This paper reports the 12-month post-TULSA improvements in quality of life experienced by a subgroup of nine patients from the previously-reported Phase I Safety & Feasibility Study of TULSA-PRO®1 who had moderate-to-severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in addition to localized prostate cancer. Using real-time MR imaging a customized treatment plan was designed for each patient with the goal of ablating 90% of their prostate. In this group of symptomatic patients, the largest pre-TULSA prostate volume was 96.7 ml.
Urinary symptoms improved significantly, as measured by a decrease in the International Prostate Symptom Score of 9.1 ± 7.1 points, from 16.1 ± 3.8 at baseline to 6.3 ± 5.0 at 12 months. At least a moderate (≥ 6 points) reduction in symptoms was experienced by 8/9 men, reaching normal symptom levels in 7/9 men, accompanied by urinary quality of life improvements to “pleased” or “delighted”. Improvements were also observed for important functional outcomes, including a decrease in post-void residual urine volume from 95.0 ± 117.5 ml at baseline to 62.5 ± 88.2 ml at 12 months, and an increase in peak urinary flow rate from 14.5 ± 4.1 ml/s at baseline to 21.9 ± 12.7 ml/s at 12 months. Prostate volume was markedly reduced in all patients at 12 months suggesting a real and durable effect. Improvements observed with TULSA-PRO® were similar to those published for modern surgical BPH therapies. There were no serious adverse events reported in this subgroup, and most of the mild or moderate adverse events were resolved by the one-month follow-up visit. All patients maintained full urinary continence (leak-free, pad-free) at 6 and 12 months. Erectile function (International Index of Erectile Function, “IIEF”) was stable from 14.6 ± 9.3 at baseline to 15.7 ± 9.0 at 12 months, as was the proportion of patients with erections sufficient for penetration (IIEF question 2), from 7/9 at baseline to 8/9 at 12 months.
While the relief of lower urinary tract symptoms was not the primary treatment goal of the original study, these improvements in symptom scores and urinary function demonstrate that TULSA is a promising modality for the relief of LUTS due to BPH in men with concomitant prostate cancer. The use of TULSA-PRO® to relieve LUTS without a prostate cancer component is currently being investigated at Turku University Hospital in prospective clinical studies of men with BPH.2 Beyond the whole-gland treatments required for this regulatory study, one of the strengths of TULSA-PRO® is that it enables highly customized and precise ablation. This customization allows the ablation of benign tissue to relieve urinary symptoms while preserving ejaculatory function, as well as targeted ablation of sectors of the gland known to harbor cancer, offering combined treatment for BPH and/or cancer tailored to each individual patient's anatomy and pathology.
Written by: Dean Elterman, MD, MSc, FRCSC, Divison of Urology, University of Toronto, Toronto, Ontario, Canada, Twitter: @DrDeanElterman
- Chin, Joseph L., Michele Billia, James Relle, Matthias C. Roethke, Ionel V. Popeneciu, Timur H. Kuru, Gencay Hatiboglu et al. "Magnetic resonance imaging–guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: a prospective phase 1 clinical trial." European urology 70, no. 3 (2016): 447-455.
- Viitala, A., M. Anttinen, P. Mäkelä, V. Suomi, T. Sainio, P. Taimen, P. Boström, and R. B. Sequeiros. "Transurethral ultrasound therapy for benign prostatic obstruction in humans." European Urology Open Science 19 (2020): e997.