Introduction: MRI-guided transurethral ultrasound ablation (TULSA) is a novel therapy option for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). We have previously reported 12-mo clinical outcomes from the first 10 patients treated at our institution. Since then, we have acquired more clinical data by treating an additional 10 patients. Combined data set of all 20 patients is reported here for the first time.
Methods: Men with LUTS due to BPH in need of surgical interventions were enrolled in this prospective, investigator-initiated, single-center, phase 1-2 study (NCT03350529). Efficacy of the procedure is assessed by uroflowmetry, PSA, and functional status and quality of life (QoL) questionnaires including EPIC-26, IPSS, and IIEF-5 at baseline and 3, 6, 9 and 12 mo post-TULSA. MRI is obtained at baseline, 3 and 12 mo. Medication use before and after TULSA and adverse events (AEs) in Clavien-Dindo classification are recorded.
Results: 20 patients have undergone TULSA, with a median follow-up of 12 mo. At baseline, median [IQR] age was 67 yr [64–72], PSA 3 ng/ml [2–6], prostate volume 51 ml [48–65], average flow rate 4 ml/s [3–7], maximum flow rate 11 ml/s [8–16], voided volume 210 ml [144–378], and post-void residual volume 71 ml [40–304]. Median sonication, hospitalization, and catheterization times were 43 min, 24 h, and 16 d, respectively. AEs included six grade 2 and one grade 3 events, including urinary tract infection, urinary retention, and epididymitis (grade 3), all resolving within 3 mo. 17 patients have completed their 3-mo follow-up. Between baseline and 3 mo, median values for measured parameters changed as follows: prostate volume reduced from 51 to 38 ml, PSA reduced from 3 to 1 ng/ml, post-void residual volume decreased from 71 to 54 ml, average flow rate increased from 4 to 8 ml/s, Qmax increased from 11 to 23 ml/s, voided volume decreased from 210 to 171 ml, IPSS score improved from 16 to 6, IPSS QoL score improved from 4 to 1, IIEF-5 improved from 17 to 21, EPIC-26 urinary incontinence domain improved from 86 to 97, EPIC-26 irritative/obstructive domain improved from 69 to 91, EPIC-26 bowel domain improved from 88 to 96 and EPIC-26 sexual domain improved from 63 to 95. The results of uroflowmetry, functional status, and QoL questionnaires all improved already at 3 mo despite discontinuation of LUTS medication in all 17 patients receiving LUTS medication before TULSA.
Conclusions: These short-term outcomes strengthen our previously reported results on the safety and efficacy of TULSA as a promising treatment option for BPH.
Source of Funding: Urology and radiology departments at Turku University Hospital have received an unrestricted educational grant from Profound Medical Inc., which enabled us to conduct this trial in accordance with our own predefined protocol. Our study was planned and implemented solely by the clinical authors.