Safety and feasibility of the prostatic urethral lift: A novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment related morbidity. Unlike the other therapies, the prostatic urethral lift mechanically opens the prostatic urethra using tensioned sutures that compress prostate tissue between the urethra and prostate capsule. This is the first publication on this technology. This manuscript reports and confirms its safety and feasibility as a minimally invasive surgical treatment for symptomatic benign prostatic hyperplasia to justify further clinical evaluation. OBJECTIVES • To investigate the Prostatic Urethral Lift (PUL) procedure, a novel, minimally invasive treatment for symptomatic benign prostatic hyperplasia (BPH), which aims to mechanically open the prostatic urethra without ablation or resection. • To demonstrate the safety and feasibility of this procedure and to make an initial assessment of effectiveness. PATIENTS AND METHODS • The PULprocedure was performed on 19 men in Australia. • Small suture-based implants were implanted transurethrally under cystoscopic visualisation to separate encroaching lateral prostatic lobes. • Patients were evaluated at 2 weeks and 3, 6, and 12 months after PUL. RESULTS • All cases were successfully completed with no serious or unexpected adverse events (AEs). • Between two and five sutures were delivered in each patient and the prostatic urethral lumen was visually increased in all patients. • Reported postoperative AEs were typically mild and transient and included dysuria and haematuria. • Follow-up cystoscopy at 6 months in a subset of patients showed no calcification. Histological findings from two of three patients who progressed to transurethral resection of the prostate for return of symptoms showed no evidence of inflammation related to the implanted materials. • The mean International Prostate Symptom Score was reduced by 37% at 2 weeks and 39% at 1 year after PUL as compared with baseline. CONCLUSIONS • We demonstrated in this initial experience that the PUL procedure is safe and feasible. • The safety profile of the PUL procedure appears favourable; most patients reported sustained symptom relief to 12 months with minimal morbidity • PUL therefore warrants further study as a new option for the many patients who seek an alternative to current therapies.