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Video: Is silodosin your best option when selecting the right α-blocker?

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A significant proportion of aging men will have bothersome LUTS and will eventually seek help for this problem. Various medical therapies are available to help aleviate these symptoms. Amongst the various treatments, α-blockers are some of the most widely used drugs. Novara et al. [1] recently published a report on the efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomized controlled trials comparing silodosin and placebo in patients with LUTS. Their study contributes pertinent information to aid the clinician in determining which α-blocker is best suited for specific patients with LUTS.

In the current study, patients were subdivided into groups in order to better understand which patient would benefit most from the use of silodosin [2]. In addition, the article examines the safety of silodosin in these same distinct patient groups. With regard to efficacy, silodosin was significantly more effective than placebo in improving all IPSS-related variables and maximum urinary flow rate, regardless of the patient’s age. When comparing the efficacy of silodosin in different age groups, no difference was observed for any of the IPSS variables, whereas patients aged <65 years had a statistically significantly greater maximum urinary flow rate.

With regard to safety, silodosin was associated with a significantly higher adverse event (AE) rate compared with placebo. When comparing the safety of silodosin in patients aged <65 years and >65 years, the overall AE rate, ejaculatory dysfunction and discontinuation rate attributable to AEs were all higher in the younger age group. Interestingly, in patients with concomitant use of antihypertensive drugs, the use of silodosin was not associated with a higher risk of either dizziness or orthostatic hypotension.

In a previous study by the same authors, no clinically relevant or statistically significant differences with regard to diastolic blood pressure, systolic blood pressure or heart rate in patients taking silodosin as compared to placebo were found [3]; however, a minor statistically significant difference vs placebo was observed with tamsulosin. The present study by Novara et al. [2] further supports the belief that silodosin is a safe drug from a cardiovascular standpoint.

From a sexual standpoint, silodosin does not seem to perform as well. In the present study, patients in the silodosin group had significantly more adverse events as compared with the placebo group. Retrograde ejaculation was by far the most common side effect affecting 32.8% of patients aged <65 years vs 0.9% in the placebo group. Similarly, in a study by Chapple et al. [3], as many as 14.2% of patients in the silodosin treatment group had ejaculatory dysfunction, compared with 2.1 and 1.1% of patients in the tamsulosin and placebo treatment groups, respectively. Although the percentage of patients who discontinued treatment because of treatment-emergent AEs in the present study was small and not significantly different among all treatment groups, one might hypothesize that over a longer follow-up period, such a prevalent side effect could be responsible for a higher discontinuation rate. Consequently, it should be kept in mind that for patients desiring to maintain antegrade ejaculation, or who are bothered by treatment-onset ejaculatory dysfunction, especially younger patients, silodosin might not be the best treatment option. Furthermore, it should be recognized that some patients would potentially accept a reduction in treatment efficacy to preserve ejaculation [4].

With regard to clinical outcomes, few published papers comparing tamsulosin with silodosin are available [5, 6]. One article found no clinically significant difference between the two α-blockers [5] whereas the other, which was a post hoc analysis, found a marginal clinical benefit for silodosin over tamsulosin [4]. Unfortunately, head-to-head trials are not forthcoming, so it will not be possible to determine if one α-blocker is clinically better than the other. Furthermore, the present study, because it lacked an active control arm, did not compare silodosin with tamsulosin, which leaves something to be desired.

In conclusion, careful consideration should be given to specific patient characteristics such as age and comorbidities, along with personal preferences towards sexual function when offering patients α-blockers for treatment of LUTS.

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Hugo Lavigueur-Blouin and Naeem Bhojani

 

Department of Urology, Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada

 

References

 

1 Novara G, Chapple CR, Montorsi F. A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). BJU Int 2014; 114: 427–33

 

2 Novara G, Chapple CR, Montorsi F. Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): subgroup analyses of efficacy and safety data. BJU Int 2015; 115: 802–4

 

3 Chapple CR, Montorsi F, Tammela TL et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol 2011; 59: 342–52

 

4 Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? BJU Int 2014. doi: 10.1111/bju.12868

 

5 Montorsi F. Profile of Silodosin. Eur Urol Suppl 2010; 9: 491–5

 

6 Novara G, Tubaro A, Sanseverino R et al. Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement. World J Urol 2013; 31: 997–1008

 

Article of the Week: Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis

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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.

