Tag: urolift

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Article of the Week: Prostatic urethral lift vs transurethral resection of the prostate

May 17, 2017/by admin Z.9

Every week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study

Christian Gratzke*, Neil Barber†, Mark J. Speakman‡, Richard Berges§, Ulrich Wetterauer¶, Damien Greene**, Karl-Dietrich Sievert††, Christopher R. Chapple‡‡, Jacob M. Patterson‡‡, Lasse Fahrenkrug§§, Martin Schoenthaler¶ and Jens Sonksen

§§*Department of Urology, Ludwig-Maximilians University, Munich, Germany, † Frimley Park Hospital NHS Foundation Trust, Surrey, UK, ‡Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK, §PAN Klinik Koln, Koln, Germany, ¶Department of Urology, University Hospital Freiburg, Freiburg, Germany, **City Hospitals Sunderland, Sunderland, UK, ††University Clinic of Lubeck, Lubeck, Germany, ‡‡Shefﬁeld Teaching Hospitals NHS Foundation Trust, Shefﬁeld, UK, and §§Department of Urology, Herlev Hospital, Herlev, Denmark

Read the full article

Abstract

Objectives

To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception.

Patients and Methods

A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time.

Results

Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Q_max) were observed in both arms throughout the 2-year follow up. Change in IPSS and Q_max in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep.

Conclusion

PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Editorial: The BPH6 study raises the bar on how we should conduct BPH surgical trials

May 17, 2017/by Henry Woo

We have all done it. We’ve all shaken our heads with bemusement when men have severe symptoms, as would be defined by the IPSS, yet their response to the quality-of-life question would either be ‘delighted’ or ‘satisfied’. Likewise, we may see men who have objective multiple-fold improvement in their urinary flow rates after a BPH surgical procedure but are more unhappy about their urinary function than they were with their preoperative state. Such mismatches in clinician and patient expectation are not uncommon in clinical practice and are likely, in part, to be a reflection of what measurements clinicians and patients consider to be of importance.

The BPH6 study has challenged the traditional way in which the success of a surgical treatment has been assessed [1]. When prostatic urethral lift (PUL) was compared with TURP in the setting of a randomized controlled trial, there was clearly superior performance of the former as highlighted by a patient-centred outcome metric referred to as the BPH6. It could be argued on the one hand that the combined metric games the outcome in favour of PUL, given that known shortfalls in TURP outcomes, such as recovery, sexual dysfunction and morbidity, could not see it fairly compete with a minimally invasive surgical treatment, but, on the other hand, perhaps the BPH6 metric is just measuring what matters to our patients. The BPH6 is made up of variables that are not in any way new and have all either been established or validated ways of measuring outcomes. A valid criticism, however, is that the combined BPH6 metric is yet to be validated.

Gratze et al. [2] report the 2-year results of the BPH6 study, in a paper that is a great deal more than just a progress report. It represents the most comprehensive patient-centred outcome and quality-of-life assessment ever performed on BPH surgical procedures. Their study also introduces several patient-centred outcome measures that were not reported in the 1-year publication. Additional to the now already well-described BPH6 variables, the study includes the Patient Global Impression of Improvement (PGI-I), the Short-Form Health Survey (SF-12) with its derivative SF-6D utility score, the minimal clinical important difference (MCID) and the Jenkins Sleep Questionnaire.

The PGI-I is perhaps the true test as to what a patient thinks about the effectiveness of a surgical procedure. There is no ambiguity about a response to a direct question as to whether a patient perceives a treatment to have improved or worsened their condition. Whilst the origins of the PGI-I are in the non-urological literature, it has recently been making its way into BPH clinical studies [3, 4]. This should be encouraged and we should indeed dare to ask our patients whether they consider our treatment has lead to improvement or otherwise.

The MCID has been used extensively in the medical literature since its introduction in 1989 [5]. The BPH6 study is the first clinical trial on BPH surgical treatment to use this metric. The MCID is exactly as the term is defined, and is assessed across a range of measures in the paper by Gratze et al. in the context of quality of life. A literature search will reveal that urologists have been very late to the party, but this study will probably have a role-modelling effect with regard to the future use of the MCID in health-related quality of life assessments in BPH studies.

