REVIEW ARTICLE. Accepted for publication 21 April 2011

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1 BJUI REVIEW ARTICLE The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes Blayne K. Welk and Sender Herschorn Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada Accepted for publication 21 April 2011 What s known on the subject? and What does the study add? Long-term cure and improved rates for the bone anchored sling range from 40 88%. Midterm cure and improved rates for the retrourethral transobturator sling rage from 76 91%. Midterm cure and improved rates for the adjustable retropubic sling rage from 72 79%. Potential complications common to all urethral slings include postoperative urinary retention, perineal pain, and urethral erosion/device infection. All male urethral slings have primarily been studied in post radical prostatectomy patients, with inconsistent success among patients with prior pelvic radiation. OBJECTIVE METHODS RESULTS CONCLUSIONS KEYWORDS INTRODUCTION To examine the outcomes and adverse events associated with novel male sling designs described in the last decade. A literature review was carried out using Medline, EmBase, Cochrane Registered Trials Database and the Center for Reviews and Dissemination Database. Three principal slings are described in the literature. The bone-anchored sling has success rates of 40 88%, with some series having a mean follow-up of months. It is associated with a mesh infection rate of 2 12%, which usually requires sling explantation. The retrourethral transobturator sling has a success rate of 76 91% among three large case series with follow-ups of months. There is a low reported explantation rate. The adjustable retropubic sling has a success rate of 72 79% with follow-ups of months. Erosion (3 13%) and infection (3 11%) can lead to explantation. Most male slings have a similar reported efficacy. Most case series define success as either dry or improved. True cure rates are lower. Mid- and long-term data are now available that indicate the male sling is a viable option for PPI. The use of male slings in severe UI, radiated patients, and non-radical prostatectomy patients is still unclear. Further study is needed to try and define criteria for the use of male slings, and to directly compare different procedures. male slings, urinary incontinence, post-prostatectomy incontinence Prostate cancer is the most common solid organ cancer in men. It accounts for 22 28% of all male cancers, and > men are diagnosed a year in the USA and Europe [ 1,2 ]. Mortality rates are estimated at 10%, and are slowly declining [1,2 ]. The improving mortality rates are contrasted by the continued long-term morbidity related to prostate cancer treatment. A significant part of this morbidity is the stress urinary incontinence (SUI) that can result from radical prostatectomy (RP) [3 ]. Risk factors for post-prostatectomy UI (PPI) are advanced age, surgical technique, and RP associated with pelvic radiation or a previous TURP [4 ]. The Prostate Cancer Outcomes Study isolated a population level , doi: /j x x

2 MALE SLINGS cohort of men with localized prostate cancer between 1994 and 1995 and followed them for 5 years [ 5 ]. While there was some improvement in continence between 6 to 12 months after diagnosis, there was little change over the next 4 years. At 60 months after diagnosis, 26% of men used 1 UI pads/day (ppd), and 14% of men felt they had frequent leakage or no control over their urination; 13% of men felt their UI was a significant problem. Almost half of all RPs in the USA are now performed with laparoscopy or robotic assistance [6 ]. Although there is a perception this will lead to improved long-term continence [7 ], a large population cohort study did not find a difference in the need for UI treatment between patients who had a minimally invasive RP and those who had an open RP [ 6 ] ; a meta-analysis showed similar results [8 ]. TURP and simple RP have an associated SUI risk of 1 3% [9,10 ]. Rates of SUI after external beam radiation therapy for prostate cancer have been reported between 1% and 16%, and can occur as a late complication years after treatment [11,12 ]. The initial management of PPI is 6 12 months of conservative therapy consisting of pelvic floor muscle training and behavioural modifications [4 ]. The efficacy of pelvic floor muscle training is unclear, and early improvement in many patients probably represents the natural history of PPI [ 13 ]. If the UI persists, the artificial urinary sphincter (AUS) is the most established treatment option [4 ]. Over the last decade, there has been revived interest in suburethral slings as a treatment option for PPI. The objective of this review is to provide a comprehensive overview of the male sling literature over the past 10 years, with an emphasis on the outcomes and complications of the commonly used male sling systems. METHODS A search strategy was designed for the Medline Database ( weeks 4) which incorporated overlapping medical subject headings and keywords (Appendix 1 ). A similar search strategy was used for the EmBase ( weeks 4) database. A search of the Cochrane Registered Trials Database and the Center for Reviews and Dissemination Database did not return any clinical trials or health technology assessments related to male slings. The reference lists of review articles and retrieved full text studies were examined to ensure that no relevant references were missed. Full text papers were reviewed if the following criteria were met: English language article, published after 2000, and related to male slings for SUI. Conference abstracts were excluded. Studies dealing primarily with neurogenic UI, AUS, urethral bulking agents, conservative SUI treatment, and the adjustable continence therapy system were also excluded. In all, 515 titles and/or abstracts were reviewed and 107 articles met our inclusion criteria, and the full text versions were reviewed, and duplicate series were identified. If a series was an update of a previously reported case series (based on similar authors, study centre, and recruitment period), the most comprehensive report was selected. Only three sling designs [ the