Reconstructive Urology Extended Outcomes in the Treatment of Male Stress Urinary Incontinence With a Transobturator Sling Jack M. Zuckerman, Brooke Edwards, Katherine Henderson, Hind A. Beydoun, and Kurt A. McCammon OBJECTIVE METHODS
RESULTS
CONCLUSION
To review extended patient outcomes after male transobturator sling placement for stress urinary incontinence. A retrospective review of a prospectively maintained database for patients with at least 12 months of postoperative follow-up after AdVance male sling placement was performed. Success was defined as a dry safety pad or less (cured) or >50% improvement in pads used per day and patient satisfaction (improved). Patients requiring repeat continence procedures were considered failures. We reviewed data from 102 patients with a minimum of 12 months of follow-up (mean standard deviation 36.2 16.5 months). The mean age at surgery was 66.1 years, and 86.4% had previously undergone a prostatectomy. At 12 months, 24 months, and final follow-up, success rates were 74%, 63%, and 62%, respectively. Although cure rates also declined over time, 40% of patients experienced a durable cure with no complaints of wet pads at final follow-up. Complications were minimal and similar with previous reports. Multivariate Cox regression analysis revealed detrusor overactivity and an elevated detrusor pressure and peak flow negatively predicted being cured using sling placement. AdVance sling placement continues to represent a viable option in the treatment of male stress incontinence. Although a decrease in efficacy over time was observed, a substantial portion of patients can expect a durable cure. UROLOGY 83: 939e945, 2014. Ó 2014 Published by Elsevier Inc.
D
espite advances in technique and experience, postprostatectomy incontinence continues to plague a portion of patients after open or laparoscopic and/or robotic radical prostatectomy. Improvements in continence rates are often seen in the first 1-2 years after surgery; however, persistent incontinence develops in a significant number of men who will eventually seek treatment.1,2 The artificial urinary sphincter (AUS) has been shown in multiple studies to offer long-term durable results in terms of continence and patient satisfaction and continues to represent the gold standard continence procedure.3,4 In 2006, the AdVance male sling was introduced by Rehder and Gozzi5 as an alternative to AUS placement. Initial reports were promising with comparable outcomes to AUS placement and minimal morbidity.6,7 In addition,
Financial Disclosure: Kurt A. McCammon is a consultant and proctor for American Medical Systems. The remaining authors declare that they have no relevant financial interests. From the Department of Urology, Eastern Virginia Medical School, Norfolk, VA; and the Graduate Program in Public Health, Eastern Virginia Medical School, Norfolk, VA Reprint requests: Kurt A. McCammon, M.D., Department of Urology, Eastern Virginia Medical School, 225 Clearfield Avenue, Virginia Beach, VA 23462. E-mail: [email protected] Submitted: August 24, 2013, accepted (with revisions): October 29, 2013
© 2014 Published by Elsevier Inc.
the sling does not require manual dexterity to use and does not carry the same risks of mechanical failure that is seen with the AUS over time. For this reason, many patients prefer this option if given a choice between the 2 procedures.8 Although early reports have been favorable, long-term data after AdVance sling placement are lacking, and therefore, it is difficult to accurately counsel patients on the longevity associated with the procedure. In this study, we review our extended outcomes and complications after transobturator sling placement.
MATERIALS AND METHODS Outcomes for all AdVance transobturator male slings (American Medical Systems, Minnetonka, MN) performed at our institution between August 2006 and June 2012 have been recorded in a prospectively maintained database. Recorded data points include preoperative clinicopathologic characteristics, perioperative outcomes, pre- and postoperative pad usage, complications, subsequent continence procedures, and urodynamic studies. Preoperative patient evaluation was consistent with what we have previously reported, including documented stress urinary incontinence (SUI), a bladder with adequate capacity and compliance on urodynamic testing, and adequate sphincter contraction visualized cystoscopically.9 Although “normal” compliance and capacity are difficult to objectify, in 0090-4295/14/$36.00 http://dx.doi.org/10.1016/j.urology.2013.10.065
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Table 1. Patient demographics and outcomes Age at AdVance (y) Body mass index (kg/m2) Race (%) White Black Other Diabetes mellitus (%) History of radical prostatectomy (%) Time radical prostatectomy to AdVance (y) History of BNC (%) Preoperative pad usage (pads/d) Follow-up duration (mo) Mean Median Range Urodynamics Detrusor overactivity (%) Valsalva leak point pressure (cm H2O) pdetQmax (cm H2O) Peak flow (mL/s) Postvoid residual (mL) Outcomes (%) 12 mo success 12 mo cure 24 mo success 24 mo cure Overall success Overall cure
66.1 9.3 28.5 3.6 66.9 27.2 5.9 25.0 86.4 4.9 4.9 18.5 4.2 2.3 36.2 16.5 33.8 12.1-71.7 30.6 48.9 25.2 24.2 16.5 16.8 10.0 13.3 41.4 74.0 58.0 70.0 48.0 62.0 40.0
BNC, bladder neck contracture; pdetQmax, mean detrusor pressure at peak flow.
general, we considered a compliance of 20 mL/cm H2O and cystometric capacity of 300 mL to be the lower limits of normal. Sphincter contractility was observed in the office at flexible cystoscopy with manual urethral repositioning (ie, perineal pressure). This effectively replicates the urethral positioning after sling placement. A patient that was able to coapt his urethra after repositioning was considered to have adequate sphincter function. All patients were referred for pelvic floor physical therapy before sling placement, which we have found especially useful for patients who recently underwent a prostatectomy. A single surgeon (K.A.M.) performed each procedure using a standard technique for each patient.10 Other than tunneling the sling arms, which we instituted quickly after the introduction of this procedure, there have not been any major technical changes over time. We do affix the sling to the corpus spongiosum in each of the 4 corners, with the proximal aspect of the sling fixed to the previous site of attachment of the central tendon. All patients are kept overnight in the hospital for observation and given a voiding trial on postoperative day 1. If they are found to have significant urinary retention (postvoid residual >200 mL), a Foley catheter is replaced, and they are sent home with a leg bag. All patients are strictly instructed to limit their activity for 6 weeks postoperatively. For this extended analysis, we retrospectively reviewed the outcomes of patients who underwent an AdVance sling for SUI for whom we had at least 12 months of postoperative follow-up. We did not exclude patients on the basis of incontinence etiology or severity, radiation history, or any other complicating factors. In our practice, we do encourage patients with severe incontinence to elect placement of an AUS but do not refuse sling placement in patients otherwise meeting criteria if they choose to 940
pursue this option. The primary objective of the study was to evaluate sling durability in terms of dryness over time. This was accomplished by recording outcomes (ie pad use, complications, satisfaction) at each follow-up visit and monitoring for changes over time. In addition, we performed univariate and multivariate regression analyses to elucidate risk factors that might distinguish patients who experience treatment failure vs those who enjoy a durable and successful outcome. For the purposes of this study, we defined success as a dry safety pad or less per day postoperatively (cured) or both a >50% improvement in pad use and patient satisfaction with the surgical outcome (improved). Pad counts were assessed at each clinic visit before, and after, AdVance placement. Satisfaction was assessed verbally during the patient interview. All patients requiring reoperation for incontinence were considered failures. In addition, patients who failed after sling placement continued to be counted as such throughout the analysis. Statistical analysis was performed using SAS version 9.3. (SAS Institute, Cary, NC). All statistics are reported as mean standard deviation unless otherwise noted. Multivariate analysis was performed as logistic or Cox regressions as indicated, and P values of 5 pads per day. Success at 24 months of follow-up was 63%, including 43% who were cured, and 20% who were improved (Table 1). Five percent of patients were worse after sling placement. At final followup, these numbers decreased slightly such that success was achieved in 62% of patients (40% cured and 22% improved). A smooth line curve was created to represent UROLOGY 83 (4), 2014
compared with an open procedure or no prostatectomy negatively influenced outcomes (Table 2). At final follow-up, higher preoperative pad counts negatively predicted outcomes both in terms on overall success and cure. Neither of these variables significantly predicted outcomes on multivariate analysis. On multivariate Cox regression analysis, DO and an elevated pdetQmax were the only significant factors, and both negatively influenced continence outcomes (Table 3). When the cohort was analyzed for overall success rather than cure, no variables were predictive of success on multivariable analysis.
