- Email: [email protected]
Re: Staged Reconstruction of Long Segment Urethral Strictures in Men With Previous Pediatric Hypospadias Repair
1234
LETTERS TO THE EDITOR/ERRATA
unfavorable results. They concluded that semirigid ureteroscopy is a safe and highly effective treatment modality for ureteral stones. The study by Leijte et al1 was cited 3 times in the article. At the first citation the authors stated the “data were not statistically analyzed to determine predictive factors for the overall results of holmium laser lithotripsy.” We suspect that they possibly overlooked a section describing the methods. Leijte et al actually analyzed data by using “a multivariate logistic regression model with success and complication as dependent variables and with age, sex, stone size, stone location, and surgeon experience as covariates. A P value ⬍0.05 was considered statistically significant.”1 Surgeon experience was a statistically significant predictive factor for complications and success. Not only was this finding confirmed by the authors, but also Schuster et al reported a significant correlation between decreased surgeon experience and postoperative complications.2 We are honored by the citation. However, we believe that the authors may have inappropriately cited Leijte et al.1 Furthermore, we agree that semirigid ureteroscopy is a safe and highly effective treatment modality for ureteral stones. Respectfully, Y. Zhu and T. M. Lock Department of Urology University Medical Center Utrecht, The Netherlands
Reply by Authors: The study by Leijte et al1 was cited 3 times in our article because we greatly appreciate their work. They did a multivariate statistical analysis to determine factors affecting the success rate of ureteroscopy for treatment of ureteral stones. They then did another multivariate statistical analysis to determine factors affecting the complication rate. In our study we did 1 multivariate statistical analysis to determine factors affecting the overall results (ie success and complications). That is why we mentioned in the introduction, “Other investigators determined factors affecting the complications and success of holmium laser lithotripsy for ureteral calculi but the data were not statistically analyzed to determine predictive factors for the overall results of the procedure.” 1. Leijte JA, Oddens JR and Lock TM: Holmium laser lithotripsy for ureteral calculi: predictive factors for complications and success. J Endourol 2008; 22: 257.
2. Schuster TG, Hollenbeck BK, Faerber GJ et al: Complications of ureteroscopy: analysis of predictive factors. J Urol 2001; 166: 538.
Re: Staged Reconstruction of Long Segment Urethral Strictures in Men With Previous Pediatric Hypospadias Repair J. J. Meeks, B. A. Erickson and C. M. Gonzalez J Urol 2009; 181: 685– 689.
To the Editor: The authors describe experience with a select group of cases referred to as hypospadias cripples due to extensive neourethral stricture. An important finding was additional bulbar stricture in 2 patients, which we also observed in 1 of 23 similar adults.1 These findings emphasize the need to assess the entire urethra at reoperation. Like us, the authors used 2-stage graft techniques popularized by Bracka to address these challenging cases.2 Unfortunately the lack of technical description makes it difficult to learn from their experience. Where were oral mucosal grafts taken (lip, cheek, tongue), and how were donor sites managed (sutured, fibrin glued, left open)? What suture materials and techniques (subepithelial vs through epithelium, interrupted vs continuous) were used for urethroplasty and glansplasty, and in how many layers? Were barrier layers used, and if so, which type (fibrin glue, dartos, tunica vaginalis)? The graft choices of Meeks et al also deserve comment. For example we find lip better suited for the glans, since it is thinner than cheek, and would have extended the neourethra into even a “small” glans. Dehiscence and meatal stenosis are uncommon in adults—we noted none in our earlier series2—while a subglanular meatus lacks normal appearance and function. Another question regards steroid injections for cheek scar, since the timing of this therapy postoperatively
LETTERS TO THE EDITOR/ERRATA
1235
