Original Paper

Urologia Internationalis

Received: September 22, 2014 Accepted after revision: March 24, 2015 Published online: May 6, 2015

Urol Int 2015;95:406–410 DOI: 10.1159/000381880

Outcomes of Male Sling Mesh Kit Placement in Patients with Neuropathic Stress Urinary Incontinence: A Single Institution Experience Michael Vainrib a, d Polina Reyblat b, c David Ginsberg a, b a c

University of Southern California, Los Angeles, Calif., b Rancho Los Amigos Rehabilitation Center, Downey, Calif., Kaiser Permanente Los Angeles Medical Center, Los Angeles, Calif., USA; d Meir Medical Center, Kfar-Saba, Israel

Key Words Stress incontinence · Neurogenic bladder · Male sling · Outcomes

to treat nSUI. There appears to be a lower success rate for UI resolution, which may be attributable to new onset detrusor failure or wound infection requiring sling removal. © 2015 S. Karger AG, Basel

© 2015 S. Karger AG, Basel 0042–1138/15/0954–0406$39.50/0 E-Mail [email protected] www.karger.com/uin

Introduction

Male stress urinary incontinence (SUI) is an increasingly recognized problem, particularly after treatment for prostate cancer. Possible treatments for male SUI include pharmacological interventions, behavioral modification and surgery. The incidence of SUI is approximately 1 to 3% after prostatectomy for benign disease [1], and has been reported to range from 2.5 to 87% after radical prostatectomy [2, 3]. This wide discrepancy is a result of varying definitions of incontinence and inconsistent methods of data acquisition. There is little dispute that the occurrence of post-prostatectomy incontinence (PPI) has a significant negative impact on a patient’s quality of life [4]. In patients with neurogenic bladder (NB) dysfunction, impaired urethral resistance may occur, particularly in patients with lesions that disrupt the thoracolumbar outflow. Many of these patients have an open bladder neck

The work was performed at Rancho Los Amigos Rehabilitation Center, Downey, Calif., USA.

Michael Vainrib, MD Urology Department, Meir Medical Center 59 Tshernichovsky Street Kfar Saba 44410 (Israel) E-Mail mvainrib @ gmail.com

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Abstract Background and Objectives: The mainstay of therapy in patients with neuropathic stress urinary incontinence (nSUI) has been through the use of artificial urinary sphincter (AUS). AUS infection/erosion rates are higher in nSUI patients and these patients tend to be younger, increasing the likelihood of multiple AUS revisions in the future. We review our experience with mesh male slings for patients with nSUI. Methods: A retrospective review of patients who had mesh sling placement. Results: Twenty patients were identified between 2003 and 2011. 14/20 (70%) (5 = AdVance, 8 = InVance, 1 = Virtue) were available for long-term evaluation; in 6/20 (30%) the sling was removed for either infection or perineal wound breakdown. The mean time from injury to male sling was 148.2 (29–449) months. Pre-/post-op fluorourodynamic study was performed in 13 and 7 patients, respectively. There were no significant differences in ALPP (46.4 vs. 55.7 cm H2O, p = 0.106) and MCC (456.6 vs. 608 ml, p = 0.21) in the 7 patients who had a post-op study: five patients had new onset low bladder compliance and two had new onset detrusor overactivity post-sling. With a mean follow-up of 24.7 (1–66) months, 4/14 (28.6%) had no UI. Conclusions: With short-term follow-up, mesh male slings are a feasible option

Methods A retrospective review of adult patients followed in the urology clinic at Rancho Los Amigos National Rehabilitation Center was performed. For this review, we used an IRB-approved database of NG male patients after polypropylene mesh slings placement between 2003 and 2011. Study variables that were evaluated included patients’ demographic data, type and level of the injury, bladder management, type of the polypropylene mesh sling kit placed in a surgery, UDS results before and after sling placement, clinical incontinence data before/after the mesh sling placement, mesh sling removal data, follow-up period of time after the mesh sling placement and adverse events. All patients but one (Virtue (Coloplast) mesh