COMMENT Figure 1. Smooth line plot for illustrating the fraction of patients cured over time after AdVance sling placement. (Color version available online.)
proportion of patients cured over time after AdVance placement (Fig. 1). As depicted visually, there is a steady decline in efficacy, which seems to plateau approximately 30-36 months postoperatively. Complications were consistent with what others and we have previously reported for transobturator male slings. We experienced intraoperative urethral injuries in 2% of patients and injuries to the corpus spongiosum in another 2%. None of these required aborting the procedure. Urinary retention after sling placement was found in 11.8% of patients, which resolved within the first few weeks in all but one. Six patients (5.9%) complained of mild transient scrotal or groin pain. This pain persisted in 1 patient, but he did not require intervention. A urinary tract infection was found in one patient, and one developed a surgical site and subsequent mesh infection. His sling was explanted and the infection resolved. Finally, one of the patients with an intraoperative urethral injury had hematuria after sling placement that persisted for several weeks. A hematuria workup, including cystoscopy was negative. Other than the cystoscopy and sling explant for infection (Clavien grade 3a/3b, respectively) all complications were Clavien grade 1. A total of 25 patients (24.5%) underwent at least 1 subsequent continence procedure at an average 22 months after the original sling placement. This includes 14 (13.6%) who elected to have a redo AdVance sling, 6 (5.9%) who had an AUS placed, and 7 (7.8%) who were injected with urethral bulking agents using Coaptite or Macroplastique. In addition, 2 patients had placement of an Interstim device (Medtronic, Minneapolis, MN) for urgency incontinence. We performed uni- and multivariate analyses to determine which factors might predict patients more or less likely to be cured after transobturator sling placement. At 24 months of follow-up, no variable was found to be predictive of being cured. Logistic regression predicting total success at 24 months, however, showed that having undergone a laparoscopic or robotic prostatectomy UROLOGY 83 (4), 2014
Urinary incontinence after radical prostatectomy negatively impacts health-related quality of life, even in those with minimal leakage.11 For this reason, many men will seek treatment for SUI. After its introduction by Scott in 1972,12 the AUS quickly became the gold standard in the treatment of male SUI. Over time, several centers have reported their long-term outcomes, and the device in its current form has been lauded for durability and patient satisfaction.3,4 However, despite excellent outcomes, AUS implantation is not without complications. Indeed, in the series by Lai et al,4 50% of patients underwent AUS revision or removal at a median of 89.4 months. Although complications of infection and erosion are primarily seen early after AUS placement, complications from urethral atrophy and device mechanical failure continue to increase over time. The AdVance transobturator sling was introduced in 2006 and represents an alternative treatment to the AUS for male SUI. Obvious advantages to its use include the absence of mechanical components that require patient dexterity to operate and elimination of the potential for device malfunction over time. Early reports of outcomes after AdVance placement have been encouraging. Some authors, however, have questioned durability of continence outcomes after AdVance placement, and extended follow-up data are lacking. Li et al13 noted decreased success from 87.3% to 62.5% and an increase in pad use from 0.8 to 1.7 pads per day at 2 years after sling placement. Interestingly, patient perceived outcomes were durable despite using more pads per day. Similarly Suskind et al14 reported a linear trajectory increase in pad use over time with 0.096 pads per day increase each month. Rehder et al15 recently reported 3-year outcomes after AdVance sling placement (mean 40.1 months of followup) on 156 patients. They found a durable success over time with 53.8% being cured at 12 months and 53% at 36 months. The overall success was also durable at 76.9% and 76.8%, respectively. Increased preoperative pad usage was the only variable found to negatively impact outcomes at 3 years on multivariate analysis. History of radiation therapy and increased patient age were not associated with worse outcomes. Complications were reported by most patients, but were all nearly mild and 941
Table 2. Logistic regression outcome analysis for success and cure at 24 mo of follow-up 24 mo Cure Variable Race White Other Age at AdVance Body mass index Prostatectomy Open Robotic/laparoscopic None History of pelvic radiation Yes No Urodynamic variables Detrussor overactivity Yes No Valsalva leak point pressure (cm H2O) Detrusor pressure at peak flow (cm H2O) Peak flow (mL/s) History of BNC Yes No Preop pad usage
Crude HR (95% CI)
24 mo Success
Adjusted HR (95% CI)
Ref. Ref. 0.82 0.32-2.11 1.68 0.99 0.94-1.04 0.98 1.02 0.90-1.15 1.12
0.32-8.90 0.87-1.09 0.90-1.39
Crude HR (95% CI) Ref. 0.44 1 0.99
Adjusted HR (95% CI)
0.16-1.18 0.96-1.05 0.87-1.14
Ref. 9.92 0.93 1.06
1.27-77.60 0.82-1.07 0.85-1.33
1.73 0.39-7.50 1.16 0.09-14.32 2.44 0.52-11.56 0.67 0.031-14.81 1.17 0.29-4.79 0.13 0.008-1.95 1.16 0.28-4.76 0.034 0.001-0.82 Ref. Ref. Ref. Ref. 0.56 0.19-1.63 0.23 Ref. Ref.
0.04-1.36
1.37 Ref.
0.43-4.33
1.74 Ref.
0.22-13.75
0.94 Ref. 1.01 0.98 1.04
0.31-6.82
1.15 Ref. 1 0.98 1.07
0.32-4.15
1.72 Ref. 1.02 0.96 1.11
0.25-11.51
0.44 Ref. 1.08
0.03-6.06
0.28-3.23 1.47 Ref. 0.98-1.04 1.01 0.94-1.02 0.97 0.98-1.10 1.07
0.97-1.04 0.93-1.02 0.98-1.16
0.94 0.29-3.09 0.28 0.028-2.86 0.68 Ref. Ref. 0.86 0.71-1.05 0.74 0.48-1.15 0.99
0.98-1.04 0.95-1.02 0.98-1.16 0.19-2.34 0.81-1.21
0.97-1.07 0.91-1.01 0.99-1.24
0.63-1.85
CI, confidence interval; HR, hazard ratio; other abbreviation as in Table 1.
