- Email: [email protected]
Re: Prospective Evaluation of Ambulatory Laser Vaporization of the Prostate for Benign Prostatic Hyperplasia
1504
BENIGN PROSTATIC HYPERPLASIA
not substantially improve or change during the study period, nor were new guidelines introduced that definitively recommended the use of urodynamics in this setting. One must wonder if the primary driving force in the increased use of urodynamics was financial. The other possibility is the practice of defensive medicine, and while this factor may have had a small role, I am still inclined to believe that reimbursement drove the increase. As the new MACRA (Medicare Access and CHIP Reauthorization Act) takes effect in the coming years and alternative payment models become more common, providers will be incentivized to do less testing in this setting. It will be interesting to see if use of urodynamics will be reduced. Either way, it is important for us as providers to ensure that our testing delivers value to the patient. Further research is needed to determine the role of urodynamic testing in the preoperative evaluation of women with mixed urinary incontinence. If the test does not add anything, we need to stop doing it. David F. Penson, MD, MPH
Re: Long Term Safety of Sacral Nerve Modulation in Medicare Beneficiaries B. Chughtai, A. Sedrakyan, A. Isaacs, R. Lee, A. Te and S. Kaplan Departments of Urology and Public Health, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, New York Neurourol Urodyn 2015; 34: 659e663. doi: 10.1002/nau.22618
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25066920 Editorial Comment: Sacral nerve modulation is a commonly used second-line therapy for refractory overactive bladder. While studies have shown that a considerable proportion of patients who undergo device implantation experience symptom relief, it is important to remember that the treatment is relatively costly and that, because the device is a foreign body, it sometimes requires explantation and/or replacement. This study uses the 5% Medicare sample from 2003 to 2011 to assess the long-term safety of the device. In the short term the majority of patients undergoing implantation experience few or no problems. However, by 3 years 17.3% of patients have had the device removed and 11.3% have had it replaced, with 26.1% of patients having undergone at least 1 of these additional interventions. Is a 1 in 4 removal/replacement rate acceptable? It is hard to say. Certainly refractory overactive bladder has a profound effect on quality of life, and sacral neuromodulation is effective in many patients. However, this approach does not work in all patients, and a 26% reoperation rate certainly adds significant cost to the treatment. As urologists, we need to consider the long-term cost-effectiveness of our interventions and have frank discussions with our patients, encouraging them to consider this factor in their decision making. If we do not do this with our patients, the payers will do it for us, and I do not believe we will like their choices. David F. Penson, MD, MPH
Suggested Reading Brazzelli M, Murray A and Fraser C: Efficacy and safety of sacral nerve stimulation for urinary urge incontinence: a systematic review. J Urol 2006; 175: 835.
Benign Prostatic Hyperplasia Re: Prospective Evaluation of Ambulatory Laser Vaporization of the Prostate for Benign Prostatic Hyperplasia re, G. Verhoest, G. Berquet, L. Corbel, E. Della Negra, R. Huet, F. Trifard, Y. Codet, F. Boulie S. Vincendeau, K. Bensalah and R. Mathieu Departments of Urology, Rennes University Hospital, University of Rennes, Rennes and Saint Brieuc Private Hospital, St. Brieuc, France Lasers Surg Med 2015; 47: 396e402. doi: 10.1002/lsm.22363
BENIGN PROSTATIC HYPERPLASIA
1505
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25997558 Editorial Comment: In an era of cost containment we are looking to do more at the office and/or ambulatory surgical center. The economics vary from country to country and depend on ownership of the facility, although from a convenience perspective for the patient and surgeon improving efficiency is a worthy goal. We now have an arsenal of minimally invasive and surgical therapies for benign prostatic hyperplasia, including those that can certainly be done at the office (Rez umÒ/UroLiftÒ), while others, such as laser and bipolar electrovaporization techniques, are prime candidates for an ambulatory setting. In this prospective study men who underwent ambulatory photoselective vaporization of the prostate (PVP) were analyzed. The procedure was successfully carried out in 121 of 134 men (90%). The functional results were similar to traditional data reported for PVP. Which patients are the best candidates for this setting? In this study men presented with relatively smaller prostate volumes (mean 54 cc, although 22 had prostate volumes greater 80 cc) and decreased anesthesia risk based on ASAÒ score (mean 2.01). Men older than 80 years were excluded, as were those who had an ASA score higher than 3, lived alone or resided more than 1 hour from the ambulatory center. Which patients did not do well in this study? Those with serious postoperative hematuria, of whom 2 required changing to a more formal electrosurgical resection due to organizational and logistical issues. The authors did not present the preoperative baseline data in that cohort. The bottom line is that proper case selection and managing expectations make PVP and, in our experience, bipolar button electrovaporization potential procedures to be performed in an ambulatory setting. However, backup provisions should be in place in case events do not proceed as planned. Steven A. Kaplan, MD
Suggested Reading Malek RS, Kang HW, Peng YS et al: Photoselective vaporization prostatectomy: experience with a novel 180 W 532 nm lithium triborate laser and fiber delivery system in living dogs. J Urol 2011; 185: 712.