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

Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis

Mauro Gacci, Giovanni Corona*, Linda Vignozzi†, Matteo Salvi, Sergio Serni, Cosimo De Nunzio‡, Andrea Tubaro‡, Matthias Oelke§, Marco Carini and Mario Maggi†

Department of Urology, University of Florence, Careggi Hospital, Florence, *Endocrinology Unit, Maggiore-Bellaria Hospital, Bologna, †Department of Clinical Physiopathology, University of Florence, Florence, ‡Department of Urology, Sant’Andrea Hospital, University ‘La Sapienza’, Rome, Italy; and §Department of Urology, Hannover Medical School, Hannover, Germany

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OBJECTIVE

To summarise and meta-analyse current literature on metabolic syndrome (MetS) and benign prostatic enlargement (BPE), focusing on all the components of MetS and their relationship with prostate volume, transitional zone volume, prostate-specific antigen and urinary symptoms, as evidence suggests an association between MetS and lower urinary tract symptoms (LUTS) due to BPE.

METHODS

An extensive PubMed and Scopus search was performed including the following keywords: ‘metabolic syndrome’, ‘diabetes’, ‘hypertension’, ‘obesity’ and ‘dyslipidaemia’ combined with ‘lower urinary tract symptoms’, ‘benign prostatic enlargement’, ‘benign prostatic hyperplasia’ and ‘prostate’.

RESULTS

Of the retrieved articles, 82 were selected for detailed evaluation, and eight were included in this review. The eight studies enrolled 5403 patients, of which 1426 (26.4%) had MetS defined according to current classification. Patients with MetS had significantly higher total prostate volume when compared with those without MetS (+1.8 mL, 95% confidence interval [CI] 0.74–2.87; P < 0.001). Conversely, there were no differences between patients with or without MetS for International Prostate Symptom Score total or LUTS subdomain scores. Meta-regression analysis showed that differences in total prostate volume were significantly higher in older (adjusted r = 0.09; P = 0.02), obese patients (adjusted r = 0.26; P < 0.005) and low serum high-density lipoprotein cholesterol concentrations (adjusted r = −0.33; P < 0.001).

CONCLUSIONS

Our results underline the exacerbating role of MetS-induced metabolic derangements in the development of BPE. Obese, dyslipidaemic, and aged men have a higher risk of having MetS as a determinant of their prostate enlargement.

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Editorial: The Prostate – The gateway to men’s health

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We have been told for many years that the management of men with LUTS due to BPH was, for most, about treating the impact of those symptoms on their quality of life. However, evidence has been accumulating over recent years to suggest that BPH may be associated with the various components of the metabolic syndrome – a combination of central obesity, impairment of glucose tolerance, dyslipidaemia and hypertension. Hammarsten et al. [1] examined the link between BPH and 22 individual aspects of the metabolic syndrome and found that BPH was linked to 21 of these factors, including increased body mass index (BMI) and waist circumference, hypertension, type 2 diabetes, dyslipidaemia and atherosclerosis, lending support to the hypothesised association with metabolic syndrome as a whole.

In this issue of BJUI, Gacci et al. [2] report the results of a meta-analysis of eight studies examining this link between BPH and metabolic syndrome, including >5000 patients, of which over a quarter had metabolic syndrome. They report a higher prostate volume (and transitional zone volume) in men with metabolic syndrome than in those without, particularly in older and obese patients and those with low high-density lipoprotein (HDL)-cholesterol levels. Interestingly however, no difference was seen between the groups in terms of LUTS, as measured by total IPSS or the storage/voiding sub-scores, although other studies have reported this in the past [1]. They conclude that modification of lifestyle and cardiovascular risk factors, by weight loss, increased exercise, dietary improvements etc., may have a role to play in improving LUTS. In addition, further exploration of the role of medication, such as statins, in the management of LUTS due to BPH is recommended. These conclusions are supported in the literature by observational studies, showing for instance a decrease in the severity of LUTS with increasing exercise, an increased risk of LUTS with obesity, and a delay in the onset of LUTS for patients taking long-term statins of up to 7 years [3, 4].

BPH is not the only urological condition that appears to have links with metabolic syndrome [1]. It is well established that erectile dysfunction has strong associations with type 2 diabetes mellitus, cardiovascular disease, obesity and sedentary lifestyle. Less well known links are also seen with prostate cancer, renal calculi, hypogonadism and overactive bladder [5]. We are familiar with carrying out cardiovascular risk assessment, screening for diabetes and giving lifestyle advice to men with erectile dysfunction. Given the evidence suggesting that erectile dysfunction and BPH are closely associated, with many men suffering from both conditions [6], it would suggest that perhaps we should be doing the same for men presenting with symptomatic BPH.

An awareness and understanding of the connection between BPH and metabolic syndrome should encourage all physicians to assess patients with LUTS/BPH for underlying cardiovascular risk. It suggests that as a minimum, a number of baseline investigations should be carried out: blood pressure measurement, a fasting lipid profile (and formal cardiovascular risk profile using established algorithms, such as QRISK®), assessment for diabetes using fasting glucose or glycated haemoglobin (HbA1c), measurement of weight and BMI, or ideally the measurement of abdominal circumference (as central obesity is a far more sensitive marker of risk than BMI). Identification of features of the metabolic syndrome allows for tailored lifestyle intervention, in terms of increasing exercise, dietary changes, weight loss, smoking cessation advice and alcohol moderation. Medical management of hypertension, diabetes, dyslipidaemia and cardiovascular disease may be required according to national guidelines.

