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The impact of prior urethral sling on artificial urinary sphincter outcomes.

Introduction

Stress urinary incontinence (SUI) is a known side effect of prostate cancer treatment, with estimated post-prostatectomy incontinence rates ranging from 5-50%. (1-4) Treatment includes observation, pelvic floor training, urethral bulking agents, male urethral sling (MUS), and artificial urinary sphincter (AUS). Of these options, AUS remains the gold standard for the treatment of severe post-prostatectomy SUI. (5-9)

Urethral slings for the treatment of male SUI was first reported in the 1970s. (1) Since that time, multiple sling systems have been developed. Van Bruwaene and colleagues recently performed an extensive review of the literature on the treatment of male SUI with slings or AUS. Given significant heterogeneity in the literature, they identified success rate for slings varying from 30-90%, depending on the type of sling and definition of success. (10)

Several factors have been associated with persistent incontinence after MUS, including high preoperative pad weight, poor external sphincter coaptation on cystoscopy, and prior pelvic radiation or urethral surgery. (10-12) Retrospective data suggests that patients without these risk factors have lower postoperative pad weights and higher patient satisfaction rates. (11) Also, patient-reported subjective improvement in continence appears to correlate with objective improvements, such as pad weight. (13)

Despite success in appropriately selected patients, up to 20% of males treated with MUS for SUI may experience a decline in their degree of improvement over time. (14,15) In those patients with persistent or recurrent SUI, treatment options include conservative management with pads or a condom catheter, repeat sling procedure, or AUS placement. Several small published series have reported improvements, such as pad reduction and higher quality of life scores, with a repeat sling procedure, and late incontinence recurrence after the primary sling seems to correlate with improved outcomes. (16,17) However, many patients who desire surgical management of their SUI after failed sling, especially in those with early-onset incontinence or other risk factors for sling failure, may benefit from AUS placement in lieu of a repeat sling procedure.

To date, few authors have evaluated device-specific outcomes in patients undergoing AUS placement after prior sling, and there is little information available to counsel this unique set of patients. (18,19) Herein, we sought to compare device-specific outcomes in patients undergoing primary AUS placement with and without a history of MUS for urinary incontinence.

Methods

After obtaining institutional review board approval, we retrospectively identified 990 AUS procedures performed at our institution from 2003-2014. Patients who declined research consent, had underlying neurologic disease, or were less than 18 years old were excluded. Here, we focused on the 540 patients who underwent primary AUS placement, including 30 patients (5.5%) with a history of prior MUS for treatment of SUI. A fellowship-trained urologist performed all AUS implantations over the timeframe of the study (DSE). All AUS devices were AMS800[TM] (Boston Scientific, Inc, Natick, MA, U.S.).

For all AUS placements, a perineal incision was used. The bulbar urethra is isolated circumferentially. The decision to incise, excise, or leave the previously placed urethral sling in situ was made intraoperatively, based on the location of the mesh and extent of peri-urethral scarring. In cases of difficult urethral dissection, a transcorporal approach was used, as has been previously described. (20,21) An abdominal reservoir was placed via a separate abdominal incision, and this was filled with 22 cc of iso-osmotic contrast.

Patient followup and evaluations were performed by charts reviews, mailed questionnaires, and subsequent clinic visits. All patients were evaluated six weeks postoperatively for device activation. Following this, patients are typically followed symptomatically and, as part of our ongoing departmental registry, patients are contacted prospectively via mailing regarding their device.

The primary outcome in this study was the rate of secondary surgery after AUS placement for urethral atrophy, mechanical failure, and device infection/erosion. Continuous features were summarized with medians and interquartile ranges (IQR). Categorical features were summarized with frequency counts and percentages. Device survival was estimated as time from AUS implantation to subsequent repeat surgery (including explantation or device revision for any reason) using Kaplan-Meier survival analysis and cumulative incidence analysis. Most recent followup was defined as the date of subsequent surgery or most recent clinical followup in those patients who did not undergo repeat surgery. Statistical analysis was performed using JMP software package (SAS Institute, Inc. Cary, NC, U.S.).