Re: The Effect of Competing Direct-to-Consumer Advertising Campaigns on the Use of Drugs for Benign Prostatic Hyperplasia: Time Series Analysis S. C. Skeldon, K. B. Kozhimannil, S. R. Majumdar and M. R. Law Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada J Gen Intern Med 2015; 30: 514e520. doi: 10.1007/s11606-014-3063-y
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25338730 Editorial Comment: How many times have you heard a radio or seen a television advertisement touting some concoction for improving urinary symptoms or sexual performance? In addition to a 30-day money-back guarantee, each of these formulas is guaranteed to help you sleep through the night and turn you back into a 25-year-old man. Would it be so simple? Unfortunately in an Internet and media driven society direct to consumer advertising (DTCA) can often dictate behavior in many disease states. This practice may delay diagnosis or appropriate therapy. Another interesting question is whether DTCA changes prescription behavior and influences health care professionals to prescribe medications that are different than guideline recommended first line therapy. In 2010 pharmaceutical companies spent more than $4.3 billion on DTCA. The authors conducted an interesting analysis where they looked at the influence of DTCA of AvodartÒ (dutasteride) and FlomaxÒ (tamsulosin) on prescription behavior between July 2005 and April 2006. They evaluated trending on Google as well as IMS Health data that track new and recurrent prescription writing. The results are somewhat encouraging in that despite the large amount of money spent by GlaxoSmithKline in pushing Avodart, tamsulosin remained the first-line therapy used for benign prostatic hyperplasia. Ironically while Avodart prescriptions increased, the net effect was a doubling of tamsulosin prescriptions. A couple of take home messages can be gleaned. Although patients may have asked for Avodart based on DTCA, they were redirected to the more appropriate alpha blocker, tamsulosin. Another
1506
BENIGN PROSTATIC HYPERPLASIA
plausible explanation is that patients went Internet searching in response to DTCA for Avodart and learned more about various therapies for benign prostatic hyperplasia and decided to ask for an alpha blocker. The findings lend credence to the notion that at least for benign prostatic hyperplasia DTCA does not result in over diagnosis or, more importantly, overtreatment. Can the same be said for sexual therapies such as phosphodiesterase type 5 inhibitors and testosterone? The bottom line is that DTCA has wanted and unwanted consequences, depending on the disease state. If the pharmaceutical industry were not making loads of money from the practice, it would not be using DTCA. Buyer beware! Steven A. Kaplan, MD
Suggested Reading Roehrborn CG and Schwinn DA: Alpha1-adrenergic receptors and their inhibitors in lower urinary tract symptoms and benign prostatic hyperplasia. J Urol 2004; 171: 1029.
