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Re: The Association of Urinary Nerve Growth Factor Levels with Bladder Outlet Obstruction in Women
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Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology Re: The Association of Urinary Nerve Growth Factor Levels with Bladder Outlet Obstruction in Women R. Chan, A. Munoz, E. P. Wenker, J. Stewart, T. Boone and R. Khavari Department of Urology, Houston Methodist Hospital, Houston Methodist Research Institute and Baylor College of Medicine, Houston, Texas Female Pelvic Med Reconstr Surg 2015; 21: 111e115.
Permission to Publish Abstract Not Granted Editorial Comment: These authors report an elevation of nerve growth factor (NGF)/creatinine levels in female patients with anatomical bladder outlet obstruction resulting from pelvic organ prolapse and/or previous incontinence surgery when compared with age matched controls, along with a significant decrease in these levels after treatment. They propose this ratio as a biomarker for bladder outlet obstruction. Bladder outlet obstruction was defined by a post-void residual of greater than 150 ml, Valsalva voiding on urodynamics, or a urinary peak flow rate of 12 ml per second or less. In looking at the scatterplot, although there were differences in before and after measurements in 9 of the 10 patients, the differences were much more marked in some than others, without obvious explanation. Nerve growth factor is an intriguing compound, and it may be that what this intriguing set of observations indicates is the involvement of nerve growth factor in some of the pathophysiological changes that occur in bladder smooth muscle as a consequence of observation. To be a biomarker, there has to be excellent sensitivity and specificity, and I am not sure that in the presence of a clinical situation which cries obstruction, in either women or men, treatment would be withheld on the basis of the NGF/creatinine ratio or, vice versa, outlet reduction or repair would be performed in an equivocal situation on the basis of an elevated ratio. The treatments employed in this series were either surgical correction of the obstruction or initiation of clean intermittent catheterization. It would be interesting to see whether the changes were more marked in 1 group than the other. The contribution is valuable because it certainly does point to the involvement of NGF in some as yet unknown way in the pathophysiological alterations that occur in response to obstruction. In men it has been reported at least once that NGF levels are increased in patients with bladder outlet obstruction and symptoms of overactive bladder.1,2 It is unknown how many, if any, of the women reported in this series had symptoms of overactive bladder. Alan J. Wein, MD, PhD (hon) 1. Liu HT and Kuo HC: Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol 2008; 179: 2270. 2. Liu HT and Kuo HC: Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology 2008; 72: 104.
0022-5347/15/1944-0001/0 THE JOURNAL OF UROLOGY® Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.07.069 Vol. 194, 1-5, October 2015 Printed in U.S.A.
www.jurology.com Dochead: Urological Survey
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Re: Autonomic Dysreflexia during Bowel Evacuation Procedures and Bladder Filling in Subjects with Spinal Cord Injury P. M. Faaborg, P. Christensen, A. Krassioukov, S. Laurberg, E. Frandsen and K. Krogh Pelvic Floor Unit, Department of Surgery P and Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, and Department of Clinical Physiology and Nuclear Medicine, Glostrup University Hospital, Copenhagen, Denmark, and Division of Physical Medicine and Rehabilitation, International Collaboration on Repair Discoveries, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada Spinal Cord 2014; 52: 494e498.