Table 3. Cox regression outcomes analysis for overall cure and success Overall Cure Variable Race White Other Age at AdVance Body mass index Prostatectomy Open Robotic/laparoscopic None History of pelvic radiation Yes No Urodynamic variables Detrussor overactivity Yes No Valsalva leak point pressure (cm H2O) Detrusor pressure at peak flow (cm H2O) Peak flow (mL/s) History of BNC Yes No Preop pad usage
Crude HR (95% CI) Ref. 1.65 1.02 1.01
0.82-3.32 0.97-1.05 0.92-1.11
Overall Success
Adjusted HR (95% CI) Ref. 1.32 1.03 1.24
0.46-3.79 0.94-1.13 1.04-1.47
Crude HR (95% CI) Ref. 1.86 1.02 0.97
Adjusted HR (95% CI)
1.05-3.29 0.99-1.05 0.90-1.05
Ref. 1.71 0.71-4.11 1.04 0.96-1.12 1.09 0.96-1.25
1.44 1.25 Ref.
0.48-4.28 0.42-3.68
6.92 1.03-46.61 1.3 0.61 0.09-3.90 1.15 Ref. Ref.
0.56-3.02 0.49-2.66
1.73 0.50-5.96 0.56 0.15-2.09 Ref.
0.54 Ref.
0.23-1.28
1.08 Ref.
0.28-3.63
0.79 Ref.
0.42-1.45
0.72 0.31-1.69 Ref.
0.24 0.069-0.87 0.18 Ref. Ref. 1.03 1.01-1.05 1.06 0.96 0.93-0.99 0.91 0.98 0.95-1.03 0.97
0.03-0.97
0.49 Ref. 1.02 0.98 1
0.21-1.14
0.54 Ref. 1.03 0.96 1
0.86 Ref. 0.73
0.05-1.65
0.33-2.21 0.62-0.87
0.29 Ref. 0.83
1.03-1.09 0.85-0.96 0.92-1.03
0.63-1.09
1.01-1.04 0.95-1.01 0.98-1.04
0.19-1.56 1.01-1.05 0.92-1.00 0.97-1.04
1.22 0.59-2.419 0.83 0.27-2.59 Ref. Ref. 0.8 0.69-0.92 0.85 0.67-1.07
Abbreviations as in Tables 1 and 2.
transient, including perineal pain, urinary retention, and dysuria being the 3 most common. In this study, we have reported our extended outcome analysis on 102 patients followed up for an average of 36.2 months. Overall success at final follow-up was 62% 942
(40% cured and 22% improved). Notably, our results do not confirm the durability reported by Rehder et al. We found a steady decline in patients who were cured after AdVance sling placement over time until 30-36 months postoperatively (Fig. 1). This translates into a decrease in UROLOGY 83 (4), 2014
the percentage of patients cured from 58%, 43%, and 40% at 12 months, 24 months, and final follow-up, respectively. Success rates also declined at 74%, 63%, and 62% at those same time points. Despite this decrease in efficacy, we still found 62% overall success. This includes 40% who continued to be dry at an average followup of 30.3 months. We found on univariate analysis that higher preoperative pad counts negatively impacted sling outcomes. We have made it part of our practice to counsel patients with severe incontinence electing to undergo sling placement that they should expect cure rates less those seen in a patient with milder incontinence. That being said, we still had a significant portion of our patients (35%) using more than 5 pads a day preoperatively. The relatively large proportion of patients with severe incontinence in our study cohort might make the generalizability of our findings somewhat skewed, especially compared with a practitioner who only offers sling placement to patients with mild or moderate incontinence. We found several factors that negatively predicted success or cure on multivariate analysis, including DO, elevated pdetQmax, and having undergone a laparoscopic prostatectomy. DO as a risk factor makes intuitive sense in that a portion of this leakage was likely caused or worsened by urinary urgency. Having undergone a laparoscopic prostatectomy compared with open or no prostatectomy or having an elevated pdetQmax, however, is not something that we can rationalize. In addition, these findings were limited to a select outcomes analysis and were not significant at each time point tested. This suggests findings that might be aberrancy rather than a true risk factor. We did not find a history of radiation to statistically significantly predict continence outcomes. Numerically, more patients without a history of radiation were dry at final follow-up (44% vs 26%), but this difference was not statistically significant (P ¼ .10). Radiation as a negative risk factor has been inconsistently reported in the literature.7,15,16 Intuitively, it makes sense that radiation might portend poor outcomes, as this will have negative effects on urethral sphincter function, inhibit tissue healing and mesh ingrowth, and limit the mobility and flexibility of tissues necessary for “repositioning” of the urethra. Despite these findings, we do advise patients with a history of radiation who desire a transobturator sling that they might experience slightly worse outcomes compared with nonirradiated patients. We have not found an increase in complications as we monitor our patients over time. No patient has experienced sling erosion into the urethra or required a late explant for other reasons. We report a nearly 12% rate of urinary retention, and this is consistent what others have reported with transobturator sling placement and also comparable with patients undergoing a bone-anchored sling.17 We did have 2 spongiosal and 2 urethral injuries in the series. These were early in our experience, and each injury occurred during trocar passage. None UROLOGY 83 (4), 2014
required us to abort the procedure, and none experienced delayed postoperative complications. Finally, we did explant a single sling for mesh infection. This developed in a patient prone to scrotal infections, and he was counseled on this risk preoperatively. Other than requiring the sling to be explanted, there were no further sequelae from the infection. Since we started performing transobturator slings we have seen a number of patients who failed after an initial dry period. Some of these were most likely secondary to sling slippage, as they noted increased leakage immediately after an increase in physical activity within a month of sling placement. We have repeated an AdVance sling in these patients with good success. Others, however, failed late, and we cannot reliably attribute these to sling displacement. It might be that there is a worsening of intrinsic sphincter deficiency, development of or an increase in the severity of overactive bladder, or potentially urethral atrophy similar to what is seen with AUSs. For these patients, we offer repeat slings, AUS placement, or urethral bulking agents as a second procedure. We have not found that placement of a second AdVance or an AUS after the initial sling to be significantly more difficult. There are several limitations to this study. First, it is retrospective in design and is at risk for bias on the basis of the study methodology, which limits its generalizability. It is also a single surgeon series, which might reduce somewhat the applicability to other practitioners. We do not have data on standardized incontinence questionnaires for most patients in this series, and therefore these data were not included. We also do not have pad weights, but instead used daily pad counts as a measure of success. Although objectively this is not as accurate, it is a surrogate marker of patient perceived outcomes, and we have found this useful when following up patients over time.
CONCLUSION The AdVance sling continues to be a reasonable option in the treatment of male SUI. The procedure is reliably performed with minimal morbidity to the patient. The success in the early postoperative period rivals that after AUS placement; however, in our series we found a decrease in efficacy over time. That being said, 40% of patients were durably cured after an AdVance sling placement. References 1. Smither AR, Guralnick ML, Davis NB, et al. Quantifying the natural history of post-radical prostatectomy incontinence using objective pad test data. BMC Urol. 2007;7:2. 2. Penson DF, McLerran D, Feng Z, et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the prostate cancer outcomes study. J Urol. 2005;173:1701-1705. 3. Kim SP, Sarmast Z, Daignault S, et al. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol. 2008;179:1912-1916.
