Tag Archive for: sexual function

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

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, ‡‡Shefeld Teaching Hospitals NHS Foundation Trust, Shefeld, UK, and §§Department of Urology, Herlev Hospital, Herlev, Denmark

 

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.

aotw-may-3-results

Results

Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax 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

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.

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

 

 

Article of the Week: Patient expectations of sexual function following RP

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.

A survey of patient expectations regarding sexual function following radical prostatectomy

Serkan Deveci*,, Geoffrey T. Gotto*, Byron Alex*, Keith OBrien* and John P. Mulhall*

 

*Department of Urology, Memorial Sloan Kettering Cancer Center, New York, NY, USA, and Department of Urology, Medical School of Acibadem University, Istanbul, Turkey

 

Objective

To assess the understanding of patients, who had previously undergone radical prostatectomy (RP), about their postoperative sexual function, as clinical experience suggests that some RP patients have unrealistic expectations about their long-term sexual function.

Patients and Methods

Patients presenting within 3 months of their open RP or robot-assisted laparoscopic prostatectomy (RALP) were questioned about the sexual function information that they had received preoperatively. Patients were questioned about erectile function (EF), postoperative ejaculatory status, orgasm, and postoperative penile morphology changes. Statistical analyses were performed to assess for differences between patients who underwent open RP vs RALP.

octaotw4-results

Results

In all, 336 consecutive patients (from nine surgeons) with a mean (SD) age of 64 (11) years had the survey instrument administered (216 underwent open RP and 120 underwent RALP). There were no significant differences in patient age or comorbidity profiles between the two groups. Only 38% of men had an accurate recollection of their nerve-sparing status. The mean (SD) elapsed time after RP at the time of postoperative assessment was 3 (2) months. RALP patients expected a shorter EF recovery time (6 vs 12 months, P = 0.02), a higher likelihood of recovery back to baseline EF (75% vs 50%, P = 0.01), and a lower potential need for intracavernosal injection therapy (4% vs 20%, P = 0.01). Almost half of all patients were unaware that they were rendered anejaculatory by their surgery. None of the RALP patients and only 10% of open RP patients recalled being informed of the potential for penile length loss (P < 0.01) and none were aware of the association between RP and Peyronie’s disease.

Conclusions

Patients who have undergone RP have largely unrealistic expectations about their postoperative sexual function.

Editorial: Managing expectations after radical prostatectomy; time to change

There have been numerous advances in the management of prostate cancer. Developments in imaging, surgical and radiotherapy technology, and pathological grading, have led to improvements in the diagnosis and management of this common malignancy. Such progress has translated to earlier diagnosis and improved disease-specific outcomes.

With improved outcomes comes increased attention on life after treatment. Survivorship in cancer has been an area of increasing focus. The aim; to live as healthy and as good a quality of life for as long as possible after diagnosis, by managing the consequences of the cancer and its treatment. In prostate cancer, the functional impact of surgery on quality of life can be considerable, especially given the falling age at first presentation. The consequences of treatment are often the reason patients’ select one form of therapy over another.

Both sexual function and urinary continence can be significantly affected after radical prostatectomy (RP). Despite numerous consequences of surgery on sexual function, the greatest focus in publications is erectile dysfunction (ED). The quoted incidence in published studies can vary from 20% to 90%, depending on whether the return of ‘normal’ erectile function is classed as the return of spontaneous erections, a ‘return to baseline function’, or functional recovery only with pharmacological assistance. This lack of agreed definition of ED after RP hampers progress by underestimating the impact of surgery and making an uneven playing field when comparing studies.

The tendency for surgeons and studies to focus solely on erectile function, when there are so many changes in sexual function after RP, does not give patients a realistic expectation of the impact of surgery on their life after treatment. Patients should be made aware 100% will experience some change in their sexual function after surgery. Patients should be aware of all the possible risks, including;

  1. ED: All will develop a degree of ED after any RP and should be aware that their risk is dependent on their baseline function, comorbidity, and nerve-spare status. They should be made aware of the protracted time course for recovery, even when the nerves are spared, the need for possible injection therapy, and the possible future dependence on some form of therapy to achieve functional erections in the long-term.
  2. Changes in ejaculation: All patients should be made aware of the loss of ejaculation as a permanent feature, and the impact this will have on their natural fertility. They should also be aware that some develop climacturia, and the possible risk of ejaculatory pain.
  3. Changes to penile size/shape: Patients should be aware of the possible reduction in penile length after RP, and the increased risk of developing Peyronie’s disease after RP, which can further impact their sexual function.

With high profile advances such as the rise of robot-assisted RP (RARP), much has been made of the improved view of local anatomy, and ability to manoeuvre within the confined space. The expectation that this translates to improved functional outcome existed way before any studies had been conducted to show any benefit. It is of no surprise, therefore, that patients’ expectations of outcomes after RP have been unrealistically raised by such technologies.

