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Editorial: Responsiveness to Medical BPH Therapy – Is There a Genetic Factor?

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In this issue, Lee et al. [1] from Taiwan demonstrate that the endothelial nitric oxide synthase (eNOS) G894T gene polymorphism predicts responsiveness to α1-blocker therapy in men with BPH/LUTS.

There is a long-standing interest in the establishment of a genetic marker for BPH/LUTS predicting clinical status, the natural history and – ideally – also responsiveness to for example medical therapy. The high prevalence of disease, the socioeconomic impact of diagnosis, medical and surgical treatment, and the availability of drugs (5α-reductase inhibitors) that alter the natural course of the disease justify the intensive search for a genetic marker for BPH/LUTS.

The few familial and twin studies suggest a (moderate) genetic background for this disease to an extent similar to other chronic diseases such as hypertension or diabetes mellitus type II [2, 3]. However, BPH/LUTS is a complex disorder and it is very unlikely that the pathogenesis can be reduced to a single gene or gene defect. Most likely, genetic alterations – besides inflammation, endocrine, myogenic, neurogenic, and morphological factors – act as co-factors.

Within the past decade numerous polymorphisms in the steroid-metabolism pathway, in cytokine genes, in the vitamin D receptor gene, the α-adrenoceptor gene, in homeobox genes, in the angiotensin converting enzyme, the glutathione S-transferase gene, and in the nitric oxide system (just to mention the most frequently studied ones) have been correlated to several clinical parameters of BPH/LUTS, such as symptom status, prostate volume, maximum urinary flow rate and the natural history of the disease [4, 5]. None of these studies provided compelling evidence that one of these polymorphisms (or combinations thereof) could serve as a clinically relevant marker [4, 5]. As indicated by Cartwright et al. [5], many of these genetic studies are hampered by a small sample size, lack of genotyping quality control, inadequate adjustment for populations from heterogeneous descent groups, and poorly defined/inhomogeneous study endpoints.

There is increasing evidence that the nitric oxide (NO)/cGMP pathway plays an important role in controlling the smooth muscle tone of the lower urinary tract. Decreases in the NO/cGMP pathway with age would result in decreased levels of intracellular cGMP and calcium, leading to less smooth muscle relaxation of the bladder and the prostate, thus worsening LUTS. NO is synthesised by at least three isoenzymes of NOS, inducible NOS (iNOS), neuronal NOS (nNOS) and eNOS [1]. The close relationship between NOS/NO pathway and the pathophysiology of BPH/LUTS was the rationale for the study by Lee et al. [1]. Using multiple logistic regression analysis adjusted for age and IPSS, the data showed that the eNOS 894T allele carrier was an independent factor for drug non-responders [1]. However, responsiveness to α1-blocker therapy was also strongly dependent on diabetes mellitus and hypertension, suggesting that the metabolic syndrome plays an important role in the pathogenesis of BPH/LUTS [1]. This is indeed the first study showing that a genetic factor is predictive of the responsiveness to medical BPH/LUTS therapy, therefore this study is significant.

Further studies in populations with other genetic backgrounds (e.g. Caucasian) are required to confirm and to generalise these data. Phosphodiesterase type 5 inhibitors have been proposed to act in BPH/LUTS via the NO systems; therefore, it would be interesting to test this genetic marker also in men treated with tadalafil 5 mg/day. Finally, one has to be aware of the fact that the authors have tested α-blocker monotherapy. All major guidelines recommend a combination of α-blocker and 5α-reductase inhibitor for men with larger prostates (e.g. prostate volume >30–40 mL) [6]. The mean prostate volume in this cohort was 35 mL suggesting that, according to guideline recommendations, these men would have required combined therapy [6].

