We encountered NeoTract last September when the company gained FDA approval and saw a first patient for its Urolift prostatic urethral lift implant. Now the UK’s National Institute for Health and Clinical Excellence (NICE) has issued Interventional Procedure Guidance (IPG) approving the UroLift prostatic urethral lift implant for use by UK doctors.
Background
BPH is a common condition afflicting more than 500 million aging men worldwide. For patients who cannot tolerate drug therapy, the classic alternative is surgery that cuts or heats prostate tissue to open the blocked urethra. However 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).
And then there’s the procedure itself: 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 uses a single use device, 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.
The NICE IPG means that UK urologists will now be able to routinely offer the novel UroLift system to their patients for the first time outside of a clinical trial. 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.
The NICE guidance was made following consultations with independent clinical experts and a literature review.
Physician comments
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.”
NICE comments
“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.”
Company comments
“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.”
Source: NeoTract, Inc., PR Newswire