis of 38 studies involving 3,329 patients suggests Thulium Fiber Laser lithotripsy has an acceptable safety profile with a 10.4% overall complication rate and very low major complication rate (1.2%). The technique achieves high stone-free rates (87.6%) with specific complications including fever (2.5%), ureteral injury (1.4%), and urosepsis (0.8%). However, the very high heterogeneity between studies (I²=81.9%) significantly limits confidence in these pooled estimates. Operative time, but not stone size, predicted complications. While TFL appears promising as an alternative to Holmium:YAG laser, the substantial between-study variation suggests results may vary considerably depending on technique, patient selection, and operator experience. Clinicians should interpret these findings cautiously and consider local expertise when selecting lithotripsy modalities.

Evidence: Moderate

Key Findings

  • P Value: Not reported for primary outcome

  • Effect Size: 10.42% pooled complication rate

  • Primary Outcome: Overall complication rate: 10.42%

  • Nnt Or Sensitivity: Stone-free rate: 87.61% (95% CI: 83.61%-91.12%); Major complications (Clavien-Dindo III-V): 1.19%

  • Confidence Interval: 95% CI: 8.01%-13.10%

Clinical Application

TFL technology increasingly available in tertiary centres, requires specialized training and equipment Relevant to Australian urological practice; TFL devices likely available through private hospitals and major public centres; may require PBS consideration for broader access Adult patients with urolithiasis requiring lithotripsy, particularly suitable for both renal and ureteral stones

Abstract

BACKGROUND: Thulium Fiber Laser (TFL) has emerged as a promising alternative to Holmium: YAG for lithotripsy, yet its safety profile remains fragmented across various trials. This study aims to synthesize available evidence to determine the pooled complication rates associated with TFL lithotripsy . METHODS: A systematic review was conducted following PRISMA guidelines. We searched PubMed, Cochrane CENTRAL, and ClinicalTrials.gov for studies reporting complications of TFL in adult patients with urolithiasis. The primary outcome was the overall complication rate. Secondary outcomes included Clavien-Dindo grading, specific adverse events (fever, sepsis, injury), and stone-free rate (SFR). A random-effects meta-analysis was performed using the Freeman-Tukey double-arcsine transformation. RESULTS: Thirty-eight studies involving 3,329 patients were included. The pooled overall complication rate was 10.42% (95% CI: 8.01%-13.10%; I²=81.9%). Major complications (Clavien-Dindo III-V) were rare, with a pooled rate of 1.19% (95% CI: 0.68%-1.84%). Specific event rates included fever (2.45%), ureteral injury (1.37%), bleeding (1.07%), urosepsis (0.77%), ureteral strictures (0.70) and acute pyelonephritis (0.59%). Meta-regression identified operative time as a significant predictor of complications (p = 0.041), whereas stone size was not (p = 0.358). Subgroup analysis showed higher complication rates in pure renal stone treatments (13.83%) compared to ureteral stones (10.64%). The pooled Stone-Free Rate (SFR) was 87.61% (95% CI: 83.61%-91.12%). CONCLUSION: Thulium Fiber Laser lithotripsy demonstrates a pretty favorable safety profile with a very low incidence of high-grade complications (< 1.2%) and high efficacy.

References

  1. 1.Katsimperis, S., Tzelves, L., Juliebø-Jones, P., Tsaturyan, A., Ventimiglia, E., Tonyali, S., Ergül, R. B., Boeykens, M., Jahrreiss, V., Peteinaris, A., Spinos, T., Olivero, A., Pietropaolo, A., Ballesta-Martinez, B., & Skolarikos, A. (2024). Complications of thulium fiber laser lithotripsy: A systematic review and meta-analysis by the EAU-YAU endourology and urolithiasis working group. World Journal of Urology. https://doi.org/10.1016/j.urology.2023.08.011
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