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Re: Mid-Urethral Sling Operations for Stress Urinary Incontinence in Women
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
regarding statistical analyses and the exact categorization of the patient populations utilized, the gravity of their incompetence and any prior attempts at therapy. They surveyed the published literature from 1990 to 2013 and ultimately included a total of 30 articles for final analysis, which included 525 men and 324 women with a median age of 21 years (range 3 to 80). Artificial urinary sphincter (AUS) was reported in 322 men and 77 women, urethral sling procedure in 108 men and 178 women, and urethral bulking agents in 82 men and 44 women. To complicate the assessment even more, a total of 280 patients (35%) underwent bladder augmentation either before or simultaneously with the continence surgery, while 46 patients (6%) underwent bladder augmentation surgery during followup. A summary of the surgical outcomes recorded is as follows. For AUS mean SD followup was 72 18 months and success (criteria not defined) was 77% 16%, with failure (criteria not specified) of 10% 11%. Mean SD complication rate was 32% 27%, and reoperation rate was 51% 25%. Number of the series included was 8. For slings 15 series were included, and mean SD followup was 37 30 months. Corresponding outcomes were 58% 25%, 22% 20%, 14% 14% and 7% 9%. For bulking agents, including 6 series, mean SD followup was 30 13 months, and corresponding outcomes were 27% 20% and 50% 16%. Mean SD complication rate was 4% 6% and reoperation rate was 12% 14%. The authors cite the European Association of Urology guidelines as classifying placement of urethral slings and artificial sphincter in such patients with a grade B recommendation, while the International Continence Society classifies sphincter with a grade A recommendation. They further comment, “It is apparent that the current urological practice using AUS in the treatment of NSUI continues to lack proper clinical evidence; however, it is still considered the gold standard. This implies that those dealing with patients with NSUI consider the AUS or urethral sling as the best option, although the proof is weak . The use of synthetic slings, which is considered the gold standard for non-neurogenic [stress urinary incontinence], is regarded as of limited value because of the risk of exposure that could occur due to the lack of sensation or an obligation to perform clean intermittent catheterization. Unfortunately, very few studies exist that substantiate this presumption.” Alan J. Wein, MD, PhD (hon)
Re: Mid-Urethral Sling Operations for Stress Urinary Incontinence in Women A. A. Ford, L. Rogerson, J. D. Cody and J. Ogah Obstetrics and Gynaecology, Bradford Royal Infirmary, Bradford, West Yorkshire, United Kingdom Cochrane Database Syst Rev 2015; 7: CD006375. doi: 10.1002/14651858.CD006375.pub3
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26130017 Editorial Comment: This is one of the best Cochrane Reviews relevant to the lower urinary tract. The authors included 81 trials encompassing 12,113 women. Comparing transobturator (TOR) to retropubic (RPR) routes, there was moderate quality evidence that up to 1 year the rate of subjective cure was similar, ranging from 62% to 98% in the TOR group and 71% to 97% in the RPR group. Short-term subjective cure was similar in the 2 groups. There were unfortunately few trials reporting 1 to 5-year followup and longer term followup, with subjective cure being similar between the 2 groups, at 43% to 92% in the TOR group and 51% to 88% in the RPR group. Those undergoing RPR mid urethral sling procedures had greater morbidity, although the overall rates of adverse events remained low. The rate of bladder perforation was lower after TOR (0.6% vs 4.5%), and major vascular or visceral injury, mean operating time, operative blood loss and length of hospital stay was lower with TOR. Postoperative voiding dysfunction was less frequent following TOR but groin pain was increased (6.4% vs 1.3%). Suprapubic pain was lower in the TOR group (0.8% vs 2.9%). The overall rate of vaginal tape erosion or exposure or extrusion was low in both groups, at 24 per 1,000 instances with TOR and 21 per 1,000 for RPR. Repeat incontinence surgery in the long term was more likely in the TOR group than the RPR group. A retropubic bottom to top route was more effective than top to bottom for subjective cure, with less voiding dysfunction and fewer bladder perforations and vaginal tape erosions. Short and intermediate subjective cure rates between TOR
847
848
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
tapes, path medial to lateral as opposed to lateral to medial, were similar. There was moderate quality evidence that voiding dysfunction was more frequent in the medial to lateral group but vaginal perforation was less in the medial to lateral group. In my opinion for sheer weight of evidence and careful compilation this will be the “standard” referred to for quite some time. The compiled numbers yield great fodder for PowerPoint presentations. Alan J. Wein, MD, PhD (hon)
