Stacks Image 759

UroLift System Experience in the UK
Development & Clinical Study

British clinical expertise has played an integral role in the development, clinical testing, and commercialization of the UroLift implant system. The earliest publication, in the British Journal of Urology,wasauthoredbyapioneeringgroupthatincluded ProfessorThomasA.McNicholas from the Lister Hospital, Stevenage1. After the two-year 64 patient feasibility study conducted in Australia, Britain again lead the way in a pan-European retrospective registration study of 102 patients at 7 centres across 5 countries.2 The experience from these studies informed the protocol of a 206 patient randomized study conducted largely in the United States.3 The one year results of the randomized study showed defnitive safety and efcacy at 1 year to support FDA review of the device, now underway. A follow-on two-year randomized study was then initiated, known as the BPH-6 Study. Four of eleven centres enrolling this study are NHS centres (Surrey, Taunton, Shefeld, and Sunderland), while other sites are in Denmark, Germany, and Italy [Appendix]. Finally, patients treated outside of NHS protocol are eligible to be entered into the ongoing GUSTO (Global UroLift System Treatment Outcomes) registry. This ongoing global registry is ambitiously enrolling up to 1,000 subjects, detailing treatment information, patient satisfaction and outcomes to one year.
Commercialisation Today, patients are treated across the UK in one of three formats: a) under private insurance; b) through self-pay; or c) within NHS clinical studies. Private insurers are processing increasing numbers of requests for authorization from several centres, including the prestigious London Clinic, Spire Bristol and Spire Clark Park Hospitals. A smaller number of British self-paying patients have sought out treatment with UroLift implants to avoid complications of currently available procedures. The Interventional Procedures Advisory Committee (IPAC) of the National Institute for Health and Care Excellence (NICE) has recently reviewed the UroLift system, and results are pending. Approval without restriction should lead to greater NHS availability outside of clinical trials.
As more and more private insurance requests for coverage are issued for UroLift implant procedures, we are currently seeking an agreed code as insurers and providers greatly prefer to use a specifc code for this novel and useful procedure.
___________________________________________________________________________ 1 Woo HH, Chin PT, McNicholas TA et al: Safety and feasibility of the prostatic urethral lift: a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hypertrophy (BPH). BJU Int 2011;108:82-88.2 McNicholas TA, Woo HH, Chin PT et al: Minimally invasive Prostatic Urethral Lift: surgical technique and multinational study. Eur Urol 2013; Roehrborn CG, Gange SN, Shore ND et al: Multi-Center randomized controlled blinded study of the prostatic urethral lift for the treatment of LUTS associated with prostate enlargement due to BPH: the L.I.F.T. study. J Urol 2013: Jun 10. pii: S0022-5347(13)04597-7. doi: 10.1016/j.juro.2013.05.116.
Stacks Image 787