bone anchored sling (BAS), the retrourethral transobturator sling (RTS), and the adjustable retropubic sling (ARS) ] had more than one unique case series in the English language literature, and will be the focus of this review. CIs were calculated for the reported success rates (SAS 9.2, SAS Inc, Cary, NC). RESULTS The BAS The BAS compresses the urethra with a silicone-coated polypropylene mesh that is fixed to the bony pelvis; this avoids the need to access the scarred retropubic space. Madjar et al. [14 ] (using synthetic mesh) and Cespedes and Jacoby [15 ] (using organic grafts) reported on this novel method of creating compression of the bulbar urethra by attaching their sling to the inferior pubic... there has been revived interest in suburethral slings as a treatment option for PPI rami with bone screws. Organic sling materials have been shown to degrade [16 18 ], and therefore synthetic mesh is now the primary material for BAS (InVance sling; American Medical Systems [AMS ], Minnetonka, Minnesota, NC, USA). The The BAS compresses the urethra with a silicone-coated polypropylene mesh that is fixed to the bony pelvis degree of sling tension is an important part of this procedure, and many different

3 WELK and HERSCHORN FIG. 1. Percentage of successful outcomes (as defined by the authors) reported in the 12 case series on the BAS (InVance sling ) Percent Success (95% CI) Carmel, 2010 [24] Athanasopoulos, 2009 [23] Gilberti, 2008 [18] Guimaraes, 2008 [27] Fassi-Fehri, 2007 [25] Fischer, 2007 [22] Gallagher, 2007 [26] Castle, 2005 [20] Comiter, 2005 [21] Dikranian, 2004 [16] Onur, 2004 [17] Madjar, 2001 [19] methods have been reported: retrograde perfusion pressure of cmh2o [18,19 ] or >60 cmh 2 O [20 22 ], cough test [16,17,22 ] or maximal compression with or without a urethral catheter in place [23 27 ]. The compressive effect of a BAS on the urethra has been shown with dynamic MRI [24 ]. Ullrich and Comiter [28 ] reported that mean detrusor pressure and maximum voided velocity did not change significantly despite a doubling of the retrograde leak-point pressure (RLPP) from 30 to 60 cmh 2 O. Giberti et al. [18 ] reported a significant increase in the Valsalva leak-point pressure (VLPP) after BAS implantation. It has been hypothesized that the BAS improves continence by causing a degree of urethral obstruction, and allowing better transmission of intra-abdominal pressure to the bulbar urethra [24 ]. In all, 12 unique case series were identified that reported the results of bone anchored slings (Table 1 ) [14,16 18,20 32 ]. Carmel et al. [24 ] reported a case series of 45 men with moderate-to-severe UI treated with the BAS. Success was reported in 76% of men at a median follow-up of 36 months. There was also a significant improvement in 1-h pad weights. Giberti et al. [18,29 ] used 1-h pad weights as their definition of success among 42 men treated with a BAS; a 70% success rate at a median follow-up of 41 months was reported. Significant improvements in male urinary quality of life (QOL) scores [18,26 ] and the Patient Global Impression of Improvement (PGI-I) scores [22 ] have also been reported. Most case series reporting on the BAS used only patient-reported daily pad use as the outcome, with either 1 ppd [20,21,25 ], or dry/improved [14,17,23,27 ] as the primary outcome. Success rates are relatively consistent in these studies at 40 88% ( Fig. 1 ). There is no agreed upon definition of success for this procedure, which makes comparison among series difficult. Many of these case series have poorly defined inclusion and exclusion criteria, which makes the application of their clinical results difficult. The primary population included in these series is RP patients with UI. Of these patients, 9 29% had adjuvant pelvic radiation. In three of these series radiation was a significant risk factor for sling failure [25,27,33 ], in the remaining seven series it was not; no conclusion can be drawn from these seven non-significant analyses due to the small sample sizes. Inclusion of few patients with varying SUI aetiologies, such as neurogenic bladder (0 13%), TURP (4 19%), simple RP (0 31%), and primary radiation therapy for prostate

4 MALE SLINGS FIG. 2. Percentage of successful outcomes (as defined by the authors) reported in the five case series on the RTS (Advance sling). Percent Success (95% CI) Bauer, 2010 [54] Cornel, 2010 [56] cancer (0 5%) make it difficult to discern population-specific outcomes (Table 1 ). Giberti et al. [18 ] and Onur et al. [17 ] did not show that the aetiology of UI was a risk factor for failure, but their sample size is underpowered for such analysis. Multiple series have found that the degree of preoperative SUI is a significant risk factor for failure of the BAS [17,20,22,23,25,27 ]. The long-term durability of the BAS has been shown in three series with follow-ups between 36 and 48 months [18,21,24 ]. Some authors have reported there were no failures after 6 months [17,25,27 ], while others have reported that late failures can occur at any point in follow-up [22,24 ]. BAS adverse events Cornu, 2010 [52] Gill, 2010 [57] Rehder, 2010 [45] Postoperative urinary retention was reported in 0 12% of patients ( Table 1 ). Reasons for this complication are probably related to the urethral compression, in addition to postoperative swelling and pain. In most cases, it was self-limited and resolved in 1 15 days [24 27,31 ]. One series reported two men that had persistent retention after 1 month and both underwent sling loosening [22 ]. Infection of the perineal incision/mesh occurred in 2 12%. These infections usually required removal of the implanted sling to treat the infection. Some superficial infections were successfully treated with antibiotics. In men with postoperative mesh infections, 75% (18/24) required surgical explantation of the sling [18,20,21,23 25,27,34 ]. Most infections occurred early, but late infections at 3 months and 1 year have been reported [24,34 ]. Osteomyelitis is a potential complication of this operation; however, it has only been reported in the French language literature [35,36 ]. Urethral erosion is a well-defined complication in the female SUI population. It has