Read the full article
Stephan Madersbacher, Professor and Chairman
Department of Urology, Kaiser-Franz-Josef Spital, Vienna, Austria

 

References

 

1 Lee Y-C, Juan Y-S, Liu C-C et al. The association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective a 1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms. BJU Int 2016; 118: 313–19

 

2 Partin AW, Page WF, Lee BR, Sanda MG, Miller RN, Walsh PC. Concordance rates for benign prostatic disease among twins suggest hereditary influence. Urology 1994; 44: 646–50

 

3 Rohrmann S, Fallin MD, Page WF et al. Concordance rates and modifiable risk factors for lower urinary tract symptoms in twins. Epidemiology 2006; 17: 419–27

 

4 Konwar R, Chattopadhyay N, Bid HK. Genetic polymorphism and pathogenesis of benign prostatic hyperplasia. BJU Int 2008; 102: 536–43

 

5 Cartwright R, Mangera A, Tikkinen KA et al. Systematic review and meta-analysis of candidate gene association studies of lower urinary tract symptoms in men. Eur Urol 2014; 66: 752–68

 

6 Gravas S, Bach T, Bachmann A et al. Treatment of Non-Neurogenic Male LUTS. Available at: www.uroweb.org. Accessed March 2016.

 

Video: Aquablation – image-guided robot-assisted waterjet ablation of the prostate

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Aquablation – image-guided robot-assisted waterjet ablation of the prostate: initial clinical experiences

Peter Gilling, Rana Reuther, Arman Kahokehr and Mark Fraundorfer

 

Department of Urology, Tauranga Hospital, Tauranga, New Zealand

 

Read the full article

Objective

To assess the safety and feasibility of aquablation in a first-in-man study. Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics (aquabeam®) for the targeted and heat-free removal of prostatic tissue in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

A prospective, non-randomised, single-centre trial in men aged 50–80 years with moderate-to-severe LUTS was conducted. Under real-time image-based ultrasonic guidance, aquabeam technology enables surgical planning and mapping, and leads to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at 1, 3, and 6 months after aquablation.

Results

In all, 15 patients were treated with aquablation under general anaesthesia. The mean (range) age was 73 (59–86) years and prostate size was 54 (27–85) mL. A substantial median lobe was present in six of the 15 patients. The mean International Prostate Symptom Score (IPSS) was 23 and the maximum urinary flow rate (Qmax) was 8.4 mL/s at baseline. The mean procedural time was 48 min with a mean aquablation treatment time of 8 min. All procedures were technically successful with no serious or unexpected adverse events (AEs). All but one patient had removal of catheter on day 1, and most of the patients were discharged on the first postoperative day. No patient required a blood transfusion, and postoperative sodium changes were negligible. There were no serious 30-day AEs. One patient underwent a second aquablation treatment within 90 days of the first procedure. The mean IPSS score statistically improved from 23.1 at baseline to 8.6 at 6 months (P < 0.001) and the Qmax increased from 8.6 mL/s at baseline to 18.6 mL/s at the 6-month follow-up (P < 0.001). At 6 months, the mean detrusor pressure at Qmax decreased to 45 cmH20 from 66 cmH20 at baseline (P < 0.05), and the mean prostate size was reduced to 36 mL, a 31% reduction in size vs baseline (P < 0.001). No cases of urinary incontinence or erectile dysfunction were reported.

Conclusions

These preliminary results from this initial study show aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardised heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared with other endoscopic methods, as well as the potential to preserve sexual function.

 

Article of the Week: Central obesity is predictive of persistent storage LUTS after surgery for BPE

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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. Mauro Gacci discussing his paper. 

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

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, Sant’Andrea 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, Springfield, IL , and Department of Urology, Weill Cornell Medical College, Cornell University, New York, NY, USA

 

Read the full article
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.

 

Read more articles of the week

Editorial: Exercise, diet and weight loss before therapy for LUTS/BPH?

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In recent decades we have had access to an increasing body of evidence evoking a strong relationship between metabolic syndrome and the development of LUTS/BPH. This relationship suggests that metabolic syndrome might be responsible not only for putting patients at higher risk of developing LUTS/BPH but also for influencing the response and outcome of therapy. In a study in the present issue of BJUI [1] it has been observed that patients with a greater waist circumference, a sign of metabolic syndrome, are at a higher risk of experiencing persistent LUTS after either TURP or open prostatectomy for BPH. Likewise, in a recent systematic review and meta-analysis, a strong relationship between metabolic syndrome and prostatic enlargement was observed, underlining the exacerbating role of this syndrome in inducing the development of benign prostate enlargement as obese, dyslipidaemic and aged men have a higher risk of metabolic syndrome being a determinant factor of their prostate enlargement [2].

