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Editorial: LUTS – an independent risk factor for CVD

Russo et al. [1] have identified LUTS as an independent risk factor for cardiovascular disease (CVD). The more severe the LUTS the more the CVD risk increased. LUTS in men is caused by a group of disorders, e.g. the metabolic syndrome and central obesity, which have similar risk factors to those that cause CVD [2]. Furthermore, LUTS is associated with erectile dysfunction (ED), which is well established as being linked to silent or symptomatic CVD [3]. The question arises as to whether the age of the patient rather than the LUTS is the cause for the CVD, in other words, is the LUTS merely a bystander or coincidental problem?

The evidence, however, is accumulating that LUTS is independent of age and a risk factor for CVD [2]. A multi-disciplinary consensus looked at ED and LUTS emphasising the importance of co-diagnosis with awareness of cardiovascular risk factors being present in patients with LUTS, ED, or LUTS and ED, and reviewed the literature on the underlying pathophysiology [2].

The link between ED and LUTS was brought home by the Multinational Survey of the Aging Male (MSAM) study. Many large epidemiological studies using well-powered multivariate analyses consistently provide overwhelming evidence of a link between ED and LUTS [4].

The pathogenic mechanisms underlying the relationships between ED and LUTS have been the subject of several recent reviews [5]. The underlying mechanisms include: the alteration of the nitric oxide-cyclic guanosine monophosphate pathway, enhancement of Rho-kinase (ROCK) signalling, autonomic hyperactivity, and pelvic atherosclerosis, secondary to endothelial dysfunction [6]. Additional contributing factors may include chronic inflammation and sex steroid ratio imbalance, all of which contribute to increased CVD risk.

LUTS, with or without ED, should trigger a search for cardiovascular risk factors and metabolic problems. In 2008, the International Journal of Impotence Research published a symposium entitled ‘Cardiac Sexology: Can we save a patient’s life and his love life?’. The recognition that urologists have an important role in the early identification of cardiovascular risk should encourage urologists to work closely with cardiologists [3].

Certainly the degree of risk recorded by Russo et al. [1] is substantially greater than one would expect from age alone. Possible mechanisms include the co-existence of inflammatory activity manifest by a raised C-reactive protein (CRP), which is commonly found in association with more severe LUTS and in turn, increased CVD risk [7]. Similarly chronic sleep disturbance, especially nocturia, is common in both LUTS and CVD, as is depression [2].

Endothelial dysfunction, which is recognised to be the major vascular risk for CVD, also occurs in LUTS that is chronic or severe usually affecting the prostate gland or bladder. There are, therefore, strong links between LUTS, ED and CVD a common denominator being increased adrenergic tone. Patients with LUTS should be asked about alternative symptoms, including ED, and screened for cardiovascular risk even if they have no cardiac symptoms. LUTS may not be as strong a risk factor as ED for CVD, but it appears to be an independent marker for increased risk, which should not be ignored. Men are reluctant to volunteer their concerns, so it is important that healthcare professionals ask the appropriate questions.

Graham Jackson, Mike G. Kirby* and Ray Rosen

 

St. Thomas Hospital, London, UK, *The Prostate Centre, London, UK and New England Research Institutes, Inc. (NERI), Waterto wn, MA, USA

 

References

 

 

Video: The severity of LUTS is associated with an increase of Framingham CVD risk score

Increase of Framingham cardiovascular disease risk score is associated with severity of lower urinary tract symptoms

Giorgio I. Russo, Tommaso Castelli, Salvatore Privitera, Eugenia Fragala, Vincenzo Favilla, Giulio Reale, Daniele Urzı, Sandro La Vignera*, Rosita A. Condorelli*, Aldo E. Calogero*, Sebastiano Cimino and Giuseppe Morgia

 

Department of Urology, and *Department of Medical and Paediatric Sciences, Section of Endocrinology, Andrology and Internal Medicine, University of Catania, Catania, Italy

 

OBJECTIVE

To determine the relationship between lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and 10-year risk of cardiovascular disease (CVD) assessed by the Framingham CVD risk score in a cohort of patients without previous episodes of stroke and/or acute myocardial infarction.