not been frequently reported with the BAS, although it may be associated with infection necessitating sling removal in some patients [22,37 ]. Abnormal postoperative pain or paraesthesia is thought to be from compression or intraoperative disruption of the superficial perineal nerves [38 ], or from healing around the newly placed bone screws. This complication is difficult to characterize because there is no standard level of pain that is considered abnormal. While some series acknowledged that most patients experience mild pain for 1 3 months after surgery [20 ], others reported only those with severe pain that required explantation of the sling [26 ]. The pain generally resolves 3 months [17,20,21,24,27 ], although persistent pain >3 months has been reported [22,25 ]. Sling removal has been reported in two patients for persistent pain [22,25 ]. By compressing the bulbar urethra, the BAS probably alters the bladder outlet resistance. This can cause de novo detrusor overactivity or urinary urgency. Rates have been reported at 0 14%, and have been treated successfully with oral anticholinergics when necessary [18 ]. A single patient required sling explantation due to this complication [25 ]. There is a report of early loosening of one of the bone screws [27 ]. This caused recurrent UI and required a second operation to replace the bone screw. Bone screw dislodgement can happen as a late complication, and has been reported in two patients in the Comiter [21 ] series and in case reports [39,40 ]. The RTS Redher and Gozzi [41 ] initially published the theory and first clinical application of the RTS in They postulated that part of the mechanism of PPI in RP patients is urethral prolapse through the pelvic floor, thereby distorting and weakening residual sphincter function [42 ]. The RTS is passed outside in through the obturator foramen; it is made of polypropylene mesh that is sutured in place on the ventral surface of the bulbar urethra. Tensioning results in cranial displacement of the urethra (AdVance sling; AMS). Sling placement through the obturator fossa limits the sling tension and does not cause urodynamic obstruction [43 ]. In the pilot clinical study by Redher and Gozzi [41 ], they used urethral pressure profiling to show that the membranous urethral length and the mean urethral closure pressure increased. MRI showed that the ventral urethral bulb moved 6 9 mm cranially after RTS placement. Two studies have reported that there is a significant increase in VLPP after sling placement and no change in detrusor voiding pressures [43,44 ]. The basic surgical procedure has been well described [41,42,45 ]. Some important points include tensioning of the sling with the patient in a lower dorsal lithotomy position [46 ], tunnelling the ends of the sling in the s.c. tissue (which is reported to increase sling fixation by 50% [47 ] ), and 6 weeks of reduced activity postoperatively to allow for tissue in-growth and sling fixation [42 ]. There are three large case series that have described the outcomes of the RTS ( Fig. 2, Table 2 [41,43,44,48 56 ] ). Bauer et al. [48,52,53 ], published their most recent case series of 137 men. Strengths of this case series are that the data was prospectively collected on consecutive patients, results of three different surgeons were included, and RTS is passed outside in through the obturator foramen; it is made of polypropylene mesh that is sutured in place on the ventral surface of the bulbar urethra it was limited to a clearly defined population with PPI. A large number of high-volume incontinent patients (median 5 ppd) were included. A success rate of 76% was reported at median follow-up of 27 months, and significant improvements in 1-h pad weight and urinary specific QOL were also

5 WELK and HERSCHORN TABLE 1 Outcomes of case series reporting on the BAS (InVance sling) Study Population description Outcome Number of patients Author, year, characteristics and recruitment period Inclusion/exclusion criteria SUI aetiology and percentage Received RT, % Previous SUI surgery, % Level of SUI, mean ( SD ), or median (range) (evaluated for primary outcome/total) Outcomes Carmel et al., 2010 [24] Prospective, single centre, Inclusion: >1year SUI after RP, no symptomatic OAB, No BNC at present, PSA level stable for 1 year Post-RRP, 93 Post-TURP, (2 30) ppd 39 (70 251) g/1h MUCP 47(17) cmh2 O 45/45 Patient reported success (cure: 0 ppd or improved: 1 2 ppd) 1-h pad test MUCP UCLA/RAND QOL Exclusion: BOO, abnormal bladder compliance, hypocontractile detrusor Athanasopoulos et al., 2009 [23] Retrospective, single centre, Post-RRP, 77 Post-TURP, 7 Post-RT, 5 Neurogenic, (1 12) ppd 43/43 Patient reported success (cure: 0 1ppd or improved: patient satisfied or < 3 ppd with >50% improvement) Giberti et al., 2008 [18,29] Retrospective, single center, Post-RRP, 86 Post-TURP, 12 Post-SP, 2% (65) g/1h I-QOL 25 (10) VLPP 42 (32) cmh 2 O MUCP 37 (21) cmh2 O 42/42 1-h pad test (cure: 0 1 g/1h, or improved: 2 50 g/1h) I-QOL VLPP MUCP Guimaraes et al., 2008 [27] Fassi-Fehri et al., 2007 [25] Prospective, single centre, Fischer et al., 2007 [22] Prospective, single centre, Exclusion: small capacity, low compliance, DO, urethral fibrosis Post-RRP, 94 Post-TURP, 5 Post-SP, 2 Post-RRP, 66 Post-TURP/HIFU, 26 Post-TURP, 8 Post-trauma, 2 Post-RRP, 94 Post-RT, (bulking agents, AUS, other slings) Mild (1 2ppd) to severe ( >5 ppd) 59/62 Patient reported success at 1 year (cure: no ppd or improved: > 50% reduction in ppd and SUI considered small/moderate) (bulking 50/50 Patient reported success (cure: no agents, AUS) pads or improved: 1 ppd) and no de novo urgency or elevated PVR (43) g/24h 62/62 Patient reported success ( significant improvement as measured by PGI-I) Gallagher et al., 2007 [26] Prospective, single centre, Castle et al., 2005 [20] Retrospective, Comiter et al., 2005 [21,28,30] Retrospective, single centre, Dikranian et al., 2004 [16] Single centre Inclusion: 6 months follow-up Exclusion: BOO, detrusor hypocontractility Post-RRP, 94 Post-SP, 3 Neurogenic, 3 Post-RRP, 93 Post-TURP, 5 Post-SP, 2 Post-RRP, 88 Post-TURP, 4 Post-RT, 4 Other, (bulking agents, AUS) 4.5 (1 12) ppd MUDI 57 (10) MUSIQ 30 (19) VLPP 