The BPH6 study raises the bar for how we should measure the full impact of the surgical treatment of BPH. There has never been a clinical study that has explored patient-centred outcome measures and quality of life after surgical treatment of BPH to an extent that is even remotely close to that reported here. Whether the combined BPH6 metric becomes popularized or not is less important than the fact that future clinical trials will undoubtedly see an adoption of patient-measured outcomes. Such measures could play an increasingly important role in the decision process for health funders to support a new or existing treatment as well as assist patients in understanding the trade-off between the negative and positive impacts of treatment. We can expect to see plenty of future work that will attempt to verify these assertions.

Read the full article

How to Cite

Woo, H. H. (2017), The BPH6 study raises the bar on how we should conduct BPH surgical trials. BJU International, 119: 654–655. doi: 10.1111/bju.13815

Henry H. Woo

Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

References

1 Sonksen J, Barber N, Speakman M et al. Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate: 12-month Results from the BPH6 Study. Eur Urol 2015; 68: 643–52

2 Gratzke C, Barber N, Speakman M et al. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int 2017; 119: 767–75

3 Viktrup L, Hayes R, Wang P, Shen W. Construct validation of patientglobal impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol 2012; 12: 30

4 Hossack T, Woo H. Validation of a patient reported outcome questionnaire for assessing success of endoscopic prostatectomy. Prostate Int 2014; 2: 182–7

5 Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407–15

RSM Urology Winter Meeting 2017, Northstar, California

February 17, 2017/6 Comments/by Niyati Lobo

This year’s Annual RSM Urology Section Winter Meeting, hosted by Roger Kirby and Matt Bultitude, was held in Lake Tahoe, California.

A pre-conference trip to sunny Los Angeles provided a warm-up to the meeting for a group of delegates who flew out early to visit Professor Indy Gill at the Keck School of Medicine. We were treated to a diverse range of live open, endourological and robotic surgery; highlights included a salvage RARP with extended lymph node dissection and a robotic simple prostatectomy which was presented as an alternative option for units with a robot but no/limited HoLEP expertise.

On arrival to Northstar, Dr Stacy Loeb (NYU) officially opened the meeting by reviewing the social media urology highlights from 2016. Next up was Professor Joseph Smith (Nashville) who gave us a fascinating insight into the last 100 years of urology as seen through the Journal of Urology. Much like today, prostate cancer and BPH were areas of significant interest although, in contrast, early papers focused heavily on venereal disease, TB and the development of cystoscopy. Perhaps most interesting was a slightly hair-raising description of the management of IVC bleeding from 1927; the operating surgeon was advised to clamp as much tissue as possible, close and then return to theatre a week later in the hopes the bleeding had ceased!

With the promise of beautifully groomed pistes and stunning views of Lake Tahoe, it was hardly surprising that the meeting was attended by a record number of trainees. One of the highlights of the trainee session was the hilarious balloon debate which saw participants trying to convince the audience of how best to manage BPH in the newly inaugurated President Trump. Although strong arguments were put forward for finasteride, sildenafil, Urolift, PVP and HoLEP, TURP ultimately won the debate. A disclaimer: this was a fictional scenario and, to the best of my knowledge, Donald Trump does not have BPH.

The meeting also provided updates on prostate, renal and bladder cancer. A standout highlight was Professor Nick James’ presentation on STAMPEDE which summarized the trial’s key results and gave us a taste of the upcoming data we can expect to see in the next few years.

We were fortunate to be joined by prominent American faculty including Dr Trinity Bivalacqua (Johns Hopkins) and Dr Matt Cooperberg (UCSF) who provided state-of-the-art lectures on potential therapeutic targets and biomarkers in bladder and prostate cancer which promise to usher in a new era of personalized therapy.

A personal highlight was Tuesday’s session on learning from complications. It was great to hear some very senior and experienced surgeons speaking candidly about their worst complications. As a trainee, it served as a reminder that complications are inevitable in surgery and that it is not their absence which distinguishes a good surgeon but rather the ability to manage them well.

There was also plenty for those interested in benign disease, including topical discussions on how to best provide care to an increasingly ageing population with multiple co-morbidities. This was followed by some lively point-counterpoint sessions on robot-assisted versus open renal transplantation (Ravi Barod and Tim O’Brien), Urolift vs TURP (Tom McNicholas and Matt Bultitude) and HOLEP vs prostate artery embolization for BPH (Ben Challacombe and Rick Popert). Professor Culley Carson (University of North Carolina) concluded the session with a state-of-the art lecture on testosterone replacement.