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.070 available at http://jurology.com/ Editorial Comment: These authors sought to quantitate the amount of autonomic change in patients with a history of autonomic dysreflexia in response to digital rectal examination, transanal irrigation and filling cystometry. All patients had injuries at or above T6. During all 3 procedures autonomic dysreflexia occurred in all 8 patients. It did not occur in 3 patients used as controls with a history of spinal cord injury between T10 and L2. Median systolic blood pressure increased from 127 to 188 mm Hg on average with digital evaluation, 126 to 163 mm Hg with transanal irrigation and 125 to 200 mm Hg with filling cystometry. The blood levels of norepinephrine, but not epinephrine, increased significantly during all 3 stimuli. The episodes of autonomic dysreflexia disappeared with sensation of the stimuli. The article cites data that 43% of patients with lesions at or above T6 have autonomic dysreflexia. All who care for these patients need to keep in mind the large shifts in homeostasis that can occur with relatively minor stimuli, closely watch these patients during these manipulations and, to the extent possible, institute prophylactic measures to minimize stimulation. Alan J. Wein, MD, PhD (hon)
Re: A Cohort Study Comparing a Single-Incision Sling with a Retropubic Midurethral Sling A. M. Madsen, S. A. El-Nashar, J. L. Woelk, C. J. Klingele, J. B. Gebhart and E. C. Trabuco Division of Gynecologic Surgery, Mayo Clinic, Rochester, Minnesota Int Urogynecol J 2014; 25: 351e358.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.071 available at http://jurology.com/ Editorial Comment: This cohort study compared 2 commercially available slings, 1 single incision and 1 retropubic. Followup was relatively short (18.6 months for single incision, 22.9 months for retropubic). These data from the Mayo Clinic require a bit of dissection to get at what I think should be the main point, and that is which procedure is more efficacious and less morbid for patients with stress urinary incontinence. The series included patients with mixed incontinence, and so numbers for what was termed treatment failure are quite high as they presumably include stress and urge incontinence (76.3% of single incision group vs 64.2% of retropubic group). However, the percent that had postoperative stress specific incontinence was rather high as well: 47.3% of the single incision group vs 29.4% of the retropubic group. After adjusting for body mass index (BMI) and length of followup women who underwent the single incision procedure had a higher stress specific treatment failure with an adjusted odds ratio of 2.4. Interestingly for the criteria of global impression of improvement 69.7% in the retropubic group reported that they were “very much better” or “much better” vs 64.2% in the single incision group. After adjusting for BMI and length of followup the adjusted odds ratio was 2.59. For patient reported severity of symptoms 29% in the single incision group reported moderate or severe symptoms, compared to 23.9% in the retropubic group. After adjusting for BMI and duration of followup the odds ratio was 1.46.
Dochead: Urological Survey
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Of the patients 49.5% in the retropubic group and 40.9% in the single incision group reported complete satisfaction. After adjusting for BMI and duration of followup the adjusted odds ratio was 2.12. The stress specific urinary incontinence rate was recorded as 47.3% in the single incision group and 29.4% in the retropubic group. Oddly 69.7% of the single incision group reported that they were “much better” on the patient reported global impression of improvement questionnaire vs 60.2% of the retropubic group, whereas 29% of the single incision group reported “moderate” or “severe” symptoms on the global impression of severity questionnaire vs 23.9% of the retropubic group. Although the data are not entirely consistent, the groups are not homogeneous and the procedures are not randomized, the authors report that compared to the ALIGNÒ Urethral Support System (retropubic mid urethral sling), the MiniArcÔ Single-Incision Sling (mini sling) placed in an “H” position is less effective. Patients who underwent single incision mini sling were more likely to report postoperative overall and stress specific urinary incontinence, had higher reoperation rates for stress urinary incontinence, had more severe symptoms, and were less likely to be satisfied and report improvement. Alan J. Wein, MD, PhD (hon)