Mesh Male Sling in Neuropathic Patients

Table 1. Demographic data, description of injuries, and bladder management

Mean ± SD (range) Age, years At SCI At sling placement Time between DOI and mesh sling placement, months Follow-up time after mesh sling placement, months Level of injury Cervical Thoracal Lumbar MMC Severity of SCI Complete injury Incomplete injury Etiology of injury GSW MVA Fall accident MMC Bladder management at time of surgery CIC Indwelling catheter (transurethral/suprapubic)

25.2±5.2 (18–32) 31.0±8.7 (21–37) 148.2±126.6 (27–449) 24.7±17.3 (1–66) 1 9 1 3 9 2 6 4 1 3 12 2

Values are mean ± SD (range) or number of patients. SD = Standard deviation; SCI = spinal cord injury; DOI = date of injury; MMC = myelomeningocele; GSW = gun shot wound injury; MVA = motor vehicle incident; CIC = clean intermittent catheterization.

sling = 1) underwent AdVance (American Medical Systems; AMS) mesh sling placement after 2010 unless their body habitus did not let the surgeon find appropriate landmarks for AdVance mesh sling placement. Patients underwent InVance (AMS) mesh sling placement between 2003 and 2010. All UDS were performed according to ICS guidelines [17] using Laborie Triton UDS machine with fluoroscopy assistance, that is, FUDS. All male mesh slings (AdVance, InVance and Virtue) were placed using the standard technique [18]. Maximally safe tension was placed on the sling in order to enhance the outlet resistance while attempting to minimize the risk for future mesh erosion into the urethra.

Results

Between January 2003 and December 2011, 20 men with neuropathic SUI (nSUI) underwent mesh male sling placement. Demographic data, description of injuries and bladder management are presented in table 1. Urol Int 2015;95:406–410 DOI: 10.1159/000381880

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and proximal urethral sphincter at rest. Urodynamic study (UDS) usually confirms a low Valsalva leak point pressure (VLPP). The mainstay of therapy for these patients has been the artificial urinary sphincter (AUS) [5] or bladder neck reconstruction [6]. However, the rates of infection and erosion of the AUS are higher in patients with a NB than those with PPI. In addition, patients with NB tend to be younger, thereby increasing the likelihood of multiple revisions over the life of the AUS. At the same time, AUS is reported to have good and immediate continence rates in younger PPI patients [7]. Male slings have long used compression to augment continence. The concept of using compression to aid in male continence dates back to the Kaufman procedures in the early 1960s [8]. A fascial bladder neck sling may provide an alternative approach and can be safely performed separately or at the time of bladder augmentation [9]. Male polypropylene mesh slings provide an alternative surgical treatment for patients with PPI who are not AUS candidates or who elect not to undergo AUS placement. Since their introduction, many versions of the bulbar urethral sling procedures have been used in men. The InVance male sling is a bone-anchored sling with polypropylene mesh and is the most widely studied male sling; it is believed to use a compressive mechanism to treat PPI [10–13]. The AdVance male sling is a transobturator (TOT)placed retrourethral sling that uses polypropylene mesh. The mechanism of action of the AdVance sling is believed to be the repositioning of the external sphincter back into the pelvis [14]. There is limited experience in using mesh male slings in neuropathic patients [15, 16]. In this report we represent our institution experience with mesh male sling placement in neuropathic patients.

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Urol Int 2015;95:406–410 DOI: 10.1159/000381880

Table 2. FUDS variables in failed male sling patients* (n = 7)

FUDS variables

Before sling placement

After sling placement

p

Mean ALPP, cm H2O Mean DLPP, cm H2O NDO (no. of patients) Mean MCC Low compliance (no. of patients)

46.4 n/a 1 456.6

55.7 39.5 4 608.0

0.106† n/a 0.21†† 0.163†

0

5

n/a

* Failed patients (n = 7); † Student’s t test; †† Fisher test. ALPP = Abdominal leak point pressure; DLPP = detrusor leak point pressure; NDO = neurogenic detrusor overactivity; MCC = maximal cystometric capacity; n/a = not available.

rinic treatment for NDO. One patient with NDO and nSUI was offered antimuscarinics. The patient with an indwelling suprapubic tube (SPT) continued to complain of persistent SUI and underwent simple cystectomy with ileal conduit diversion.

