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 dilation therapy. About 95% of patient do not require a post-treatment Foley catheter, and experience significant and immediate relief of their lower urinary tract symptoms (LUTS). We present our 5-year follow-up clinical safety and efficacy data on 35 Asian patients.

From August 2018-February 2020, 35 patients (Age 54-79, mean 62) with LUTS were treated with the TUTD device, PROLIEVE( Medifocus inc.). Their 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 reported worsening LUTs and received TURP. Histopathology confirmed BPH. They were excluded from further data collection. 1 patient at 46month with raised PSA, PSA Ratio and PHI. mpMRP suggested PIRADS 3 lesions. Transperineal Target fusion biopsy was performed and confirmed benign prostatic hyperplasia with fibrosis and chronic inflammation only, without high risk malignancy. This patient was also excluded from further data collection for the current study, and PSA follow up at 3 monthly. 30 patients were eligible for final data collection and assessment: IPSS: 2-23 (median 12) at 6 weeks; 2-15 (median 7) at 36 months. QOL: 2-3(median 2) at 6 weeks; 2-3 (median 2) at 36 months. Qmax: 3.6-14.9ml/s (mean 10ml/s) at 6 weeks; 6.8-17.5ml/s (mean 13.2ml/s) at 6 months. PMRV: 0-33ml (mean 8ml) at 6 weeks, and 0-45ml (mean 20ml) 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 up to 5 years in IPSS, QOL, Qmax and PMRV in majority of 90% of the current cohort 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 ambulatory microwave TUTD for symptomatic BPH remains safe and efficacious in the Asian population and should be offered as a cost effective option . Long-term prospective data collection in a larger patient population remains in progress.