PATIENTS AND METHODS

From September 2010 to September 2014, 336 consecutive patients with BPH-related LUTS were prospectively enrolled. The general 10-year Framingham CVD risk score, expressed as percentage and assessing the risk of atherosclerotic CVD events, was calculated for each patient. Individuals with low risk had ≤10% CVD risk at 10 years, with intermediate risk 10–20% and with high risk ≥20%. Logistic regression analyses were used to identify variables for predicting a Framingham CVD risk score of ≥10% and moderate–severe LUTS (International Prostate Symptom Score [IPSS] ≥8), adjusted for confounding factors.

RESULTS

As category of Framingham CVD risk score increased, we observed higher IPSS (18.0 vs 18.50 vs 19.0; P < 0.05), high IPSS–voiding (6.0 vs 9.0 vs 9.5; P < 0.05) and worse sexual function. Prostate volume significantly increased in those with intermediate- vs low-risk scores (54.5 vs 44.1 mL; P < 0.05). Multivariate logistic regression analysis showed that intermediate- [odds ratio (OR) 8.65; P < 0.01) and high-risk scores (OR 1.79; P < 0.05) were independently associated with moderate–severe LUTS. At age-adjusted logistic regression analysis, moderate–severe LUTS was independently associated with Framingham CVD risk score of ≥10% (OR 5.91; P < 0.05).

CONCLUSION

Our cross-sectional study in a cohort of patients with LUTS–BPH showed an increase of more than five-fold of having a Framingham CVD risk score of ≥10% in men with moderate–severe LUTS.

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Guideline of Guidelines: Imaging of Localized Prostate Cancer

Guidelines Localised Prostate Cacner

 

Introduction

In the era before the widespread adoption of PSA screening for prostate cancer, most incident cases were already advanced stage. Because treatment options, such as surgery or radiation, are thought mainly to benefit patients with localised disease, prostate cancer imaging was necessary before treatment of almost all patients. However, in the PSA era >90% of incident cases are localised, making the need for routine imaging with CT, MRI, or bone scan obsolete [1]. Numerous studies show a relatively low rate of positive staging imaging in low- and intermediate-risk patients. Recognising these trends, several professional societies issued prostate cancer imaging guidelines in the mid-1990s in an effort to curb the overuse of imaging. However, despite these longstanding guidelines, a great number of patients undergo improper imaging [2]. Given how stubborn this problem has been to eradicate, there has been a renewed interest in finding ways to decrease unnecessary imaging, including a Physician Quality Reporting System (PQRS) quality measure and a highlighting of the problem in the ‘Choosing Wisely’ campaign [3-5]. In addition to the guidelines regarding the staging of incident prostate cancer, some groups have also presented guidelines on the use of imaging to follow men with advanced disease [6]. The purpose of the present article is to summarise the main points from multiple professional society guidelines on imaging in prostate cancer to help clarify when patients with prostate cancer should be imaged and with which modalities.

Prostate Cancer Key Points

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Controversies in management of high-risk prostate and bladder cancer