Discussion

The management of lower urinary tract voiding dysfunction secondary to neurogenic etiology can be challenging. Potential issues include high intravesical storage pressures, which can lead to upper urinary tract deterioration and/or urinary incontinence, as well as loss of sphincteric competence, which can also contribute to urinary incontinence. The most commonly used option for sphincteric incompetence is the AUS [5, 19]. The AUS has been successful in the management of PPI with infection and erosion rates between 1.5 and 3.5%. In a review about the use of the AUS in patients with NB, Petrou et al. found higher rates of infection and erosion [19]. In addition, in light of the younger age of most patients with NB compared to those with PPI, one would expect a higher percentage requiring revision and/or AUS replacement during their lifetime. This finding was documented by Gonzalez et al. in patients with congenital urinary incontinence treated with the AUS [5]. However, a patient’s satisfaction and continence rates documented in this neuropathic population were higher than in other treatments for nSUI [5]. We have previously described our experience [20] treating nSUI with the use of a puboprostatic sling, which avoids some of the long-term issues seen with AUS. This operation is typically performed using a free graft of recVainrib/Reyblat/Ginsberg

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InVance was implanted in 12/20 patients, AdVance – in 5/20 patients, Virtue – in 1/20 patients and Dacron mesh – in 2/20 patients. 6/20 (30%) patients underwent sling removal within 7.3 ± 5.9 months due to sling infection or perineal wound breakdown. Of the remaining fourteen patients who were available for evaluation, the etiology of nSUI was SCI in 11/14 (79%) and myelomeningocele (MMC) in 3/14 (21%) patients with 8/14 of patients had InVance implanted, 5/14 of patients had AdVance implanted and one patient had Virtue implanted. The mean follow-up after mesh sling placement was 24.7 ± 17.3 (range 1–66) months. Before mesh sling placement 11/14 (79%) patients had complaints of SUI that occurred only during the day; the remaining 3/14 (21%) patients had symptoms of SUI day and night. 10/14 (71%) patients had no prior lower urinary tract reconstructive (LUTR) surgeries. Four patients had prior LUTR before undergoing sling placement: two bladder augmentation enterocystoplasty, one outlet enhancement surgery (bulking agent injection) and one patient bladder augmentation enterocystoplasty and outlet enhancement surgery (bulking agent injection). All patients underwent UDS prior to sling placement except one patient with indwelling suprapubic tube (SPT) and documented nSUI at the time of cystography. All patients underwent evaluation with FUDS prior to surgical intervention. Normal compliance was noted in all patients. In addition, a lack of NDO was noted in all but one patient; the solitary patient with low-level NDO was adequately treated with anticholinergics prior to sling placement. As for the symptoms of SUI and bladder management, post-sling placement, the following was noted: 4/14 (29%) patients were satisfied and continent, 6/14 (43%) patients still complained of urinary incontinence day and night, 1/14 (7%) patient was incontinent during the day only at transfers and rare episodes of urinary incontinence between CIC, 2/14 (14%) patients had an indwelling catheter and 1/14 (7%) patient was lost to follow-up. Repeat FUDS post-sling placement was performed in seven patients with recurrent incontinence (n = 7). Urodynamic findings pre- and post-sling placement in failed male sling patients (n = 7) are noted in table 2. New-onset low bladder compliance and continued nSUI, with no significant change in ALPP, was identified in 5/7 patients. These patients ultimately underwent bladder augmentation enterocystoplasty with puboprostatic sling placement. One patient with neurogenic detrusor overactivity (NDO) and nSUI was recommended to undergo bariatric surgery before planning another outlet enhancement procedure due to severe obesity along with antimusca-