In this month’s BJUI, Deveci et al. [1] present their survey looking at patient expectations of sexual function after RP. In this study, patients who had undergone RP (open or robot-assisted) in the last 3 months were asked to recall the counselling they had received about possible changes in sexual function preoperatively. The comprehensive approach of this study examined patients’ expectations in all the different facets of sexual function, including erectile function, expected time to full recovery of erections, the possible need for intracavernosal injections (ICI), changes in ejaculation including intensity, pain, and climacturia, and awareness of penile length changes and risk of postoperative Peyronie’s disease.

Compared with those undergoing open RP, patient’s expectations after RARP were greater, with more expecting a shorter recovery time (6 vs 12 months, P = 0.02), a higher expectation of a recovery back to baseline erectile function (75% vs 50%, P = 0.01), and lower expected need for ICI (4% vs 20%, P = 0.01) [1]. This greater expectation of newer technology leads to greater regret, and a greater need to manage expectations preoperatively [1, 2].

In addition to the misconceptions on erectile function, ~50% were unaware of the risk of anejaculation, <10% were aware of changes to penile length, and none were aware of risks of developing Peyronie’s disease after RP.

While the Deveci et al. [1] study does have flaws, primarily the lack of ability to differentiate between what patients were exactly told before RP by the nine different operating surgeons, and what could be recalled after RP, it does highlight an important point. No matter what patients were told before surgery, within 3 months of surgery their recollection and understanding of its possible impact on sexual function was poor. Previous studies have highlighted this disparity between clinician’s recall of discussions on the consequences of surgery and patient recall. In one study, while 100% of clinicians felt they had adequately addressed patients concerns on ED, <30% of patients felt the issues had been adequately addressed [3].

Effective management of patients’ expectations of the possible consequences of RP preoperatively allows for better informed consent, a realistic expectation of outcome and time course for recovery, better compliance with postoperative treatments for ED, and less regret of the initial surgical approach.

Given the limited time in consultations, there is not enough time to address all the possible consequences of surgery in detail. When being diagnosed with cancer, often the last thing on the patients mind is sexual function a year down the line. The more important issue at first is coming to terms with the cancer diagnosis, and just making it through the surgery. In addition, one has to wonder if it is fitting for the oncological surgeon to discuss the functional consequences, possible outcomes and their management when other specialists will manage this in the future. A discussion of sexual consequences of surgery is very different coming from the robotic surgeon, rather than the andrologist who would see them after.

The most ideal approach would be for all patients to see an andrologist and continence specialist before RP or be seen in preoperative ‘survivorship’ seminars, based on discussing possible consequences and optimising functional recovery after treatment. Such seminars should be run by the teams involved in managing sexual function and continence postoperatively. Patients should be given a simple, one page sheet outlining the possible consequences of their intended treatment, be that radiotherapy or surgery, on sexual function and continence. In the same way that patients are given a key contact for their cancer care, they should have access to a key contact for their functional recovery. In addition to follow-up visits with the operating surgeon, focusing on the oncological outcome, a separate follow-up based on functional outcome with an andrologist and continence specialist would focus on functional recovery.

There has been a drive to develop high-volume cancer centres of excellence, with pooled resources to allow excellence in imaging, pathology, as well as surgical and non-surgical treatments. The most utopian approach would see these centres also having andrology and continence specialists focused on the management of all postoperative functional consequences, including the ability to undertake penile implant and artificial sphincter surgery as required.

The progress in developing such an infrastructure has been slow. Research on optimising functional recovery has not been as extensive as the focus on diagnosis and treatment in prostate cancer, which can dominate many urology journals and meetings. This imbalance needs to be addressed, to provide not only the best treatment for prostate cancer, but also the best management of the consequences of treatment, aimed at improving quality of life after surgery.

Majid Shabbir
Guys Hospital, London, UK

 

References

 

1 Deveci S, Gotto GT, Alex B, OBrien K, Mulhall JP. A survey of patient

 

2 Schroeck FR, Krupski TL, Sun L et al. Satisfaction and regret after open

 

3 Crawford ED, Bennett CL, Stone NN et al. Comparison of perspectives

 

Ejaculatory Function and Treatment for Male LUTS due to BPH

This month’s twitter-based international urology journal club discussed “Impact of Medical Treatments for Male LUTS due to BPH on Ejaculatory Function: A Systematic Review and Meta-analysis”, published online in the Journal of Sexual Medicine. The discussion was enriched by the participation of Asst. Prof. Giacomo Novara (@giacomonovara) of the University of Padua, the senior author of the paper.