66 (17 194) cmh2 O 19 Mild ( <4ppd) to severe ( >6 ppd) VLPP 46 (5 84) cmh2 O (2.1) ppd (bulking agents, UCLA/RAND PCI 63 AUS) 8 11 Organic: 3.5 ppd Synthetic: 4 ppd 24/31 Overall patient reported success ( <2 ppd) MUDI QOL MUSIQ QOL 38/42 Patient reported success ( 1 ppd) 48/48 Patient reported success ( 1 ppd) UCLA/RAND PCI QOL 32/36 Comparison of cure rate of organic (20) vs synthetic mesh (16) for BAS Onur et al., 2004 [17,31,32] Retrospective, single centre, Post-RRP, 89 Post-RT, 4 Other, Mostly 3 5 ppd, or >5 ppd 46/46 Patient reported success (cure: 0 ppd, improved: 1 2 pp) UCLA/RAND PCI QOL Madjar et al., 2001 [14] Multicenter Post-RRP, 50 Post-SP, 31 Post-TURP, (bulking agents) 4 (2 6) 16/16 Patient reported success (cure: 0 1 ppd or improved: >50% reduction in ppd) *95% CIl (using the exact binomial distribution) calculated with SAS 9.2. **Non-significant results are not included, as all studies were significantly underpowered for subgroup analysis. DO, detrusor overactivity; OAB, overactive bladder; BNC, bladder neck contracture; PVR, postvoid residual urine volume; RRP, retropubic RP; SP, simple RP; HIFU, high-intensity focused ultrasound; RT, radiation therapy; MUCP, mean urethral closure pressure; AUR, acute urinary retention; CIC, clean intermittent catheterization; UCLA-PCI, the University of California at Los Angeles Prostate Cancer Index; I-QOL, Incontinence QOL Questionnaire; MUDI, Male Urogenital Distress Inventory; MUSIQ, Male Urinary Symptom Impact Questionnaire

6 MALE SLINGS Follow-up Complications, % Success: overall % [ 95% CI ]* and secondary outcomes 76 [60 87] Significant improvement in 1-h pad test 0 (0 88)g/1 h Significant improvement in MUCP, 65 (28) cmh2 O Satisfied or very satisfied: 72% Patient reported success: cure, % Patient reported success: improved, % Significant results from subgroup analysis ** Mean ( SD ) or median (range), months AUR Wound infection (2 64) 7 2 (1/1 patient required explantation at 1 year) Perineal paresthesia/ De novo discomfort urgency 22 4 Other 70 [54 83] Significantly worse with higher degree of SUI and RT 24 (4 38) 2 12 (4/5 men required [55 84] Significant improvement in I-QOL, 76 (29) Significantly improved VLPP, 93 (60) cmh2 O No change to MUCP 39 (19) cmh2 O 62 8 Significantly worse with RT 87 [74 93] Significantly worse with RT, previous surgery, higher degree of SUI 76 [62 87] Significantly worse with RT patients, higher degree of SUI 58 [45 70] Significantly worse with higher degree of SUI 58 [37 78] Significant improvement in MUDI, 48 (13) Significant improvement in MUSIQ 16 (20) 40 [24 57] Significantly worse with higher degree of SUI 41 (5 74) 5 (0/2 men required explantation. Both treated with hyperbaric oxygen.) (2/2 men required 6 (1 22) 12 6 (3/3 men required 15 (9 204) 3 6 (2/2 men (3/4 men required required sling revision) 15 (9 21) 3 6 (2/2 men requiring sling explanation) 18 (6 26) 8 (1/3 men required patient: bone screws dislodged Perineal (patient required hematoma patient had sling adjusted for obstructive symptoms 3 Explantation in 1 (the patient patient due to required need for CIC explanation) Majority 79 [65 90] Significant improved in UCLA PCI (343) Significantly worse with previous AUS 48 (24 60) 2 (1/1 required 16 Bone screw dislodgement in 2 patients Organic: 56 Synthetic: 87 Organic: 31 Synthetic: 13 Organic: 18 (14 29) Synthetic: (1/1 required (12 16) 76 [61 87] Significantly worse with higher degree of SUI, organic sling material 18 (6 30) [62 98] (4 20)

7 WELK and HERSCHORN TABLE 2 Outcomes of case series reporting on the RTS (Advance sling) Study Population description Author, year, characteristics and recruitment period Inclusion/exclusion Criteria SUI aetiology Received RT, % Previous SUI surgery, % Preop level of SUI, mean (SD) or median (range) Outcome No. of patients (reported/ available) Outcomes Bauer et al., 2010 [48,52,53] Prospective, single centre, 3 surgeons Bauer et al., 2010 [54] RT only Prospective, single surgeon Bauer et al., 2010 [55] complications only Prospective, Inclusion: failed conservative therapy/other treatment, positive urethral repositioning test, active urethral sphincter. Exclusion: PSA recurrence, DSD, DO Exclusion: negative repositioning test, no attempt at conservative treatment, worsening SUI after adjuvant RT, RT 6 months, BNC, DSD, DO, PVR >50 ml, failed bulking agents 6 months Inclusion: failed conservative therapy/other treatment, positive urethral repositioning test, active urethral sphincter. Exclusion: PSA recurrence, DSD, DO Post-RRP 14 (see Bauer et al. 2010, RT only) 26 5 (1 24) ppd 110 g/1h ( g) I-QOL 55 (25 95) ICIQ-UI SF 17 (5 22) 126/137 Patient reported success at 1 year (cure: no pads/security pad or improved: >50% reduction in pad usage) 1-h pad test ICIQ-UI SF, I-QOL Post-RRP with (2 12) ppd 24/24 Patient reported success (cure: adjuvant RT 90 g/1h no pads/security pad or I-QOL improved: 1 2 pads with 53 (20 78) ICIQ-SF > 50% reduction in pads) 18 (5 22) 1-h pad test I-QOL, ICIQ-UI SF Post-RRP, (1 25) ppd 230/230 Occurrence of a postoperative Post-TURP, 7 complication Other, 1 Cornel et al., 2010 [50] Prospective, multicenter, 2 surgeons, Post-RRP, 94 Post-TURP, 6 14 Mild to severe 35/36 Cure: no pads, and <2 g 24-h pad test VAS Cornu et al., 2010 [49,56] Prospective, single centre Inclusion: SUI on urodynamics, previous RP, failed trial of PFMT Exclusion: Severe UI ( >500 ml pad test/24h or >5 ppd) Post-RRP, 92 Post-TURP, 6 Post-SP, (1 5) ppd 131 g/24h ( g) 136/136 Patient reported success at 1 year (cure: no pads/security pad or improved: >50% reduction in pad usage) PGI-I ( improved score ) Gill et al., 2010 [51] Restrospective, multiple surgeons Post-RRP, (2.6) ppd 33/35 Patient reported success (cure: no pads or improved: <3 ppd) PGI ( better, much better ) Rehder et al., 2010 [41,44] Prospective, single centre, 2 surgeons Inclusions: >12 months conservative therapy Exclusion: > 500 g 24-h pad test, > 5 ppd, DO, urethral stricture Post-RRP or Post-TURP (1 5) ppd 132 (90) g/24h ICIQ-SF 18 (4) VLPP 19 (7) mmhg 118/118 Patient reported success (cure: no pads/security pad or improved: < 2 pads and reduced by >50%) 24-h pad test ICIQ-SF VLPP Davies et al., 2009 [43] Post-RRP, 92 Post-TURP, 8 5 ppd 779 g/24h VLPP 29 (15) mmhg I-QOL 67 (26) 13 Daily pad usage 24-h pad test VLPP I-QOL *95% CI (using the exact binomial distribution) calculated with SAS 9.2. **Non-significant results are not included, as all studies were underpowered for subgroup analysis. DSD, detrusor sphincter dyssynergia; DO, detrusor overactivity; PFMT, pelvic floor muscle training; BNC, bladder neck contracture; PVR, postvoid residual urine volume; RRP, retropubic RP; SP, simple RP; RT, radiation therapy; AUR, acute urinary retention; ICIQ, International Consultation on Incontinence Questionnaire; I-QOL, Incontinence QOL Questionnaire; SF, short form; VAS, visual analogue scale

