12-month outcomes of MRI-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic hyperplasia
Author Block: A. Viitala1, M. Anttinen1, P. Mäkelä1, P. Doerwald2, P. Nurminen1, H. E. Pärssinen1, T. Sainio1, R. Blanco Sequeiros1, P. J. Boström1; 1Turku/FI, 2Hamburg/DE
Purpose: The aim of this study was to assess clinical outcomes of MRI-guided transurethral ultrasound ablation (TULSA) in treating benign prostatic hyperplasia (BPH).
Methods or Background: Men with BPH scheduled for TURP were enrolled. EPIC-26, IPSS, IIEF-5, uroflowmetry, PSA, MRI, and complications in Clavien-Dindo were recorded.
Results or Findings: Thirty patients received TULSA, with a median follow-up of 16-mo (max 48-mo). At baseline, median [IQR] age was 67 years [64–72], PSA 3.1 ug/l [2.2–6.9], prostate volume 51.5 ml [min 29-max 107], average flow rate 4.1 ml/s [3.4–7], maximum flow rate 11 ml/s [8–15], voided volume 211 ml [139–336], and post-void residual(PVR) 71 ml [40–247]. Median sonication, hospitalization, and catheterization times were 39 min, 24 h, and 16 d, respectively. Complications included one grade 1, 8 grade 2, and one grade 3 events, all resolving within three-months. 24/30 patients have completed their 12-month follow-up with two men dropping off due to cancer diagnosis. Between baseline and 12 months, median values for measured parameters changed as follows: prostate volume, PSA, PVR reduced from 51.5 to 31 ml, 3.1 to 1.5 ug/l, and 71 to 41.5 ml, respectively. Average flow rate, Qmax, and voided volume increased from 4.1 to 8.7 ml/s, 11 to 18 ml/s, 211 to 301 ml, respectively. IPSS, IPSS QoL, IIEF-5 scores improved from 16.5 to 4, 4 to 1, and 15 to 19, respectively. EPIC-26 urinary incontinence, irritative/obstructive, bowel, sexual, and hormonal domains improved from 85.5 to 100, 65.6 to 94, 87.5 to 100, 54 to 67, and 95 to 100, respectively. Results of uroflowmetry, functional, and QOL questionnaires all improved at 12-month despite discontinuation of LUTS medication in 26/30 patients.
Conclusion: 12-mo clinical-outcomes demonstrate safety and efficacy of TULSA for treating BPH.
Limitations: Small population
Funding for this study: Study was funded by Profound Medical.
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: Ethics committee approval was granted and informed consent was obtained from all study participants.