Socioeconomic Factors, Urological Epidemiology and Practice Patterns Re: Real-World Patterns of Care for the Overactive Bladder Syndrome in the United States H. B. Goldman, J. T. Anger, C. B. Esinduy, K. H. Zou, D. Russell, X. Luo, F. Ntanios, M. O. Carlsson and J. Q. Clemens Lerner College of Medicine, Cleveland Clinic, Cleveland, Ohio, Cedars-Sinai Medical Center, Los Angeles, California, Pfizer Inc., New York, New York, and University of Michigan, Ann Arbor, Michigan Urology 2016; 87: 64e69. doi: 10.1016/j.urology.2015.09.025
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26436212 Editorial Comment: This observational study leverages an electronic health records system that includes data on nearly 30 million individuals to look at patterns of care around overactive bladder (OAB) in a real-world setting. While the large sample size makes the data source powerful, it neither eliminates the problems of using administrative data to answer clinical questions nor makes it more real-world. The authors use a series of ICD-9 codes to identify roughly 46,000 people with symptoms of OAB. They conclude that, while there does not appear to be overuse of invasive testing in the population, there may be underuse of anticholinergic medications. This last point would certainly be true if every patient identified in the study had truly bothersome overactive bladder but it is difficult to determine if this is the case. The patients in this study were identified from those with a series of fairly ubiquitous urinary symptoms. Does every patient with urinary urgency or frequency truly have overactive bladder? Likely not. In addition, even for patients who truly have OAB in this population symptom severity may vary and many patients may not be bothered by their condition. In this setting it would be inappropriate to prescribe medications. To this end, urologists should not interpret these data as a call to use more anticholinergic medications. Rather, they should use these data to understand the limitations of administrative data sets. David F. Penson, MD, MPH
Benign Prostatic Hyperplasia Re: A Population-Based Nested Case-Control Study: The Use of 5-Alpha-Reductase Inhibitors and the Increased Risk of Osteoporosis Diagnosis in Patients with Benign Prostate Hyperplasia W. L. Lin, Y. W. Hsieh, C. L. Lin, F. C. Sung, C. H. Wu and C. H. Kao Institute of Pharmacy, China Medical University and Department of Pharmacy, China Medical University Hospital, Taichung, Taiwan Clin Endocrinol (Oxf) 2015; 82: 503e508. doi: 10.1111/cen.12599
regarding statistical analyses and the exact categorization of the patient populations utilized, the gravity of their incompetence and any prior attempts at therapy. They surveyed the published literature from 1990 to 2013 and ultimately included a total of 30 articles for final analysis, which included 525 men and 324 women with a median age of 21 years (range 3 to 80). Artificial urinary sphincter (AUS) was reported in 322 men and 77 women, urethral sling procedure in 108 men and 178 women, and urethral bulking agents in 82 men and 44 women. To complicate the assessment even more, a total of 280 patients (35%) underwent bladder augmentation either before or simultaneously with the continence surgery, while 46 patients (6%) underwent bladder augmentation surgery during followup. A summary of the surgical outcomes recorded is as follows. For AUS mean SD followup was 72 18 months and success (criteria not defined) was 77% 16%, with failure (criteria not specified) of 10% 11%. Mean SD complication rate was 32% 27%, and reoperation rate was 51% 25%. Number of the series included was 8. For slings 15 series were included, and mean SD followup was 37 30 months. Corresponding outcomes were 58% 25%, 22% 20%, 14% 14% and 7% 9%. For bulking agents, including 6 series, mean SD followup was 30 13 months, and corresponding outcomes were 27% 20% and 50% 16%. Mean SD complication rate was 4% 6% and reoperation rate was 12% 14%. The authors cite the European Association of Urology guidelines as classifying placement of urethral slings and artificial sphincter in such patients with a grade B recommendation, while the International Continence Society classifies sphincter with a grade A recommendation. They further comment, “It is apparent that the current urological practice using AUS in the treatment of NSUI continues to lack proper clinical evidence; however, it is still considered the gold standard. This implies that those dealing with patients with NSUI consider the AUS or urethral sling as the best option, although the proof is weak . The use of synthetic slings, which is considered the gold standard for non-neurogenic [stress urinary incontinence], is regarded as of limited value because of the risk of exposure that could occur due to the lack of sensation or an obligation to perform clean intermittent catheterization. Unfortunately, very few studies exist that substantiate this presumption.” Alan J. Wein, MD, PhD (hon)