Re: 5a-Reductase Inhibitors and the Risk of Cancer-Related Mortality in Men with Prostate Cancer L. Azoulay, M. Eberg, S. Benayoun and M. Pollak Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Department of Oncology, McGill University and Division of Urology, University of Montreal, Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada JAMA Oncol 2015; 1: 314e320. doi: 10.1001/jamaoncol.2015.0387
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26181177 Editorial Comment: Following PCPT (Prostate Cancer Prevention Trial) and REDUCE (Reduction by Dutasteride of Prostate Cancer Events trial) there was a lot of buzz about the association between 5a-reductase inhibitors and more aggressive prostate cancers. Subsequently numerous explanations, including sampling bias, and subsequent post hoc analysis of longer term data seemed to have allayed those fears. Currently it appears that the 5a-reductase inhibitor story has quieted down. In this study 4 large electronic databases from the United Kingdom were analyzed, including NCDR (National Cancer Data Repository), CPRD (Clinical Practice Research Datalink), HES (Hospital Episode Statistics) and ONS (Office for National Statistics). Specifically a cohort of 14,000 men diagnosed with prostate cancer between January 1999 and December 2009 who were followed until October 2012 were retrospectively evaluated. Using various forms of statistical analysis, there appeared to be no association between the use of 5a-reductase inhibitors and an increased risk of either prostate cancer specific or all cause mortality. Coming at it from a benign prostatic hyperplasia angle from the research and clinical perspectives, I have always been intrigued by the 5a-reductase inhibitor/prostate cancer story. From a pragmatic perspective given that finasteride has been prescribed since the early 1990s, if there were indeed a causative relationship to prostate cancer, would we not have seen it? Currently at our male health center we have more than 700 men on 5a-reductase inhibitors and have not noted an increased incidence of prostate cancer in this cohort. Frankly no one else has reported it. Sometimes we tend to try to extrapolate findings from carefully designed trials that often may not reflect clinical reality. That said, we have used 5a-reductase inhibitors as stressors in men with fluctuating prostate specific antigen and repeat biopsy and have found them useful as a proxy for need for repeat biopsy. At this point these agents seem to be safe and effective in treating men with lower urinary tract symptoms secondary to benign prostatic hyperplasia with prostate enlargement. Steven A. Kaplan, MD
Suggested Reading Kaplan SA, Lee RK, Chung DE et al: Prostate biopsy in response to a change in nadir prostate specific antigen of 0.4 ng/ml after treatment with 5a-reductase inhibitors markedly enhances the detection rate of prostate cancer. J Urol 2012; 188: 757.
BENIGN PROSTATIC HYPERPLASIA
not substantially improve or change during the study period, nor were new guidelines introduced that definitively recommended the use of urodynamics in this setting. One must wonder if the primary driving force in the increased use of urodynamics was financial. The other possibility is the practice of defensive medicine, and while this factor may have had a small role, I am still inclined to believe that reimbursement drove the increase. As the new MACRA (Medicare Access and CHIP Reauthorization Act) takes effect in the coming years and alternative payment models become more common, providers will be incentivized to do less testing in this setting. It will be interesting to see if use of urodynamics will be reduced. Either way, it is important for us as providers to ensure that our testing delivers value to the patient. Further research is needed to determine the role of urodynamic testing in the preoperative evaluation of women with mixed urinary incontinence. If the test does not add anything, we need to stop doing it. David F. Penson, MD, MPH
Re: Long Term Safety of Sacral Nerve Modulation in Medicare Beneficiaries B. Chughtai, A. Sedrakyan, A. Isaacs, R. Lee, A. Te and S. Kaplan Departments of Urology and Public Health, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, New York Neurourol Urodyn 2015; 34: 659e663. doi: 10.1002/nau.22618
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25066920 Editorial Comment: Sacral nerve modulation is a commonly used second-line therapy for refractory overactive bladder. While studies have shown that a considerable proportion of patients who undergo device implantation experience symptom relief, it is important to remember that the treatment is relatively costly and that, because the device is a foreign body, it sometimes requires explantation and/or replacement. This study uses the 5% Medicare sample from 2003 to 2011 to assess the long-term safety of the device. In the short term the majority of patients undergoing implantation experience few or no problems. However, by 3 years 17.3% of patients have had the device removed and 11.3% have had it replaced, with 26.1% of patients having undergone at least 1 of these additional interventions. Is a 1 in 4 removal/replacement rate acceptable? It is hard to say. Certainly refractory overactive bladder has a profound effect on quality of life, and sacral neuromodulation is effective in many patients. However, this approach does not work in all patients, and a 26% reoperation rate certainly adds significant cost to the treatment. As urologists, we need to consider the long-term cost-effectiveness of our interventions and have frank discussions with our patients, encouraging them to consider this factor in their decision making. If we do not do this with our patients, the payers will do it for us, and I do not believe we will like their choices. David F. Penson, MD, MPH
Suggested Reading Brazzelli M, Murray A and Fraser C: Efficacy and safety of sacral nerve stimulation for urinary urge incontinence: a systematic review. J Urol 2006; 175: 835.