There was general consensus that this was a well constructed paper addressing an important and sometimes neglected side-effect of a group of medications that most urologists use commonly. The principal messages of the paper were:

  1. Ejaculatory dysfunction (EjD) was significantly more common with alphablockers (ABs) in general than placebo
  2. This effect was mainly seen with selective ABs (tamsulosin and sildosin). Non-selective ABs (doxazosin and terazosin) had similar rates of EjD to placebo.
  3. Finasteride and dutasteride both cause EjD, and to a similar extent as each other.
  4. Combination therapy (5ARI + AB) resulted in a three-fold increase in EjD compared to either monotherapy

The authors were congratulated on the amount of work that had obviously gone into the analysis. There was a discussion of some of the technical aspects of how to conduct a systematic review (SR) and meta-analysis. The PRISMA guidelines are a mandatory standard, and are recommended to anyone considering undertaking one. @LoebStacy also recommended the Cochrane handbook as a useful source of info. @DrHWoo asked whether Jadad scores had been used to rate RCT quality. They were not used in this study, but are one method of assessing RCT quality for an SR. @chrisfilson and @jleow advocated the Cochrane Collaboration’s tool for risk of bias assessment (found in Section 8.5 of the handbook), as an alternative.

After the technical aspects, discussion focussed on how best to avoid EjD in men who are concerned about it. @linton_kate asked whether PDE5 inhibitors were an option in this regard. General consensus was that they are an option, especially where LUTS and erectile dysfunction (ED) coexist, but concerns were expressed about the cost (which varied country by country, but is generally far in excess of the cost of ABs) and by @nickbrookMD about the uncertainty surrounding their mechanism of action for LUTS improvement.

Several correspondants were using PDE5Is in clinical practice for this indication however, including @VMisrai. It was pointed out however, that alfuzosin also offers a reduced risk of EjD compared to other ABs, and is substantially less expensive than PDE5Is. Alfuzosin was not evaluated in this paper, however @giacomonovara agreed that it was an option in men with LUTS who wish to avoid EjD, especially where ED is not a concern. @DrHWoo pointed out the Rosen data demonstrating the correlation between increasing LUTS and decreasing erectile function, but indeed (as suggested by @JCLinMD) treatment of LUTS, e.g. with an AB, may in itself improve erectile function.

Discussion moved on to 5ARIs. @giacomonovara stated that these agents had a broad spectrum of potential effects on ejaculatory/erectile function. @shomik_S raised the issue of whether 5ARIs could cause irreversible sexual side-effects. This is certainly a medicolegal concern, and undoubtedly some men report persistent effects on libido and sexual function, although a firm causal link has not been established.

The medicolegal theme was further explored with a discussion on what to warn patients of when commencing these medications. All were agreed that patients commencing ABs/5ARIs, including those undergoing medical expulsive therapy for stones should be warned about EjD. There was some discussion however, about whether patients commencing a 5ARI should be warned about the increased rates of high-grade prostate cancer seen in the PCPT and REDUCE trials. This increase may be an artefact of more effective cancer detection, but none-the-less @loebStacy was of the opinion that it should be included in pre-treatment counselling.

 

But is all the concern about sexual side-effects justified? It was pointed out that many patients are prepared to tolerate sexual side-effects in return for improvement in their LUTS.

Regardless, this paper from @giacomonovara and co-authors provided useful insight and stimulated a valuable discussion. Undoubtedly, some patients are very concerned about EjD and this paper will help all urologists who treat male LUTS to address these concerns.

Winner of the Best Tweet Prize was David Gillatt for his response to the discussion regarding the needs of various nationalities for PDE5I. Special thanks to the SIU for offering a prize of free registration to the 2014 SIU Congress in Glasgow. Also special thanks to Wiley for allowing open access of the article for the May #urojc discussion.

Ben Jackson has completed urological training in the East Midlands, and is now undertaking a fellowship at St. Vincent’s Hospital, Sydney. His principal clinical interest is urologic oncology.
Twitter @Ben_L_Jackson

 

Article of the week: Preserving sexual function with the prostatic urethral lift

Every week the Editor-in-Chief selects the 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.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Henry Woo discussing his paper.

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

Multicentre prospective crossover study of the ‘prostatic urethral lift’ for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

Anthony L. Cantwell, William K. Bogache*, Steven F. Richardson, Ronald F. Tutrone, Jack Barkin§, James E. Fagelson, Peter T. Chin†† and Henry H. Woo

‡‡Atlantic Urological Associates, Daytona Beach, FL, *Carolina Urological Research Center, Myrtle Beach, SC, Western Urological Clinic, Salt Lake City, UT, Chesapeake Urology, Baltimore, MD, USA, §University of Toronto, Toronto, ON, Canada, Urology Associates of Denver, Denver, CO, USA, ††Figtree Private Hospital, Figtree, and ‡‡Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

OBJECTIVE

• To assess the clinical effect of the ‘prostatic urethral lift’ (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study.