Results

Clinical/demographic features for the 540 primary AUS placements stratified by the presence of a prior urethral sling are shown in Table 1. There was no significant difference in age or the presence of medical comorbidities. More than 87% of patients had a history of radical prostatectomy and there was no significant difference in the rates of additional cancer treatments, including radiation and androgen-deprivation therapy. Notably, patients who underwent prior MUS had higher rates of urethral collagen injection for SUI compared to those without (23% vs. 9%; p=0.01). Additionally, the median followup was significant longer in those patients without a history of MUS (3.2 years compared with 1.8 years; p=0.008).

Data related to the 30 patients with prior MUS are shown in Table 2. These patients were more likely to receive their sling in the later part of the timeframe that we analyzed. Specifically, over 65% of patients with a history of MUS underwent primary AUS placement between 2011 and 2014. AMS AdVance[TM] slings were the most common device encountered, comprising over 43% of our cohort. Interestingly, 70% of patients required intraoperative sling management in the form of sling excision/incision (37%) or extensive urethrolysis (33%). While not shown here, there was no significant difference in the incidence of device revision based on the need for sling management or urethrolysis (hazard ratio [HR] 1.2; p=0.27). On univariate analysis, overall device failure was similar when patients were stratified by the presence of prior MUS (p=0.20). In contrast, coronary artery disease was associated with a significant increase in the risk for device failure (HR 1.62; p=0.02) (Table 3).

As shown in Fig. 1, three-year device survival was 85% for patients without a history of MUS compared with 70% for patients with prior MUS. However, this did not reach statistical significance (p=0.21). Also, given the potential impact that prior slings may have on specific device outcomes, additional independent cumulative incidence models were created for infection/erosion, mechanical failure, and urethral atrophy. As shown in Fig. 2, there was no significant difference in these specific device outcomes based on history of MUS.

Discussion

Here, we evaluated AUS device outcomes in patients with a history of MUS in order to more appropriately counsel patients regarding postoperative expectations in this unique cohort. We found that patients who underwent MUS for the treatment of SUI prior to primary AUS placement had no significant difference in overall three-year survival than those patients without a prior sling procedure. Additionally, no significant differences were identified in specific device outcomes, including device infection/erosion, mechanical malfunction, and urethral atrophy. This information is useful when counselling patients on treatments for SUI.

Liu and colleagues recently evaluated the American Board of Urology six-month case log data for certifying urologists between 2003 and 2013. Slings represented 48% of the male anti-incontinence procedures performed, while AUS represented 52%. Notably, sling procedures as a percentage of all procedure performed increased by 13% over the 10-year period. (22) Reasons for this trend include ease of placement and patient preference. (10) In fact, it appears that many patients may favour MUS over AUS, despite recommendations from the performing surgeon to pursue AUS placement. (23)

Despite success with slings in a select group of patients, i.e., those with low preoperative pad weights, appropriate external sphincter coaptation on preoperative cystoscopy, and no history of prior radiation or urethral surgery, there are many patients who do not fit these criteria and are better served with AUS. (10-12) Sturm and colleagues identified significantly lower postoperative pad weights and higher patient satisfaction rates after male urethral sling in "ideal" patients who fit into these criteria compared with "non-ideal" patients with one or more risk factors. (11) Importantly, even in the setting of initial improvement, some patients experience a decline in their degree of continence over time with slings. (14,15)

For those patients who desire surgery for recurrent or persistent incontinence, surgeons are faced with the decision to pursue a repeat sling or proceed to AUS placement. Repeat slings are successful in some patients, and an increased success rate has been reported in patients who present with recurrent incontinence further out from their initial MUS. (16,17) On the other hand, outcomes associated with primary AUS placement after prior MUS in the setting of recurrent or persistent incontinence after initial sling placement has been the subject of few studies. (18,19) Ajay and colleagues performed a retrospective analysis comparing outcomes in patients undergoing AUS vs. repeat sling after prior failed MUS. They identified a seven-fold difference in the rate of persistent incontinence in favour of primary AUS placement. (24)