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4. Lai HH, Hsu EI, Teh BS, et al. 13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine. J Urol. 2007;177:1021-1025. 5. Rehder P, Gozzi C. Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol. 2007; 52:860-866. 6. Bauer RM, Soljanik I, Fullhase C, et al. Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy. BJU Int. 2011;108:94-98. 7. Cornu JN, Sebe P, Ciofu C, et al. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors. BJU Int. 2011;108:236-240. 8. Kumar A, Litt ER, Ballert KN, et al. Artificial urinary sphincter versus male sling for post-prostatectomy incontinenceewhat do patients choose? J Urol. 2009;181:1231-1235. 9. Davies TO, Bepple JL, McCammon KA. Urodynamic changes and initial results of the AdVance male sling. Urology. 2009;74:354-357. 10. McCammon KA, Haab F. AdVance male sling: surgical technique and post operative patient management. Eur Urol. 2011;10:395-400. 11. Liss MA, Osann K, Canvasser N, et al. Continence definition after radical prostatectomy using urinary quality of life: evaluation of patient reported validated questionnaires. J Urol. 2010;183:14641468. 12. Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by implantable prosthetic sphincter. Urology. 1973;1: 252-259. 13. Li H, Gill BC, Nowacki AS, et al. Therapeutic durability of the male transobturator sling: midterm patient reported outcomes. J Urol. 2012;187:1331-1335. 14. Suskind AM, Bernstein B, Murphy-Setzko M. Patient-perceived outcomes of the AdVance sling up to 40 months post procedure. Neurourol Urodyn. 2011;30:1267-1270. 15. Rehder P, Haab F, Cornu JN, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol. 2012;62: 140-145. 16. Soljanik I, Gozzi C, Becker AJ, et al. Risk factors of treatment failure after retrourethral transobturator male sling. World J Urol. 2012;30:201-206. 17. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109:328-344.
EDITORIAL COMMENT The authors present a large cohort with relatively long-term follow-up. In contrast to Rehder’s recent report that initial efficacy rates were indeed maintained over a 3-year period,1 this present article notes that the initial success realized with the transobturator sling diminishes over time. Thus, it remains important for investigators to continue to monitor their sling patients and to report the intermediate and longer-term continence status. It is becoming more apparent that careful patient selection is vital for optimizing sling efficacy, as risk factors for sling failure include high pad use/weight, previous stricture, radiation, or artificial urinary sphincter placement, low functional urethral length, poor sling fixation, and a negative repositioning test. Taken together, these risk factors represent more severe sphincteric insufficiency. Although all patients included in this cohort indeed had a positive repositioning test, 58% were cured at 1 year, which is somewhat lower than that reported by Bauer et al,2 who achieved a 83% cure rate in a cohort with similar incontinence severity (median 4.6 pads per day). Nevertheless, despite a decline in the cure rate over time, patient satisfaction is maintained. Thus, it appears that “cure” is not a criterion for “success”. After all, patients generally enter prostate surgery dry, 944
and any postoperative pad use is associated with deterioration in quality of life.3 However, men enter sling surgery wet, and reduction in pad use translates into an improvement in quality of life. Thus most improved patients are satisfied, even if still requiring pads. In addition to adverse preoperative factors, insufficient maintenance of sling tension might also contribute to recurrent incontinence. Use of a resorbable sling is associated with a high rate of sling failure,4 as is insufficient sling tunneling or fixationefor both the transobturator sling and the new quadratic sling. One-year outcomes of the quadratic sling demonstrate higher success with tunneling of the transobturator arms and fixation of the suprapubic arms to the soft tissue over the pubic bone compared with the unfixed device.5 Finally, it appears that there is no “best single option” for all patients; rather there are different devices that might be more appropriate for a particular patient. Even when a sling is adequately tensioned and fixed, there appears to be a ceiling with respect to efficacy with noncircumferential compression. Reports of the various sling devices generally support a cure rate of 50%-60%, with an improvement rate of 75%-85% in properly selected patients.6 Thus, in patients with high volume incontinence and more severe sphincteric dysfunction, the artificial urinary sphincter should be considered the most efficacious option. For those with mild to moderate leakage, a sling might more efficiently balance efficacy and risk. For those with detrusor hypocontractility and mild to moderate leakage, a noncompressive transobturator sling might be most suitable, whereas for those with more substantial leakage who have adequate detrusor contractility, a more compressive device such as the quadratic sling might be preferred. Craig V. Comiter, M.D., Stanford University Medical School, Stanford, CA
References 1. Rehder P, Haab F, Cornu JN, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol. 2012;62: 140-145. 2. Bauer RM, Gozzi C, Roosen A, et al. Impact of the ‘repositioning test’ on postoperative outcome of retroluminar transobturator male sling implantation. Urol Int. 2013;90:334-338. 3. Liss MA, Osann K, Canvasser N, et al. Continence definition after radical prostatectomy using urinary quality of life: evaluation of patient reported validated questionnaires. J Urol. 2010;183:1464-1468. 4. Onur R, Rajpurkar A, Singla A. New perineal bone-anchored male sling: lessons learned. Urology. 2004;64:58-61. 5. Comiter CV, Elliott C, Glowe P. The VIRTUE sling for post-prostatectomy incontinence e a novel method of fixation improves outcome. Neurourol Urodyn. 2012;31:217. 6. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109:328-344.
http://dx.doi.org/10.1016/j.urology.2013.10.066 UROLOGY 83: 944, 2014. Ó 2014 Published by Elsevier Inc.
REPLY Patient selection in all aspects of urology is of utmost importance, and this fact is no different when discussing male stress urinary incontinence (SUI). As nicely outlined in the editorial comment, it seems that the bulk of available literature would UROLOGY 83 (4), 2014
support the use of artificial urinary sphincters (AUS) in men with severe SUI. This device has the longest follow-up data available and has proven to be efficacious even in the most incontinent patients. Because of this, we specifically counsel patients with large volume incontinence toward AUS placement. Patients with less severe incontinence or those unable or unwilling to undergo placement of an AUS, however, should be considered for male sling placement. In our practice, those patients electing sling placement despite an increased severity of incontinence and those with a history of previous radiation are extensively counseled on the potential for less optimal outcomes. Specifically, we believe that the likelihood of “cure” rather than “improvement” in this cohort is diminished. However, we have found that thorough preoperative counseling with this high-risk group does help to temper expectations somewhat and can improve postoperative satisfaction. Since introduction of the AdVance transobturator sling we have preferentially chosen this sling for male SUI. In our practice, we have stopped using bone-anchored slings secondary to not uncommon complaints of pain, presumably from the
UROLOGY 83 (4), 2014
bone anchors and an element of low-grade osteitis pubis. Although the Virtue quadratic sling has been available for a number of years, we believe it is prudent to await the release of further outcomes data before making any determinations regarding patient selection. We would disagree with the inference made in the editorial comment that the Virtue sling offers a middle ground for those patients perceived to be too “wet” for a pure transobturator approach, but not candidates for an AUS. In our opinion, the available published data do not support this algorithm, and we will continue to recommend AUS placement to those patients who we believe are less than ideal candidates for male sling placement. Jack M. Zuckerman, M.D., and Kurt A. McCammon, M.D., Department of Urology, Eastern Virginia Medical School, Norfolk, VA http://dx.doi.org/10.1016/j.urology.2013.10.067 UROLOGY 83: 944e945, 2014. Ó 2014 Published by
Elsevier Inc.