Re: Antimuscarinic Persistence Patterns in Newly Treated Patients with Overactive Bladder: A Retrospective Comparative Analysis n, A. Sicras-Mainar, J. Rejas, R. Navarro-Artieda, A. Aguado-Jodar, A. Ruiz-Torrejo n ~ ez-Nolla and M. Kvasz J. Iba Directorate of Planning, Badalona Serveis Assistencials SA, Badalona, Barcelona, Spain Int Urogynecol J 2014; 25: 485e492.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.072 available at http://jurology.com/ Editorial Comment: Many do not put much stock in persistence studies sponsored by a single pharmaceutical company. This study looked at such rates for 3 agents and, in Spain at least, persistence rates were higher at 1 year than those generally reported. That is between 30.9% and 35.8% of patients, depending on the drug utilized, remained on their initial therapy. The unadjusted mean treatment duration ranged from 29.0 to 31.5 weeks. The reasons for discontinuation were not reported. Alan J. Wein, MD, PhD (hon)
Re: Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation with InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects with Mild Symptoms of Overactive Bladder S. Siegel, K. Noblett, J. Mangel, T. L. Griebling, S. E. Sutherland, E. T. Bird, C. Comiter, D. Culkin, J. Bennett, S. Zylstra, K. C. Berg, F. Kan and C. P. Irwin Metro Urology, Woodbury, Minnesota Neurourol Urodyn 2015; 34: 224e230.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.073 available at http://jurology.com/ Editorial Comment: This report details the results of a prospective, randomized, but not blinded, multicenter trial comparing the 6-month “success” rate of sacral neuromodulation vs standard medical therapy in a group where at least 1 medication had been tried but others were still available. Results were evaluated at 6 months. Urinary incontinence was not required to enter the trial. Inclusion criteria were 8 voids or more per day on a 3-day voiding diary or having a minimum of 2 involuntary leaking episodes during that period. Baseline leaks per day were 2.6 and voids per day 11.6, considerably less than some prior reported trials of sacral neuromodulation.1,2 Patients with Dochead: Urological Survey
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neurological disease, obstruction and stress urinary incontinence predominant mixed incontinence were excluded. The data are a bit confusing to interpret, as of 70 patients allocated to the neuromodulation group only 51% received a permanent stimulator, although the 9 patients who were originally allocated to that group but who received medical therapy were analyzed in the group to which they were originally assigned (the neuromodulation group). Of 77 patients originally allocated to medical therapy 2 received a stimulator but all 77 were counted in the medical therapy group. “Success” constituted either greater than 50% improvement in leaks per day or voids per day from baseline, or return to normal voiding frequency (less than 8 per day). Intention to treat analysis showed a 61% success rate for neuromodulation and 42% for standard medical therapy, the latter higher than expected. Success rate was 76% in the patients actually treated (those who received a permanent stimulator) and 49% in those who received medical therapy. For those with urinary incontinence at baseline 71% and 47% demonstrated greater than 50% improvement, and for urinary frequency 61% and 37%, respectively, had more than 50% improvement. Complete continence was demonstrated in 39% of the neuromodulation group and 21% of the medication group. Device related adverse events occurred in 30.5% of patients who received either only a lead implant or a permanent stimulator (18 of 59). The reoperation rate for neuromodulation patients was 3.9% at the 6-month study termination. Interestingly the differences in quality of life improvements between the 2 therapies seem greatly out of proportion to the actual differences in success rates, in favor of neuromodulation. It would have been interesting to continue the observation period for a year or more. The standard initial therapy for previously untreated patients with the symptoms of overactive bladder, at least for most practitioners, remains behavioral modification and medication. The medication now includes not just antimuscarinics, but also a beta-3 agonist. Beyond that each therapy (posterior tibial stimulation, sacral neuromodulation, intravesical botulinum toxin) has its advocates. The results of the ongoing study of botulinum toxin vs neuromodulation will be interesting. Alan J. Wein, MD, PhD (hon) 1. Hassouna MM, Siegel SW, N€yeholt AA et al: Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol 2000; 163: 1849. 2. Schmidt RA, Jonas U, Oleson KA et al: Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol 1999; 162: 352.