Benign Prostatic Hyperplasia Re: Prospective Evaluation of Ambulatory Laser Vaporization of the Prostate for Benign Prostatic Hyperplasia re, G. Verhoest, G. Berquet, L. Corbel, E. Della Negra, R. Huet, F. Trifard, Y. Codet, F. Boulie S. Vincendeau, K. Bensalah and R. Mathieu Departments of Urology, Rennes University Hospital, University of Rennes, Rennes and Saint Brieuc Private Hospital, St. Brieuc, France Lasers Surg Med 2015; 47: 396e402. doi: 10.1002/lsm.22363
BENIGN PROSTATIC HYPERPLASIA
1505
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25997558 Editorial Comment: In an era of cost containment we are looking to do more at the office and/or ambulatory surgical center. The economics vary from country to country and depend on ownership of the facility, although from a convenience perspective for the patient and surgeon improving efficiency is a worthy goal. We now have an arsenal of minimally invasive and surgical therapies for benign prostatic hyperplasia, including those that can certainly be done at the office (Rez umÒ/UroLiftÒ), while others, such as laser and bipolar electrovaporization techniques, are prime candidates for an ambulatory setting. In this prospective study men who underwent ambulatory photoselective vaporization of the prostate (PVP) were analyzed. The procedure was successfully carried out in 121 of 134 men (90%). The functional results were similar to traditional data reported for PVP. Which patients are the best candidates for this setting? In this study men presented with relatively smaller prostate volumes (mean 54 cc, although 22 had prostate volumes greater 80 cc) and decreased anesthesia risk based on ASAÒ score (mean 2.01). Men older than 80 years were excluded, as were those who had an ASA score higher than 3, lived alone or resided more than 1 hour from the ambulatory center. Which patients did not do well in this study? Those with serious postoperative hematuria, of whom 2 required changing to a more formal electrosurgical resection due to organizational and logistical issues. The authors did not present the preoperative baseline data in that cohort. The bottom line is that proper case selection and managing expectations make PVP and, in our experience, bipolar button electrovaporization potential procedures to be performed in an ambulatory setting. However, backup provisions should be in place in case events do not proceed as planned. Steven A. Kaplan, MD
Suggested Reading Malek RS, Kang HW, Peng YS et al: Photoselective vaporization prostatectomy: experience with a novel 180 W 532 nm lithium triborate laser and fiber delivery system in living dogs. J Urol 2011; 185: 712.
