- 12-month clinical outcomes for 30 men who underwent TULSAÂ ultrasound as part of a phase 1-2 clinical trial (NCT03350529). Clinicians thoroughly evaluated participants who experienced lower urinary tract symptoms (LUTS) due to BPH and were initially scheduled for primary transurethral resection of the prostate (TURP). They administered quality of life (QoL) questionnaires, including the EPIC-26, International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIEF-5), at multiple intervals: baseline, as well as 3, 6, 9, 12, 18, 24, and 36 months after the TULSA procedure.
12-Month Clinical Outcomes prostate-specific antigen
Clinicians recorded prostate-specific antigen (PSA) levels and conducted MRI scans at baseline, as well as 3 months and 12 months after the procedure. The results indicated significant improvements across multiple parameters.
At baseline, the study population had a median age of 67 years, with participants exhibiting a median prostate-specific antigen (PSA) level of 3.1 µg/l and an average prostate volume of 51.5 ml. These parameters highlight the demographic and clinical characteristics of patients undergoing MRI-guided Transurethral Ultrasound Ablation (TULSA) for the treatment of benign prostatic hyperplasia (BPH).
Post-treatment analysis revealed substantial and clinically meaningful changes in several key outcomes. Prostate volume showed a remarkable reduction, decreasing from an average of 51.5 ml at baseline to 31 ml following the TULSA procedure. Similarly, PSA levels exhibited a significant decline, dropping from 3.1 µg/l to 1.5 µg/l. These reductions are indicative of effective prostate tissue ablation and decreased prostatic activity, directly addressing the underlying pathology of BPH.
At the 12-month follow-up, there were notable improvements in urinary function, as evidenced by enhanced urinary flow rates and reductions in post-void residual volumes. These improvements reflected a restoration of normal bladder and urethral function, contributing to an overall enhancement in the functional status of the participants. The International Prostate Symptom Score (IPSS) also improved significantly, with median scores decreasing from 16.5 at baseline to just 4 at the 12-month mark. This substantial reduction in IPSS scores underscores a marked alleviation of urinary symptoms, including frequency, urgency, and nocturia, leading to a profound improvement in the participants’ quality of life.