945
RESULTS
CONCLUSION
To review extended patient outcomes after male transobturator sling placement for stress urinary incontinence. A retrospective review of a prospectively maintained database for patients with at least 12 months of postoperative follow-up after AdVance male sling placement was performed. Success was defined as a dry safety pad or less (cured) or >50% improvement in pads used per day and patient satisfaction (improved). Patients requiring repeat continence procedures were considered failures. We reviewed data from 102 patients with a minimum of 12 months of follow-up (mean standard deviation 36.2 16.5 months). The mean age at surgery was 66.1 years, and 86.4% had previously undergone a prostatectomy. At 12 months, 24 months, and final follow-up, success rates were 74%, 63%, and 62%, respectively. Although cure rates also declined over time, 40% of patients experienced a durable cure with no complaints of wet pads at final follow-up. Complications were minimal and similar with previous reports. Multivariate Cox regression analysis revealed detrusor overactivity and an elevated detrusor pressure and peak flow negatively predicted being cured using sling placement. AdVance sling placement continues to represent a viable option in the treatment of male stress incontinence. Although a decrease in efficacy over time was observed, a substantial portion of patients can expect a durable cure. UROLOGY 83: 939e945, 2014. Ó 2014 Published by Elsevier Inc.
D
espite advances in technique and experience, postprostatectomy incontinence continues to plague a portion of patients after open or laparoscopic and/or robotic radical prostatectomy. Improvements in continence rates are often seen in the first 1-2 years after surgery; however, persistent incontinence develops in a significant number of men who will eventually seek treatment.1,2 The artificial urinary sphincter (AUS) has been shown in multiple studies to offer long-term durable results in terms of continence and patient satisfaction and continues to represent the gold standard continence procedure.3,4 In 2006, the AdVance male sling was introduced by Rehder and Gozzi5 as an alternative to AUS placement. Initial reports were promising with comparable outcomes to AUS placement and minimal morbidity.6,7 In addition,
Financial Disclosure: Kurt A. McCammon is a consultant and proctor for American Medical Systems. The remaining authors declare that they have no relevant financial interests. From the Department of Urology, Eastern Virginia Medical School, Norfolk, VA; and the Graduate Program in Public Health, Eastern Virginia Medical School, Norfolk, VA Reprint requests: Kurt A. McCammon, M.D., Department of Urology, Eastern Virginia Medical School, 225 Clearfield Avenue, Virginia Beach, VA 23462. E-mail: [email protected] Submitted: August 24, 2013, accepted (with revisions): October 29, 2013
© 2014 Published by Elsevier Inc.
the sling does not require manual dexterity to use and does not carry the same risks of mechanical failure that is seen with the AUS over time. For this reason, many patients prefer this option if given a choice between the 2 procedures.8 Although early reports have been favorable, long-term data after AdVance sling placement are lacking, and therefore, it is difficult to accurately counsel patients on the longevity associated with the procedure. In this study, we review our extended outcomes and complications after transobturator sling placement.
MATERIALS AND METHODS Outcomes for all AdVance transobturator male slings (American Medical Systems, Minnetonka, MN) performed at our institution between August 2006 and June 2012 have been recorded in a prospectively maintained database. Recorded data points include preoperative clinicopathologic characteristics, perioperative outcomes, pre- and postoperative pad usage, complications, subsequent continence procedures, and urodynamic studies. Preoperative patient evaluation was consistent with what we have previously reported, including documented stress urinary incontinence (SUI), a bladder with adequate capacity and compliance on urodynamic testing, and adequate sphincter contraction visualized cystoscopically.9 Although “normal” compliance and capacity are difficult to objectify, in 0090-4295/14/$36.00 http://dx.doi.org/10.1016/j.urology.2013.10.065
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Table 1. Patient demographics and outcomes Age at AdVance (y) Body mass index (kg/m2) Race (%) White Black Other Diabetes mellitus (%) History of radical prostatectomy (%) Time radical prostatectomy to AdVance (y) History of BNC (%) Preoperative pad usage (pads/d) Follow-up duration (mo) Mean Median Range Urodynamics Detrusor overactivity (%) Valsalva leak point pressure (cm H2O) pdetQmax (cm H2O) Peak flow (mL/s) Postvoid residual (mL) Outcomes (%) 12 mo success 12 mo cure 24 mo success 24 mo cure Overall success Overall cure
66.1 9.3 28.5 3.6 66.9 27.2 5.9 25.0 86.4 4.9 4.9 18.5 4.2 2.3 36.2 16.5 33.8 12.1-71.7 30.6 48.9 25.2 24.2 16.5 16.8 10.0 13.3 41.4 74.0 58.0 70.0 48.0 62.0 40.0
BNC, bladder neck contracture; pdetQmax, mean detrusor pressure at peak flow.
general, we considered a compliance of 20 mL/cm H2O and cystometric capacity of 300 mL to be the lower limits of normal. Sphincter contractility was observed in the office at flexible cystoscopy with manual urethral repositioning (ie, perineal pressure). This effectively replicates the urethral positioning after sling placement. A patient that was able to coapt his urethra after repositioning was considered to have adequate sphincter function. All patients were referred for pelvic floor physical therapy before sling placement, which we have found especially useful for patients who recently underwent a prostatectomy. A single surgeon (K.A.M.) performed each procedure using a standard technique for each patient.10 Other than tunneling the sling arms, which we instituted quickly after the introduction of this procedure, there have not been any major technical changes over time. We do affix the sling to the corpus spongiosum in each of the 4 corners, with the proximal aspect of the sling fixed to the previous site of attachment of the central tendon. All patients are kept overnight in the hospital for observation and given a voiding trial on postoperative day 1. If they are found to have significant urinary retention (postvoid residual >200 mL), a Foley catheter is replaced, and they are sent home with a leg bag. All patients are strictly instructed to limit their activity for 6 weeks postoperatively. For this extended analysis, we retrospectively reviewed the outcomes of patients who underwent an AdVance sling for SUI for whom we had at least 12 months of postoperative follow-up. We did not exclude patients on the basis of incontinence etiology or severity, radiation history, or any other complicating factors. In our practice, we do encourage patients with severe incontinence to elect placement of an AUS but do not refuse sling placement in patients otherwise meeting criteria if they choose to 940
pursue this option. The primary objective of the study was to evaluate sling durability in terms of dryness over time. This was accomplished by recording outcomes (ie pad use, complications, satisfaction) at each follow-up visit and monitoring for changes over time. In addition, we performed univariate and multivariate regression analyses to elucidate risk factors that might distinguish patients who experience treatment failure vs those who enjoy a durable and successful outcome. For the purposes of this study, we defined success as a dry safety pad or less per day postoperatively (cured) or both a >50% improvement in pad use and patient satisfaction with the surgical outcome (improved). Pad counts were assessed at each clinic visit before, and after, AdVance placement. Satisfaction was assessed verbally during the patient interview. All patients requiring reoperation for incontinence were considered failures. In addition, patients who failed after sling placement continued to be counted as such throughout the analysis. Statistical analysis was performed using SAS version 9.3. (SAS Institute, Cary, NC). All statistics are reported as mean standard deviation unless otherwise noted. Multivariate analysis was performed as logistic or Cox regressions as indicated, and P values of 5 pads per day. Success at 24 months of follow-up was 63%, including 43% who were cured, and 20% who were improved (Table 1). Five percent of patients were worse after sling placement. At final followup, these numbers decreased slightly such that success was achieved in 62% of patients (40% cured and 22% improved). A smooth line curve was created to represent UROLOGY 83 (4), 2014
compared with an open procedure or no prostatectomy negatively influenced outcomes (Table 2). At final follow-up, higher preoperative pad counts negatively predicted outcomes both in terms on overall success and cure. Neither of these variables significantly predicted outcomes on multivariate analysis. On multivariate Cox regression analysis, DO and an elevated pdetQmax were the only significant factors, and both negatively influenced continence outcomes (Table 3). When the cohort was analyzed for overall success rather than cure, no variables were predictive of success on multivariable analysis.
