- Email: [email protected]
Re: Update on AUA Guideline on the Management of Benign Prostatic Hyperplasia
358
LETTERS TO THE EDITOR/ERRATA
Reply by Authors: We agree with Page and Page that our multicenter, randomized, controlled trial demonstrates inferiority of the TVT Secur compared to the TVT Obturator System. We disagree with the statement that our data are an underestimation of the observed effect. Less loss to followup could also have reduced the observed difference, as it is pure speculation that those who did not complete 12 months of followup had an unfavorable outcome. The same accounts for cost efficacy, which really needs to be evaluated in future studies to allow expression of any evidence-based thoughts. We question the remark that the gain in postoperative pain is low, as the difference is limited to “only” 2 weeks. We believe it was quite surprising that the difference in pain remained present during the first 6 weeks and was statistically significant during the first 2 weeks. Which difference in visual analogue scale score is clinically significant has not yet been assessed in this population, and it is valuable to study this area. There is a subcategory of patients in whom the TVT Secur is as sufficient as the TVT Obturator System, and we hypothesize that a subcategory of patients could be identified in future studies who rate less postoperative pain as more relevant than others. Hopefully our reply motivates researchers worldwide to continue their efforts to assess the optimal indication area for single incision mid urethral slings.
Re: Update on AUA Guideline on the Management of Benign Prostatic Hyperplasia K. T. McVary, C. G. Roehrborn, A. L. Avins, M. J. Barry, R. C. Bruskewitz, R. F. Donnell, H. E. Foster, Jr., C. M. Gonzalez, S. A. Kaplan, D. F. Penson, J. C. Ulchaker and J. T. Wei J Urol 2011; 185: 1793–1803.
To the Editor: The AUA guideline on benign prostatic hyperplasia (BPH) is an excellent document but does it also represent a missed opportunity? The adoption and reprinting of the lower urinary tract symptoms (LUTS) algorithms from the International Consultation on Urological Diseases in 2006 provide clarity for urologists managing male LUTS (MLUTS). This article and the full guideline document are exemplars of the guideline process. However, there are a number of clarifications that would have been helpful. Both articles start with the statement, “BPH is a histological diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the transition zone.” Furthermore, in the guideline BPH, benign gland enlargement, benign prostatic obstruction (BPO, “when obstruction has been proved by pressure flow studies, or is highly suspected from flow rates, and if the gland is enlarged”) and bladder outlet obstruction are defined. However in the title and within the article and guidelines the old nomenclature is used interchangeably. Does this matter? Certainly science and medical practice are about the correct use of words, and if BPH is a histological term, it is no more and no less than that. As the prevalence of histological BPH nears 100% in the 7th, 8th and 9th decades, to say to a man, “You have BPH” is relatively unhelpful. In terms of treating MLUTS due to the prostate urologists are interested in treating men with obstruction in whom enlargement of the prostate is shown to be the cause, and the correct term for this condition is BPO. Hence, there seems a strong argument that these guidelines should substitute BPO for BPH in almost all instances. The next issue that needs to be settled is whether these guidelines are about MLUTS overall or only those thought due to BPO. This distinction is unclear from the document, which describes the index patient as one who “does not have a history suggesting non-BPH causes of LUTS.” Within the methodology section of the guidelines this concept is explained a little further, in that men with “LUTS due to polyuria or neurological disease or preexisting [lower urinary tract] disease” are excluded. However, the algorithms reprinted in the article include in the “Basic Management of LUTS in Men” the sequential assessment of LUTS whereby significant nocturia is an indication to evaluate 24-hour polyuria and nocturnal polyuria. The distinction between these 2 entities does not appear in the guideline article. In the algorithm titled “Detailed Management for Persistent Bothersome LUTS After Basic Management” the issue of overactive bladder with or without bladder outlet obstruction is illustrated. Within the article and the guidelines it is unclear whether this entity is or is not a “non-BPH cause of LUTS.”
