NeoTract, Inc., has announced that the UK's National Institute for Health and Clinical Excellence (NICE) has issued an Interventional Procedure Guidance (IPG) approving the UroLift prostatic urethral lift implant for use by UK doctors. The NICE guidance was made following consultations with independent clinical experts and a literature review.
NICE says: "The specialist advisers listed key efficacy outcomes as symptom improvement, improvement in quality of life, reducing or stopping medical therapy [drug therapy], flow improvement, reduction in residual volume and maintenance of sexual and ejaculatory function."
The NICE IPG means that UK urologists will be able to routinely offer the novel UroLift system to their patients for the first time outside of a clinical trial. The implants are used to treat BPH - a condition caused by an enlarged prostate that begins to obstruct the urinary system. The condition is common, affecting over 40% of men over 50 years of age. BPH symptoms can include urgency, hesitation, straining, dribbling, incomplete emptying (the sensation that the bladder is not empty after urinating), weak urine flow, increased frequency of urination, nocturia, dysuria, and depression resulting in a decreased quality of life.
Patients receiving the UroLift implants report rapid symptomatic improvement, increased urinary flow rates, and preserved sexual function. A significant improvement in Quality of Life for patients was also observed.
Unlike the traditional treatment options for enlarged prostates that require administration of a spinal or a general anesthetic, the minimally invasive procedure to insert the UroLift implants typically lasts no more than an hour, can be carried out using local anesthesia and the patient is able to go home shortly afterwards; the procedure provides rapid, significant relief with lower risk.
Mr Neil Barber, Consultant Urologist at Frimley Park Hospital in Surrey says: "Up to now, men with BPH have had two pretty unattractive options - either lifelong drug treatment which is less effective than surgery and has possible side effects including sexual dysfunction, dizziness and headaches, or cutting away parts of the prostate - known as TURP - that is really good at relieving BPH symptoms but has a significant chance of causing permanent dry orgasms and erection problems, and a small chance of developing urinary incontinence. That's not much of a choice. Many men I see in clinic are, understandably, very nervous of having TURP - they may be older but they are men - so whatever their age, they don't want to have an operation which may make them feel less of a man. [The] UroLift [implant] involves retracting and holding back the enlarged prostate so it's gentler than TURP with minimal side effects and it's more effective than drugs. I think it's a really exciting, game changing treatment for men. UroLift [implants] add another option in the armamentarium for some men and is particularly useful in those who want to quickly return to their normal activities and preserve sexual function."
Urologist Professor Tom McNicholas, who works at the London Clinic and Spire Hospital, Harpenden, as well as in the NHS, has been involved since the start of the project. He says: "Several leading UK surgeons have been using UroLift [implants] for a while now. But there are always difficulties in introducing a new idea and it's reassuring and encouraging that NICE have rigorously assessed [the] UroLift [system treatment] and regard it as both safe and effective. We now hope to use UroLift more widely in the NHS and in the private sector now that NICE has supported it. I have been involved in an NHS pilot research study on the UroLift device because we saw that, aside from the clinical value of the procedure, there were savings and efficiencies that could be achieved by reduced bed stays for this day case procedure - compared to the other, more invasive surgical procedures that are available. I am looking forward to offering it to my NHS patients because UroLift [implants] improve symptoms whilst preserving men's sexual function and these are worthwhile and important outcomes."
Mr Mark Speakman, Consultant Urologist at Taunton's Musgrove Park Hospital, says: "The UroLift [prostatic implant] procedure is a middle ground option for men sitting between drug treatment and surgical transurethral resection of the prostate (TURP). The problem of drug treatment is compliance - men aren't good at taking drugs - and the problem with TURP is the potential side effects, including ejaculatory problems. UroLift [implantation] beats drugs on efficacy and TURP on side effects. Many men have contacted us wanting UroLift, and the announcement will make life easier for British surgeons who want to offer it."
"Receiving NICE interventional procedure guidance is another huge milestone for UroLift® and NeoTract," commented Dave Amerson, president and CEO of NeoTract. "We are extremely pleased to bring our innovative UroLift System to more physicians and patients in the U.K. as we believe it will make a significant difference in the lives of aging men."
About BPH and the UroLift Implant Treatment
BPH is a common condition afflicting more than 500 million aging men worldwide. Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. Medication is often the first line therapy but relief can be inadequate and temporary. Side-effects can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts or heats prostate tissue to open the blocked urethra. Although effective, patients have to 'earn' their symptom relief after a difficult period of irritative voiding symptoms and catheterization. Even the 'gold standard' surgery, TURP (Transurethral Resection of the Prostate), can leave patients with permanent side-effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
The UroLift System is designed to open the urethra directly without applying incisions, surgical resection or thermal injury to the prostate. Obstructive prostate lobes are transurethrally pushed aside and small permanent UroLift implants hold the lobes in the retracted position, thus opening the urethra while leaving the prostate intact.