Re: Contemporary Comparison between Retropubic Midurethral Sling and Autologous Pubovaginal Sling for Stress Urinary Incontinence after the FDA Advisory Notification S. Mock, J. Angelle, W. S. Reynolds, D. J. Osborn, R. R. Dmochowski and A. Gomelsky Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville and Division of Urology, University of Tennessee-Knoxville, Knoxville, Tennessee, and Department of Urology, Louisiana State University Health-Shreveport, Shreveport, Louisiana Urology 2015; 85: 321e325.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.074 available at http://jurology.com/ Editorial Comment: This is a very unique series which compares the efficacy and morbidity of the traditional pubovaginal sling (PVS) in a surgically naive group who, in many practices, would be typically considered good candidates for a mid urethral sling (MUS) and who, before the Food and Drug Administration notification regarding mesh, would have likely received one without being offered another. The surgery was done by a high volume fellowship trained surgeon at a tertiary care referral center. A total of 201 women were given an option between the 2 procedures, of whom 45% chose PVS and 55% chose MUS. Median followup was 13.8 months. The results were remarkably similar but, in addition to the comparison, the article gives us a realistic view of what to expect with each procedure when done for demonstrable stress incontinence in women without prior anti-incontinence surgery or Dochead: Urological Survey
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prior pelvic surgery other than hysterectomy, without pelvic organ prolapse greater than stage 2, without neurogenic disease and without urgency predominant mixed incontinence. The stress urinary incontinence cure rate was 75.8% in the PVS group and 80.9% in the MUS group (not statistically significant). De novo urinary urgency incontinence appeared in 16.7% of the PVS group and 33.3% of the MUS group (not statistically significant). Urgency urinary incontinence persisted in 58.2% of PVS and 57.9% of MUS cases, and resolved in 41.8% and 42.1%, respectively. Postoperative complications were minimal in both groups. Of the PVS patients 4.4% experienced voiding difficulty vs 2.7% of MUS patients (not significant). There was 1 mesh exposure in the MUS group and none in the PVS group. It will be very interesting to follow these 2 groups up to 2 and 5 years for a mid and long-term comparison of the results. Operative time was not recorded, but the length of hospitalization was no different (1.17 vs 1.16 days). Likewise, cost was not reported. Both of these latter factors would be quite interesting in this economically charged climate. Another pertinent question would be, if the 2 procedures were discussed and the results in this series given as valid examples of each, and the mesh controversy discussed, what would prompt an individual to choose the procedure utilizing a synthetic material? Alan J. Wein, MD, PhD (hon)
Re: Transobturator Sling Compared with Single-Incision Mini-Sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial ~o L. M. Djehdian, M. P. Araujo, C. C. Takano, C. A. Del-Roy, M. G. Sartori, M. J. Gira and R. A. Castro Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of Sa˜o Paulo, Sa˜o Paulo, Brazil Obstet Gynecol 2014; 123: 553e561.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.075 available at http://jurology.com/
Re: A Randomized Comparison of a Single-Incision Midurethral Sling and a Transobturator Midurethral Sling in Women with Stress Urinary Incontinence: Results of 12-Mo Follow-up R. P. Schellart, K. Oude Rengerink, F. Van der Aa, J. P. Lucot, B. Kimpe, D. J. de Ridder, M. G. Dijkgraaf and J. P. Roovers Department of Obstetrics and Gynecology, Kennemer Gasthuis, Haarlem, and Department of Obstetrics and Gynecology, and Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands, Departments of Urology, University Hospital Leuven, Leuven and General Hospital Sint Lucas, Bruges, Belgium, and Department of Obstetrics and Gynecology, Jeanne de Flandre Hoˆpital, Lille Cedex, France Eur Urol 2014; 66: 1179e1185.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.075 available at http://jurology.com/ Editorial Comment: I cite these 2 articles only to share the difficulty in drawing conclusions about a procedure or the relative worth of 1 procedure compared to another based on only a single or perhaps even a few articles. Both of these studies were randomized. They did use a different mini sling kit but I doubt that the differences reported were due solely to the use of different kits, ie the Ophira Mini Sling System (Promedon, Buenos Aires, Argentina) in the case of Djehdian et al and MiniArcÔ in the case of Schellart et al. The results following transobturator surgery were different as well. Both groups reported results at 12-month followup. The Djehdian group reported objective cure rates for the transobturator and mini sling at 81.9% and 68.1%, respectively, and subjective cure rates of 88.5% and 81.1%. The Schellart group reported objective cure rates of 91% and 89%, and subjective cure rates and 86% and 83%. Go figure. Alan J. Wein, MD, PhD (hon)
Dochead: Urological Survey
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Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology Re: The Association of Urinary Nerve Growth Factor Levels with Bladder Outlet Obstruction in Women R. Chan, A. Munoz, E. P. Wenker, J. Stewart, T. Boone and R. Khavari Department of Urology, Houston Methodist Hospital, Houston Methodist Research Institute and Baylor College of Medicine, Houston, Texas Female Pelvic Med Reconstr Surg 2015; 21: 111e115.