CaptureRecently, there has been substantial progress in our understanding of many key issues in urological oncology, which is the focus of this months BJUI. One of the most substantial paradigm shifts over the past few years has been the increasing use of radical prostatectomy (RP) for high-risk prostate cancer and increasing use of active surveillance for low-risk disease [1,2]
Consistent with these trends, this months BJUI features several useful articles on the management of high-risk prostate cancer. The rst article by Abdollah et al. [3] reports on a large series of 810 men with DAmico high-risk prostate cancer (PSA level >20 ng/mL, Gleason score 810, and/or clinical stage T2c) undergoing robot-assisted RP (RARP). Despite high-risk characteristics preoperatively, 55% had specimen-conned disease at RARP, which was associated with higher 8-year biochemical recurrence-free (72.7% vs 31.7%, P < 0.001) and prostate cancer-specic survival rates (100% vs 86.9%, P < 0.001). The authors therefore designed a nomogram to predict specimen-conned disease at RARP for DAmico high-risk prostate cancer. Using PSA level, clinical stage, maximum tumour percentage quartile, primary and secondary biopsy Gleason score, the nomogram had 76% predictive accuracy. Once externally validated, this could provide a useful tool for pre-treatment assessment of men with high-risk prostate cancer. 
Another major controversy in prostate cancer management is the optimal timing of postoperative radiation therapy (RT) for patients with high-risk features at RP. In this months BJUI, Hsu et al. [4] compare the results of adjuvant (6 months after RP with an undetectable PSA level), early salvage (administered while PSA levels at 1 ng/mL) and late salvage RT (administered at PSA levels of >1 ng/mL) in 305 men with adverse RP pathology from the USA Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry. At 6.2 years median follow-up, late salvage RT was associated with signicantly higher rates of metastasis and/or prostate cancer-death. By contrast, there was no difference in prostate cancer mortality and/or metastasis between early salvage vs adjuvant RT. A recent study from the USA National Cancer Data Base reported infrequent and declining use of postoperative RT within 6 months for men with adverse RP pathology, from 9.1% in 2005 to 7.3% in 2011 [5]. As we await data from prospective studies comparing adjuvant vs early salvage RT, the results of Hsu et al. [4] are encouraging, suggesting similar disease-specic outcomes if salvage therapy is administered at PSA levels of <1 ng/mL. 
Finally, this issues Article of the Month by Baltaci et al. [6] examines the timing of second transurethral resection of the bladder (re-TURB) for  high-risk non-muscle-invasive bladder cancer (NMIBC). The management ofbladder cancer at this stage is a key point to improve the overall survival of bladder cancer. Re-TURB is already recommended in the European Association of Urology guidelines [7], but it remains controversial as to whether all patients require re-TURB and what timing is optimal. The range of 26 weeks after primary TURB was established based on a randomised trial assessing the effect of re-TURB on recurrence in patients treated with intravesical chemotherapy [8], but it has not been subsequently tested in randomised trial. Baltaci et al. [6], in a multi-institutional retrospective review of 242 patients, report that patients with high-risk NMIBC undergoing early re-TURB (1442 days) have better recurrence-free survival vs later re-TURB (73.6% vs 46.2%, P < 0.01). Although prospective studies are warranted to conrm their results, these novel data suggest that early re-TURB is signicantly associated with lower rates of recurrence and progression.
 
 
References

 

 

 

4 Hsu CC , Paciorek AT, Cooperberg MR, Roach M 3rd, Hsu IC, Carroll PRPostoperative radiation therapy for patients at high-risk of recurrence after radical prostat ectomy: does timing matter? BJU Int 2015; 116: 71320

 

5 Sineshaw HM, Gray PJ, Efstathiou JA, Jemal A. Declining use of radiotherapy for adverse features after radical prostatectomy: results from the National Cancer Data Base. Eur Urol 2015; [Epub ahead of print]. DOI: 10.1016/ j.eururo.2015.04.003

 

 

7 Babjuk M, Bohle A, Burger M et al. European Association of Urology Guidelines on Non-Muscle-Invasive Bladder Cancer (Ta, T1, and CIS). Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines- Non-muscle-invasive-Bladder-Cancer-2015-v1.pdf. Accessed September 2015

 

 

Stacy Loeb – Department of Urology, Population Health, and the Laura and Isaac Perlmutter Cancer Center, New York University, New York City, NY, USA

 

Maria J. Ribal – Department of Urology, Hospital Clinic, University of Barcelona, Barcelona, Spain

 
 

Article of the Week: HLE and PVP for Patients with BPH and CUR

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 Dr. Axel Merseburger discussing his paper. 

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

Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary Retention

Christopher D. Jaeger, Christopher R. Mitchell, Lance A. Mynderse and Amy E. Krambeck

Department of Urology, Mayo Clinic School of Medicine, Rochester, MN, USA

Read the full article
OBJECTIVES

To evaluate short-term outcomes of holmium laser enucleation of the prostate (HoLEP) and photoselective vaporisation of the prostate (PVP) in patients with benign prostatic hyperplasia (BPH) and chronic urinary retention (CUR).

PATIENTS AND METHODS

A retrospective chart review was performed of all patients with CUR who underwent HoLEP or PVP at our institution over a 3-year period. CUR was defined as a persistent post-void residual urine volume (PVR) of >300 mL or refractory urinary retention requiring catheterisation.

RESULTS

We identified 72 patients with CUR who underwent HoLEP and 31 who underwent PVP. Preoperative parameters including median catheterisation duration (3 vs 5 months, P = 0.71), American Urological Association Symptom Index score (AUASI; 18 vs 21, P = 0.24), and PVR (555 vs 473 mL, P = 0.096) were similar between the HoLEP and PVP groups. The HoLEP group had a larger prostate volume (88.5 vs 49 mL, P < 0.001) and higher PSA concentration (4.5 vs 2.4 ng/mL, P = 0.001). At median 6-month follow-up, 71 (99%) HoLEP patients and 23 (74%) PVP patients were catheter-free (P < 0.001). Of the voiding patients, postoperative AUASI (3 vs 4, P = 0.06), maximum urinary flow rate (23 vs 18 mL/s, P = 0.28) and PVR (56.5 vs 54 mL, P = 1.0) were improved in both groups.