was not stated. The authors worry about morbidity from harvesting oral mucosa, highlighting symptoms of numbness and tightness. Most of these symptoms resolve within a few weeks or months, and a recent systematic literature review demonstrated only a 4% overall complication rate, including a 3% risk of scar contracture and a 2% risk of lip paresthesia.3 Most importantly the authors seem to endorse abdominal wall skin for urethral replacement in patients with balanitis xerotica obliterans (BXO). Bracka, who has the largest experience worldwide with BXO, states preputial, groin or post-auricular skin grafts initially do well but after several years there is a high recurrence rate so far not seen with similar followup using buccal mucosa.2 For this reason he switched to oral mucosa as the preferred tissue source when BXO is suspected. Perhaps the followup of Meeks et al is insufficient to detect recurrent BXO stricturing. Finally since pediatric hypospadias and adult stricture surgeons increasingly are influenced by each other, consistent terminology is needed in scientific reporting to avoid confusion. The authors refer to their 2-stage procedure replacing the urethra as “inlay” grafting, whereas pediatric urologists use this term when grafts are placed dorsally into the defect created by midline urethral plate or skin incision to supplement the neourethra during 1-stage repair.4,5 Respectfully, Warren T. Snodgrass Department of Urology, Pediatric Urology Section University of Texas Southwestern Medical Center at Dallas 5323 Harry Hines Blvd. Dallas, Texas 75390-9142 1. Snodgrass W and Elmore J: Initial experience with staged buccal graft (Bracka) hypospadias reoperations. J Urol 2004; 172: 1720. 2. Bracka A: Hypospadias repair: the two-stage alternative. Br J Urol, suppl, 1995; 76: 31. 3. Markiewicz MR, DeSantis JL, Margarone JE et al: Morbidity associated with oral mucosa harvest for urological reconstruction: an overview. J Oral Maxillofac Surg 2008; 66: 739.
4. Kolon TF and Gonzales ET Jr: The dorsal inlay graft for hypospadias repair. J Urol 2000; 163: 1941. 5. Schwentner C, Gozzi C, Lunacek A et al: Interim outcome of the single stage dorsal inlay skin graft for complex hypospadias reoperations. J Urol 2006; 175: 1872.
Reply by Authors: In this series we harvested oral mucosa from the cheek in all but 1 early case, in which we harvested mucosa from the lip and cheek. We left all graft harvest sites in the oral cavity open to heal by secondary intention. We no longer harvest oral mucosa from the lip, nor do we close the cheek harvest site secondary to an increased risk of contracture and morbidity, which we and others have previously reported.1–3 We used steroid injection in 1 case where 33.25 cm2 oral mucosa was harvested. The patient experienced persistent pain at 9 months postoperatively, and he responded well to this treatment. Regarding the questions on technique, during second stage urethroplasty the epithelium is incised, and the neourethra is rolled and closed with a running 5-zero polyglactin suture placed transepithelial. An additional layer of subepithelial tissue is reapproximated in running fashion over the previous suture line. The dartos is subsequently closed in 2 separate layers followed by skin closure, all with running 4-zero polyglactin suture. A tunica vaginalis flap was mobilized and used to cover the suture line in 2 patients secondary to a limited amount of available dartos tissue resulting from multiple previous procedures. Glansplasty involved mobilization of glans tissue “wings” over the neourethra in a tension-free approximation with interrupted 4-zero polyglactin suture. The 2 cases that were left with a subglanular meatus represented a challenge. Many of these men were born with penoscrotal hypospadias or had not had the reconstructed neourethra brought into the glans initially as children. We found that tension-free mobilization of adequate tissue from a small glans around a 22Fr to 24Fr neourethra significantly narrowed meatal size (determined by intraoperative calibration) and created tension on the glans suture line. In one of the largest series to date on the treatment of men with pediatric hypospadias failure Barbagli et al reported on 3 patients with glans dehiscence and another 4 with meatal stenosis following urethroplasty,4 reinforcing our concern regarding glans related morbidity in this population. In addition, a recent study by Morey et al reinforced how difficult distal urethroplasty may be in men, with recurrence rates ranging from 9% to 46% for fossa navicularis repairs.5 Fortunately in our series we were unable to bring the neourethra into the glans in only 2 men. These patients reported no postoperative