Re: The Effect of Competing Direct-to-Consumer Advertising Campaigns on the Use of Drugs for Benign Prostatic Hyperplasia: Time Series Analysis S. C. Skeldon, K. B. Kozhimannil, S. R. Majumdar and M. R. Law Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada J Gen Intern Med 2015; 30: 514e520. doi: 10.1007/s11606-014-3063-y
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25338730 Editorial Comment: How many times have you heard a radio or seen a television advertisement touting some concoction for improving urinary symptoms or sexual performance? In addition to a 30-day money-back guarantee, each of these formulas is guaranteed to help you sleep through the night and turn you back into a 25-year-old man. Would it be so simple? Unfortunately in an Internet and media driven society direct to consumer advertising (DTCA) can often dictate behavior in many disease states. This practice may delay diagnosis or appropriate therapy. Another interesting question is whether DTCA changes prescription behavior and influences health care professionals to prescribe medications that are different than guideline recommended first line therapy. In 2010 pharmaceutical companies spent more than $4.3 billion on DTCA. The authors conducted an interesting analysis where they looked at the influence of DTCA of AvodartÒ (dutasteride) and FlomaxÒ (tamsulosin) on prescription behavior between July 2005 and April 2006. They evaluated trending on Google as well as IMS Health data that track new and recurrent prescription writing. The results are somewhat encouraging in that despite the large amount of money spent by GlaxoSmithKline in pushing Avodart, tamsulosin remained the first-line therapy used for benign prostatic hyperplasia. Ironically while Avodart prescriptions increased, the net effect was a doubling of tamsulosin prescriptions. A couple of take home messages can be gleaned. Although patients may have asked for Avodart based on DTCA, they were redirected to the more appropriate alpha blocker, tamsulosin. Another
1506
BENIGN PROSTATIC HYPERPLASIA
plausible explanation is that patients went Internet searching in response to DTCA for Avodart and learned more about various therapies for benign prostatic hyperplasia and decided to ask for an alpha blocker. The findings lend credence to the notion that at least for benign prostatic hyperplasia DTCA does not result in over diagnosis or, more importantly, overtreatment. Can the same be said for sexual therapies such as phosphodiesterase type 5 inhibitors and testosterone? The bottom line is that DTCA has wanted and unwanted consequences, depending on the disease state. If the pharmaceutical industry were not making loads of money from the practice, it would not be using DTCA. Buyer beware! Steven A. Kaplan, MD
Suggested Reading Roehrborn CG and Schwinn DA: Alpha1-adrenergic receptors and their inhibitors in lower urinary tract symptoms and benign prostatic hyperplasia. J Urol 2004; 171: 1029.
Re: 5a-Reductase Inhibitors and the Risk of Cancer-Related Mortality in Men with Prostate Cancer L. Azoulay, M. Eberg, S. Benayoun and M. Pollak Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Department of Oncology, McGill University and Division of Urology, University of Montreal, Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada JAMA Oncol 2015; 1: 314e320. doi: 10.1001/jamaoncol.2015.0387
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26181177 Editorial Comment: Following PCPT (Prostate Cancer Prevention Trial) and REDUCE (Reduction by Dutasteride of Prostate Cancer Events trial) there was a lot of buzz about the association between 5a-reductase inhibitors and more aggressive prostate cancers. Subsequently numerous explanations, including sampling bias, and subsequent post hoc analysis of longer term data seemed to have allayed those fears. Currently it appears that the 5a-reductase inhibitor story has quieted down. In this study 4 large electronic databases from the United Kingdom were analyzed, including NCDR (National Cancer Data Repository), CPRD (Clinical Practice Research Datalink), HES (Hospital Episode Statistics) and ONS (Office for National Statistics). Specifically a cohort of 14,000 men diagnosed with prostate cancer between January 1999 and December 2009 who were followed until October 2012 were retrospectively evaluated. Using various forms of statistical analysis, there appeared to be no association between the use of 5a-reductase inhibitors and an increased risk of either prostate cancer specific or all cause mortality. Coming at it from a benign prostatic hyperplasia angle from the research and clinical perspectives, I have always been intrigued by the 5a-reductase inhibitor/prostate cancer story. From a pragmatic perspective given that finasteride has been prescribed since the early 1990s, if there were indeed a causative relationship to prostate cancer, would we not have seen it? Currently at our male health center we have more than 700 men on 5a-reductase inhibitors and have not noted an increased incidence of prostate cancer in this cohort. Frankly no one else has reported it. Sometimes we tend to try to extrapolate findings from carefully designed trials that often may not reflect clinical reality. That said, we have used 5a-reductase inhibitors as stressors in men with fluctuating prostate specific antigen and repeat biopsy and have found them useful as a proxy for need for repeat biopsy. At this point these agents seem to be safe and effective in treating men with lower urinary tract symptoms secondary to benign prostatic hyperplasia with prostate enlargement. Steven A. Kaplan, MD
Suggested Reading Kaplan SA, Lee RK, Chung DE et al: Prostate biopsy in response to a change in nadir prostate specific antigen of 0.4 ng/ml after treatment with 5a-reductase inhibitors markedly enhances the detection rate of prostate cancer. J Urol 2012; 188: 757.