CONCLUSIONS

Both HoLEP and PVP are effective at improving urinary parameters in men with CUR. Despite larger prostate volumes, HoLEP had a 99% successful deobstruction rate, thus rendering patients catheter-free.

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Editorial: Opening the flood gates – HLE is superior to PVP for the treatment of CUR

With the expansion in laser technology for treating symptomatic BPH, there are now two main techniques available to the budding urologist. Yet the management of chronic urinary retention (CUR) remains a significant challenge. In this issue of BJUI Jaeger et al. [1]present a retrospective study comparing holmium laser enucleation of the prostate (HoLEP) and photoselective vaporization of the prostate (PVP; using XPS 180 watt and HPS 120 watt systems) in the treatment of CUR.

Both HoLEP and PVP are now well-established treatment methods. Although PVP has seen a greater level of acceptance because of its shorter learning period, its use remains limited by prostate size and concerns about long-term durability. In contrast the favourable and enduring outcomes reported for HoLEP have meant that it is gaining recognition as the new ‘gold standard’ surgical treatment for BPH. Whilst PVP ablates the tissue laterally from the prostatic urethra, HoLEP involves an anatomical enucleation of all the prostatic adenoma before morcellation.

Over the past decade, there has been a shift towards medical management of BPH. Despite the resultant increase in numbers of men developing CUR, best practice for this challenging and clinically important group remains highly debated. The term CUR is used to describe a constellation of presentations, and current imprecise, even arbitrary, definitions make the interpretation of existing studies difficult. Historically, CUR has been almost universally excluded from trials because of the anticipation of poor outcomes and high complication rates, while the presence of detrusor hypotonia, particularly with low-pressure retention, has led to concerns of treatment failure following surgery. This dilemma for urologists has been aggravated by conflicting evidence in the published literature [2].

Jaeger et al. [1] assessed all patients with CUR who were treated in their institution either with HoLEP (72 patients) or PVP (31 patients). CUR was defined as a persistent post-void residual urine volume (PVR) >300 mL or urinary retention refractory to multiple voiding trials. While preoperative urodynamic studies were not routinely performed, those patients found to have low bladder contractility or acontractility were not excluded.

Both HoLEP and PVP produced similarly effective outcomes in terms of symptom score improvement, PVR reduction and Qmax increase in voiding patients. Complication rates were also similar in the two groups (15 and 26% for HoLEP and PVP, respectively, P = 0.27), but, importantly, HoLEP was shown to offer substantially better rates of spontaneous voiding than PVP, 99 vs 74% of patients, in spite of a lower median bladder contractility index in the HoLEP group (73 vs 90, P = 0.012).

Both PVP and HoLEP have previously been studied in isolation in treating patients with CUR. Whilst Woo et al. [3] demonstrated significant reductions in PVR after PVP (GreenLight HPS 120-W), the presence of detrusor under-activity was not established. Outcomes after PVP in patients with urodynamically proven detrusor hypotonia have been shown to be significantly worse than in patients with normal detrusor funtion [4].

The effectiveness of HoLEP has been shown in treating CUR secondary to BPH in a large study of 169 patients with symptom score improvements of 159% and spontaneous voiding in 98.25% [5]. Furthermore, even in patients with proven impaired bladder contractility, HoLEP led to spontaneous voiding in 95% [6] at least in the short term.

The findings from the present study further support the use of HoLEP specifically in CUR. Jaeger et al. are the first to compare the two technologies head on, albeit in a non-randomised study, in the treatment of CUR. Whilst both treatments showed reasonable efficacy despite low or absent bladder contractility in a number of patients, a significant advantage was seen with HoLEP, with the total removal of any obstructing tissue. These results were unaffected by the presence of preoperative impaired bladder on urodynamic studies. This study suggests that HoLEP is superior to PVP in the treatment of CUR, probably because of the larger prostatic channel that enucleation produces. Measurement of postoperative PSA readings would have been a useful addition to illustrate this. Nevertheless, the findings add to the growing body of evidence to support the use of HoLEP in treating CUR, irrespective of preoperative bladder function.