1236
LETTERS TO THE EDITOR/ERRATA
voiding difficulty in the standing position and no impact on sexual function. Cosmesis was a concern for 1 of these 2 patients, emphasizing the importance of preoperative counseling in this population. Use of extragenital skin is most appropriate for men who have undergone prior urethroplasty and have stricture disease in association with lichen sclerosis (BXO). Abdominal wall skin may be considered for longer segment defects since it is plentiful, extragenital and easily harvested with little morbidity. However, at present we do not advocate the use of this tissue over oral mucosa. As stated in the article, we currently have intermediate followup and we plan to report our longer term data with abdominal wall skin once available. We agree that there is a need for common nomenclature in the adult and pediatric urological and plastic surgery literature. As Snodgrass indicates, use of multiple terms for similar concepts may be confusing to the reader and may prevent appropriate meta-analysis of studies. 1. Dublin N and Stewart LH: Oral complications after buccal mucosal graft harvest for urethroplasty. BJU Int 2004; 94: 867. 2. Jang TL, Erickson B, Medendorp A et al: Comparison of donor site intraoral morbidity after mucosal graft harvesting for urethral reconstruction. Urology 2005; 66: 716. 3. Wood DN, Allen SE, Andrich DE et al: The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain. J Urol 2004; 172: 580.
4. Barbagli G, De Angelis M, Palminteri E et al: Failed hypospadias repair presenting in adults. Eur Urol 2006; 49: 887. 5. Morey AF, Lin HC, DeRosa CA et al: Fossa navicularis reconstruction: impact of stricture length on outcomes and assessment of extended meatotomy (first stage Johanson) maneuver. J Urol 2007; 177: 184.
Re: Evidence-Based Medicine in Urology: Hope and Peril C. Niederberger J Urol 2009; 181: 1528 –1529.
To the Editor: We read with interest this editorial regarding the role of evidence-based medicine (EBM) in urology. Niederberger correctly highlights several of the limitations of this discipline. However, his focus on these negatives may have overshadowed the significant benefits EBM offers. He implies adherents of EBM will accept nothing less than a randomized controlled trial and deride other forms of investigation as worthless. This notion fundamentally mischaracterizes the nature of EBM philosophy. All studies have intrinsic limitations but the hierarchy of evidence illustrates that certain study designs are more limited than others. The hierarchy reminds us that when applying the results of any study to individuals or populations we must consider the inherent limitations of that study. To find confirmation that such reminders are necessary, one need only peruse the current urological literature, which contains countless studies whose authors draw explicit conclusions that simply cannot be supported by the data presented. EBM findings obviously may be misinterpreted or misapplied. It is indeed true, as Niederberger suggests, that insurers and other regulators may make coverage or eligibility determinations based on conclusions reached by EBM guided processes. Is this outcome really worse than the alternative? These bodies are going to make determinations regardless. Would we not prefer their decisions be based on the best available evidence? Niederberger also suggests that the methods used in certain systematic reviews may themselves be flawed. Should such flaws lead urologists simply to forgo these techniques? Of course not. If urologists believe that EBM efforts thus far have been inadequate, we should become more, not less, involved in the universe of EBM. The question is not whether systematic reviews and EBM will have a role in urology, but rather who will perform them. Furthermore, EBM will continue to have a role in clinical and policy decision making in urology. Recent interest (and National Institutes of Health funding) in comparative effectiveness research, for example, is indicative of this trend. Thus, urologists are faced with a choice—to put our heads in the sand and ignore EBM, or to embrace it and adapt it to reflect patient needs and our clinical knowledge. The reality is that demand for EBM, from policy makers, pundits and patients alike, is high. Urologists can lead the way or we can find ourselves being led. Winston Churchill famously noted that democracy is the worst form of government except for all those others that have been tried.1 Similarly in EBM we have a set of tools that, while imperfect, are