8 MALE SLINGS Follow-up Complications, % Success: overall % [95% CI ]* and secondary outcomes Patient reported success: cure, % Patient reported success: improved, % Significant results from subgroup analysis ** mean (SD) or median (range), months AUR Wound infection Perineal paresthesia/ pain Other 75 [68 83] Significant improvement in 1-h pad test, 8 (0 320) g/h, P < Significant improvement in I-QOL 63 (29 110) P < and ICIQ-UI SF 8 (0 21) P < 0.001} 50 [29 71] Significant improvement in 1-h pad weight (40 g/1h) Significant improvement in I-QOL 72 (22 110) P = and ICIQ-UI SF 12 (0 21) 9 [2 23] No difference in VAS 78 [70 85] 85% met PGI-I criteria Significantly worse in RT patients 27 (20 37) (See Bauer complications, 2010) (12 33) 16 1 patient had sling erosion, requiring explantation 17 (4 42) (persistent in 1 patient had sling (1 patient required 1/6 patients) erosion, requiring sling incision explantation due to persistent 1 patient had sling AUR) explantation associated with osteitis pubis 9 46 Significantly worse in RT (deep infection required sling Significantly worse in 21 (6) mild dysuria BNC, RT, higher 1 perineal degree of SUI haematoma 60 [42 76] 51% met PGI-I criteria 9 (18) 9 91 [84 95] Significant improvement in 24-h pad weight, 21 (12) g/24h Significant improvement in ICIQ-SF 4 (3) Significant improvement in VLPP 42 (12) mmhg Significant reduction in pad usage (1ppd) Significant reduction in 24-h pad weight, 68g/24h Significant improvement in VLPP 47 (11) mmhg Significant improvement in I-QOL, 87 (25) Significantly worse in RT patients mild pain 2 severe adductor pain

9 WELK and HERSCHORN reported. Cornu et al. [49,56 ] reported a prospective case series of 136 men with PPI of < 5 ppd. The primary outcome was 24-h pad usage, and 78% met the criteria for success at a mean follow-up of 21 months. Rehder et al. [44 ] recently published updated results from their case series of 118 men with PPI with 5 ppd. Overall success rate after a minimum of 12 months follow-up was 91%. Two smaller series have reported on the use of the RTS. Cornel et al. [50 ] reported on 36 men. A stringent definition of cure based on < 2 g/24-h pad test was used, which makes it difficult to compare with other series. Only 9% of men met this definition of cure at 12 months follow-up, but improvement was noted in 46%. Gill et al. [51 ] reported a subjective success rate of 51% (based on the PGI-I scale) and a success rate of 60% (based on pad usage) among 35 men at a mean of 9 months. The population that has the best chance of benefiting from the RTS has not been clearly defined. Rehder et al. [42 ] suggest that patients with severe UI, UI while supine in bed, and prior pelvic radiation are poor candidates for the RTS. The urethral repositioning test has been advocated as a way to predict if a patient s UI is likely to respond to the RTS [42 ]. The urethral repositioning test is performed with the patient in lithotomy position with a flexible cystoscope just distal to the membranous urethra. For a successful test, perineal pressure directed cranially (but not directly into the urethral lumen) should produce cm of circumferential coaptation of the membraneous urethra [42,48 ]. This is distinct from the ability to voluntary contract the urethral sphincter. The use of the RTS in a very select group of patients with a previous RP and adjuvant radiation therapy was reported by Bauer et al. [54 ]. They reported a 50% success rate in 24 men with a median follow-up of 18 months. This lower success rate is consistent with the Bauer et al. [48 ] full series of non-radiated (86%) and radiated (14%) men, in which adjuvant radiation was a risk factor for sling failure. The series of Cornu et al. [49 ] and Rehder et al. [44 ] contained 17% and 3% patients with adjuvant radiation respectively, and both of these studies also found that adjuvant radiation was a risk factor for sling failure. It is difficult to assess the efficacy of the RTS sling in patients with post-turp SUI. There are no case series to date consisting solely of TURP-related SUI. The previously discussed case series included only a small proportion of these patients (6 8% [43,49,50 ] ). As the prostate and its supporting structures remain in place, there should not be significant prolapse of the membranous urethra, and therefore the RTS mechanism may not be applicable. Rehder et al. [42 ] suggest that the RTS sling should only be offered if there is a sphincteric defect between the 5 7 o clock position, and acknowledge the mechanism may be obstructive in these patients. The degree of SUI may be related to the success of all male slings, including the RTS. Cornu et al. [49 ] was the only series that reported a significantly increased risk of failure of the RTS in patients with >200 g pad weight/day. However, subgroup analyses in the other RTS studies were not powered to answer this question [48,50 ]. The durability of the RTS has now been shown over months of follow-up [44,48,49 ]. A small proportion of patients (3 8% [48,49 ] ) have late recurrence of UI. RTS adverse events Acute urinary retention can occur in the immediate postoperative period. The reasons for this may be perineal pain, urethral manipulation, postoperative swelling, or urethral compression (although cadaveric studies showed that < 4% of the RTS tension is directed on urethral lumen [41 ] ). Reported rates range from 3% to21% ( Table 2 ). This can persist for up to 12 weeks before it resolves [44,55 ]. A single case required incision of the sling due to persistent retention [55 ] and two cases of retention lasting 3 5 months [51 ] have been reported. Perineal pain beyond the normally expected postoperative discomfort has been reported in 0 20% of patients undergoing a RTS. Different definitions of postoperative pain probably contribute to the large range. Most of these patients did not require any treatment, and the symptoms abated within 3 months [44,49,55 ]. A single patient had persistent perineal pain throughout follow-up [55 ], and two patients reported significant adductor muscle pain that resolved after 3 months [44 ]