In addition to the excellent academic programme, delegates enjoyed fantastic skiing with perfect weather and unparalleled views of the Sierra Nevada Mountains. For the more adventurous skiiers, there was also a trip to Squaw Valley, the home of the 1960 Winter Olympics. Another highlight was a Western-themed dinner on the shores of Lake Tahoe which culminated in almost all delegates trying their hand at line dancing to varying degrees of success! I have no doubt that next year’s meeting in Corvara, Italy will be equally successful and would especially encourage trainees to attend what promises to be another excellent week of skiing and urological education.

Miss Niyati Lobo
ST3 Urology Trainee, Brighton and Sussex University Hospitals NHS Trust

@niyatilobo

Highlights from BAUS 2016

July 5, 2016/3 Comments/by Nishant Bedi

In the week following Britain’s exit from Europe after the BREXIT referendum, BAUS 2016 got underway in Liverpool’s BT convention Centre. This was the 72^nd meeting of the British Association of Urological Surgeons and it was well attended with 1120 delegates (50% Consultant Member Urologists, 30% Trainees, 10% Non member Urologists/Other, 10% Nurses, HCP’S, Scientists).

Monday saw a cautionary session on medicolegal aspects in Andrology, focusing on lawsuits over the last year. Mr Mark Speakman presented on the management issue of testicular torsion. This sparked further discussion on emergency cover for paediatrics with particular uncertainty noted at 4 and 5 year olds and great variation in approach dependent on local trust policy. Mr Julian Shah noted the most litigious areas of andrology, with focus on cosmesis following circumcisions. Therefore serving a reminder on the importance of good consent to manage patients’ expectations.

In the Dragons’ Den, like the TV show, junior urologists pitched their ideas for collaborative research projects, to an expert panel. This year’s panel was made up of – Mark Emberton, Ian Pearce, and Graeme MacLennan. The session was chaired by Veeru Kasivisvanathan, Chair of the BURST Research Collaborative.

Eventual winner Ben Lamb, a trainee from London, presented “Just add water”. The pitch was for an RCT to investigate the efficacy of water irrigation following TURBT against MMC in reducing tumour recurrence. Ben proposed that water, with its experimental tumouricidal properties, might provide a low risk, low cost alternative as an adjuvant agent following TURBT. Judges liked the scientific basis for this study and the initial planning for an RCT. The panel discussed the merits of non-inferiority vs. superiority methodology, and whether the team might compare MMC to MMC with the addition of water, or water instead of MMC. They Dragons’ suggested that an initial focus group to investigate patients’ views on chemotherapy might help to focus the investigation and give credence to the final research question, important when making the next pitch- to a funding body, or ethics committee.

Other proposals were from Ryad Chebbout, working with Marcus Cumberbatch, an academic trainee from Sheffield. Proposing to address the current controversy over the optimal surgical technique for orchidopexy following testicular torsion. His idea involved conducting a systematic review, a national survey of current practice followed by a Delphi consensus meeting to produce evidence based statement of best practice. The final presentation was from Sophia Cashman, East of England Trainee for an RCT to assess the optimal timing for a TWOC after urinary retention. The panel liked the idea of finally nailing down an answer to this age-old question.

Waking up on Tuesday with England out of the European football cup as well as Europe the conference got underway with an update from the PROMIS trial (use of MRI to detect prostate cancer). Early data shows that multi-parametric MRI may be accurate enough to help avoid some prostate biopsies.

The SURG meeting provided useful information for trainees, with advice on progressing through training and Consultant interviews. A debate was held over run through training, which may well be returning in the future. The Silver cystoscope was awarded to Professor Rob Pickard voted for by the trainees in his deanery, for his devotion to their training.
Wednesday continued the debate on medical expulsion therapy (MET) for ureteric stones following the SUSPEND trial. Most UK Urologists seem to follow the results of the trial and have stopped prescribing alpha blockers to try and aid stone passage and symptoms. However the AUA are yet to adopt this stance and feel that a sub analysis shows some benefit for stones >5mm, although this is not significant and pragmatic outcomes. Assistant Professor John Hollingsworth (USA) argued for MET, with Professor Sam McClinton (UK) against. A live poll at the end of the session showed 62.9% of the audience persuaded to follow the SUSPEND trial evidence and stop prescribing MET.