LETTERS TO THE EDITOR/ERRATA
unfavorable results. They concluded that semirigid ureteroscopy is a safe and highly effective treatment modality for ureteral stones. The study by Leijte et al1 was cited 3 times in the article. At the first citation the authors stated the “data were not statistically analyzed to determine predictive factors for the overall results of holmium laser lithotripsy.” We suspect that they possibly overlooked a section describing the methods. Leijte et al actually analyzed data by using “a multivariate logistic regression model with success and complication as dependent variables and with age, sex, stone size, stone location, and surgeon experience as covariates. A P value ⬍0.05 was considered statistically significant.”1 Surgeon experience was a statistically significant predictive factor for complications and success. Not only was this finding confirmed by the authors, but also Schuster et al reported a significant correlation between decreased surgeon experience and postoperative complications.2 We are honored by the citation. However, we believe that the authors may have inappropriately cited Leijte et al.1 Furthermore, we agree that semirigid ureteroscopy is a safe and highly effective treatment modality for ureteral stones. Respectfully, Y. Zhu and T. M. Lock Department of Urology University Medical Center Utrecht, The Netherlands
Reply by Authors: The study by Leijte et al1 was cited 3 times in our article because we greatly appreciate their work. They did a multivariate statistical analysis to determine factors affecting the success rate of ureteroscopy for treatment of ureteral stones. They then did another multivariate statistical analysis to determine factors affecting the complication rate. In our study we did 1 multivariate statistical analysis to determine factors affecting the overall results (ie success and complications). That is why we mentioned in the introduction, “Other investigators determined factors affecting the complications and success of holmium laser lithotripsy for ureteral calculi but the data were not statistically analyzed to determine predictive factors for the overall results of the procedure.” 1. Leijte JA, Oddens JR and Lock TM: Holmium laser lithotripsy for ureteral calculi: predictive factors for complications and success. J Endourol 2008; 22: 257.
2. Schuster TG, Hollenbeck BK, Faerber GJ et al: Complications of ureteroscopy: analysis of predictive factors. J Urol 2001; 166: 538.
Re: Staged Reconstruction of Long Segment Urethral Strictures in Men With Previous Pediatric Hypospadias Repair J. J. Meeks, B. A. Erickson and C. M. Gonzalez J Urol 2009; 181: 685– 689.
To the Editor: The authors describe experience with a select group of cases referred to as hypospadias cripples due to extensive neourethral stricture. An important finding was additional bulbar stricture in 2 patients, which we also observed in 1 of 23 similar adults.1 These findings emphasize the need to assess the entire urethra at reoperation. Like us, the authors used 2-stage graft techniques popularized by Bracka to address these challenging cases.2 Unfortunately the lack of technical description makes it difficult to learn from their experience. Where were oral mucosal grafts taken (lip, cheek, tongue), and how were donor sites managed (sutured, fibrin glued, left open)? What suture materials and techniques (subepithelial vs through epithelium, interrupted vs continuous) were used for urethroplasty and glansplasty, and in how many layers? Were barrier layers used, and if so, which type (fibrin glue, dartos, tunica vaginalis)? The graft choices of Meeks et al also deserve comment. For example we find lip better suited for the glans, since it is thinner than cheek, and would have extended the neourethra into even a “small” glans. Dehiscence and meatal stenosis are uncommon in adults—we noted none in our earlier series2—while a subglanular meatus lacks normal appearance and function. Another question regards steroid injections for cheek scar, since the timing of this therapy postoperatively
LETTERS TO THE EDITOR/ERRATA
1235