COMMENT Figure 1. Smooth line plot for illustrating the fraction of patients cured over time after AdVance sling placement. (Color version available online.)
proportion of patients cured over time after AdVance placement (Fig. 1). As depicted visually, there is a steady decline in efficacy, which seems to plateau approximately 30-36 months postoperatively. Complications were consistent with what others and we have previously reported for transobturator male slings. We experienced intraoperative urethral injuries in 2% of patients and injuries to the corpus spongiosum in another 2%. None of these required aborting the procedure. Urinary retention after sling placement was found in 11.8% of patients, which resolved within the first few weeks in all but one. Six patients (5.9%) complained of mild transient scrotal or groin pain. This pain persisted in 1 patient, but he did not require intervention. A urinary tract infection was found in one patient, and one developed a surgical site and subsequent mesh infection. His sling was explanted and the infection resolved. Finally, one of the patients with an intraoperative urethral injury had hematuria after sling placement that persisted for several weeks. A hematuria workup, including cystoscopy was negative. Other than the cystoscopy and sling explant for infection (Clavien grade 3a/3b, respectively) all complications were Clavien grade 1. A total of 25 patients (24.5%) underwent at least 1 subsequent continence procedure at an average 22 months after the original sling placement. This includes 14 (13.6%) who elected to have a redo AdVance sling, 6 (5.9%) who had an AUS placed, and 7 (7.8%) who were injected with urethral bulking agents using Coaptite or Macroplastique. In addition, 2 patients had placement of an Interstim device (Medtronic, Minneapolis, MN) for urgency incontinence. We performed uni- and multivariate analyses to determine which factors might predict patients more or less likely to be cured after transobturator sling placement. At 24 months of follow-up, no variable was found to be predictive of being cured. Logistic regression predicting total success at 24 months, however, showed that having undergone a laparoscopic or robotic prostatectomy UROLOGY 83 (4), 2014
Urinary incontinence after radical prostatectomy negatively impacts health-related quality of life, even in those with minimal leakage.11 For this reason, many men will seek treatment for SUI. After its introduction by Scott in 1972,12 the AUS quickly became the gold standard in the treatment of male SUI. Over time, several centers have reported their long-term outcomes, and the device in its current form has been lauded for durability and patient satisfaction.3,4 However, despite excellent outcomes, AUS implantation is not without complications. Indeed, in the series by Lai et al,4 50% of patients underwent AUS revision or removal at a median of 89.4 months. Although complications of infection and erosion are primarily seen early after AUS placement, complications from urethral atrophy and device mechanical failure continue to increase over time. The AdVance transobturator sling was introduced in 2006 and represents an alternative treatment to the AUS for male SUI. Obvious advantages to its use include the absence of mechanical components that require patient dexterity to operate and elimination of the potential for device malfunction over time. Early reports of outcomes after AdVance placement have been encouraging. Some authors, however, have questioned durability of continence outcomes after AdVance placement, and extended follow-up data are lacking. Li et al13 noted decreased success from 87.3% to 62.5% and an increase in pad use from 0.8 to 1.7 pads per day at 2 years after sling placement. Interestingly, patient perceived outcomes were durable despite using more pads per day. Similarly Suskind et al14 reported a linear trajectory increase in pad use over time with 0.096 pads per day increase each month. Rehder et al15 recently reported 3-year outcomes after AdVance sling placement (mean 40.1 months of followup) on 156 patients. They found a durable success over time with 53.8% being cured at 12 months and 53% at 36 months. The overall success was also durable at 76.9% and 76.8%, respectively. Increased preoperative pad usage was the only variable found to negatively impact outcomes at 3 years on multivariate analysis. History of radiation therapy and increased patient age were not associated with worse outcomes. Complications were reported by most patients, but were all nearly mild and 941
Table 2. Logistic regression outcome analysis for success and cure at 24 mo of follow-up 24 mo Cure Variable Race White Other Age at AdVance Body mass index Prostatectomy Open Robotic/laparoscopic None History of pelvic radiation Yes No Urodynamic variables Detrussor overactivity Yes No Valsalva leak point pressure (cm H2O) Detrusor pressure at peak flow (cm H2O) Peak flow (mL/s) History of BNC Yes No Preop pad usage
Crude HR (95% CI)
24 mo Success
Adjusted HR (95% CI)
Ref. Ref. 0.82 0.32-2.11 1.68 0.99 0.94-1.04 0.98 1.02 0.90-1.15 1.12
0.32-8.90 0.87-1.09 0.90-1.39
Crude HR (95% CI) Ref. 0.44 1 0.99
Adjusted HR (95% CI)
0.16-1.18 0.96-1.05 0.87-1.14
Ref. 9.92 0.93 1.06
1.27-77.60 0.82-1.07 0.85-1.33
1.73 0.39-7.50 1.16 0.09-14.32 2.44 0.52-11.56 0.67 0.031-14.81 1.17 0.29-4.79 0.13 0.008-1.95 1.16 0.28-4.76 0.034 0.001-0.82 Ref. Ref. Ref. Ref. 0.56 0.19-1.63 0.23 Ref. Ref.
0.04-1.36
1.37 Ref.
0.43-4.33
1.74 Ref.
0.22-13.75
0.94 Ref. 1.01 0.98 1.04
0.31-6.82
1.15 Ref. 1 0.98 1.07
0.32-4.15
1.72 Ref. 1.02 0.96 1.11
0.25-11.51
0.44 Ref. 1.08
0.03-6.06
0.28-3.23 1.47 Ref. 0.98-1.04 1.01 0.94-1.02 0.97 0.98-1.10 1.07
0.97-1.04 0.93-1.02 0.98-1.16
0.94 0.29-3.09 0.28 0.028-2.86 0.68 Ref. Ref. 0.86 0.71-1.05 0.74 0.48-1.15 0.99
0.98-1.04 0.95-1.02 0.98-1.16 0.19-2.34 0.81-1.21
0.97-1.07 0.91-1.01 0.99-1.24
0.63-1.85
CI, confidence interval; HR, hazard ratio; other abbreviation as in Table 1.