Re: Mid-Urethral Sling Operations for Stress Urinary Incontinence in Women A. A. Ford, L. Rogerson, J. D. Cody and J. Ogah Obstetrics and Gynaecology, Bradford Royal Infirmary, Bradford, West Yorkshire, United Kingdom Cochrane Database Syst Rev 2015; 7: CD006375. doi: 10.1002/14651858.CD006375.pub3
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26130017 Editorial Comment: This is one of the best Cochrane Reviews relevant to the lower urinary tract. The authors included 81 trials encompassing 12,113 women. Comparing transobturator (TOR) to retropubic (RPR) routes, there was moderate quality evidence that up to 1 year the rate of subjective cure was similar, ranging from 62% to 98% in the TOR group and 71% to 97% in the RPR group. Short-term subjective cure was similar in the 2 groups. There were unfortunately few trials reporting 1 to 5-year followup and longer term followup, with subjective cure being similar between the 2 groups, at 43% to 92% in the TOR group and 51% to 88% in the RPR group. Those undergoing RPR mid urethral sling procedures had greater morbidity, although the overall rates of adverse events remained low. The rate of bladder perforation was lower after TOR (0.6% vs 4.5%), and major vascular or visceral injury, mean operating time, operative blood loss and length of hospital stay was lower with TOR. Postoperative voiding dysfunction was less frequent following TOR but groin pain was increased (6.4% vs 1.3%). Suprapubic pain was lower in the TOR group (0.8% vs 2.9%). The overall rate of vaginal tape erosion or exposure or extrusion was low in both groups, at 24 per 1,000 instances with TOR and 21 per 1,000 for RPR. Repeat incontinence surgery in the long term was more likely in the TOR group than the RPR group. A retropubic bottom to top route was more effective than top to bottom for subjective cure, with less voiding dysfunction and fewer bladder perforations and vaginal tape erosions. Short and intermediate subjective cure rates between TOR
847
848
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
tapes, path medial to lateral as opposed to lateral to medial, were similar. There was moderate quality evidence that voiding dysfunction was more frequent in the medial to lateral group but vaginal perforation was less in the medial to lateral group. In my opinion for sheer weight of evidence and careful compilation this will be the “standard” referred to for quite some time. The compiled numbers yield great fodder for PowerPoint presentations. Alan J. Wein, MD, PhD (hon)
Socioeconomic Factors, Urological Epidemiology and Practice Patterns Re: Real-World Patterns of Care for the Overactive Bladder Syndrome in the United States H. B. Goldman, J. T. Anger, C. B. Esinduy, K. H. Zou, D. Russell, X. Luo, F. Ntanios, M. O. Carlsson and J. Q. Clemens Lerner College of Medicine, Cleveland Clinic, Cleveland, Ohio, Cedars-Sinai Medical Center, Los Angeles, California, Pfizer Inc., New York, New York, and University of Michigan, Ann Arbor, Michigan Urology 2016; 87: 64e69. doi: 10.1016/j.urology.2015.09.025
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26436212 Editorial Comment: This observational study leverages an electronic health records system that includes data on nearly 30 million individuals to look at patterns of care around overactive bladder (OAB) in a real-world setting. While the large sample size makes the data source powerful, it neither eliminates the problems of using administrative data to answer clinical questions nor makes it more real-world. The authors use a series of ICD-9 codes to identify roughly 46,000 people with symptoms of OAB. They conclude that, while there does not appear to be overuse of invasive testing in the population, there may be underuse of anticholinergic medications. This last point would certainly be true if every patient identified in the study had truly bothersome overactive bladder but it is difficult to determine if this is the case. The patients in this study were identified from those with a series of fairly ubiquitous urinary symptoms. Does every patient with urinary urgency or frequency truly have overactive bladder? Likely not. In addition, even for patients who truly have OAB in this population symptom severity may vary and many patients may not be bothered by their condition. In this setting it would be inappropriate to prescribe medications. To this end, urologists should not interpret these data as a call to use more anticholinergic medications. Rather, they should use these data to understand the limitations of administrative data sets. David F. Penson, MD, MPH
Benign Prostatic Hyperplasia Re: A Population-Based Nested Case-Control Study: The Use of 5-Alpha-Reductase Inhibitors and the Increased Risk of Osteoporosis Diagnosis in Patients with Benign Prostate Hyperplasia W. L. Lin, Y. W. Hsieh, C. L. Lin, F. C. Sung, C. H. Wu and C. H. Kao Institute of Pharmacy, China Medical University and Department of Pharmacy, China Medical University Hospital, Taichung, Taiwan Clin Endocrinol (Oxf) 2015; 82: 503e508. doi: 10.1111/cen.12599