Permission to Publish Abstract Not Granted Editorial Comment: These authors report an elevation of nerve growth factor (NGF)/creatinine levels in female patients with anatomical bladder outlet obstruction resulting from pelvic organ prolapse and/or previous incontinence surgery when compared with age matched controls, along with a significant decrease in these levels after treatment. They propose this ratio as a biomarker for bladder outlet obstruction. Bladder outlet obstruction was defined by a post-void residual of greater than 150 ml, Valsalva voiding on urodynamics, or a urinary peak flow rate of 12 ml per second or less. In looking at the scatterplot, although there were differences in before and after measurements in 9 of the 10 patients, the differences were much more marked in some than others, without obvious explanation. Nerve growth factor is an intriguing compound, and it may be that what this intriguing set of observations indicates is the involvement of nerve growth factor in some of the pathophysiological changes that occur in bladder smooth muscle as a consequence of observation. To be a biomarker, there has to be excellent sensitivity and specificity, and I am not sure that in the presence of a clinical situation which cries obstruction, in either women or men, treatment would be withheld on the basis of the NGF/creatinine ratio or, vice versa, outlet reduction or repair would be performed in an equivocal situation on the basis of an elevated ratio. The treatments employed in this series were either surgical correction of the obstruction or initiation of clean intermittent catheterization. It would be interesting to see whether the changes were more marked in 1 group than the other. The contribution is valuable because it certainly does point to the involvement of NGF in some as yet unknown way in the pathophysiological alterations that occur in response to obstruction. In men it has been reported at least once that NGF levels are increased in patients with bladder outlet obstruction and symptoms of overactive bladder.1,2 It is unknown how many, if any, of the women reported in this series had symptoms of overactive bladder. Alan J. Wein, MD, PhD (hon) 1. Liu HT and Kuo HC: Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol 2008; 179: 2270. 2. Liu HT and Kuo HC: Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology 2008; 72: 104.
0022-5347/15/1944-0001/0 THE JOURNAL OF UROLOGY® Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.07.069 Vol. 194, 1-5, October 2015 Printed in U.S.A.
www.jurology.com Dochead: Urological Survey
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VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
Re: Autonomic Dysreflexia during Bowel Evacuation Procedures and Bladder Filling in Subjects with Spinal Cord Injury P. M. Faaborg, P. Christensen, A. Krassioukov, S. Laurberg, E. Frandsen and K. Krogh Pelvic Floor Unit, Department of Surgery P and Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, and Department of Clinical Physiology and Nuclear Medicine, Glostrup University Hospital, Copenhagen, Denmark, and Division of Physical Medicine and Rehabilitation, International Collaboration on Repair Discoveries, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada Spinal Cord 2014; 52: 494e498.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.070 available at http://jurology.com/ Editorial Comment: These authors sought to quantitate the amount of autonomic change in patients with a history of autonomic dysreflexia in response to digital rectal examination, transanal irrigation and filling cystometry. All patients had injuries at or above T6. During all 3 procedures autonomic dysreflexia occurred in all 8 patients. It did not occur in 3 patients used as controls with a history of spinal cord injury between T10 and L2. Median systolic blood pressure increased from 127 to 188 mm Hg on average with digital evaluation, 126 to 163 mm Hg with transanal irrigation and 125 to 200 mm Hg with filling cystometry. The blood levels of norepinephrine, but not epinephrine, increased significantly during all 3 stimuli. The episodes of autonomic dysreflexia disappeared with sensation of the stimuli. The article cites data that 43% of patients with lesions at or above T6 have autonomic dysreflexia. All who care for these patients need to keep in mind the large shifts in homeostasis that can occur with relatively minor stimuli, closely watch these patients during these manipulations and, to the extent possible, institute prophylactic measures to minimize stimulation. Alan J. Wein, MD, PhD (hon)