In the debate of digital versus fibreoptic scopes for flexible ureteroscopy digital triumphed, but with a narrow margin.

In other updates and breaking news it appears that BCG is back! However during the shortage EMDA has shown itself to be a promising alternative in the treatment of high grade superficial bladder cancer.
The latest BAUS nephrectomy data shows that 90% are performed by consultant, with 16 on average per consultant per year. This raises some issues for registrar training, however with BAUS guidelines likely to suggest 20 as indicative numbers this is looking to be an achievable target for most consultants. Robotic advocates will be encouraged, as robotic partial nephrectomy numbers have overtaken open this year. The data shows 36% of kidney tumours in the under 40 years old are benign. Will we have to consider biopsying more often? However data suggests we should be offering more cytoreductive nephrectomies, with only roughly 1/10 in the UK performed compared to 3/10 in the USA.

The andrology section called for more recruitment to The MASTER trial (Male slings vs artificial urinary sphincters), whereas the OPEN trial has recruited(open urethroplasty vs optical urethotomy). In the treatment of Peyronie’s disease collagenase has been approved by NICE but not yet within the NHS.

Endoluminal endourology presentation showed big increases in operative numbers with ureteroscopy up by 50% and flexible ureteroscopy up by 100%. Stents on strings were advocated to avoid troubling stent symptoms experienced by most patients. New evidence may help provide a consensus on defining “stone free” post operation. Any residual stones post-operatively less than 2mm were shown to pass spontaneously and therefore perhaps may be classed as “stone free”.

Big changes seem likely in the treatment of benign prostatic hyperplasia, with a race to replace the old favorite TURP. Trials have of TURP (mono and bipolar) vs greenlight laser are already showing similar 2 year outcomes with the added benefit of shorter hospital stays and less blood loss. UROLIFT is an ever more popular alternative with data showing superiority to TURP in lifestyle measures, likely because it preserves sexual function, and we are told it can be performed as a 15 minute day case operation. The latest new therapy is apparently “Aquabeam Aquablation”, using high pressured water to remove the prostate. Non surgical treatments are also advancing with ever more accurate super selective embolisation of the prostatic blood supply.

This year all accepted abstracts were presented in moderated EPoster sessions. The format was extremely successful removing the need for paper at future conferences? A total of 538 abstracts were submitted and 168 EPosters displayed. The winner of best EPoster was P5-5 Altaf Mangera: Bladder Cancer in the Neuropathic Bladder.

The best Academic Paper winner was Mark Salji of the CRUK Beatson institute, titled “A Urinary Peptide Biomarker Panel to Identify Significant Prostate Cancer”. Using capillary electrophoresis coupled to mass spectrometry (CE-MS) they analysed 313 urine samples from significant prostate cancer patients (Gleason 8-10 or T3/4 disease) and low grade control disease. They identified 94 peptide urine biomarkers which may provide a useful adjunct in identifying significant prostate cancer from insignificant disease.

The Office of Education offered 20 courses. Popular off-site courses were ultrasound for the Urologist, at Broadgreen Hospital, a slightly painful 30 min drive from the conference centre. However well worth the trip, delivered by Radiology consultants this included the chance to scan patients volunteers under guidance, with separate stations for kidneys, bladder and testicles and learning the “knobology” of the machines.

Organised by Tamsin Greenwell with other consultant experts in female, andrology and retroperitoneal cancer, a human cadaveric anatomy course was held at Liverpool university. The anatomy teaching was delivered by both Urology consultants and anatomists allowing for an excellent combination of theory and functional anatomy.

BAUS social events are renowned and with multiple events planned most evenings were pretty lively. The official drinks reception was held at the beautiful Royal Liver Building. The venue was stunning with great views over the waterfront and the sun finally shining. Several awards were presented including the Gold cystoscope to Mr John McGrath for significant contribution to Urology within 10 years appointment as consultant. The Keith Yeates medal was awarded to Mr Raj Pal, the most outstanding candidate in the first sitting of the intercollegiate specilaity examination, with a score of over 80%.

During the conference other BAUS awards presented include the St Peter’s medal was awarded to Margeret Knowles, Head of section of molecular oncology, Leeds Institute of Cancer and Pathology, St James University hospital Leeds. The St Paul’s medal awarded to Professor Joseph A. Smith, Vanderbilt University, Nashville, USA. The Gold medal went to Mr. Tim Terry, Leicester General Hospital.

