To investigate the safety and feasibility of MRI-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic obstruction (BPO).
An investigator-initiated, prospective, registered (NCT03350529), phase-1 study enrolled men with LUTS due to BPH in need of surgical intervention. Patients were followed for one year after TULSA. Uroflowmetry, PSA, and a comprehensive set of functional questionnaires including EPIC-26, IPSS and IIEF-5 were obtained at baseline and every three months afterwards. MRI was obtained at baseline, 3- and 12-months post-TULSA. Medication use before and after TULSA were recorded. Adverse events were reported using Clavien-Dindo classification.
Ten men underwent TULSA with no severe adverse events encountered. Baseline median (IQR) age and prostate volume were 68 years (63-72) and 53 ml (45-66), respectively. At baseline, six patients were moderately symptomatic and four patients severely symptomatic. Nine patients at baseline were on BPO medication. The median (IQR) improvement in IPSS was 82%, from 17.5 (15.3-23.0) at baseline to 4.0 (2.3-6.3) at 12 months. Similarly, the median (IQR) Qmax improved by 101%, from 12.4 ml/s (8.8-17.6) at baseline to 21.8 ml/s (17.6-26.5) at 12 months. Improvements were already seen at 3 months. Median prostate volume and PSA reduction at 12 months were 33% and 48%, respectively. No changes were observed in continence, sexual, erectile or bowel functions. At 12 months, five out of six men with normal ejaculatory function prior to TULSA reported normal antegrade ejaculations. All patients taking BPO medication before TULSA discontinued medication after TULSA.
TULSA appears to be a safe and effective treatment for BPO, with promising one year follow-up outcomes. Further studies with larger cohorts are needed to confirm the observed results.

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