Huge numbers of men die prematurely from cardiovascular disease and complications of type 2 diabetes, and men are renowned for poor engagement with primary preventive strategies to decrease this risk. Men presenting to their GP or Urologist with symptoms from BPH are therefore presenting us with an opportunity to intervene and potentially save lives in the process – the prostate can be considered a gateway to wider aspects of men’s health, far beyond the quality-of-life impact of LUTS.

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Jonathan Rees

Backwell & Nailsea Medical Group, North Somerset, UK

References

1 Hammarsten J, Peeker R. Urological aspects of the metabolic syndrome. Nat Rev Urol 2011; 8: 483–94

2 Gacci M, Corona G, Vignozzi L et al. Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis. BJU Int 2015; 115: 24–31

3 Parsons JK, Messer K, White M et al. Obesity increases and physical activity decreases lower urinary tract symptom risk in older men: the Osteoporotic Fractures in Men Study. Eur Urol 2011; 60: 1173–80

4 St Sauver J, Jacobsen SJ, Jacobson DJ et al. Statin use and decreased risk of benign prostatic enlargement and lower urinary tract symptoms. BJU Int 2011; 107: 443–50

5 Rees J, Kirby M. Metabolic syndrome and common urological conditions: looking beyond the obvious. Trends in Urology and Men’s Health 2014; 5: 9–14

6 Rosen R, Altwein J, Boyle P et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol 2003; 44: 637–49

 

Article of the Month: Progression and treatment of incident lower urinary tract symptoms (LUTS) among men in the California Men’s Health Study

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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.

This week we feature a video from Dr. Steven Jacobsen discussing his paper. 

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

Progression and treatment of incident lower urinary tract symptoms (LUTS) among men in the California Men’s Health Study

Lauren P. Wallner, Jeff M. Slezak*, Ronald K. Loo†, Virginia P. Quinn*, Stephen K. Van Den Eeden‡ and Steven J. Jacobsen*

Department of Medicine and Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, *Department of Research and Evaluation, Kaiser Permanente Southern California, †Department of Urology, Southern California Permanente Medical Group, Pasadena, CA, and ‡Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA

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OBJECTIVES

To characterise the progression and treatment of lower urinary tract symptoms (LUTS) among men aged 45–69 years in the California Men’s Health Study.

PATIENTS AND METHODS

A total of 39 222 men, aged 45–69 years, enrolled in the Southern California Kaiser Permanente Health Plan were surveyed in 2002–2003 and again in 2006–2007. Those men who completed both surveys who did not have a diagnosis of benign prostatic hyperplasia (BPH) and were not on medication for LUTS at baseline were included in the study (N = 19 505). Among the men with no or mild symptoms at baseline, the incidence of moderate/severe LUTS (American Urological Association Symptom Index [AUASI] score ≥8) and odds of progression to severe LUTS (AUASI score ≥20) was estimated during 4 years of follow-up.

RESULTS

Of the 9640 men who reported no/mild LUTS at baseline, 3993 (41%) reported moderate/severe symptoms at follow-up and experienced a 4-point change in AUASI score on average. Of these men, 351 (8.8%) had received a pharmacological treatment, eight (0.2%) had undergone a minimally invasive or surgical procedure and 3634 (91.0%) had no treatment recorded. Men who progressed to severe symptoms (AUASI score ≥20; n = 165) were more likely to be on medication for BPH (odds ratio [OR] 8.09, 95% confidence interval [CI] 5.77–11.35), have a BPH diagnosis (OR 4.74, 95% CI 3.40–6.61) or have seen a urologist (OR 2.49, 95% CI 1.81–3.43) when compared with men who did not progress to severe symptoms (AUASI score <20).

CONCLUSION

These data show that the majority of men who experienced progression did not have pharmacological or surgical therapy for their symptoms and, therefore, may prove to be good candidates for a self-management plan.

Read more articles of the week

Video: Progression and treatment of incident lower urinary tract symptoms (LUTS) among men in the California Men’s Health Study

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Progression and treatment of incident lower urinary tract symptoms (LUTS) among men in the California Men’s Health Study

Lauren P. Wallner, Jeff M. Slezak*, Ronald K. Loo†, Virginia P. Quinn*, Stephen K. Van Den Eeden‡ and Steven J. Jacobsen*

Department of Medicine and Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, *Department of Research and Evaluation, Kaiser Permanente Southern California, †Department of Urology, Southern California Permanente Medical Group, Pasadena, CA, and ‡Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA

Read the full article

OBJECTIVES

To characterise the progression and treatment of lower urinary tract symptoms (LUTS) among men aged 45–69 years in the California Men’s Health Study.