LETTERS TO THE EDITOR/ERRATA
359
In summary, it could be clearer whether this guideline is a LUTS and BPO guideline or just a BPO guideline. The description of the index patient could be clearer, and the modern terminology listed within the article and the full guideline could be used strictly and consistently according to the meaning. Patients will benefit if MLUTS escapes from the “prostate centric” approach by having those LUTS due to “non-BPO cause of LUTS” treated. Respectfully, Paul Abrams Bristol Urological Institute Bristol, United Kingdom
Reply by Authors: We thank Abrams for the excellent letter regarding the recent AUA BPH clinical guidelines. We also appreciate the acknowledgment about the end product of a group effort of many urologists, panel members, reviewers, consultants and AUA staff who made its publication possible. The 2011 BPH guidelines document represents a new effort by the AUA to produce quality reports. This particular effort was accomplished in record time and below budget while maintaining usefulness to clinicians. We would like to address the points raised in the letter. Use of the “B” word (BPH) continues to raise ire in select circles but it is clearly mentioned in our publication (“The 2010 BPH guideline attempts to acknowledge that LUTS represent a broad spectrum of etiologies, and focuses on the management of such symptoms”). Additionally to focus on a more defined clinical phenotype, the index patient is clearly outlined. In view of this fact the document clearly uses LUTS secondary to BPH to ensure that the reader understands the focus is on more specific LUTS and not LUTS related to other causes, such as osmotic diuresis. In fact, LUTS/BPH is used more than 150 times. The evidence suggests that this point is well made. Despite the shudders that the word “BPH” induces in these select MLUTS centric circles, this concept resonates with health care providers and patients. Are they our target? We think the answer is a resounding affirmative. Clearly this guideline is addressing LUTS secondary to prostate enlargement. However, in doing so the diagnostic algorithm (figure 1 in article) is more encompassing, as it briefly mentions other etiologies such as nocturnal polyuria. This inclusion is required, given the clinical conundrum clinicians may find themselves facing when men present with less than clear complaints. A rigid adherence to the prostate centric mantra here would serve no one well. Most efforts by medicine must now exist within new financial and time constraints. This effort is no exception. A more extensive review of all LUTS occurring in the male was simply not in our mandate. Regardless, it is our hope that this publication is a useful document for caregivers.
Re: Concordance of Near Infrared Spectroscopy With Pressure Flow Studies in Men With Lower Urinary Tract Symptoms D. E. Chung, R. K. Lee, S. A. Kaplan and A. E. Te J Urol 2010; 184: 2434 –2439.
To the Editor: Chung et al report poor correlation when using the algorithm available for near infrared spectroscopy (NIRS) voiding data combined with maximum flow and post-void residual to classify for the presence or absence of bladder outlet obstruction (BOO) after concordance analysis of data from 26 obstructed and 7 unobstructed subjects studied with simultaneous NIRS and urodynamic studies (UDS). In doing so they have articulately reviewed the relevance and science behind NIRS applications in voiding dysfunction and called for more studies to determine the clinical value of this technology. Previously this group reported this algorithm had comparable discriminant ability to the Abrams-Griffiths nomogram in 31 obstructed and 5 unobstructed subjects,1 as we reported.2 The authors also identified the predominant trend of chromophore change separately from the algorithm, and although they interpret the positive and negative trends as not tallying consis-
LETTERS TO THE EDITOR/ERRATA
Reply by Authors: We agree with Page and Page that our multicenter, randomized, controlled trial demonstrates inferiority of the TVT Secur compared to the TVT Obturator System. We disagree with the statement that our data are an underestimation of the observed effect. Less loss to followup could also have reduced the observed difference, as it is pure speculation that those who did not complete 12 months of followup had an unfavorable outcome. The same accounts for cost efficacy, which really needs to be evaluated in future studies to allow expression of any evidence-based thoughts. We question the remark that the gain in postoperative pain is low, as the difference is limited to “only” 2 weeks. We believe it was quite surprising that the difference in pain remained present during the first 6 weeks and was statistically significant during the first 2 weeks. Which difference in visual analogue scale score is clinically significant has not yet been assessed in this population, and it is valuable to study this area. There is a subcategory of patients in whom the TVT Secur is as sufficient as the TVT Obturator System, and we hypothesize that a subcategory of patients could be identified in future studies who rate less postoperative pain as more relevant than others. Hopefully our reply motivates researchers worldwide to continue their efforts to assess the optimal indication area for single incision mid urethral slings.
Re: Update on AUA Guideline on the Management of Benign Prostatic Hyperplasia K. T. McVary, C. G. Roehrborn, A. L. Avins, M. J. Barry, R. C. Bruskewitz, R. F. Donnell, H. E. Foster, Jr., C. M. Gonzalez, S. A. Kaplan, D. F. Penson, J. C. Ulchaker and J. T. Wei J Urol 2011; 185: 1793–1803.