Re: A Cohort Study Comparing a Single-Incision Sling with a Retropubic Midurethral Sling A. M. Madsen, S. A. El-Nashar, J. L. Woelk, C. J. Klingele, J. B. Gebhart and E. C. Trabuco Division of Gynecologic Surgery, Mayo Clinic, Rochester, Minnesota Int Urogynecol J 2014; 25: 351e358.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.071 available at http://jurology.com/ Editorial Comment: This cohort study compared 2 commercially available slings, 1 single incision and 1 retropubic. Followup was relatively short (18.6 months for single incision, 22.9 months for retropubic). These data from the Mayo Clinic require a bit of dissection to get at what I think should be the main point, and that is which procedure is more efficacious and less morbid for patients with stress urinary incontinence. The series included patients with mixed incontinence, and so numbers for what was termed treatment failure are quite high as they presumably include stress and urge incontinence (76.3% of single incision group vs 64.2% of retropubic group). However, the percent that had postoperative stress specific incontinence was rather high as well: 47.3% of the single incision group vs 29.4% of the retropubic group. After adjusting for body mass index (BMI) and length of followup women who underwent the single incision procedure had a higher stress specific treatment failure with an adjusted odds ratio of 2.4. Interestingly for the criteria of global impression of improvement 69.7% in the retropubic group reported that they were “very much better” or “much better” vs 64.2% in the single incision group. After adjusting for BMI and length of followup the adjusted odds ratio was 2.59. For patient reported severity of symptoms 29% in the single incision group reported moderate or severe symptoms, compared to 23.9% in the retropubic group. After adjusting for BMI and duration of followup the odds ratio was 1.46.
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Of the patients 49.5% in the retropubic group and 40.9% in the single incision group reported complete satisfaction. After adjusting for BMI and duration of followup the adjusted odds ratio was 2.12. The stress specific urinary incontinence rate was recorded as 47.3% in the single incision group and 29.4% in the retropubic group. Oddly 69.7% of the single incision group reported that they were “much better” on the patient reported global impression of improvement questionnaire vs 60.2% of the retropubic group, whereas 29% of the single incision group reported “moderate” or “severe” symptoms on the global impression of severity questionnaire vs 23.9% of the retropubic group. Although the data are not entirely consistent, the groups are not homogeneous and the procedures are not randomized, the authors report that compared to the ALIGNÒ Urethral Support System (retropubic mid urethral sling), the MiniArcÔ Single-Incision Sling (mini sling) placed in an “H” position is less effective. Patients who underwent single incision mini sling were more likely to report postoperative overall and stress specific urinary incontinence, had higher reoperation rates for stress urinary incontinence, had more severe symptoms, and were less likely to be satisfied and report improvement. Alan J. Wein, MD, PhD (hon)
Re: Antimuscarinic Persistence Patterns in Newly Treated Patients with Overactive Bladder: A Retrospective Comparative Analysis n, A. Sicras-Mainar, J. Rejas, R. Navarro-Artieda, A. Aguado-Jodar, A. Ruiz-Torrejo n ~ ez-Nolla and M. Kvasz J. Iba Directorate of Planning, Badalona Serveis Assistencials SA, Badalona, Barcelona, Spain Int Urogynecol J 2014; 25: 485e492.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.072 available at http://jurology.com/ Editorial Comment: Many do not put much stock in persistence studies sponsored by a single pharmaceutical company. This study looked at such rates for 3 agents and, in Spain at least, persistence rates were higher at 1 year than those generally reported. That is between 30.9% and 35.8% of patients, depending on the drug utilized, remained on their initial therapy. The unadjusted mean treatment duration ranged from 29.0 to 31.5 weeks. The reasons for discontinuation were not reported. Alan J. Wein, MD, PhD (hon)