PATIENTS AND METHODS

A total of 39 222 men, aged 45–69 years, enrolled in the Southern California Kaiser Permanente Health Plan were surveyed in 2002–2003 and again in 2006–2007. Those men who completed both surveys who did not have a diagnosis of benign prostatic hyperplasia (BPH) and were not on medication for LUTS at baseline were included in the study (N = 19 505). Among the men with no or mild symptoms at baseline, the incidence of moderate/severe LUTS (American Urological Association Symptom Index [AUASI] score ≥8) and odds of progression to severe LUTS (AUASI score ≥20) was estimated during 4 years of follow-up.

RESULTS

Of the 9640 men who reported no/mild LUTS at baseline, 3993 (41%) reported moderate/severe symptoms at follow-up and experienced a 4-point change in AUASI score on average. Of these men, 351 (8.8%) had received a pharmacological treatment, eight (0.2%) had undergone a minimally invasive or surgical procedure and 3634 (91.0%) had no treatment recorded. Men who progressed to severe symptoms (AUASI score ≥20; n = 165) were more likely to be on medication for BPH (odds ratio [OR] 8.09, 95% confidence interval [CI] 5.77–11.35), have a BPH diagnosis (OR 4.74, 95% CI 3.40–6.61) or have seen a urologist (OR 2.49, 95% CI 1.81–3.43) when compared with men who did not progress to severe symptoms (AUASI score <20).

CONCLUSION

These data show that the majority of men who experienced progression did not have pharmacological or surgical therapy for their symptoms and, therefore, may prove to be good candidates for a self-management plan.

Read more articles of the week

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

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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

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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.

 

Read more articles of the week

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

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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

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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

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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.

 

Read more articles of the week

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

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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.

Article of the week: No difference in sexual function seen between monopolar and bipolar TURP

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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.

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

Bipolar vs monopolar transurethral resection of the prostate: evaluation of the impact on overall sexual function in an international randomized controlled trial setting

Charalampos Mamoulakis1,2, Andreas Skolarikos3, Michael Schulze4, Cesare M. Scoffone5, Jens J. Rassweiler4, Gerasimos Alivizatos3, Roberto M. Scarpa5 and Jean J.M.C.H. de la Rosette1

1Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands, 2Department of Urology, University Hospital of Heraklion, University of Crete Medical School, Heraklion, Crete, Greece, 3Second Department of Urology, Sismanoglio Hospital, University of Athens Medical School, Athens, Greece, 4Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany, and 5Department of Urology, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy

Read the full article
OBJECTIVE

• To compare monopolar and bipolar transurethral resection of the prostate (M-TURP and B-TURP, respectively) using a true bipolar system, for the first time in an international multicentre double-blind randomized controlled trial focusing on the overall sexual function quantified with the International Index of Erectile Function Questionnaire (IIEF-15). Other baseline/perioperative parameters potentially influencing erectile function (EF) after TURP were secondarily investigated.

MATERIALS AND METHODS

• From July 2006 to June 2009, consecutive TURP candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into M-TURP/B-TURP arms and followed up at 6 weeks, 6 and 12 months after surgery. In all, 295 eligible patients were enrolled.

• Overall sexual function was quantified using self-administered IIEF-15 at baseline and at each subsequent visit.

•  Total IIEF/domain scores were calculated and EF score classified erectile dysfunction severity. Differences in erectile dysfunction severity at each visit compared with baseline (EF evolution), classified patients into ‘improved’, ‘stable’ or ‘deteriorated’.

•  Pre-postoperative IIEF/domain scores and differences in the distribution of EF evolution were compared between arms throughout follow-up.

RESULTS

• In all, 279 patients received the allocated intervention; 218/279 patients (78.1%) provided complete IIEF-15 data at baseline and were considered in sexual function analysis. Complete IIEF-15 data were available from 193/218 (88.5%), 186/218 (85.3%) and 179/218 (82.1%) patients at 6 weeks, 6 months and 12 months, respectively.

• Sexual function did not differ significantly between arms during follow-up (scores: IIEF, P = 0.750; EF, P = 0.636; orgasmic function, P = 0.868; sexual desire, P = 0.735; intercourse satisfaction, P = 0.917; overall satisfaction, P = 0.927).

• Resection type was not a predictor of any sexual function changes observed.

• Distribution of EF evolution did not differ between arms at any time (M-TURP vs B-TURP at 12 months: improved, 23/87 [26.4%] vs 18/92 [19.6%]; stable, 53/87 [60.9%] vs 56/92 [60.8%]; deteriorated, 11/87 [12.7%] vs 18/92 [19.6%]; P = 0.323).

CONCLUSION

• There were no differences between M-TURP/B-TURP in any aspect of sexual function.

 

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