Introduction: BPH affects tens of millions of men across the world. Most procedures require either general or regional anesthesia or a transurethral approach. Upon completed accrual for NCT04760483 is a phase trial, the protocol was amended into a Phase II registration, prospective registry interventional study evaluating transperineal fusion laser ablation (TPFLA) of BPH tissues, carried in Office setting under local anesthesia. Here in we present a step-by-step video using imaging fusion with clear targets aimed to enhance precision and safety. The objectives call for safety, feasibility, and impact in pertinent outcomes measures, such as Uroflowmetry, IPSS, Hematuria, Erectile function, and ejaculation
Methods: Between December 2020 and September 2021, 92 patients underwent TPFLA in the office setting under local anesthesia. Men aged between 45 and 85 years, with prostate volumes between 30 and 120 cc, IPSS scores >9, peak flows between 5 and 15 cc/s and void residuals under <250 ml were eligible for the study. IPSS assessments, Flow studies and prostate volume measures were recorded. Bayesian analysis for continuous measurements were performed and non-parametric differences were evaluated using chi2 tests
Results: Median (range) for age and BMI was 65 (49,78) and 28 (23,37), respectively. Median and interquartile range (IQR) for procedure, ablation times, watts and total joules were 23 (21,26), 9 minutes (6,12), 6 (5,7) wats and 3,500 (3,100, 3600) joules, respectively. Median pain score was 3/10. No procedure was aborted, and all patients were discharged within 40 minutes. At 1 month, 4 patients experienced dysuria, urgency and frequency, 79 (86%) patients had engaged in sexual intercourse and 75 reported hematospermia that subsided within 6-8 weeks. Two and 6 month assessments were completed by 80 and 46 patients, 69 and 38 had sustained improvements in IPSS scores and mean flows, greater than 8 and 4 cc/s, respectively
Conclusions: TFPLA in the office setting is safe and well tolerated. Short term- 6-month response in symptoms and flows are seen in over 80% of patients. Furthermore, erections or ejaculations were not affected. This novel procedure represents a new tool for men with BPH
Source of Funding: Urological Research Network Foundation
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