Introduction: MRI-guided transurethral ultrasound ablation (TULSA) is a novel therapy option for treating lower urinary tract symptoms (LUTS) caused by benign prostatic obstruction (BPO). The combined data set of all 27 patients is reported here with 12-month outcomes available for 21 men. Methods: Men with LUTS due to BPO, previously scheduled for primary TURP, were enrolled in this prospective, investigator-initiated, single-center, phase 1-2 study (NCT03350529). Quality of life (QoL) questionnaires including EPIC-26, IPSS , IIEF-5 as well as uroflowmetry and PSA were recorded at baseline, 3, 6, 9, 12, 18, 24, and 36 months post-TULSA. MRI was obtained at baseline, 3- and 12-months. Medication use before and after TULSA and adverse events (AEs) in Clavien-Dindo classification were recorded. Results: 27 patients received TULSA, with a median follow-up of 16-mo. At baseline, median [IQR] age was 67 years [64–72], PSA 3 ug/l [2.2–6.5], prostate volume 53 ml [45–66], average flow rate 3.9 ml/s [3.3–7], maximum flow rate 10.5 ml/s [7.7–14], voided volume 210 ml [123–335], and post-void residual 71 ml [39–249]. Median sonication, hospitalization, and catheterization times were 42 min, 24 h, and 16 d, respectively. AEs included one grade 1, seven grade 2, and one grade 3 events, including urinary tract infection, urinary retention, and epididymitis (grade 3), all resolving within three months. 16/27 patients have completed their 12-mo follow-up with 2 men dropping off due to cancer diagnosis. Between baseline and 12 months, median values for measured parameters changed as follows: prostate volume (based on the elliptic formula) reduced from 53 to 32.5 ml, PSA reduced from 3 to 1.45 ug/l, post-void residual volume decreased from 71 to 54 ml, average flow rate increased from 3.9 to 8 ml/s, Qmax increased from 10.3 to 18.45 ml/s, voided volume increased from 210 to 300.8 ml, IPSS score improved from 17 to 4, IPSS QoL score improved from 4 to 1, IIEF-5 improved from 15 to 20.5, EPIC-26 urinary incontinence domain improved from 85.5 to 100, EPIC-26 irritative/obstructive domain improved from 62.5 to 93.5,EPIC-26 bowel domain improved from 87.5 to 97.92, EPIC-26 sexual domain improved from 55.58 to 68.75, and EPIC-26 hormonal domain remained unchanged at 95. Results of uroflowmetry, functional status, and QOL questionnaires all improved at 12 months despite discontinuation of LUTS medication in 23/27 men receiving medication before. Conclusions: 12-mon outcomes strengthen our previously reported results on the safety and efficacy of TULSA as a promising treatment option for BPO. SOURCE OF Funding: Profound Medical
