Preliminary Experiment On The Efficacy And Safety Of Boiling Histotripsy In Canines With Benign Prostatic Hyperplasia

Background and subjectBenign prostatic hyperplasia(BPH)is one of the most common diseases in older men,with a morbidity of almost 100%in men over the age of 80.Although the combination of tamsulosin and finasteride is effective in most patients,about one-third of patients require surgical treatment.The current standard procedure for the treatment of BPH is considered transurethral resection of the prostate(TURP),but many randomized controlled trials and meta-analyses have confirmed that TURP is inferior in terms of efficacy and complication rates to laser-based and bipolar-plasma based transurethral enucleation of the prostate.However,these procedures are invasive transurethral procedures that still carry the risk of complications during the perioperative and postoperative period.Boiling histotripsy is a high intensity focused ultrasound(HIFU)-based non-thermal,non-invasive technique for immediate ablation of tissue that can be monitored under ultrasound image.The main purpose of this study was to explore the efficacy and safety of boiling histotripsy in animals with benign prostatic hyperplasiaMaterials and MethodsFour male beagles over 2 years old were purchased to model the benign prostatic hyperplasia,and animal experiments were performed on them with the boiling histotripsy therapeutic apparatus under anesthesia.Comparing laboratory tests,continuous imaging monitoring and pathological examination to estimate determine whether boiling histotripsy can effectively ablate hyperplastic prostate tissue in living animals and whether the ablated cavity disappears over time.Statistical method:wilcoxon signed rank sum test in the nonparametric test,and p<0.05 indicates that the difference is statistically significant.Result80 days after implantation of high-dose dihydrotestosterone and estradiol self-made silicone tubes in all 4 test animals,the prostate volume was enlarged but not significantly different(p=0.068).No definite and experience-related adverse events were observed during ablation in beagles with boiling histotripsy,and there were no significant changes in laboratory tests before and after treatment(p>0.05).After 32 days of treatment,the cavity tends to be stable,and it is basically consistent with the planned ablation area before treatment.No adverse events were observed in all animals tested until sacrifice.ConclusionBoiling histotripsy was safe and feasible to ablate the cavity in the hyperplastic prostate of live animals,and the cavity was partially recovered by epithelial tissue 32 days after treatment,demonstrating the stabilization of the cavity.As a preliminary exploratory study,due to the limited number of experimental animals,the statistical inference accuracy of this study was insufficient,and the urodynamic-related parameters were not be evaluated,nor the long-term therapeutic effect of boiling histotripsy.