Session: PD41: Benign Prostatic Hyperplasia: Surgical Therapy & New Technology V
PD41-04: First in man clinical data through 24-months of a novel, minimally invasive treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia
Introduction: The ProVee Expander is a nitinol implant which is deployed between the bladder neck and the verumontanum to mechanically open the prostatic urethra without ablation, resection or piercing of the prostate. The first in man (FIM) evaluation to demonstrate the safety and feasibility of the ProVee was conducted at the Royal Melbourne Hospital, Australia. The Primary Endpoint was successful deployment of the implant. Secondary endpoints included 1) the rates of complications throughout the follow-up periods and 2) a preliminary assessment of the effectiveness in alleviating lower urinary tract symptoms LUTS using the IPSS, QoL and Qmax measurements Methods: This was a prospective, non-randomised, 10 patient safety and feasibility study. Males = 50 years, IPSS > 15, Qmax <12 mL/s and prostate volume 30-80 cc were enrolled. No washout for medications was mandated and it is noteworthy that 7 of the 10 subjects were on BPH or OAB drug therapy immediately prior to the procedure and discontinued their medication from the day of the index procedure. Follow up visits were performed at 2 weeks, 1, 3, 6, 12 and 24 months using the IPSS, Qmax, PVR, IIEF, pain score and flexible cystoscopy at 3, 6 and 12 months. Results: Men aged 58 – 75 years with a mean IPSS of 23 and mean Qmax of 8 ml/s were enrolled. The ProVee was successfully deployed in all subjects and all men voided following the procedure and no catheterisations were required. Reported postoperative AEs were typically mild and transient. All 10 subjects have completed 24-month follow up and all data has been independently monitored from source. The device was well tolerated with no unexpected procedural or device related adverse events or complications in any subject. No device migration was detected and there were no reported cases of de novo retrograde ejaculation. Although the trial was not powered to demonstrate efficacy there was a 40% improvement in Qmax at 24-months. All men not on LUTS medication prior to the procedure showed a =30% improvement in IPSS at 24-months and there were no surgical re-treatments through 24-months. Conclusions: The ProVee Expander can be safely and reliably deployed in the prostatic urethra. The 24-month data from this FIM study of 10 subjects demonstrates the ProVee can safely alleviate LUTS in men with benign prostatic hyperplasia. Further larger clinical studies commenced in June 2022 and are ongoing. SOURCE OF Funding: ProVerum Limited
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