tus fascia placed around the bladder neck or urethra. This treatment is an outstanding option for NB patients with nSUI who are candidates for concomitant bladder augmentation enterocystoplasty and outlet enhancement surgery. The main disadvantage of this treatment is its transabdominal approach. If a patient requires surgery only for SUI, a mesh sling placed via a perineal incision, compared to an autologous sling placed transabdominally, is less morbid with a smaller incision, easier recuperation, shorter hospital stay and less chance of injury to intra-abdominal organs, especially in patients who underwent prior bladder augmentation. Postoperative continence in our study group was achieved in 29% of patients. It is much lower when compared to the larger population studies in PPI patients [21] or in PPI patients after radiotherapy [22] where the continence rates are reported to be between 50 and 80%. One possible reason is our study population, comprised of both SCI and MMC patients, is more complex with both bladder and outlet issues. Five of our failed slings had new onset low compliance bladder (LOC) as well as unresolved nSUI and two failed patients had new onset NDO as well as unresolved nSUI. It is certainly possible that the success rate in this population can be confounded by bladder behavior changes after sling placement [23]. In addition, several patients who failed had no significant difference in VLPP after the sling placement. This could reflect a significantly incompetent outlet that could not be improved by the compressive force of a male sling alone. Recent report in PPI patients suggests that the performance of preoperative ‘repositioning test’ could help in the prediction of successful results after AdVance sling placement [24]. Six out of twenty (30%) patients underwent sling removal soon after placement due to wound infection. This is a higher infection rate than what has been previously reported in the PPI population (3/230 (1.4%)) [25]. Higher infection rates could be related to our specific study population of wheelchair-bound patients. Our patients have constant pressures on their wound, compared to able-bodied, PPI patients who are able to ambulate on their own. This may lead to an increased risk of perineal wound breakdown and a higher infection rate. The issue has also been noted in neuropathic patients after AUS placement [5] as well as in previously described small series with the InVance male sling in neuropathic patients [15]. Based on this data, we recommend that our patients try and decrease pressure on their wound by increasing the number of pressure releases when in the wheelchair and, if possible, decrease the actual time they spend in

their wheelchair during the first few months after surgery. We did not observe the need for sling explantation due to wound breakdown and sling infection in our AdVance male sling patients, which is similar to earlier published experience with AdVance male sling in neuropathic patients [16]. No patients in our and previously published series [15, 16] underwent sling explantation due to urethral erosion although the sling was placed at a bit of higher tension on the urethra than usually recommended in PPI patients. Despite this tension our cure results are lower than in PPI patients, which is similar to previously published data for both InVance and AdVance male slings in neuropathic patients [15, 16]. Most of our patients’ failures like in other studies [15, 16], are secondary failures due to detrusor dysfunction such as low compliance or NDO. The risk of a changing bladder after improving outlet resistance is a potentially significant issue for patients with NB. We did not see any deterioration of the upper tracts in our patient population; however, that is certainly a risk over time. The lack of upper tract damage in our patients may be secondary to early urodynamic evaluation of clinical failures or the fact that the sling tightness may not be enough to result in elevated detrusor storage pressures in the patients that did have new-onset overactivity or loss of compliance. However, it is important to recognize this risk and follow these patients regularly with upper tract studies and urodynamics postoperatively [26, 27]. Our study limitations were a small study population size and its retrospective nature as well as a qualitative description of urinary incontinence before and after sling placement based on medical chart review. Another study limitation was FUDS performance only in failed patients postoperatively as well as in a previously published report [16]. Further prospective studies in a larger population are needed to verify the outcomes of male sling placement in nSUI patients.

Mesh Male Sling in Neuropathic Patients

Urol Int 2015;95:406–410 DOI: 10.1159/000381880

Conclusions

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Male mesh kits are a feasible technique option to treat nSUI. Lower success rates may be attributable to new onset detrusor failure or wound infection (due to constant perineal pressure). It could be suitable and recommended in patients who are not scheduled for a concomitant surgery for detrusor failure; however, the success rate may not be as high as would be expected with an artificial urinary sphincter.

References

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11 Ullrich NF, Comiter CV: The male sling for stress urinary incontinence: 24-month follow-up with questionnaire based assessment. J Urol 2004;172:207–209. 12 Fassi-Fehri H, Badet L, Cherass A, et al: Efficacy of the InVance male sling in men with stress urinary incontinence. Eur Urol 2007; 51:498–503. 13 Rajpurkar AD, Onur R, Singla A: Patient satisfaction and clinical efficacy of the new perineal bone-anchored male sling. Eur Urol 2005;47:237–242; discussion 242. 14 Rehder P, Gozzi C: Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol 2007;52:860–866. 15 Dean GE, Kunkle DA: Outpatient perineal sling in adolescent boys with neurogenic incontinence. J Urol 2009; 182(4 suppl):1792– 1796. 16 Groen LA, Spinoit AF, Hoebeke P, et al: The AdVance male sling as a minimally invasive treatment for intrinsic sphincter deficiency in patients with neurogenic bladder sphincter dysfunction: a pilot study. Neurourol Urodyn 2012;31:1284–1287. 17 Schäfer W, Abrams P, Liao L, et al; International Continence Society: Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn 2002;21:261–274. 18 Wessells H, Peterson AC: Surgical procedures for sphincteric incontinence in the male: the artificial genitourinary sphincter and perineal sling procedures; in Kavoussi LR, Novick AC, Partin AW, Peters CA (eds): Campbell-Walsh Urology, ed 10. WB Saunders, 2011, pp 2299– 2302.

