Tom McNicholas has written widely on many aspects of urinary disease. He is particularly in demand for teaching on benign prostatic disease and urinary symptoms. He has major interests in the management of prostate cancer, the treatment of urinary stone disease and in making common urological investigations (especially prostatic biopsy) both painless and safer.
He has written over 150 major scientific papers which can be reviewed in the bibliography. Most recently he has been lead author of the chapter on Benign Prostatic Disease in the latest addition of Campbell’s Urology. This 4 volume textbook is the “bible” for urology and is used by urological experts worldwide. He is one of only a small handful of British urologists to have been recognised in this way.




Going with the flow! Relieving men's urinary symptoms yet still preserving sexual function and especially ejaculation by Urolift

Within the last few months of 2013 the Prostatic Urethral Lift procedure, using the UroLift implant device (NeoTract, Inc.), appeared on the global urology stage. Urolift has the unusual distinction of being both radically new and yet highly studied.  The creative cross-over study by Woo et al in a forthcoming early 2014 edition of British Journal of Urology International adds to the positive evidence for this new treatment option for men with LUTS [1]. Roehrborn et al have also recently published a high quality randomized, blinded study [2]. The accumulating published data indicates a new response profile of rapid relief from LUTS and improved urinary flow while preserving sexual function, including the often overlooked but much valued benefit of preserving ejaculation. In September 2013 Urolift was approved by the US FDA[3]  and then subsequently by NICE in the UK[4].  Gaining regulatory approval at the first attempt is a strikingly unusual achievement but one we can learn from.

The development of this technique began with our initial work in 2005 showing that prostatic glandular tissue could be compressed and tethered to the outer prostatic capsule to open up the prostatic urethra[5]. Neotract and its clinical advisors (of whom I was the first)  then embarked on years of device development and iteration, culminating in the current version of the UroLift implant device and the currently preferred technique[6].  The rigorous development and clinical testing program represents a master class in how a new minimally invasive procedure should be developed.

The process illustrates the benefits of co-operation between active clinicians and expert engineers.  One particularly important element in this co-operation was the identification of the critical evidence that would be necessary to overcome regulatory hurdles but also to allow clinicians to understand and evaluate this procedure as they adopt it into practice. Neotract’s determination to produce high quality data first, rather than publicising the method and developing the data to support it later, represents a refreshing change.

So, get a good and novel idea; develop the engineering; do the high quality studies, et voila – approval! But is it as easy as that?  No, the missing element is finance – lots of it.  For a company to tread this recommended path, though required by regulators (and indeed by editors), takes “a shed load” of money.  An FDA pivotal trial of sufficient quality to convince is likely to cost upwards of 20 million dollars.  

Few start up companies or indeed established device companies will take that gamble on truly innovative solutions, particularly when economic conditions are tough. NeoTract and its UroLift technology persevered through the economic crash of 2008 and have continued to achieve key clinical milestones against fierce regulatory and financial headwinds. Given these formidable challenges, it is reasonable to wonder how many other developers with novel ideas would be capable of completing the course? Most, unfortunately, would fail so many very good ideas do not reach a stage when they could help mankind and relieve disease.
  
The Prostatic Urethral Lift technique (or "Urolift") is an innovation that is now available for wider adoption.  It does require judgement to select those most likely to benefit and endoscopic skill to achieve the maximal therapeutic benefit, so a man needs to find a specialist who is interested in preservation of sexual function and ejaculation.

Urolift appears an effective option for men poorly served by drugs yet wishing to avoid the negative effects of existing surgical options. Additional studies continue to be enrolled, including a European randomized study, but the evidence currently available greatly exceeds that of most newly introduced minimally invasive developments. You can take a look at it yourself on www.neotract.com or www.urolift.co.uk

Tom McNicholas




References

  1. Woo et al BJU-2013-1479.R1 - Multi-Center Prospective Crossover Study of the Prostatic Urethral Lift for the Treatment of LUTS Secondary to BPH.
  2. 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; 190: 2162-2167.
  3. FDA News Release: New medical device treats urinary symptoms related to enlarged prostate. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368...5.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
  4. NICE http://guidance.nice.org.uk/IP/1032
  5. 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.

McNicholas TA, Woo HH, Chin PT et al. Minimally invasive prostatic urethral lift: surgical technique and multinational study. Eur Urol 2013; 64: 292-299.



Comments
See Older Posts...