Metabolic syndrome is a constellation of clinical findings characterizing patients affected by a combination of abdominal obesity, elevated serum triglyceride levels, lowered HDL cholesterol levels, increased blood pressure or a high level of plasma glucose. It has also been considered an important risk factor for the eventual development of a number of diseases including type 2 diabetes, coronary vascular disease, fatty liver disease, chronic kidney disease and hyperuricaemia [3]. Furthermore metabolic syndrome has been recently associated with an increased risk of clinical progression of LUTS/BPH in men with moderate to severe LUTS, reinforcing this syndrome as a factor for progression in addition to IPSS score, prostate volume, PSA, maximum urinary flow rate and post-void residual urine volume [4]. Several studies have recently shown that patients with LUTS/BPH and metabolic syndrome have a higher prostate volume than those without, and express a worse response to pharmacological therapy, suggesting the need to consider this at the time of selecting patients with LUTS/BPH for drug therapy [5, 6]. Check these leptitox reviews for harmless and natural weight loss treatment.

Several factors in the development of metabolic syndrome have been elucidated, including hyperinsulinaemia and autonomic hyperactivity, increased adiposity, ischaemia and hypoxia, chronic proinflamatory state and abnormal androgen levels. These factors are probably inter-related. A lack of exercise, together with obesity, may lead to insulin resistance, exerting a detrimental effect on lipid ratios decreasing blood levels of HDL cholesterol and increasing blood levels of triglycerides and LDL cholesterol. These undesirable levels of cholesterol may lead to deposits of atheromatous plaques in artery walls, increasing the risk of cardiovascular disease. In addition, hyperinsulinaemia may lead to sodium retention, causing hypertension.

The implications for clinical practice are that, if metabolic syndrome is related to the development of BPH/LUTS, lifestyle interventions including weight loss (you can check resurge reviews and find how this supplement heal you losing weight), a healthy diet, and physical activity would have a positive effect in both symptom relief and disease progression. As a consequence we should develop management strategies to address both the symptoms and the underlying processes, not only because men with LUTS/BPH and metabolic syndrome respond worse than those without metabolic syndrome, but also because lifestyle change, a healthy diet and exercise might be enough to achieve symptom improvement and decrease the risk of cardiovascular disease, prevent most obesity related conditions just by reading these meticore reviews.

Read the full article
David Castro-Diaz
Department of Urology, University Hospital of the Canary Islands, University of La Laguna, Tenerife, Spain

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

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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, Sant’Andrea 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, Springfield, IL , and Department of Urology, Weill Cornell Medical College, Cornell University, New York, NY, USA

 

Read the full article
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.

 

Read more articles of the week

Highlights from #BAUS15

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#BAUS15 started to gain momentum from as early as the 26th June 2014 and by the time we entered the Manchester Central Convention Complex well over 100 tweets had been made. Of course it wasn’t just Twitter that started early with a group of keen urologists cycling 210 miles to conference in order to raise money for The Urology Foundation.

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Monday 15th June 2015

By the time the cyclists arrived conference was well under way with the andrology, FNUU and academic section meetings taking place on Monday morning:

  • The BJU International Prize for the Best Academic Paper was awarded to Richard Bryant from the University of Oxford for his work on epithelial-to-mesenchymal transition changes found within the extraprostatic extension component of locally invasive prostate cancers.
  • Donna Daly from the University of Sheffield received the BJUI John Blandy prize for her work on Botox, demonstrating reductions in afferent bladder signaling and urothelial ATP release.