was not stated. The authors worry about morbidity from harvesting oral mucosa, highlighting symptoms of numbness and tightness. Most of these symptoms resolve within a few weeks or months, and a recent systematic literature review demonstrated only a 4% overall complication rate, including a 3% risk of scar contracture and a 2% risk of lip paresthesia.3 Most importantly the authors seem to endorse abdominal wall skin for urethral replacement in patients with balanitis xerotica obliterans (BXO). Bracka, who has the largest experience worldwide with BXO, states preputial, groin or post-auricular skin grafts initially do well but after several years there is a high recurrence rate so far not seen with similar followup using buccal mucosa.2 For this reason he switched to oral mucosa as the preferred tissue source when BXO is suspected. Perhaps the followup of Meeks et al is insufficient to detect recurrent BXO stricturing. Finally since pediatric hypospadias and adult stricture surgeons increasingly are influenced by each other, consistent terminology is needed in scientific reporting to avoid confusion. The authors refer to their 2-stage procedure replacing the urethra as “inlay” grafting, whereas pediatric urologists use this term when grafts are placed dorsally into the defect created by midline urethral plate or skin incision to supplement the neourethra during 1-stage repair.4,5 Respectfully, Warren T. Snodgrass Department of Urology, Pediatric Urology Section University of Texas Southwestern Medical Center at Dallas 5323 Harry Hines Blvd. Dallas, Texas 75390-9142 1. Snodgrass W and Elmore J: Initial experience with staged buccal graft (Bracka) hypospadias reoperations. J Urol 2004; 172: 1720. 2. Bracka A: Hypospadias repair: the two-stage alternative. Br J Urol, suppl, 1995; 76: 31. 3. Markiewicz MR, DeSantis JL, Margarone JE et al: Morbidity associated with oral mucosa harvest for urological reconstruction: an overview. J Oral Maxillofac Surg 2008; 66: 739.
4. Kolon TF and Gonzales ET Jr: The dorsal inlay graft for hypospadias repair. J Urol 2000; 163: 1941. 5. Schwentner C, Gozzi C, Lunacek A et al: Interim outcome of the single stage dorsal inlay skin graft for complex hypospadias reoperations. J Urol 2006; 175: 1872.
Reply by Authors: In this series we harvested oral mucosa from the cheek in all but 1 early case, in which we harvested mucosa from the lip and cheek. We left all graft harvest sites in the oral cavity open to heal by secondary intention. We no longer harvest oral mucosa from the lip, nor do we close the cheek harvest site secondary to an increased risk of contracture and morbidity, which we and others have previously reported.1–3 We used steroid injection in 1 case where 33.25 cm2 oral mucosa was harvested. The patient experienced persistent pain at 9 months postoperatively, and he responded well to this treatment. Regarding the questions on technique, during second stage urethroplasty the epithelium is incised, and the neourethra is rolled and closed with a running 5-zero polyglactin suture placed transepithelial. An additional layer of subepithelial tissue is reapproximated in running fashion over the previous suture line. The dartos is subsequently closed in 2 separate layers followed by skin closure, all with running 4-zero polyglactin suture. A tunica vaginalis flap was mobilized and used to cover the suture line in 2 patients secondary to a limited amount of available dartos tissue resulting from multiple previous procedures. Glansplasty involved mobilization of glans tissue “wings” over the neourethra in a tension-free approximation with interrupted 4-zero polyglactin suture. The 2 cases that were left with a subglanular meatus represented a challenge. Many of these men were born with penoscrotal hypospadias or had not had the reconstructed neourethra brought into the glans initially as children. We found that tension-free mobilization of adequate tissue from a small glans around a 22Fr to 24Fr neourethra significantly narrowed meatal size (determined by intraoperative calibration) and created tension on the glans suture line. In one of the largest series to date on the treatment of men with pediatric hypospadias failure Barbagli et al reported on 3 patients with glans dehiscence and another 4 with meatal stenosis following urethroplasty,4 reinforcing our concern regarding glans related morbidity in this population. In addition, a recent study by Morey et al reinforced how difficult distal urethroplasty may be in men, with recurrence rates ranging from 9% to 46% for fossa navicularis repairs.5 Fortunately in our series we were unable to bring the neourethra into the glans in only 2 men. These patients reported no postoperative
1236
LETTERS TO THE EDITOR/ERRATA