19 Petrou SP, Elliott DS, Barrett DM: Artificial urethral sphincter for incontinence. Urology 2000;56:353–359. 20 Daneshmand S, Ginsberg DA, Bennet JK, et al: Puboprostatic sling repair for treatment of urethral incompetence in adult neurogenic incontinence. J Urol 2003;169:199–202. 21 Bauer RM, Mayer ME, Gratzke C, et al: Prospective evaluation of the functional sling suspension for male postprostatectomy stress urinary incontinence: results after 1 year. Eur Urol 2009;56:928–933. 22 Bauer RM, Soljanik I, Füllhase C, et al: Results of the AdVance transobturator male sling after radical prostatectomy and adjuvant radiotherapy. Urology 2011;77:474–479. 23 Soljanik I, Becker AJ, Stief CG, et al: Urodynamic parameters after retrourethral transobturator male sling and their influence on outcome. Urology 2011;78:708–712. 24 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. 25 Bauer RM, Mayer ME, May F, et al: Complications of the AdVance transobturator male sling in the treatment of male stress urinary incontinence. Urology 2010;75:1494–1498. 26 Cameron AP, Rodriguez GM, Schomer KG: Systematic review of urological followup after spinal cord injury. J Urol 2012; 187: 391– 397. 27 Danforth TL, Ginsberg DA: Neurogenic lower urinary tract dysfunction: how, when, and with which patients do we use urodynamics? Urol Clin North Am 2014;41:445–452.

Vainrib/Reyblat/Ginsberg

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1 Marks JL, Light JK: Management of urinary incontinence after prostatectomy with the artificial urinary sphincter. J Urol 1989; 142: 302–304. 2 Walsh PC, Jewett HJ: Radical surgery for prostatic cancer. Cancer 1980; 45(7 suppl): 1906–1911. 3 Rudy DC, Woodside JR, Crawford ED: Urodynamic evaluation of incontinence in patients undergoing modified Campbell radical retropubic prostatectomy: a prospective study. J Urol 1984;132:708–712. 4 Holm HV, Fosså SD, Hedlund H, et al: Study of generic quality of life in patients operated on for post-prostatectomy incontinence. Int J Urol 2013;20:889–895. 5 Gonzalez R, Koleilat N, Austin C, et al: The artificial sphincter AS800 in congenital urinary incontinence. J Urol 1989; 142: 512–515; discussion 520–521. 6 Rink RC, Mitchell ME: Bladder neck/urethral reconstruction in the neuropathic bladder. Dial Ped Urol 1987;10:5. 7 Campodonico F, Manuputty EE, Campora S, et al: Age is predictive of immediate postoperative urinary continence after radical retropubic prostatectomy. Urol Int 2014; 92: 276– 281. 8 Kaufman JJ: Treatment of post-prostatectomy urinary incontinence using a silicone gel prosthesis. Br J Urol 1973;45:646–653. 9 Raz S, McGuire EJ, Ehrlich RM, et al: Fascial sling to correct male neurogenic sphincter incompetence: the McGuire/Raz approach. J Urol 1988;139:528–531. 10 Comiter CV: The male sling for stress urinary incontinence: a prospective study. J Urol 2002;167:597–601.

Outcomes of Male Sling Mesh Kit Placement in Patients with Neuropathic Stress Urinary Incontinence: A Single Institution Experience.

The mainstay of therapy in patients with neuropathic stress urinary incontinence (nSUI) has been through the use of artificial urinary sphincter (AUS)...
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