Tag Archive for: Lower urinary tract symptoms

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Video: Central obesity is predictive of persistent storage LUTS after surgery for BPE

 

Central obesity is predictive of persistent storage LUTS after surgery for Benign Prostatic Enlargement: results of a multicenter prospective study

Mauro Gacci, Arcangelo Sebastianelli, Matteo Salvi, Cosimo De Nunzio*, Andrea
Tubaro*, Linda Vignozzi, Giovanni Corona, Kevin T. McVary§, Steven A. Kaplan¶, Mario Maggi, Marco Carini and Sergio Serni

 

Department of Urology, Careggi Hospital, University of Florence, Florence, *Department of Urology, SantAndrea Hospital, University La Sapienza, Rome, Department of Clinical Physiopathology, University of Florence, Florence Endocrinology Unit, Medical Department, Maggiore-Bellaria Hospital, Bologna, Italy, §Department of Urology, Southern Illinois University School of Medicine, Springeld, IL , and Department of Urology, Weill Cornell Medical College, Cornell University, New York, NY, USA

 

OBJECTIVE

To evaluate the impact of components of metabolic syndrome (MetS) on urinary outcomes after surgery for severe lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE), as central obesity can be associated with the development of BPE and with the worsening of LUTS.

PATIENTS AND METHODS

A multicentre prospective study was conducted including 378 consecutive men surgically treated for large BPE with simple open prostatectomy (OP) or transurethral resection of the prostate (TURP), between January 2012 and October 2013. LUTS were measured by the International Prostate Symptom Score (IPSS), immediately before surgery and at 6–12 months postoperatively. MetS was defined according the USA National Cholesterol Education Program-Adult Treatment Panel III.

RESULTS

The improvement of total and storage IPSS postoperatively was related to diastolic blood pressure and waist circumference (WC). A WC of >102 cm was associated with a higher risk of an incomplete recovery of both total IPSS (odds ratio [OR] 0.343, P = 0.001) and storage IPSS (OR 0.208, P < 0.001), as compared with a WC of <102 cm. The main limitations were: (i) population selected from a tertiary centre, (ii) Use exclusively of IPSS questionnaire, and (iii) No inclusion of further data.

CONCLUSIONS

Increased WC is associated with persistent postoperative urinary symptoms after surgical treatment of BPE. Obese men have a higher risk of persistent storage LUTS after TURP or OP.

 

Article of the Week: Evaluating Silodosin in the Treatment of LUTS Associated with BPE

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.

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. Naeem Bhojani, discussing his accompanying editorial to the Article of the Week. 

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

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

Giacomo Novara, Christopher R. Chapple* and Francesco Montorsi
Department of Oncological, Surgical, and Gastroenterological Sciences, Urology Clinic, University of Padua, Padua,Italy, Deprtment of Urology, Vita-Salute University, San Raffaele Hospital, Milan, Italy, and *Department of Urology, Royal Hallamshire Hospital, Shefeld, UK
Read the full article
OBJECTIVE

To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS).

PATIENTS AND METHODS

A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Vertigo is one of the most common health problems in adults. It is a symptom, not a disease and is usually associated with a problem in the inner ear balance mechanisms (vestibular system), in the brain, or with the nerve connections between the two organs. Vertigo can also be brought on suddenly through various actions or incidents, such as sudden changes in blood pressure or as a symptom of motion sickness while sailing, on amusement rides, airplanes or in an automobile. It can be acute and severe, lasting for days, or it may be recurrent, with attacks that last for minutes to hours. Vertigo los angeles associated with panic attacks can sometimes be caused by hyperventilating.  For the best treatment for vertigo, do visit us.

Patients often describe balance problems, dizziness, light headedness, and motion sickness. They may also describe an intense or severe sensation of movement, tilting, or imbalance; the sensation is aggravated by movement and improved by remaining stationary. Patients may say that they are having continuous vertigo, when in reality, they are having repeated episodes (with each episode lasting less than a minute). Those with persistent vomiting or intractable vertigo may require admission for hydration and vestibular suppressant medication. These disorders are the ninth most common complaint that leads people to visit their physicians. It is important to not use general terms when describing balance problems. To put it another way, it is best to simply describe the sensation they feel without using general terms like dizziness or vertigo. The cause is often revealed by the patient’s history and physical examination. In migraine-associated vertigo for instance, the patient may report a history of acute-onset vertigo that lasts minutes, a few hours, many hours, or days.

 RESULTS

Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax) regardless of patients age (P < 0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged <65 years (P = 0.009). Silodosin was significantly more effective than placebo in reducing all IPSS-related parameters regardless of baseline IPSS (P ≤ 0.001). Similarly, silodosin was more effective than placebo in improving IPSS-related parameters regardless of baseline Qmax (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups.

CONCLUSIONS

We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.

Read more articles of the week

Editorial: Selecting the right α-blocker – is silodosin your best option?

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.

Read the full article
Hugo Lavigueur-Blouin and Naeem Bhojani

 

Department of Urology, Centre Hospitalier de lUniversite dMontreal, Montreal, QC, Canada

 

References

 

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

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.

Read the full article
Hugo Lavigueur-Blouin and Naeem Bhojani

 

Department of Urology, Centre Hospitalier de lUniversite dMontreal, Montreal, QC, Canada

 

References

 

 

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

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

Read the full article
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.

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

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.

Read the full article

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

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

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.

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

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.

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

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

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

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

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

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

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

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

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

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

 

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

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

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