Table 3. Cox regression outcomes analysis for overall cure and success Overall Cure Variable Race White Other Age at AdVance Body mass index Prostatectomy Open Robotic/laparoscopic None History of pelvic radiation Yes No Urodynamic variables Detrussor overactivity Yes No Valsalva leak point pressure (cm H2O) Detrusor pressure at peak flow (cm H2O) Peak flow (mL/s) History of BNC Yes No Preop pad usage
Crude HR (95% CI) Ref. 1.65 1.02 1.01
0.82-3.32 0.97-1.05 0.92-1.11
Overall Success
Adjusted HR (95% CI) Ref. 1.32 1.03 1.24
0.46-3.79 0.94-1.13 1.04-1.47
Crude HR (95% CI) Ref. 1.86 1.02 0.97
Adjusted HR (95% CI)
1.05-3.29 0.99-1.05 0.90-1.05
Ref. 1.71 0.71-4.11 1.04 0.96-1.12 1.09 0.96-1.25
1.44 1.25 Ref.
0.48-4.28 0.42-3.68
6.92 1.03-46.61 1.3 0.61 0.09-3.90 1.15 Ref. Ref.
0.56-3.02 0.49-2.66
1.73 0.50-5.96 0.56 0.15-2.09 Ref.
0.54 Ref.
0.23-1.28
1.08 Ref.
0.28-3.63
0.79 Ref.
0.42-1.45
0.72 0.31-1.69 Ref.
0.24 0.069-0.87 0.18 Ref. Ref. 1.03 1.01-1.05 1.06 0.96 0.93-0.99 0.91 0.98 0.95-1.03 0.97
0.03-0.97
0.49 Ref. 1.02 0.98 1
0.21-1.14
0.54 Ref. 1.03 0.96 1
0.86 Ref. 0.73
0.05-1.65
0.33-2.21 0.62-0.87
0.29 Ref. 0.83
1.03-1.09 0.85-0.96 0.92-1.03
0.63-1.09
1.01-1.04 0.95-1.01 0.98-1.04
0.19-1.56 1.01-1.05 0.92-1.00 0.97-1.04
1.22 0.59-2.419 0.83 0.27-2.59 Ref. Ref. 0.8 0.69-0.92 0.85 0.67-1.07
Abbreviations as in Tables 1 and 2.
transient, including perineal pain, urinary retention, and dysuria being the 3 most common. In this study, we have reported our extended outcome analysis on 102 patients followed up for an average of 36.2 months. Overall success at final follow-up was 62% 942
(40% cured and 22% improved). Notably, our results do not confirm the durability reported by Rehder et al. We found a steady decline in patients who were cured after AdVance sling placement over time until 30-36 months postoperatively (Fig. 1). This translates into a decrease in UROLOGY 83 (4), 2014
the percentage of patients cured from 58%, 43%, and 40% at 12 months, 24 months, and final follow-up, respectively. Success rates also declined at 74%, 63%, and 62% at those same time points. Despite this decrease in efficacy, we still found 62% overall success. This includes 40% who continued to be dry at an average followup of 30.3 months. We found on univariate analysis that higher preoperative pad counts negatively impacted sling outcomes. We have made it part of our practice to counsel patients with severe incontinence electing to undergo sling placement that they should expect cure rates less those seen in a patient with milder incontinence. That being said, we still had a significant portion of our patients (35%) using more than 5 pads a day preoperatively. The relatively large proportion of patients with severe incontinence in our study cohort might make the generalizability of our findings somewhat skewed, especially compared with a practitioner who only offers sling placement to patients with mild or moderate incontinence. We found several factors that negatively predicted success or cure on multivariate analysis, including DO, elevated pdetQmax, and having undergone a laparoscopic prostatectomy. DO as a risk factor makes intuitive sense in that a portion of this leakage was likely caused or worsened by urinary urgency. Having undergone a laparoscopic prostatectomy compared with open or no prostatectomy or having an elevated pdetQmax, however, is not something that we can rationalize. In addition, these findings were limited to a select outcomes analysis and were not significant at each time point tested. This suggests findings that might be aberrancy rather than a true risk factor. We did not find a history of radiation to statistically significantly predict continence outcomes. Numerically, more patients without a history of radiation were dry at final follow-up (44% vs 26%), but this difference was not statistically significant (P ¼ .10). Radiation as a negative risk factor has been inconsistently reported in the literature.7,15,16 Intuitively, it makes sense that radiation might portend poor outcomes, as this will have negative effects on urethral sphincter function, inhibit tissue healing and mesh ingrowth, and limit the mobility and flexibility of tissues necessary for “repositioning” of the urethra. Despite these findings, we do advise patients with a history of radiation who desire a transobturator sling that they might experience slightly worse outcomes compared with nonirradiated patients. We have not found an increase in complications as we monitor our patients over time. No patient has experienced sling erosion into the urethra or required a late explant for other reasons. We report a nearly 12% rate of urinary retention, and this is consistent what others have reported with transobturator sling placement and also comparable with patients undergoing a bone-anchored sling.17 We did have 2 spongiosal and 2 urethral injuries in the series. These were early in our experience, and each injury occurred during trocar passage. None UROLOGY 83 (4), 2014
required us to abort the procedure, and none experienced delayed postoperative complications. Finally, we did explant a single sling for mesh infection. This developed in a patient prone to scrotal infections, and he was counseled on this risk preoperatively. Other than requiring the sling to be explanted, there were no further sequelae from the infection. Since we started performing transobturator slings we have seen a number of patients who failed after an initial dry period. Some of these were most likely secondary to sling slippage, as they noted increased leakage immediately after an increase in physical activity within a month of sling placement. We have repeated an AdVance sling in these patients with good success. Others, however, failed late, and we cannot reliably attribute these to sling displacement. It might be that there is a worsening of intrinsic sphincter deficiency, development of or an increase in the severity of overactive bladder, or potentially urethral atrophy similar to what is seen with AUSs. For these patients, we offer repeat slings, AUS placement, or urethral bulking agents as a second procedure. We have not found that placement of a second AdVance or an AUS after the initial sling to be significantly more difficult. There are several limitations to this study. First, it is retrospective in design and is at risk for bias on the basis of the study methodology, which limits its generalizability. It is also a single surgeon series, which might reduce somewhat the applicability to other practitioners. We do not have data on standardized incontinence questionnaires for most patients in this series, and therefore these data were not included. We also do not have pad weights, but instead used daily pad counts as a measure of success. Although objectively this is not as accurate, it is a surrogate marker of patient perceived outcomes, and we have found this useful when following up patients over time.
CONCLUSION The AdVance sling continues to be a reasonable option in the treatment of male SUI. The procedure is reliably performed with minimal morbidity to the patient. The success in the early postoperative period rivals that after AUS placement; however, in our series we found a decrease in efficacy over time. That being said, 40% of patients were durably cured after an AdVance sling placement. References 1. Smither AR, Guralnick ML, Davis NB, et al. Quantifying the natural history of post-radical prostatectomy incontinence using objective pad test data. BMC Urol. 2007;7:2. 2. Penson DF, McLerran D, Feng Z, et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the prostate cancer outcomes study. J Urol. 2005;173:1701-1705. 3. Kim SP, Sarmast Z, Daignault S, et al. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol. 2008;179:1912-1916.