Lentz and colleagues identified similar AUS device survival in patients with and without a prior sling, as well as excellent continence rates at a mean followup of 20.7 months. All prior devices were Advance slings, and the authors report leaving all slings in situ at the time of primary AUS placement, with the cuff placed distally. (18) In contrast, our experience involves patients with multiple types of prior slings placed by many different surgeons. We found significant peri-urethral reaction around the sling, requiring sling incision, excision, urethrolysis, or a combination of these maneuvers in >70% of patients in order to correctly place the AUS cuff in the proximal bulbar urethra, which we feel offers patients the highest chance of treatment success.

AUS revision after previous infection or erosion has been associated with an increased risk for device-related complications, and we hypothesize that alterations to the urethral blood supply and peri-urethral tissue may be the underlying cause for the worse outcomes observed. (25) Given the need for peri-urethral dissection and subsequent foreign body reaction with MUS, it seems plausible that these procedures would result in alterations to the urethral blood flow in a similar manner. Surprisingly, the current analysis did not identify a statistically significant difference in device infection/erosion or urethral atrophy in those patients with a history of prior sling. However, at three years, the overall device survival was 15% lower in the sling-patients. While not statistically significant, this is noteworthy and suggests that longer-term followup is necessary. Certain conditions, such as urethral atrophy, may present later as worsening of urinary incontinence. In our cohort, 65% of patients underwent sphincter placement after 2011, accounting for the shorter followup. This is not surprising, given the increasing rate of sling placement for male SUI, as noted earlier. (22,26) As such, longer-term followup may help to delineate any significant difference in primary sphincter outcomes in those patients with a history of prior MUS.

Our study has limitations. This is a single-surgeon cohort from a high-volume tertiary care centre. The data may not be well-extrapolated to lower-volume practices. Additionally, given the nature of our practice, many of the slings were placed by outside surgeons. Specifically, the patient's preoperative clinical characteristics and intraoperative details at the time of MUS placement could not be assessed. As such, the role that these variables play in the eventual success with primary AUS could not be determined. Finally, patient followup was not standardized. In an attempt to account for the lack of standardized followup, we send out yearly prospective written correspondence to follow up on device status and gain information on functional outcomes.

Conclusion

In conclusion, primary AUS placement remains a viable treatment option for men with persistent or recurrent SUI after prior MUS. However, while not statistically significant, we identified a trend towards lower three-year device outcomes in patients with prior sling compared to those without. As such, longer-term and possibly multi-institutional studies are warranted; in the interim, patients should be counselled regarding the possible increased risk for device-related complications. Additionally, when counselling a patient with prior radiation therapy, higher volume urine leakage, and poor coaptation on cystoscopy, surgeons should give consideration to primary AUS over placement of a sling.

http://dx.doi.org/10.5489/cuaj.3922

Competing interests: The authors report no competing personal or financial interests.

This paper has been peer-reviewed.

References

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(2.) Sacco E, Prayer-Galetti T, Pinto F, et al. Urinary incontinence after radical prostatectomy: Incidence by definition, risk factors, and temporal trend in a large series with a long-term followup. BJU Int 2006;97:1234-41. http://dx.doi.org/10.1111/j.1464-410X.2006.06185.x

(3.) Haglind E, Carlsson S, Stranne J, et al. Urinary incontinence and erectile dysfunction after robotic vs. open radical prostatectomy: A prospective, controlled, non-randomized trial. Eur Urology 2015;68:216-25. http://dx.doi.org/10.1016/j.eururo.2015.02.029

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(7.) Leon P, Chartier-Kastler E, Roupret M, et al. Long-term functional outcomes after artificial urinary sphincter implantation in men with stress urinary incontinence. BJU Int 2015;115:951-7. http://dx.doi. org/10.1111/bju.12848

(8.) 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;177:1021-5. http://dx.doi.org/10.1016/jquro.2006.10.062

(9.) 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; 179:1912-6. http://dx.doi.org/10.1016/jquro.2008.01.048

