The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance

Abstract

As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer’s submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published ‘marked improvement’ in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting.

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)

“…It may also be of interest to compare PAE with the UroLift implant, as this presents another emerging, less invasive alternative to transurethral surgical options. Our findings in the UK‐ROPE study are very similar to those presented in a recent meta‐analysis, which reported the following improvements at 12‐months post‐Urolift treatment: an IPSS improvement of −10.5 points, a QoL improvement of −2.3 points, a clinically non‐significant +0.8 point improvement in IIEF score, a +3.5‐mL/s improvement in Q max , and a small improvement in PVR of −5.7 mL . That study also presented economic data in which day‐case Urolift treatment was cost‐saving compared with inpatient TURP and HoLEP.…”

Update on minimally invasive surgery and benign prostatic hyperplasia

“…In September 2013, the US Food and Drug Administration approved the UroLift. In September 2015, the UK National Institute for Clinical and Health Excellence also approved the UroLift as an effective, safe and cost-effective treatment for use in the UK health system, when implemented in a day-case setting [6] , [12] . It has been postulated that even earlier management with PUL may even reduce overall cost for those patients managed with medication.…”

UroLift for the Treatment of Lower Urinary Tract Symptoms in a Patient with AMS 700 Penile Prosthesis: The First Reported Case

“…1 The UroLift procedure is undertaken transurethrally with either general or local anesthesia. 8 The UroLift device works by introducing a single-use, pre-loaded delivery device through a rigid sheath under cystoscopic visualization. The delivery device then deploys permanent, trans-prostatic, Nitinol implants to retract the lobes of the prostate towards the capsule.…”

“…The delivery device then deploys permanent, trans-prostatic, Nitinol implants to retract the lobes of the prostate towards the capsule. 8 Typically, multiple implants are used to retract the obstructing lateral lobes and create an open, continuous voiding channel 1 (Figure 4).…”