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4. Lai HH, Hsu EI, Teh BS, et al. 13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine. J Urol. 2007;177:1021-1025. 5. Rehder P, Gozzi C. Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol. 2007; 52:860-866. 6. Bauer RM, Soljanik I, Fullhase C, et al. Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy. BJU Int. 2011;108:94-98. 7. Cornu JN, Sebe P, Ciofu C, et al. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors. BJU Int. 2011;108:236-240. 8. Kumar A, Litt ER, Ballert KN, et al. Artificial urinary sphincter versus male sling for post-prostatectomy incontinenceewhat do patients choose? J Urol. 2009;181:1231-1235. 9. Davies TO, Bepple JL, McCammon KA. Urodynamic changes and initial results of the AdVance male sling. Urology. 2009;74:354-357. 10. McCammon KA, Haab F. AdVance male sling: surgical technique and post operative patient management. Eur Urol. 2011;10:395-400. 11. Liss MA, Osann K, Canvasser N, et al. Continence definition after radical prostatectomy using urinary quality of life: evaluation of patient reported validated questionnaires. J Urol. 2010;183:14641468. 12. Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by implantable prosthetic sphincter. Urology. 1973;1: 252-259. 13. Li H, Gill BC, Nowacki AS, et al. Therapeutic durability of the male transobturator sling: midterm patient reported outcomes. J Urol. 2012;187:1331-1335. 14. Suskind AM, Bernstein B, Murphy-Setzko M. Patient-perceived outcomes of the AdVance sling up to 40 months post procedure. Neurourol Urodyn. 2011;30:1267-1270. 15. Rehder P, Haab F, Cornu JN, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol. 2012;62: 140-145. 16. Soljanik I, Gozzi C, Becker AJ, et al. Risk factors of treatment failure after retrourethral transobturator male sling. World J Urol. 2012;30:201-206. 17. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109:328-344.
EDITORIAL COMMENT The authors present a large cohort with relatively long-term follow-up. In contrast to Rehder’s recent report that initial efficacy rates were indeed maintained over a 3-year period,1 this present article notes that the initial success realized with the transobturator sling diminishes over time. Thus, it remains important for investigators to continue to monitor their sling patients and to report the intermediate and longer-term continence status. It is becoming more apparent that careful patient selection is vital for optimizing sling efficacy, as risk factors for sling failure include high pad use/weight, previous stricture, radiation, or artificial urinary sphincter placement, low functional urethral length, poor sling fixation, and a negative repositioning test. Taken together, these risk factors represent more severe sphincteric insufficiency. Although all patients included in this cohort indeed had a positive repositioning test, 58% were cured at 1 year, which is somewhat lower than that reported by Bauer et al,2 who achieved a 83% cure rate in a cohort with similar incontinence severity (median 4.6 pads per day). Nevertheless, despite a decline in the cure rate over time, patient satisfaction is maintained. Thus, it appears that “cure” is not a criterion for “success”. After all, patients generally enter prostate surgery dry, 944
and any postoperative pad use is associated with deterioration in quality of life.3 However, men enter sling surgery wet, and reduction in pad use translates into an improvement in quality of life. Thus most improved patients are satisfied, even if still requiring pads. In addition to adverse preoperative factors, insufficient maintenance of sling tension might also contribute to recurrent incontinence. Use of a resorbable sling is associated with a high rate of sling failure,4 as is insufficient sling tunneling or fixationefor both the transobturator sling and the new quadratic sling. One-year outcomes of the quadratic sling demonstrate higher success with tunneling of the transobturator arms and fixation of the suprapubic arms to the soft tissue over the pubic bone compared with the unfixed device.5 Finally, it appears that there is no “best single option” for all patients; rather there are different devices that might be more appropriate for a particular patient. Even when a sling is adequately tensioned and fixed, there appears to be a ceiling with respect to efficacy with noncircumferential compression. Reports of the various sling devices generally support a cure rate of 50%-60%, with an improvement rate of 75%-85% in properly selected patients.6 Thus, in patients with high volume incontinence and more severe sphincteric dysfunction, the artificial urinary sphincter should be considered the most efficacious option. For those with mild to moderate leakage, a sling might more efficiently balance efficacy and risk. For those with detrusor hypocontractility and mild to moderate leakage, a noncompressive transobturator sling might be most suitable, whereas for those with more substantial leakage who have adequate detrusor contractility, a more compressive device such as the quadratic sling might be preferred. Craig V. Comiter, M.D., Stanford University Medical School, Stanford, CA
References 1. Rehder P, Haab F, Cornu JN, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol. 2012;62: 140-145. 2. Bauer RM, Gozzi C, Roosen A, et al. Impact of the ‘repositioning test’ on postoperative outcome of retroluminar transobturator male sling implantation. Urol Int. 2013;90:334-338. 3. Liss MA, Osann K, Canvasser N, et al. Continence definition after radical prostatectomy using urinary quality of life: evaluation of patient reported validated questionnaires. J Urol. 2010;183:1464-1468. 4. Onur R, Rajpurkar A, Singla A. New perineal bone-anchored male sling: lessons learned. Urology. 2004;64:58-61. 5. Comiter CV, Elliott C, Glowe P. The VIRTUE sling for post-prostatectomy incontinence e a novel method of fixation improves outcome. Neurourol Urodyn. 2012;31:217. 6. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109:328-344.
http://dx.doi.org/10.1016/j.urology.2013.10.066 UROLOGY 83: 944, 2014. Ó 2014 Published by Elsevier Inc.
REPLY Patient selection in all aspects of urology is of utmost importance, and this fact is no different when discussing male stress urinary incontinence (SUI). As nicely outlined in the editorial comment, it seems that the bulk of available literature would UROLOGY 83 (4), 2014
support the use of artificial urinary sphincters (AUS) in men with severe SUI. This device has the longest follow-up data available and has proven to be efficacious even in the most incontinent patients. Because of this, we specifically counsel patients with large volume incontinence toward AUS placement. Patients with less severe incontinence or those unable or unwilling to undergo placement of an AUS, however, should be considered for male sling placement. In our practice, those patients electing sling placement despite an increased severity of incontinence and those with a history of previous radiation are extensively counseled on the potential for less optimal outcomes. Specifically, we believe that the likelihood of “cure” rather than “improvement” in this cohort is diminished. However, we have found that thorough preoperative counseling with this high-risk group does help to temper expectations somewhat and can improve postoperative satisfaction. Since introduction of the AdVance transobturator sling we have preferentially chosen this sling for male SUI. In our practice, we have stopped using bone-anchored slings secondary to not uncommon complaints of pain, presumably from the
UROLOGY 83 (4), 2014
bone anchors and an element of low-grade osteitis pubis. Although the Virtue quadratic sling has been available for a number of years, we believe it is prudent to await the release of further outcomes data before making any determinations regarding patient selection. We would disagree with the inference made in the editorial comment that the Virtue sling offers a middle ground for those patients perceived to be too “wet” for a pure transobturator approach, but not candidates for an AUS. In our opinion, the available published data do not support this algorithm, and we will continue to recommend AUS placement to those patients who we believe are less than ideal candidates for male sling placement. Jack M. Zuckerman, M.D., and Kurt A. McCammon, M.D., Department of Urology, Eastern Virginia Medical School, Norfolk, VA http://dx.doi.org/10.1016/j.urology.2013.10.067 UROLOGY 83: 944e945, 2014. Ó 2014 Published by
Elsevier Inc.
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