voiding difficulty in the standing position and no impact on sexual function. Cosmesis was a concern for 1 of these 2 patients, emphasizing the importance of preoperative counseling in this population. Use of extragenital skin is most appropriate for men who have undergone prior urethroplasty and have stricture disease in association with lichen sclerosis (BXO). Abdominal wall skin may be considered for longer segment defects since it is plentiful, extragenital and easily harvested with little morbidity. However, at present we do not advocate the use of this tissue over oral mucosa. As stated in the article, we currently have intermediate followup and we plan to report our longer term data with abdominal wall skin once available. We agree that there is a need for common nomenclature in the adult and pediatric urological and plastic surgery literature. As Snodgrass indicates, use of multiple terms for similar concepts may be confusing to the reader and may prevent appropriate meta-analysis of studies. 1. Dublin N and Stewart LH: Oral complications after buccal mucosal graft harvest for urethroplasty. BJU Int 2004; 94: 867. 2. Jang TL, Erickson B, Medendorp A et al: Comparison of donor site intraoral morbidity after mucosal graft harvesting for urethral reconstruction. Urology 2005; 66: 716. 3. Wood DN, Allen SE, Andrich DE et al: The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain. J Urol 2004; 172: 580.
4. Barbagli G, De Angelis M, Palminteri E et al: Failed hypospadias repair presenting in adults. Eur Urol 2006; 49: 887. 5. Morey AF, Lin HC, DeRosa CA et al: Fossa navicularis reconstruction: impact of stricture length on outcomes and assessment of extended meatotomy (first stage Johanson) maneuver. J Urol 2007; 177: 184.
Re: Evidence-Based Medicine in Urology: Hope and Peril C. Niederberger J Urol 2009; 181: 1528 –1529.
To the Editor: We read with interest this editorial regarding the role of evidence-based medicine (EBM) in urology. Niederberger correctly highlights several of the limitations of this discipline. However, his focus on these negatives may have overshadowed the significant benefits EBM offers. He implies adherents of EBM will accept nothing less than a randomized controlled trial and deride other forms of investigation as worthless. This notion fundamentally mischaracterizes the nature of EBM philosophy. All studies have intrinsic limitations but the hierarchy of evidence illustrates that certain study designs are more limited than others. The hierarchy reminds us that when applying the results of any study to individuals or populations we must consider the inherent limitations of that study. To find confirmation that such reminders are necessary, one need only peruse the current urological literature, which contains countless studies whose authors draw explicit conclusions that simply cannot be supported by the data presented. EBM findings obviously may be misinterpreted or misapplied. It is indeed true, as Niederberger suggests, that insurers and other regulators may make coverage or eligibility determinations based on conclusions reached by EBM guided processes. Is this outcome really worse than the alternative? These bodies are going to make determinations regardless. Would we not prefer their decisions be based on the best available evidence? Niederberger also suggests that the methods used in certain systematic reviews may themselves be flawed. Should such flaws lead urologists simply to forgo these techniques? Of course not. If urologists believe that EBM efforts thus far have been inadequate, we should become more, not less, involved in the universe of EBM. The question is not whether systematic reviews and EBM will have a role in urology, but rather who will perform them. Furthermore, EBM will continue to have a role in clinical and policy decision making in urology. Recent interest (and National Institutes of Health funding) in comparative effectiveness research, for example, is indicative of this trend. Thus, urologists are faced with a choice—to put our heads in the sand and ignore EBM, or to embrace it and adapt it to reflect patient needs and our clinical knowledge. The reality is that demand for EBM, from policy makers, pundits and patients alike, is high. Urologists can lead the way or we can find ourselves being led. Winston Churchill famously noted that democracy is the worst form of government except for all those others that have been tried.1 Similarly in EBM we have a set of tools that, while imperfect, are