(10.) Van Bruwaene S, De Ridder D, Van der Aa F. The use of sling vs sphincter in post-prostatectomy urinary incontinence. BJU Int 2015;1 16:330-42. http://dx.doi.org/10.1111/bju.12976

(11.) Sturm RM, Guralnick ML, Stone AR, et al. Comparison of clinical outcomes between "ideal" and "non-ideal" transobturator male sling patients for treatment of post-prostatectomy incontinence. Urology 2014;83:1 186-8. http://dx.doi.org/10.1016/j.urology.2013.12.061

(12.) Kim SW, Walsh R, Berger Y, et al. Male readjustable sling (MRS) system for post-prostatectomy incontinence: Experiences of two centres. Urology 2016;88:195-200. http://dx.doi.org/10.1016/j.urology.2015.10.016

(13.) Gill BC, Swartz MA, Klein JB, et al. Patient perceived effectiveness of a new male sling as treatment for post- prostatectomy incontinence. J Urol 2010;183:247-52. http://dx.doi.org/10.1016/jquro.2009.08.159

(14.) Li H, Gill BC, Nowacki AS, et al. Therapeutic durability of the male transobturator sling: Mid-term patient- reported outcomes. J Urol 2012;187:1331-5. http://dx.doi.org/10.1016/jquro.201 1.1 1.091

(15.) Zuckerman JM, Edwards B, Henderson K, et al. Extended outcomes in the treatment of male stress urinary incontinence with a transobturator sling. Urology 2014;83:939-45. http://dx.doi.org/10.1016/j.urology.2013.10.065

(16.) Martinez EJ, Zuckerman JM, Henderson K, et al. Evaluation of salvage male transobturator sling placement following recurrent stress urinary incontinence after failed transobturator sling. Urology 2015;85:478-82. http://dx.doi.org/10.1016/j.urology.2014.10.016

(17.) Soljanik I, Becker AJ, Stief CG, et al. Repeat retrourethral transobturator sling in the management of recurrent post-prostatectomy stress urinary incontinence after failed first male sling. Eur Urol 2010;58:767-72. http://dx.doi.org/10.1016/j.eururo.2010.08.034

(18.) Lentz AC, Peterson AC, Webster GD. Outcomes following artificial sphincter implantation after prior unsuccessful male sling. J Urol 2012;187:2149-53. http://dx.doi.org/10.1016/jquro.2012.01.119

(19.) Fisher MB, Aggaiwal N, Vuruskan H, et al. Efficacy of artificial urinary sphincter implantation after failed bone-anchored male sling for post-prostatectomy incontinence. Urology 2007;70:942-4. http://dx.doi. org/10.1016/j.urology.2007.07.022

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(22.) Liu JS, et al. male sling and artificial urethral sphincter for male stress urinary incontinence amongst certifying American urologists. Urology 2015;193:e1097. http://dx.doi.org/10.1016/jquro.2015.02.1846

(23.) Kumar A, Litt ER, Ballert KN, et al. Artificial urinary sphincter vs. male sling for post-prostatectomy incontinence--what do patients choose? J Urol 2009;181:231-5. http://dx.doi.org/10.1016/j. juro.2008.1 1.022

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Matthew J. Ziegelmann, MD; Brian J. Linder, MD; Marcelino E. Rivera, MD; Boyd R. Viers, MD; Daniel S. Elliott, MD

Department of Urology, Mayo Clinic, Rochester, MN, United States

Correspondence: Dr. Matthew J. Ziegelmann, Department of Urology, Mayo Clinic, Rochester, MN, United States; ziegelmann.matthew@mayo.edu

Caption: Fig. 1. Kaplan-Meier curve for overall device survival.

Caption: Fig 2. Cumulative-incidence curve for: (A) device infection/erosion; (B) mechanical malfunction; and (C) urethral atrophy.