Re: Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation with InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects with Mild Symptoms of Overactive Bladder S. Siegel, K. Noblett, J. Mangel, T. L. Griebling, S. E. Sutherland, E. T. Bird, C. Comiter, D. Culkin, J. Bennett, S. Zylstra, K. C. Berg, F. Kan and C. P. Irwin Metro Urology, Woodbury, Minnesota Neurourol Urodyn 2015; 34: 224e230.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.073 available at http://jurology.com/ Editorial Comment: This report details the results of a prospective, randomized, but not blinded, multicenter trial comparing the 6-month “success” rate of sacral neuromodulation vs standard medical therapy in a group where at least 1 medication had been tried but others were still available. Results were evaluated at 6 months. Urinary incontinence was not required to enter the trial. Inclusion criteria were 8 voids or more per day on a 3-day voiding diary or having a minimum of 2 involuntary leaking episodes during that period. Baseline leaks per day were 2.6 and voids per day 11.6, considerably less than some prior reported trials of sacral neuromodulation.1,2 Patients with Dochead: Urological Survey
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neurological disease, obstruction and stress urinary incontinence predominant mixed incontinence were excluded. The data are a bit confusing to interpret, as of 70 patients allocated to the neuromodulation group only 51% received a permanent stimulator, although the 9 patients who were originally allocated to that group but who received medical therapy were analyzed in the group to which they were originally assigned (the neuromodulation group). Of 77 patients originally allocated to medical therapy 2 received a stimulator but all 77 were counted in the medical therapy group. “Success” constituted either greater than 50% improvement in leaks per day or voids per day from baseline, or return to normal voiding frequency (less than 8 per day). Intention to treat analysis showed a 61% success rate for neuromodulation and 42% for standard medical therapy, the latter higher than expected. Success rate was 76% in the patients actually treated (those who received a permanent stimulator) and 49% in those who received medical therapy. For those with urinary incontinence at baseline 71% and 47% demonstrated greater than 50% improvement, and for urinary frequency 61% and 37%, respectively, had more than 50% improvement. Complete continence was demonstrated in 39% of the neuromodulation group and 21% of the medication group. Device related adverse events occurred in 30.5% of patients who received either only a lead implant or a permanent stimulator (18 of 59). The reoperation rate for neuromodulation patients was 3.9% at the 6-month study termination. Interestingly the differences in quality of life improvements between the 2 therapies seem greatly out of proportion to the actual differences in success rates, in favor of neuromodulation. It would have been interesting to continue the observation period for a year or more. The standard initial therapy for previously untreated patients with the symptoms of overactive bladder, at least for most practitioners, remains behavioral modification and medication. The medication now includes not just antimuscarinics, but also a beta-3 agonist. Beyond that each therapy (posterior tibial stimulation, sacral neuromodulation, intravesical botulinum toxin) has its advocates. The results of the ongoing study of botulinum toxin vs neuromodulation will be interesting. Alan J. Wein, MD, PhD (hon) 1. Hassouna MM, Siegel SW, N€yeholt AA et al: Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol 2000; 163: 1849. 2. Schmidt RA, Jonas U, Oleson KA et al: Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol 1999; 162: 352.