10 MALE SLINGS FIG. 3. Percentage of successful outcomes (as defined by the authors) reported in the three cases series on the ARS (Argus sling). Percent Success (95% CI) Romano, 2009 [63] Hubner, 2010 [65] Bochove, 2011 [64] Postoperative wound infection is a rare complication, and only two cases were reported [55,50 ], one of which required sling explantation. There is a single case report of patient that presented 2 weeks after AdVance sling placement with significant perineal and adductor compartment haematoma [57 ]. This patient had an increased risk of bleeding as he was on anticoagulation for a mechanical heart valve. Postoperative worsening of UI has been reported in three men [50 ]. This may be from the trocar being placed too far dorsally (close to anus) and therefore positioning the RTS to pull open the urinary sphincter [58 ]. Bauer et al. [55 ] reported two patients who required sling explantation: one had a sling mistakenly placed through the urethra at the time of surgery (and did not present until 5 weeks later), and one patient had the sling removed due to osteitis pubis (the sling was not thought to be the primary cause). A case of urethral erosion diagnosed 5 months after placement has been reported [ 59 ], but the sling may have been misplaced at the time of surgery [60 ]. Overall, serious complications that require removal or revision of the RTS are uncommon with only five reported cases [55,50,59 ]. The ARS This sling was based on the success of the Schaeffer et al. [61 ] retropubic urethral bolsters. The sling consists of a silicone foam bolster, ribbed silicone struts and adjustable tensioning washers (Argus adjustable male sling, Promedon SA, Cordoba, Argentina). It is positioned with a trocar that is passed through the perineal membrane, retropubic space and abdominal fascia [ 62 ]. The sling tension is set to a RLPP of 45 cmh 2O [63 ], or 37 cmh2o, which Hubner et al. [64 ] found was associated with significantly less erosion, and Romano et al. [62 ] found was associated with reduced pain and urinary retention. This tension is maintained with the adjustable washers. The primary advantage of this design is that the sling tension can be modified through a superficial suprapubic incision [63,64 ]. Results of the ARS sling have been reported in three case series (Fig. 3, Table 3 [62 65 ] ) and compared to the AUS in a small retrospective cohort study. Romano et al. [62 ] published the initial multicenter case series of 48 men, and a recent update with a mean follow-up of 45 months [65 ]. Preoperative UI is difficult to judge as most patients used a condom catheter or penile clamp. Of the 47 patients available for follow-up, 66% were dry (no pads) and 13% were improved (1 pad); significant improvements in urinary QOL were also shown. Of the men who were dry, 16% required a single adjustment of the sling. Only one patient was unable to achieve continence; the other sling failures all resulted from sling removal for complications. This experience lead to modifications of the ARS to try and address the urethral erosions, fascial erosions, and strut ruptures complications [65 ]. Hubner et al. [64 ] reported on 101 men with a mean follow-up of 26 months. A success rate (defined as a 20-min pad test weight of 0 1 g) of 79% was achieved; 10% of patients required sling loosening for discomfort, and one, two, or three or more tensioning procedures were required in 18%, 3%, and 4% of patients, respectively. Bochove-Overgaauw and Schrier [63 ] retrospectively reviewed their case series of 100 men with a median follow-up of 27 months. Overall success rate (including cured and improved patients) was 72%. Tensioning was preformed once in 24%, twice in 7% and three times in 1% of men. They found that there was some loss of durability over time, with 20% failing over the course of follow-up. Tuygun et al. [66 ] published a retrospective cohort study of 16 men with recurrent UI after AUS erosion. They were treated with either an ARS, or a second AUS. Patients who received the AUS had significantly less pad usage and lower daily pad weights compared with the ARS group. Among the ARS patients, only one patient was cured, despite sling adjustments in the remaining seven patients. There is little guidance on which patients this device should be used in. There are conflicting results as to the impact of radiation: Hubner et al. [64 ] included 22 men who had previous radiation, and reported a good success rate. Bochove- Overgaauw and Schrier [63 ] included 13 The primary advantage of this design is that the sling tension can be modified through a superficial suprapubic incision men with previous radiation therapy; they found that radiated patients had a significantly worse success rate of 15%. ARS adverse events Overall erosion rate was initially reported at 13% [65 ]. This included four patients with immediate urethral erosions (due to pad rotation), one with a washer eroding through the abdominal fascia, and one with a retropubic erosion into the bladder. Hubner et al. [64 ] reported a 13% urethral erosion rate. Bochove-Overgaauw and Schrier [63 ] reported a low urethral/bladder erosion rate of 3%. Infection necessitating sling removal was reported in 3 11% of patients [63 65 ]. Intraoperative bladder perforation was reported in 5 6% of cases [63 65 ]. It was recognised during intraoperative cystoscopy and simply required repositioning of the trocar