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  • Professor Reisman’s talk on ‘Porn, Paint and Piercing’ as expected drew in the crowds and due to a staggering 44% complication rate with genital piercings it is important for us to try to manage these without necessarily removing the offending article as this will only serve to prevent those in need from seeking medical attention.
  • With the worsening worldwide catastrophe of antibiotic resistance, the cycling of antibiotics for prevention of recurrent UTIs is no longer recommended. Instead, Tharani Nitkunan provided convincing evidence for the use of probiotics and D-Mannose.

The afternoon was dominated by the joint oncology and academic session with Professor Noel Clarke presenting the current data from the STAMPEDE trial. Zolendronic acid conferred no survival benefit over hormones alone and consequently has been removed from the trial (stampede 1). However, Docetaxal plus hormones has shown benefit, demonstrated significantly in M1 patients with disease-free survival of 65 months vs. 43 months on hormones alone (Hazard ratio 0.73) (stampede 2). This means that the control arm of M1 patients who are fit for chemotherapy will now need to be started on this treatment as the trial continues to recruit in enzalutamide, abiraterone and metformin arms.

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The evening was rounded off with the annual BAUS football tournament won this year by team Manchester (obviously a rigged competition!), whilst some donned the

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lycra and set out for a competition at the National Cycle Centre. For those of us not quite so energetic, it was fantastic to catch up with old friends at the welcome drinks reception.

 

Tuesday 16th June 2015

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Tuesday kicked off bright and early with Professor John Kelly presenting results from the BOXIT clinical trial, which has shown some benefit over standard treatment of non-muscle invasive bladder cancer, but with significant cardiovascular toxicity.

The new NICE bladder cancer guidelines were presented with concerns voiced by Professor Marek Babjuk over discharging low-risk bladder cancer at 12 months given a quoted 30-50% five-year recurrence risk. Accurate risk stratification, it would seem, is going to be key.

The President’s address followed along with the presentation of the St. Peter’s medal for notable contribution to the advancement of urology, which was presented to Pat Malone from Southampton General Hospital. Other medal winners included Adrian Joyce who received the BAUS Gold Medal, and the St. Paul’s medal went to Mark Soloway.

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A plethora of other sessions ensued but with the help of the new ‘native’ BAUS app my programme was already conveniently arranged in advance:

  •     ‘Heartsink Conditions’ included pelvic and testicular pain and a fascinating talk by Dr Gareth Greenslade highlighted the importance of early and motivational referral to pain management services once no cause has been established and our treatments have been exhausted. The patient’s recovery will only start once we have said no to further tests: ‘Fix the thinking’
  • Poster sessions are now presented as ‘e-posters’, abolishing the need to fiddle with those little pieces of Velcro and allowing for an interactive review of the posters.

 

Photo 22-06-2015 22 36 07Pravisha Ravindra from Nottingham demonstrated that compliance with periodic imaging of patients with asymptomatic small renal calculi (n=147) in primary care is poor, and indeed, these patients may be better managed with symptomatic imaging and re-referral as no patients required intervention based on radiograph changes alone.

Archana Fernando from Guy’s presented a prospective study demonstrating the value of CTPET in the diagnosis of malignancy in  patients with retroperitoneal fibrosis (n=35), as well as demonstrating that those with positive PET are twice as likely to respond to steroids.

 

Wednesday 17th June 2015

Another new addition to the programme this year was the Section of Endourology ‘as live surgery’ sessions. This was extremely well received and allowed delegates to benefit from observing operating sessions from experts in the field whilst removing the stressful environment and potential for risk to patient associated with live surgery. This also meant that the surgeon was present in the room to answer questions and talk through various steps of the operation allowing for a truly interactive session.
Wednesday saw multiple international speakers dominating the Exchange Auditorium:

