ThuFLEP shows early safety, high catheter-free rate in small BPH cohort

A single-arm prospective cohort study evaluated the early safety and functional outcomes of Thulium fiber laser enucleation of the prostate (ThuFLEP) using SOLTIVE™ systems in 32 consecutive Asian men with benign prostatic hyperplasia. The cohort had a median prostate size of 60 ml, and half were catheter-dependent preoperatively. The primary safety signal was the rate of Clavien-Dindo grade ≥3 complications, of which none occurred (0 of 32). Regarding functional recovery, 87.5% (28 of 32) were catheter-free on postoperative day 1, increasing to 100% by day 14. At the 3-month follow-up, median IPSS was 4 (IQR 1–8) and median Qmax was 21.5 ml/s (IQR 12.9–28.4 ml/s). PSA decreased from a median of 6.05 ng/ml to 1.20 ng/ml, with the source reporting a significant p-value. Safety was characterized by the absence of major complications, though detailed adverse event reporting was not provided. Key limitations include the small sample size (n=32), single-arm design, short 3-month follow-up, and lack of a comparator group, which precludes efficacy comparisons with other surgical techniques. The findings suggest ThuFLEP may be a feasible option with a favorable early safety profile in this specific population, but the low certainty evidence, due to the study design, means it should be interpreted as preliminary. Practice decisions should await data from larger, randomized controlled trials with longer follow-up.