Re: Contemporary Comparison between Retropubic Midurethral Sling and Autologous Pubovaginal Sling for Stress Urinary Incontinence after the FDA Advisory Notification S. Mock, J. Angelle, W. S. Reynolds, D. J. Osborn, R. R. Dmochowski and A. Gomelsky Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville and Division of Urology, University of Tennessee-Knoxville, Knoxville, Tennessee, and Department of Urology, Louisiana State University Health-Shreveport, Shreveport, Louisiana Urology 2015; 85: 321e325.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.074 available at http://jurology.com/ Editorial Comment: This is a very unique series which compares the efficacy and morbidity of the traditional pubovaginal sling (PVS) in a surgically naive group who, in many practices, would be typically considered good candidates for a mid urethral sling (MUS) and who, before the Food and Drug Administration notification regarding mesh, would have likely received one without being offered another. The surgery was done by a high volume fellowship trained surgeon at a tertiary care referral center. A total of 201 women were given an option between the 2 procedures, of whom 45% chose PVS and 55% chose MUS. Median followup was 13.8 months. The results were remarkably similar but, in addition to the comparison, the article gives us a realistic view of what to expect with each procedure when done for demonstrable stress incontinence in women without prior anti-incontinence surgery or Dochead: Urological Survey
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prior pelvic surgery other than hysterectomy, without pelvic organ prolapse greater than stage 2, without neurogenic disease and without urgency predominant mixed incontinence. The stress urinary incontinence cure rate was 75.8% in the PVS group and 80.9% in the MUS group (not statistically significant). De novo urinary urgency incontinence appeared in 16.7% of the PVS group and 33.3% of the MUS group (not statistically significant). Urgency urinary incontinence persisted in 58.2% of PVS and 57.9% of MUS cases, and resolved in 41.8% and 42.1%, respectively. Postoperative complications were minimal in both groups. Of the PVS patients 4.4% experienced voiding difficulty vs 2.7% of MUS patients (not significant). There was 1 mesh exposure in the MUS group and none in the PVS group. It will be very interesting to follow these 2 groups up to 2 and 5 years for a mid and long-term comparison of the results. Operative time was not recorded, but the length of hospitalization was no different (1.17 vs 1.16 days). Likewise, cost was not reported. Both of these latter factors would be quite interesting in this economically charged climate. Another pertinent question would be, if the 2 procedures were discussed and the results in this series given as valid examples of each, and the mesh controversy discussed, what would prompt an individual to choose the procedure utilizing a synthetic material? Alan J. Wein, MD, PhD (hon)
Re: Transobturator Sling Compared with Single-Incision Mini-Sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial ~o L. M. Djehdian, M. P. Araujo, C. C. Takano, C. A. Del-Roy, M. G. Sartori, M. J. Gira and R. A. Castro Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of Sa˜o Paulo, Sa˜o Paulo, Brazil Obstet Gynecol 2014; 123: 553e561.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.075 available at http://jurology.com/
Re: A Randomized Comparison of a Single-Incision Midurethral Sling and a Transobturator Midurethral Sling in Women with Stress Urinary Incontinence: Results of 12-Mo Follow-up R. P. Schellart, K. Oude Rengerink, F. Van der Aa, J. P. Lucot, B. Kimpe, D. J. de Ridder, M. G. Dijkgraaf and J. P. Roovers Department of Obstetrics and Gynecology, Kennemer Gasthuis, Haarlem, and Department of Obstetrics and Gynecology, and Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands, Departments of Urology, University Hospital Leuven, Leuven and General Hospital Sint Lucas, Bruges, Belgium, and Department of Obstetrics and Gynecology, Jeanne de Flandre Hoˆpital, Lille Cedex, France Eur Urol 2014; 66: 1179e1185.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.07.075 available at http://jurology.com/ Editorial Comment: I cite these 2 articles only to share the difficulty in drawing conclusions about a procedure or the relative worth of 1 procedure compared to another based on only a single or perhaps even a few articles. Both of these studies were randomized. They did use a different mini sling kit but I doubt that the differences reported were due solely to the use of different kits, ie the Ophira Mini Sling System (Promedon, Buenos Aires, Argentina) in the case of Djehdian et al and MiniArcÔ in the case of Schellart et al. The results following transobturator surgery were different as well. Both groups reported results at 12-month followup. The Djehdian group reported objective cure rates for the transobturator and mini sling at 81.9% and 68.1%, respectively, and subjective cure rates of 88.5% and 81.1%. The Schellart group reported objective cure rates of 91% and 89%, and subjective cure rates and 86% and 83%. Go figure. Alan J. Wein, MD, PhD (hon)
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