11 WELK and HERSCHORN TABLE 3 Outcomes of case series reporting on the ARS (Argus sling) Study Population description Outcome Author, year characteristics and recruitment period Inclusion/exclusion criteria SUI aetiology, % Bochove-Oergaauw and Inclusion: failed >6 Post-RRP, 96 Schrier, 2011 [63] months of PFMT, Post-TURP, 3 Retrospective, supple urethra Post-RT, Exclusion: DO on urodynamics Hubner et al., 2010 [64 ] Single centre Romano et al., 2009 [62,65 ] Prospective, multicenter, Inclusion: >1 year of SUI Post-RRP, 86 Post-TURP, 10 Post-SP, 3 Post-RT, 1 Post-RRP, 81 Post-TURP, 19 Previous SUI surgery, % Preop level of SUI, mean ( SD ) or median (range) Received RT, % 13 13% 2ppd 46% 3 5ppd 41% 6 10ppd min pad test 31 (1 117)g I-QOL 29 (15 62) None 5 (3 8) ppd 29 patients used penile clamp or condom catheter ICIQ-SF 20 No. of patients, included/ total Outcomes 95/100 Patient reported success (cure: 0 1 security pad or improved 1 2ppd and >50% reduction) 101/ min pad test weight of 0 1 g I-QOL 47/48 Patient reported success (cure: no pads or improved: 1ppd) ICIQ-SF *95% CI (using the exact binomial distribution) calculated with SAS 9.2. * *Non-significant results are not included, as all studies were underpowered for subgroup analysis. DO, detrusor overactivity; PFMT, pelvic floor muscle training; RRP, retropubic RP; SP, simple RP; RT, radiation therapy; AUR, acute urinary retention; ICIQ, International Consultation on Incontinence Questionnaire; I-QOL, Incontinence QOL questionnaire; SF, short form. Transient perineal pain was reported in 9 15% of men [63,64 ], and in three of eight patients in the Tuygun et al. cohort [66 ]. Persistent perineal pain was reported for 4 5% of patients [63,65 ] ; a few instances of sling removal for this complication have been reported. Additional complications reported in a single series include urethral strictures in 12%, acute urinary retention in 16% and wound dehiscence in 6% [63 ]. Other sling designs ARS The Remeex sling (Neomedic Inc., Terrasa, Spain) is an alternative ARS that was originally designed for female SUI [67 ]. It is a monofilament polypropylene mesh bulbar urethral sling, which is attached to sutures that are passed through the retropubic space. These sutures are then connected to a s.c. varitensor that sits above the abdominal fascia, and allows the sling sutures to be tensioned on postoperative day 1 using a manipulator that is temporarily left protruding through the incision. This varitensor can be used for future adjustments if necessary. Outcomes in two small case series were encouraging [ 68,69 ]. A multicenter case series of 50 men has been reported [70 ]. Almost all patients needed a second adjustment at 1 4 months. There was a 65% cure rate, and a 20% improvement rate at a median of 32 months of follow-up. Reported complications included 10% rate of bladder perforation, 4% rate of varitensor infection requiring removal, and a 2% urethral erosion rate. Other adjustable slings Inci et al. [71 ] described a bone anchored mesh sling with and a tissue expander that can be used to adjust the amount of urethral pressure postoperatively. Palma et al. [ 72 ] published a case report of an ARS sling (Argus) that was placed via the transobturator approach. Transobturator slings Bauer et al. [73 ] described a cadaveric study of an inside out transobturator sling that compresses the bulbar urethra. Using a similar concept, de Leval and Waltregny [74 ] reported a 45% cure and a 40% improved rate in 20 men; they added the additional step of anchoring the ends of the mesh arms together to prevent sling slippage. Comiter and Rhee [75 ] described a sling (the ventral urethral elevation plus ), which has transobturator and prepubic arms. Grise et al. [76 ] reported that their transobturator sling (I-stop TOMS, CL Medical, Cambridge, MA, USA) cured 30% of men and improved 32%. Transperineal retropubic slings The largest series of retropubic suburethral slings was originally reported by Schaeffer

12 MALE SLINGS Success: overall % [95% CI ]* and secondary outcomes Patient reported success: cure, % Patient reported success: improved, % Significant results from subgroup analysis ** 72 [61 80] Worse in RT patients Follow-up Complications, % mean ( SD ) or median (range), months AUR Wound infection 27 (14 57) 16 8 (6/8 required Perineal paresthesia/ pain Erosion Other 15 (1/15 required 3 urethral/ bladder erosion 12 urethral stricture 6 bladder perforation 1 column rupture 80 [70 87] Significant improvement in I-QOL 63 (16 115) 79 [64 89] ICIQ-SF 6 25 (1 54) 6 (5/6 required urethral erosion (36 54) 6 9 urethral erosion 2 fascial erosion 2 bladder erosion 5 Bladder perforation 2 column rupture et al. [61 ], and then updated by Stern et al. [77 ]. In all, 95 men underwent the procedure, and of the 71 patients available for assessment at a median follow-up of 4 years, 81% considered themselves cured or improved. However, there was a 12% rate of moderate/severe pain, and an 8% rate of urethral bolster removal [77 ]. Wadie [78 ] reported on a similar technique, and reported an 85% success rate, with a 25% rate of postoperative sling re-tensioning. John and Blick [79 ] reported on a retropubic urethral sling that had a 74% success rate at a median follow-up of 36 months. Xu et al. [80 ] used a transvaginal retropubic sling kit to perform a retropubic sling in 26 male patients. Schaal et al. [81 ] reported a modification of the retropubic sling that involved passing the anchoring sutures prepubically and retropubically, and then tying them over the pubic symphysis. Several other authors have reported on their experiences with home-made retropubic slings [82 84 ]. DISCUSSION The male sling has experienced resurgence over the last decade. There were six publications in the 2001 compared with 32 in The dominant slings in the literature include the BAS (Invance), the RTS (Advance), and the ARS (Argus). The BAS places a compressive synthetic mesh over the bulbar urethra and anchors it to the bony pelvis. The literature suggests: 1. Success is achieved in 40 88% of patients. Success usually includes cured patients, and those that are improved ( >50% improvement, 1 2 ppd). Actual cure rates are lower at 16 75%. Results in most cases are durable to 4 years [14,17,18,20 27 ]. 2. Efficacy is reduced in previously radiated patients, perhaps because of periurethral fibrosis that prevents urethral coaptation [20,27,85 ]. 3. Efficacy is reduced in more severe cases of UI, probably because of more severe intrinsic sphincter deficiency [17,20,22,23,25,27 ]. 4. Efficacy is reduced in patients that have failed a previous BAS. Repeat BAS or re-tensioning is not well reported, but it appears to have a poor success rate [22,23 ]. 5. Use of this sling in patients with UI as a result of TURP, simple RP, primary radiation therapy for prostate cancer or neurogenic UI is unclear. Only small numbers of these patients have been studied. 6. Mesh infection is a significant complication, which generally requires removal of the sling. 7. If the patient does not achieve acceptable continence, placement of an AUS is not technically difficult or associated with altered efficacy [22,25,34 ]. The RTS is a transobturator sling that is hypothesized to support the proximal