An excellent industry exhibition was on display, with 75 Exhibiting Companies present. My personal fun highlight was a flexible cystoscope with integrated stent remover, which sparked Top Gear style competiveness when the manufacturer set up a time-trial leaderboard. Obviously this best demonstrated the speed of stent removal with some interesting results…

Social media review shows good contribution daily.

Thanks BAUS a great conference, very well organised and delivered with a great educational and social content, looking forward to Glasgow 2017! #BAUS2017 #Glasgow #BAUSurology

Nishant Bedi

Specialist Training Registrar North West London

Twitter: @nishbedi

Could Urolift stand the test of time for LUTS management?

August 4, 2015/by admin Z.9

Several new surgical technologies have been assessed during the last decades in order to improve the management of LUTS (Lower Urinary Tract Symptoms): HoLEP (Holmium laser enucleation of the prostate), HoLAP (Holmium laser ablation of the prostate), TUMT (transurethral microwave therapy), TUNA (transurethral needle ablation), HIFU (high-intensity frequency ultrasound) and more recently Greenlight laser vaporization. All these techniques have been compared to TURP (transurethral resection of the prostate), which it is currently considered as the surgical standard procedure for men with mid-size prostate gland associated with moderate-severe LUTS and obstruction.
This month, the #urojc tribe discussed a multicentric randomized trial of a new surgical treatment option for LUTS caused by prostate enlargement: the Prostatic Urethral Lift (PUL), which supposedly reduces the negative effects of other surgical therapies on sexual function. One important controversy of the article is the use of a composite end-point, the BPH6 that includes the assessment of 1) LUTS relief, 2) postoperative recovery experience, 3) erectile function, 4) ejaculatory function, 5) urinary continence preservation and 6) safety, a concept that may resemble the Pentafecta from the surgical treatment of prostate cancer.
The PUL vs TURP – BPH6 study seems to be a well done RCT that accurately follows the CONSORT
statement.

Despite of this, #urojc participants showed reluctance to accept the main outcomes of the study. Interestingly, comments about COI (conflict of interest) and the impact of the industry in manuscripts were mentioned…

People were not completely convinced about using a novel endpoint to compare TURP and PUL… the BPH6 seems to balance the impact of the 6 elements… or perhaps it gave more magnitude to the sexual side effects…

As usual in this #urojc, urologists mentioned specific details about the design and methods of the study…

And participants questioned about why authors emphasized in the manuscript specific points that may favor PUL over TURP…

Good discussion went throughout the 48 hours session, constructive comments about the study, and some other tweets revealed skepticism at this new technique….

And then, @sivanrij evoked the truth about LUTS (by the way, one of the most retweeted/favorited comments)…

Despite being something completely related to the type of health care system, and the specific conditions of each continent or region, costs were compared…

Some experts in PUL shared their thoughts…
Final thoughts were mentioned…

Only time will determine the real success of this novel therapy…

But some questions remain unanswered…

… And helpful references were mentioned…

https://www.bmj.com/content/326/7400/1167

#urojc Commentary on #BPH endpoints “Patients not p-values” by Rees @MattBultitude @CanesDavid @antnoah @soph_cash https://t.co/IMVK6DbAvL — Stacy Loeb, MD (@LoebStacy) July 6, 2015

https://www.ncbi.nlm.nih.gov/pubmed/?term=25885560

Classic Barry paper-BPH minimum clinically important difference #urojc @MattBultitude @CanesDavid @antnoah @soph_cash https://t.co/KDdzc0uZpy

— Stacy Loeb, MD (@LoebStacy) July 6, 2015

https://www.ncbi.nlm.nih.gov/pubmed/7563343

At this time we do not have any treatment options for LUTS/BPO that preserves the ejaculatory function, and PUL may be an option in selected cases; we should accept that it is another option to increase our therapeutic armamentarium…
#urojc demonstrates that Twitter is a powerful tool to share our scientific thoughts all over the world. #urojc gives the opportunity to discuss articles with world-wide experts and authors of the published articles. Following and participating in these discussing definitely opens our minds, expands our medical knowledge and contributes to offer better health care to our patients.

Daniel Olvera-Posada (@OlveraPosada) is a Mexican Urologist, trained at @incmnszmx, currently in his second year of the Endourology Fellowship (@EndourolSoc) at @westernu, in London Ontario, Canada.