Read the full article

Nicholas Raison and Ben Challacombe

Urology Department, Guy’s and St Thomas’ NHS Trust, Guy’s Hospital, Great Maze Pond, London, UK

References

1 Jaeger CD, Mitchell CR, Mynderse LA, Krambeck AE. Holmium laser enucleation and photoselective vaporization of the prostate for patients with benign prostatic hyperplasia and chronic urinary retention. BJU Int 2015; 115: 295–9

2 Ghalayini IF, Al-Ghazo MA, Pickard RS. A prospective randomized trial comparing transurethral prostatic resection and clean intermittent self-catheterization in men with chronic urinary retention. BJU Int 2005; 96: 93–7

3 Woo H, Reich O, Bachmann A et al. Outcome of GreenLight HPS 120-W laser therapy in specific patient populations: those in retention, on anticoagulants, and with large prostates (≥ 80 ml). Eur Urol Suppl 2008; 7: 378–83

4 Monoski MA, Gonzalez RR, Sandhu JS, Reddy B, Te AE. Urodynamic predictors of outcomes with photoselective laser vaporization prostatectomy in patients with benign prostatic hyperplasia and preoperative retention. Urology 2006; 68: 312–7

5 Elzayat EA, Habib EI, Elhilali MM. Holmium laser enucleation of prostate for patients in urinary retention. Urology 2005; 66: 789–93

6 Mitchell CR, Mynderse LA, Lightner DJ, Husmann DA, Krambeck AE. Efficacy of holmium laser enucleation of the prostate in patients with non-neurogenic impaired bladder contractility: results of a prospective trial. Urology 2014; 83: 428–32

Video: Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary

Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary Retention

Christopher D. Jaeger, Christopher R. Mitchell, Lance A. Mynderse and Amy E. Krambeck

Department of Urology, Mayo Clinic School of Medicine, Rochester, MN, USA

Read the full article
OBJECTIVES

To evaluate short-term outcomes of holmium laser enucleation of the prostate (HoLEP) and photoselective vaporisation of the prostate (PVP) in patients with benign prostatic hyperplasia (BPH) and chronic urinary retention (CUR).

PATIENTS AND METHODS

A retrospective chart review was performed of all patients with CUR who underwent HoLEP or PVP at our institution over a 3-year period. CUR was defined as a persistent post-void residual urine volume (PVR) of >300 mL or refractory urinary retention requiring catheterisation.

RESULTS

We identified 72 patients with CUR who underwent HoLEP and 31 who underwent PVP. Preoperative parameters including median catheterisation duration (3 vs 5 months, P = 0.71), American Urological Association Symptom Index score (AUASI; 18 vs 21, P = 0.24), and PVR (555 vs 473 mL, P = 0.096) were similar between the HoLEP and PVP groups. The HoLEP group had a larger prostate volume (88.5 vs 49 mL, P < 0.001) and higher PSA concentration (4.5 vs 2.4 ng/mL, P = 0.001). At median 6-month follow-up, 71 (99%) HoLEP patients and 23 (74%) PVP patients were catheter-free (P < 0.001). Of the voiding patients, postoperative AUASI (3 vs 4, P = 0.06), maximum urinary flow rate (23 vs 18 mL/s, P = 0.28) and PVR (56.5 vs 54 mL, P = 1.0) were improved in both groups.

CONCLUSIONS

Both HoLEP and PVP are effective at improving urinary parameters in men with CUR. Despite larger prostate volumes, HoLEP had a 99% successful deobstruction rate, thus rendering patients catheter-free.

Read more articles of the week

Article of the week: Guideline of guidelines: prostate cancer screening

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The introduction 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.

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

Guideline of guidelines: prostate cancer screening

Stacy Loeb
Department of Urology and Population Health, New York University, New York, NY, USA

Read the full article
INTRODUCTION

Prostate cancer screening is one of the most controversial topics in urology [1]. On one hand, there is randomised data showing that PSA screening results in earlier stages at diagnosis, improved oncological outcomes after treatment, and lower prostate cancer mortality rates. However, the downsides include unnecessary biopsies due to false-positive PSA tests, over-diagnosis of some insignificant cancers, and potential side-effects from prostate biopsy and/or prostate cancer treatment. The ongoing controversy is highlighted by the divergent recommendations on screening from multiple professional organisations. The purpose of this article is to summarise the recent guidelines on prostate cancer screening from 2012 to present.

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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

Read the full article
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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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

Read the full article

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

 

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