13 WELK and HERSCHORN urethra and optimize the function of the external urethral sphincter. The literature suggests: 1. Success is achieved in 76 91% of cases at months of follow-up [44,48,49 ], although small case series have shown lower success rates [50,51 ]. Actual cure rates are lower at 9 74%. 2. Efficacy is reduced in previously radiated patients [44,49 ], but careful patient selection may allow some men to achieve good results [54 ]. 3. Use of this sling in patients with UI due to TURP or simple RP is unclear. Few patients have been studied, and the mechanism of action may not be applicable to these patients. 4. Serious complications requiring sling explantation are rare. The RTS sling has been reported as a possible alternative to AUS revision in patients with recurrent UI from AUS-related urethral atrophy: of 19 men who had an RTS added to their AUS, 15 of them became fully continent [86 ]. Half of these men did not require re-activation of their AUS after placement of the sling. Soljanik et al. [87 ] described their attempt to salvage men who had an early (within 1 13 weeks) failure of their first RTS. A second RTS was placed, and this time the sling was fixed with nonabsorbable sutures to the outside of the bulbar urethra. At 17 months follow-up, 72% were dry or using only a security pad. This suggests that early failure of the RTS in some patients may be due to sling loosening or slippage. The ARS is an adjustable retropubic sling that compresses the bulbar urethra. The literature suggests: 1. Success is obtained in 72 79% of men at months [63 65 ]. Actual cure rates are lower at 40 66%. 2. Use of this sling in patients with UI as a result of TURP, RP, or in men with adjuvant pelvic radiation is unclear. 3. After a failed AUS, the ARS is less successful than repeat AUS placement [66 ]. 4. Serious complications requiring sling explantation include erosion rates of 3 13%, and infection rates of 3 11%. When compared to the BAS and RTS, the desirable feature of adjustability must be balanced against the risk of trocar passage through the scarred retropubic space, and the sling explantation rate. The adaptation of this sling via the transobturator route may avoid problems associated with retropubic device passage [72 ]. Many urologists now consider urethral slings to be an acceptable treatment for PPI. To date, BAS, RTS, and 4500 ARS slings have been sold worldwide (personal communication, Lisa Cribb, AMS and Hern á n Lucero Giai, Promedon). The European Association of Urology Guidelines on UI includes male slings as an option for surgical treatment of PPI [88 ]. The Fourth International Consultation on Urinary Incontinence also listed male slings as an alternative [4 ]. In the UK, the National Institute for Health and Clinical Excellence (NICE) stated that the current evidence on the safety and efficacy of suburethral synthetic slings for SUI in men appears adequate to support the use of this procedure; however, a randomized controlled trial is recommended to compare retrobulbar non-compressive male slings, adjustable compression slings, and implanted adjustable compression devices [89 ]. The advantages of male slings compared with the AUS include: no mechanical parts, no need for manual dexterity or device training, immediate efficacy, no need to cycle a device before micturition, no device to deactivate if catheterized, and possibly reduced overall cost. These advantages are clear to patients, and may be as, or more important than their surgeons recommendation. When given a choice between a BAS and an AUS, the BAS was chosen by 92% of patients, and when an AUS was recommended, 25% of men still chose a BAS [90 ]. The articles cited in this review represent the hard work and dedication of many surgeons around the world. The natural cycle of surgical advancement has been well described [91 ]. The evolution of the male sling through the stages of innovation, development, early dispersion, and assessment can be traced in this literature. However, the assessment phase has struggled to provide an evidence-based approach for the use of male slings. A Cochrane systematic review protocol has been opened on the surgical treatment of PPI (including male slings), but results are not yet available [92 ]. Surgical investigators

14 MALE SLINGS have always found it challenging to randomize patients, conceal allocation, obtain suitable sample sizes, and standardize surgical technique. An adaptation of evidence-based medicine has been proposed that takes into account some of these difficulties, and is very applicable to future study of male slings [93 ]. Suggestions include: multiple centres to ensure adequate statistical power, clear inclusion and exclusion criteria to produce a homogenous study population, clear reporting standards, device registries, and higher level study designs (such as true cohort studies or case-control studies). Until this happens, it will not be possible to make evidence-based decisions for the use of male slings in PPI. CONFLICT OF INTEREST Blayne K. Welk: none. Sender Herschorn: Grant funding for clinical trials from Astellas, Pfizer, AMS, Allergan, and Contura. Advisory boards for Pfizer, Allergan, Astellas, and AMS. Speaker for Astellas, Pfizer, AMS. 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