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  • The BJU International guest lecture was given by Professor Hendrik Van Poppel: a heartfelt presentation describing what he believes to be the superiority of surgery over radiotherapy for high-risk localised prostate cancer.
  • The Urology Foundation presented the Research Scholar Medal to Ashwin Sachdeva from Freeman Hospital, Newcastle for his work on the ‘Role of mitochondrial DNA mutations in prostate carcinogenesis’. This was followed by an inspiring guest lecture by Inderbir Gill on ‘Robotic Urologic Oncology: the best is yet to come’ with the tag line ‘the only thing that should be open in 2015 is our minds’
  • Robotic Surgery in UK Urology: Clinical & Commissioning Priorities was a real highlight in the programme with talks from Jim Adshead and Professor Jens-Uwe Stolzenburg focussing on the fact that only 40% of T1a tumours in the UK were treated with partial (as opposed to radical) nephrectomy, and that the robot really is the ‘game-changer’ for this procedure. Inderbir Gill again took to the stage to stress that all current randomised trials into open vs. robotic cystectomy have used extracorporeal reconstruction and so do not reflect the true benefits of the robotic procedure as the dominant driver of complications is in the open reconstruction.

These lectures were heard by James Palmer, Clinical Director of Specialised Commissioning for NHS England who then discussed difficulties in making decisions to provide new technologies, controlling roll out and removing them if they show no benefit. Clinical commissioning policies are currently being drafted for robotic surgery in kidney and bladder cancer. This led to a lively debate with Professor Alan McNeill having the last word as he pointed out that what urologists spend on the robot to potentially cure cancer is a drop in the ocean compared with what the oncologists spend to palliate!

 

Thursday 18th June 2015

The BJU International session on evidence-based urology highlighted the need for high-quality evidence, especially in convincing commissioners to spend in a cash-strapped NHS. Professor Philipp Dahm presented a recent review in the Journal of Urology indicated that the quality of systematic reviews in four major urological journals was sub-standard. Assistant Professor Alessandro Volpe then reviewed the current evidence behind partial nephrectomy and different approaches to this procedure.

Another fantastic technology, which BAUS adopted this year, was the BOD-POD which allowed delegates to catch-up on sessions in the two main auditoria that they may have missed due to perhaps being in one of the 21 well designed teaching courses that were available this year. Many of these will soon be live on the BAUS website for members to view.

The IBUS and BAUS joint session included a lecture from Manoj Monga from The Cleveland Clinic, which led to the question being posed on Twitter: ‘Are you a duster or a basketer?’The audience was also advised to always stent a patient after using an access sheath unless the patient was pre-stented.

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The updates session is always valuable especially for those studying for the FRCS (Urol) exam with far too many headlines to completely cover:

  • Endourology: The SUSPEND trial published earlier this year was a large multi-centre RCT that showed no difference in terms of rates of spontaneous passage of ureteric stone, time to stone passage or analgesic use between placebo, tamsulosin and nifedipine. There was a hot debate on this: should we be waiting for the meta-analysis or should a trial of this size and design be enough to change practice?
  • Oncology-Prostate: The Klotz et al., paper showed active surveillance can avoid over treatment, with 98% prostate cancer survival at 10 years.
  • Oncology-Kidney: Ellimah Mensah’s team from Imperial College London (presented at BAUS earlier in the week) demonstrated that over a 14-year period there were a higher number of cardiovascular-related admissions to hospital in patients who have had T1 renal tumours resected than the general population, but no difference between those who have had partial or radical nephrectomy.
  • Oncology-Bladder: Arends’s team presented at EAU in March on the favourable results of hyperthermic mitomycin C vs. BCG in the treatment of intermediate- and high-risk bladder cancer.
  • Female and BPH: The BESIDE study has demonstrated increased efficacy with combination solifenacin and mirabegron.
  • Andrology: Currently recruiting in the UK is the MASTER RCT to evaluate synthetic sling vs. artificial sphincter in men with post-prostatectomy urinary incontinence.

 

Overall BAUS yet again put on a varied and enjoyable meeting. The atmosphere was fantastic and the organisers should be proud of the new additions in terms of allowing delegates to engage with new technologies, making for a memorable week. See you all in Liverpool!

 

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Rebecca Tregunna, Urological Trainee, West Midlands Deanery @rebeccatregunna

 

Dominic Hodgson, Consultant Urologist, Portsmouth @hodgson_dominic

 

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

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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, Sheffield, 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.

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

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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.

Read the full article
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

 

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.

Read the full article
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

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.

Read more articles of the week
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