Table 1. Patient demographics

                      Without sling     With sling (n=30)
                         (n=510)

Age
  Median (IQR)      71.3 (66.1; 75.8)   70.6 (66.4; 79.5)
BMI
  Median (IQR)      28.9 (26.5; 32.1)   27.8 (26.6; 31.1)
Hypertension (%)       348 (68.5)           18 (60.0)
Diabetes (%)            90 (17.7)           3 (10.0)
Cerebrovascular         23 (4.5)             1 (3.3)
  accident (%)
Coronary               132 (26.0)           7 (23.3)
  disease (%)
Radiation (%)          227 (57.9)          19 (67.9%)
Androgen                85 (17.2)           6 (23.1)
  deprivation (%)
Prostatectomy (%)      411 (87.1)           27 (93.1)
Collagen (%)            46 (9.0)            7 (23.3)
Followup
  Median (IQR)       3.2 (0.0-12.0)      1.8 (0.1-10.0)

                     Overall (n=540)     p
                                        value

Age
  Median (IQR)      71.3 (66.1; 75.9)   0.63
BMI
  Median (IQR)      28.8 (26.6; 32.0)   0.35
Hypertension (%)       366 (68.0)       0.30
Diabetes (%)            92 (17.3)       0.28
Cerebrovascular         23 (4.5)        0.76
  accident (%)
Coronary               139 (25.8)       0.75
  disease (%)
Radiation (%)          246 (58.6%)      0.30
Androgen                91 (17.5)       0.45
  deprivation (%)
Prostatectomy (%)      438 (87.4)       0.34
Collagen (%)            53 (9.8)        0.01
Followup
  Median (IQR)       3.0 (0.0-12.0)     0.008

BMI: body mass index; IQR: interquartile range.

Table 2. Urethral sling patient cohort (n=30)

Year of AUS            n (%)
surgery

  2003                2 (6.7)
  2004                0 (0.0)
  2005                1 (3.3)
  2006                2 (6.7)
  2007                1 (3.3)
  2008                1 (3.3)
  2009                2 (6.7)
  2010                1 (3.3)
  2011               3 (10.0)
  2012               7 (23.3)
  2013               6 (20.0)
  2014               4 (13.3)
Sling type
  Coloplast Virtue   4 (13.3)
  AMS AdVance        13 (43.3)
  AMS InVance        3 (10.0)
  Unknown            10 (33.3)
Intraoperative
  sling management
  Incision/partial   11 (36.7)
    excision
  Urethrolysis       10 (33.3)
  None                9 (30.0)

AUS: artificial urinary sphincter.

Table 3. Univariate and multivariate analysis of AUS failure

                       Overall AUS failure

                            Univariate

                     HR (95% CI)       p value

Age               1.025 (0.99; 1.05)    0.06
BMI               0.98 (0.93; 1.02)     0.28
Hypertension      1.26 (0.84; 1.89)     0.26
Diabetes          1.38 (0.86; 2.22)     0.18
Cerebrovascular   1.00 (0.37; 2.72)     1.00
  accident
Coronary          1.64 (1.10; 2.44)     0.01
  disease
Radiation         1.22 (0.81; 1.82)     0.34
Androgen          1.13 (0.68; 1.89)     0.63
  deprivation
Prostatectomy     0.60 (0.345; 1.04)    0.07
Collagen          1.11 (0.62; 1.99)     0.71
Prior sling       1.63 (0.77; 3.46)     0.20

                   Overall AUS failure

                       Multivariate

                  HR (95% CI)    p value

Age
BMI
Hypertension
Diabetes
Cerebrovascular
  accident
Coronary              1.62        0.02
  disease         (1.09; 2.41)
Radiation
Androgen
  deprivation
Prostatectomy
Collagen
Prior sling           1.54        0.27
                  (0.71; 3.32)

AUS: artificial urinary sphincter; BMI: body mass index; CI:
confidence interval; HR: hazard ratio.


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Title Annotation:ORIGINAL RESEARCH
Author:Ziegelmann, Matthew J.; Linder, Brian J.; Rivera, Marcelino E.; Viers, Boyd R.; Elliott, Daniel S.
Publication:Canadian Urological Association Journal (CUAJ)
Article Type:Clinical report
Geographic Code:1CANA
Date:Nov 1, 2016
Words:3636
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