2.1 The UroLift system (NeoTract) is used to perform a prostatic urethral lift, a procedure that is an alternative to current standard surgical interventions such as transurethral resection of the prostate (TURP) and holmium laser enucleation (HoLEP). The UroLift system uses adjustable, permanent implants to pull excess prostatic tissue away so that it does not narrow or block the urethra. In this way, the device is designed to relieve symptoms of urinary outflow obstruction without cutting or removing tissue.
2.2 The UroLift system comprises 2 single‑use components: a delivery device and an implant. The delivery device consists of a hand‑held pistol grip to which a needle‑shaped probe is attached. Each UroLift implant consists of a superelastic nitinol capsular tab, a polyethylene terephthalate monofilament, and a stainless steel urethral end‑piece. The surgeon inserts the probe into the urethra until it reaches the prostatic urethra (the widest part of the urethral canal); a fine needle at the end of the probe deploys and secures an implant in a lobe of the prostate. One end of the implant is anchored in the urethra and the other is attached to the firm outer surface of the prostatic capsule, so pulling the prostatic lobe away from the urethra. This is repeated on the other lobe of the prostate. Typically about 4 implants are used. The procedure can be done with the patient under local or general anaesthetic and may be done either on an in‑patient or day‑case basis.
2.3 The UroLift system received a CE mark in November 2009 as a prostatic retraction implant for use in treating urinary outflow obstruction secondary to benign prostatic hyperplasia. The instructions for use specify that it is indicated for use in men aged 50 years and older and is contraindicated in men that have prostates larger than 100 ml. However, the company's training materials recommend that the system should not be used in men whose prostate has an obstructing middle lobe.
2.4 The cost of the UroLift system (comprising 1 delivery device and 1 implant) stated in the company's submission was £330 (excluding VAT).
2.5 In the case for adoption presented by the company, the claimed benefits of the UroLift system were as follows:
Reduction in diminished ejaculatory or sexual function.
Reduced need for post‑operative catheterisation and reduced catheterisation time.
Quicker return to pre‑treatment activities following treatment.
Reduced risk of hospital‑acquired infections and shorter hospital length of stay, because the UroLift procedure can be done as a day surgery.
Reduction in inpatient resource use, such as theatre operating time and associated staffing costs and resources.
Fewer follow‑up visits after patients are discharged, both in primary care settings and in an outpatient setting.
Better adverse event profile, leading to savings in the cost of complications associated with other surgical procedures.
Reduced costs from avoiding conditions that result from neglecting treatment, such as atonic bladder, kidney infection or failure, and detrusor sphincter dyssynergia (by using the UroLift system in men who would not consider more intrusive surgical treatment).
2.6 NICE guidance on lower urinary tract symptoms defines benign prostatic enlargement as an increase in the size of the prostate gland because of benign prostatic hyperplasia, and states that this is the cause in around half of all patients with lower urinary tract symptoms. Initial treatment options for benign prostatic hyperplasia include conservative management and medication (5 alpha reductase inhibitors and alpha‑blockers).
2.7 If conservative management or drug treatment have been unsuccessful or are not appropriate and symptoms are severe, then surgical options are considered. The guideline recommends using monopolar or bipolar TURP, monopolar transurethral vaporisation of the prostate or HoLEP. It specifies that HoLEP should only be done at a centre that specialises in the technique, or which has mentorship arrangements in place. TURP and HoLEP are usually done as inpatient procedures.
2.8 Currently, surgical procedures used to relieve lower urinary tract symptoms aim to resect or remove prostatic tissue to open up the blocked urethra. Although this is effective in relieving symptoms, resecting or removing prostate tissue induces a healing response and associated tissue inflammation. Use of a catheter is usual after the operation, which may be uncomfortable. TURP may also be associated with permanent side effects including erectile dysfunction, retrograde ejaculation and urinary incontinence.
2.9 TURP is considered to be the standard of care for symptomatic benign prostatic hyperplasia. However, improvements in the outcomes, durability, side effects and safety profiles of other technologies mean that TURP is becoming less widely used. NICE recommends the TURis system, which is a bipolar TURP system as an alternative to monopolar TURP.
2.10 NICE interventional procedure guidance on the insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia states that current evidence on inserting prostatic urethral lift implants (such as the UroLift system) in this indication is adequate to support their use, provided that normal arrangements are in place for clinical governance, consent and audit. The guidance also recommends that, during the consent procedure, clinicians should advise patients about the range of treatments available and the possible need for further procedures if symptoms recur. The guidance states that the procedure should only be done by clinicians with specific training in inserting prostatic urethral lift implants, and it encourages further research and the publication of results from consecutive case series.