To the Editor: The AUA guideline on benign prostatic hyperplasia (BPH) is an excellent document but does it also represent a missed opportunity? The adoption and reprinting of the lower urinary tract symptoms (LUTS) algorithms from the International Consultation on Urological Diseases in 2006 provide clarity for urologists managing male LUTS (MLUTS). This article and the full guideline document are exemplars of the guideline process. However, there are a number of clarifications that would have been helpful. Both articles start with the statement, “BPH is a histological diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the transition zone.” Furthermore, in the guideline BPH, benign gland enlargement, benign prostatic obstruction (BPO, “when obstruction has been proved by pressure flow studies, or is highly suspected from flow rates, and if the gland is enlarged”) and bladder outlet obstruction are defined. However in the title and within the article and guidelines the old nomenclature is used interchangeably. Does this matter? Certainly science and medical practice are about the correct use of words, and if BPH is a histological term, it is no more and no less than that. As the prevalence of histological BPH nears 100% in the 7th, 8th and 9th decades, to say to a man, “You have BPH” is relatively unhelpful. In terms of treating MLUTS due to the prostate urologists are interested in treating men with obstruction in whom enlargement of the prostate is shown to be the cause, and the correct term for this condition is BPO. Hence, there seems a strong argument that these guidelines should substitute BPO for BPH in almost all instances. The next issue that needs to be settled is whether these guidelines are about MLUTS overall or only those thought due to BPO. This distinction is unclear from the document, which describes the index patient as one who “does not have a history suggesting non-BPH causes of LUTS.” Within the methodology section of the guidelines this concept is explained a little further, in that men with “LUTS due to polyuria or neurological disease or preexisting [lower urinary tract] disease” are excluded. However, the algorithms reprinted in the article include in the “Basic Management of LUTS in Men” the sequential assessment of LUTS whereby significant nocturia is an indication to evaluate 24-hour polyuria and nocturnal polyuria. The distinction between these 2 entities does not appear in the guideline article. In the algorithm titled “Detailed Management for Persistent Bothersome LUTS After Basic Management” the issue of overactive bladder with or without bladder outlet obstruction is illustrated. Within the article and the guidelines it is unclear whether this entity is or is not a “non-BPH cause of LUTS.”
LETTERS TO THE EDITOR/ERRATA
359
In summary, it could be clearer whether this guideline is a LUTS and BPO guideline or just a BPO guideline. The description of the index patient could be clearer, and the modern terminology listed within the article and the full guideline could be used strictly and consistently according to the meaning. Patients will benefit if MLUTS escapes from the “prostate centric” approach by having those LUTS due to “non-BPO cause of LUTS” treated. Respectfully, Paul Abrams Bristol Urological Institute Bristol, United Kingdom
Reply by Authors: We thank Abrams for the excellent letter regarding the recent AUA BPH clinical guidelines. We also appreciate the acknowledgment about the end product of a group effort of many urologists, panel members, reviewers, consultants and AUA staff who made its publication possible. The 2011 BPH guidelines document represents a new effort by the AUA to produce quality reports. This particular effort was accomplished in record time and below budget while maintaining usefulness to clinicians. We would like to address the points raised in the letter. Use of the “B” word (BPH) continues to raise ire in select circles but it is clearly mentioned in our publication (“The 2010 BPH guideline attempts to acknowledge that LUTS represent a broad spectrum of etiologies, and focuses on the management of such symptoms”). Additionally to focus on a more defined clinical phenotype, the index patient is clearly outlined. In view of this fact the document clearly uses LUTS secondary to BPH to ensure that the reader understands the focus is on more specific LUTS and not LUTS related to other causes, such as osmotic diuresis. In fact, LUTS/BPH is used more than 150 times. The evidence suggests that this point is well made. Despite the shudders that the word “BPH” induces in these select MLUTS centric circles, this concept resonates with health care providers and patients. Are they our target? We think the answer is a resounding affirmative. Clearly this guideline is addressing LUTS secondary to prostate enlargement. However, in doing so the diagnostic algorithm (figure 1 in article) is more encompassing, as it briefly mentions other etiologies such as nocturnal polyuria. This inclusion is required, given the clinical conundrum clinicians may find themselves facing when men present with less than clear complaints. A rigid adherence to the prostate centric mantra here would serve no one well. Most efforts by medicine must now exist within new financial and time constraints. This effort is no exception. A more extensive review of all LUTS occurring in the male was simply not in our mandate. Regardless, it is our hope that this publication is a useful document for caregivers.
Re: Concordance of Near Infrared Spectroscopy With Pressure Flow Studies in Men With Lower Urinary Tract Symptoms D. E. Chung, R. K. Lee, S. A. Kaplan and A. E. Te J Urol 2010; 184: 2434 –2439.
To the Editor: Chung et al report poor correlation when using the algorithm available for near infrared spectroscopy (NIRS) voiding data combined with maximum flow and post-void residual to classify for the presence or absence of bladder outlet obstruction (BOO) after concordance analysis of data from 26 obstructed and 7 unobstructed subjects studied with simultaneous NIRS and urodynamic studies (UDS). In doing so they have articulately reviewed the relevance and science behind NIRS applications in voiding dysfunction and called for more studies to determine the clinical value of this technology. Previously this group reported this algorithm had comparable discriminant ability to the Abrams-Griffiths nomogram in 31 obstructed and 5 unobstructed subjects,1 as we reported.2 The authors also identified the predominant trend of chromophore change separately from the algorithm, and although they interpret the positive and negative trends as not tallying consis-