UroLift Takes Off From Down Under. The Potential Rewards When Engineers Bring You Into Their Inner Circle

September 17, 2013/2 Comments/by Henry Woo

At the American Urological Association meeting in San Antonio in May 2005, I was introduced to a four engineers from a small start up company called NC2 (New Company 2). It had at that time been recently spun off from the medical device incubator company Exploramed. They had no product and not even a prototype of a product that could possibly be used in humans but what they did have was a passion to make a difference, incredible ideas and a laptop computer.

They had thought about the failings of existing mechanical treatments for LUTS/ BPH and the first that comes to your mind is prostatic stents. No stent conforms perfectly to the shape of the prostatic urethra and there were the issues of encrustation of any elements of stent material that were exposed to the urine. Rather than throw the baby out with the bathwater, they harnessed what was good about stents, which was the potentially immediate effects they could have on urinary function without associated destruction of tissue and that perhaps tailoring the radial expansion to just a few critical points rather than the entire length of the prostatic urethra could do the trick.

The original idea was that some sort of metallic disc could be placed outside the prostate capsule and one on the urethral side and between them, a non absorbable suture could be placed under tension and therefore draw open the prostatic urethra and defined sites. How these engineers were to find a way of designing a delivery tool to do this had me a little skeptical at first but there seemed to be no doubt in their minds, even thought they had not yet worked it out, were going to find a way. Their confidence, intellect and enthusiasm was infectious and you just felt like you wanted to be a part of this project. It so turned out that the metallic discs would be replaced by linear metallic tabs which logically make for easier delivery.

So why involve Australians? It is difficult to keep things under the radar and one way of doing so is to take the idea where it is less likely to be visible. Additionally, the data needed to be trustworthy and in a place where strong ethic committee governance structures exist. We make no illusion that for once, being Australian, gave us a clinical research opportunity from a company based in the US that would rarely be directed our way.

My Australian colleague, Dr Peter Chin was also brought in on the project. Over the next few months, we did not hear anything but there was then an urgent call that ‘California was the place we ought to be’ so we literally dropped everything and headed over to Silicon Valley where we had the opportunity to use the first prototype of the device on human cadavers. Whilst our travel costs were covered by NC2, we received no payment for our time spent during these exercises but remuneration was the last thing on our minds given the exciting path that the idea could potentially take. Simultaneously, animal studies were being conducted and these demonstrated that the internal metallic tabs of the prosthesis would become covered by urothelium and in combination with the cadaveric work, provided a convincing argument to move forward with human clinical trials.

Putting on a brave face doing the first human Urolift case at Westmead Hospital in Sydney in December 2005

By December 2005, we were ready to conduct the first human trials. We measured everything that could possibly move and it probably took close to 2 hours to perform the first case. The initial prototype device used looked like it was literally built in somebody’s garage workshop but it was functional and confirmed proof in principle that a transurethral delivery system could deploy metallic tabs on the capsular side of the prostate and within the urethra that was connected by a tensioned suture. Through this, it created mechanical alteration to the anatomy of the prostatic urethra with positive influence on lower urinary tract symptoms. From here, multiple clinical trials have been performed by the company that became known as Neotract Inc and as of 13 September 2013, the device received FDA approval.

It is enormous privilege to have played a role in product development from inception of an idea through to FDA approval. These opportunities are rare and whilst healthy skepticism and caution should be applied to all ideas presented to you, if you are offered such an opportunity to take a side project, it could be a rewarding diversion from your daily clinical practice. Financially, you will never recoup your time investment but the rewards of making a difference is priceless.

Shared passion for a project can go a long way. This experience emphasizes the value of engineers interacting with clinicians to achieve a desired outcome and there is certainly room for of such interactions. Opportunities to embrace these relationships are out there and perhaps a good place to start is to become active in the Engineering and Urology Society which as a section of the Endourological Society meets each year at the AUA Annual Meeting.

Henry Woo is an Associate Professor of Surgery at the Sydney Adventist Hospital Clinical School of the University of Sydney in Australia. He has been appointed as the inaugural BJUI CME Editor. He is currently the coordinator of the International Urology Journal Club on Twitter. Follow him on Twitter @DrHWoo

Disclosure: Henry Woo has formerly been an investigator and advisor to Neotract Inc. He holds a small stock investment in the company.

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