PATIENTS AND METHODS

• Men aged ≥50 years with an International Prostate Symptom Score of ≥13, a maximum urinary flow rate (Qmax) of ≤12 mL/s, and a prostate of 30–80 mL were enrolled into a crossover study after completing a prospective, randomised, controlled, ‘blinded’ pivotal study in which they were control subjects receiving a sham procedure.

• Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds.

• PUL involved placing permanent UroLift® (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen.

• Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis.

RESULTS

• Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients.

• Symptom, flow, and HRQL improvements were durable over the 12 months of the study.

• Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year.

• There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction.

CONCLUSION

• The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.

 

Editorial: Going with the flow! Relieving LUTS and preserving ejaculation

Within the last few months of 2013, the Prostatic Urethral Lift procedure, using the UroLift® implant device (NeoTract, Inc., Pleasonton, CA, USA), appeared on the global urology stage. UroLift has the unusual distinction of being both radically new and yet highly studied. The creative crossover study by Cantwell et al. [1] in the present edition of the BJUI adds to the positive evidence for this new treatment option for men with LUTS. Roehrborn et al. [2] have also recently published a high-quality randomized, blinded study. 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 Food and Drug Administration (FDA) [3] and then subsequently by the National Institute for Health and Care Excellence (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 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 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 programme represents a master class in how a new minimally invasive procedure should be developed.

The process illustrates the benefits of cooperation between active clinicians and expert engineers. One particularly important element in this cooperation 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, although required by regulators (and indeed by editors), takes a huge amount of money. An FDA pivotal trial of sufficient quality to convince is likely to cost upwards of $20 m. 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.

for detailed instructions and video.

I encourage you to both review the data of Cantwell et al. [1] in this journal and take a look at the Prostatic Urethral Lift technique, as an innovation that is now available for wider adoption (Fig. 1). It does require judgement to select those most likely to benefit and endoscopic skill to achieve the maximum therapeutic benefit, but it appears to be an effective option for men poorly served by drugs, yet wishing to avoid the negative effects of existing surgical options. Additional studies continue to enrol participants, including a European randomized study, but the evidence currently available greatly exceeds that of most newly introduced minimally invasive developments. Why not take the opportunity to assess it yourself?

Tom McNicholas
Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, and University of Hertfordshire, Hatfield, UK


References

  1. Cantwell AL, Bogache WK, Richardson SF et al. Multicentre prospective crossover study of the prostatic Urethral Lift for the treatment of LUTS secondary to BPH. BJU Int 2014; 113: 615–622
  2. Roehrborn CG, Gange SN, Shore ND et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. study. J Urol 2013; 190: 2162–2167
  3. FDA. FDA News Release: new medical device treats urinary symptoms related to enlarged prostate. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm368325.htm. Accessed 14 January 2014
  4. NICE. https://guidance.nice.org.uk/IP/1032. Accessed 15 January 2014
  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
  6. McNicholas TA, Woo HH, Chin PT et al. Minimally invasive prostatic urethral lift: surgical technique and multinational study. Eur Urol 2013; 64: 292–299

 

Video: Prostatic urethral lift for the treatment of LUTS

Multicentre prospective crossover study of the ‘prostatic urethral lift’ for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

Anthony L. Cantwell, William K. Bogache*, Steven F. Richardson, Ronald F. Tutrone, Jack Barkin§, James E. Fagelson, Peter T. Chin†† and Henry H. Woo

‡‡Atlantic Urological Associates, Daytona Beach, FL, *Carolina Urological Research Center, Myrtle Beach, SC, Western Urological Clinic, Salt Lake City, UT, Chesapeake Urology, Baltimore, MD, USA, §University of Toronto, Toronto, ON, Canada, Urology Associates of Denver, Denver, CO, USA, ††Figtree Private Hospital, Figtree, and ‡‡Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

OBJECTIVE

• To assess the clinical effect of the ‘prostatic urethral lift’ (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study.

PATIENTS AND METHODS

• Men aged ≥50 years with an International Prostate Symptom Score of ≥13, a maximum urinary flow rate (Qmax) of ≤12 mL/s, and a prostate of 30–80 mL were enrolled into a crossover study after completing a prospective, randomised, controlled, ‘blinded’ pivotal study in which they were control subjects receiving a sham procedure.

• Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds.

• PUL involved placing permanent UroLift® (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen.

• Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis.

RESULTS

• Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients.

• Symptom, flow, and HRQL improvements were durable over the 12 months of the study.

• Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year.

• There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction.

CONCLUSION

• The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.

 

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