Microwave Transurethral ThermoDilatation (TUTD) offers a unique 45-minute, ambulatory, well-tolerated, outpatient procedure under local anaesthesia for symptomatic benign prostatic hyperplasia (BPH) by deploying simultaneous focused microwave heating and pressurized balloon dilatation therapy. About 95% of patient who do not require a post-treatment Foley catheter experience significant and immediate relief of their lower urinary tract symptoms (LUTS). We present our 5-year clinical data on 35 Asian patients pertaining to the clinical safety and efficacy of TUTD.

From August 2018 to March 2020, 35 patients (Age 54-79, mean 62) with LUTS were treated with the microwave TUTD device, PROLIEVE (Medifocus inc.) Their initial IPSS (17- 35, median 24), QOL (4-6, median 5), PSA (0.57-7.7, mean 3.5), prostatic volumes (35- 84cc, mean 54cc), Qmax (1.7-10.5 ml/s, mean 7.5ml/s) and PMRV (50-330ml, mean 190ml) were recorded pre-treatment. The parameters were reassessed at 6 weeks, 3-, and 6-months post-treatment. Subsequent annual follow up were carried out by telephone review of IPSS and QOL

4 patients at 36, and 49 months required TURP. Histopathology confirmed BPH. 1 Patient returned at 46 month with raised PSA, PSA Ratio and PHI. mpMRP suggested PIRADS 3 lesions at periurethral transitional zone. Transperineal targetted fusion biopsy was performed with histopathology confirmed benign prostatic hyperplasia with fibrosis and chronic inflammation only. All 5 patients were excluded from further data collection for the current study. 30 patients were eligible for final data assessment: IPSS: 2-23 (median 12) at 6 weeks; 2-16 (median 9) at 3 months; 2-11 (median 6) at 6 months; 2-15 (median 7) at 60 months. QOL: 2-3(median 2) at 6 weeks; 2-3 (median 2) at 3 and 6 months; 2-4 (median 3) at 60 months. Qmax: 3.6-14.9ml/s (mean 10ml/s) at 6 weeks; 8ml/s-15.6 ml/s (median 12.6ml/s) at 3 months; 10.8-17.5ml/s (mean 13.2ml/s) at 6 months. PMRV: 0-133ml (mean 78ml) at 6 weeks; 0-120ml (median 70ml) at 3 months; 0-95ml (mean 50ml) at 6 months. Urological complications e.g., clot retention and sepsis were not observed. One patient required temporary post-treatment Foley catheterization for 72 hours. Treatment related retrograde ejaculation or erectile dysfunction has not been reported. The procedure was well tolerated under local anaesthesia. Both voiding and storage symptoms improved.

Our 5-year experience with TUTD in 35 Asian patients compares favourably to the clinical outcomes and efficacy of the Caucasian cohort in the USFDA 5-year follow-up post-approval study. We observed lasting post-treatment improvements after 5 years in IPSS, QOL, Qmax and PMRV in 90%t of 35 consecutive Asian patients. The recurrence of LUTS in 4 patients with middle lobe enlargement obstruction who required TURP is understandable. We conclude that microwave TUTD for symptomatic BPH remains safe and efficacious in the Asian population and should be offered as a cost-effective option.