Short-term evaluation of the adjustable bulbourethral male sling for post-prostatectomy urinary incontinence

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1 Received: 26 September 2017 Revised: 9 March 2018 Accepted: 23 April 2018 DOI: /luts ORIGINAL ARTICLE Short-term evaluation of the adjustable bulbourethral male sling for post-prostatectomy urinary incontinence Samer Shamout 1 Yu Qing Huang 2 Hani Kabbara 3 Jacques Corcos 1 Lysanne Campeau 1 1 Division of Urology, Department of Surgery, Jewish General Hospital, McGill University, Montreal, Canada 2 Faculty of Medicine, McGill University, Montreal, Canada 3 StatRAC Statistical Research and Analysis Consultancy Firm, Montreal, Canada Correspondence Lysanne Campeau, Division of Urology, Department of Surgery, Lady Davis Institute for Medical Research, McGill University, Jewish General Hospital, E959, 3755 C.te Ste- Catherine Road, Montreal, QC, Canada, H3T 1E2. lysanne.campeau@mcgill.ca Objective: The Argus perineal sling is a minimally invasive surgical option to treat postprostatectomy stress urinary incontinence (PPSUI). This study retrospectively evaluated the short-term clinical outcomes with the Argus sling for PPSUI management and determined the effects of potential preoperative parameters on intraoperative retrograde leak point pressure (RLPP). Methods: In this retrospective review of 16 men with various degrees of stress incontinence after prostatic surgery who underwent Argus sling, PPSUI was evaluated by pad usage, urodynamics, 24-hour pad weight, and validated questionnaires. Findings before and a minimum of 6 months after sling placement were compared. Cure was defined as no pad usage or the use of 1 pad for security; improvement was defined as a reduction in daily pad use by >50%. Results: After a mean (SD) follow-up of months, 62.5% of patients were cured, 18.75% were improved, and 18.75% were still incontinent. Preoperative 24-hour pad weight was positively correlated with RLPP (P =.0121, r = ). Mean RLPP was cmh 2 O. During follow-up, 44% of men had transient perineal or scrotal pain managed conservatively. Sling explantation, reported in 3 of 16 patients, was associated with urethral erosion or previous radiation therapy. Conclusion: The Argus male sling can lead to satisfactory results in carefully selected patients. Increased stress urinary incontinence severity based on 24-hour pad weight required higher RLPP to achieve continence. Favorable satisfaction variables and quality of life scores are affected by appropriate intraoperative tensioning pressure. KEYWORDS male sling, prostatectomy, urinary stress incontinence 1 INTRODUCTION Stress urinary incontinence (SUI) remains a major complication following radical prostatectomy despite improvements in surgical techniques and implementation of minimally invasive procedures. The reported incidence of SUI after prostate surgery is widely variable, ranging from <10% to >80%. 1,2 Surgical therapy is often required in patients who are persistently incontinent despite conservative treatment. Current surgical options include the artificial urinary sphincter (AUS), considered as the gold standard, and various commercially available male perineal slings. Even though AUS has well-recognized superior long-term outcomes, several patients would prefer a minimally invasive non-mechanical sling device. 3 Previous studies have shown that the Argus male perineal sling has good early results with a reasonably low complication rate, and that it could be an alternative surgical option for patients suffering from mild to moderate post-prostatectomy incontinence. 4,5 Adjustable bulbourethral male perineal slings do not require manipulation before voiding, making them an appealing surgical option. 6 In addition, the Argus sling system can have its tension adjusted intraoperatively or in follow-up clinic visits if outcomes of continence are not initially achieved. Lower Urinary Tract Symptoms. 2018;1 6. wileyonlinelibrary.com/journal/luts 2018 John Wiley & Sons Australia, Ltd 1

2 2 SHAMOUT ET AL. To implement the Argus adjustable perineal sling system, surgeons have to consider the intraoperative retrograde leak point pressure (RLPP) for appropriate adjustment. An RLPP of cmh 2 Ois recommended by standards for male slings because it corresponds with the normal physiological pressure exerted on the urinary sphincter. 4,7,8 If the sling is not tightened enough, the patient may remain incontinent. Therefore, the optimal RLPP could be adjusted from measures of the severity of a patient s incontinence prior to the procedure. Herein we describe our experience at a single institution with the Argus male sling and evaluate its short-term efficacy and complication rates. In addition, we determined whether any preoperative parameters were predictive of the intraoperative RLPP. 2 METHODS 2.1 Population We conducted a retrospective chart review identifying all consecutive men who underwent a male Argus adjustable sling at Jewish General Hospital in Canada from February 2013 to August The study was approved by the ethics board of the tertiary care center in which it was conducted. The incontinence was a result of radical prostatectomy in all patients included, except 1 who underwent laser transurethral resection of the prostate. To be eligible for the study, patients had to have had mild to moderate SUI for more than 1 year after surgery. Incontinence severity in the present study was categorized on the basis of 24-hour pad weight, as described previously, 3 as mild Post Prostatectomy Incontinence (PPI) (<100 g/24 h), moderate ( g/24 h), or severe (>400 g/24 h). All patients had failed adequate trial of conservative management for 1 year (all patients had pelvic floor muscle training, with or without electrical stimulation therapy) and required more than 1 incontinence pad per day. Patients with urethral strictures or bladder neck contracture were excluded from the study, as well as those with bladder outlet obstruction or decreased compliance during urodynamic evaluation. All patients were informed regarding risks and benefits of both the Argus sling and AUS and offered the opportunity for AUS implantation as the gold standard treatment of post-prostatectomy SUI (PPSUI). Moreover, patients were instructed concerning the possibility of additional surgical procedures if they were still incontinent after device implantation. Information regarding all baseline characteristics and preoperative evaluation parameters was collected. The evaluation prior to implantation of the sling included a medical history, previous treatments for SUI, history of pelvic irradiation, physical examination, a urodynamic evaluation, a 24-hour pad weight, pad count, and a diagnostic cystoscopy of the bladder, bladder neck, and urethra. All patients were requested to complete validated questionnaires preoperatively and during follow-up. 2.2 Surgical procedure The Argus male perineal sling (Promedon, Cordoba, Argentina) was implanted by 2 experienced surgeons at 1 hospital, as described previously. 4 The Foley catheter was left in situ at the end of the procedure and removed the following morning. Patients are usually discharged from the hospital on Postoperative Day 1. In the current series, the adjustment pressure was manipulated intraoperatively for each subject using a simple standing column manometer and arterial line tubing. The Argus sling is gradually adjusted by tightening the silicone columns through the washers to achieve continence. Correct sling tension was arbitrated if cystoscopy demonstrated coaptation of the bulbar urethra with a discontinuation of water drip. To avoid persistent pain, urethral atrophy and erosion while maintaining efficacy, the sling was positioned with an RLPP in the range cmh 2 O. 2.3 Follow-up Postoperatively, patients were evaluated at 6 weeks, 6 months, 12 months, and yearly thereafter. The primary outcome was evaluated according to pad count over a 24-hour period at the last followup visit. Patients were categorized as either cured if they were not using any pads or were using 1 dry pad for security reasons or as improved if daily pad use was reduced by >50%. Otherwise, the procedure was classified as a treatment failure. Secondary efficacy outcomes were patient response scores on the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and Incontinence Impact Questionnaire (IIQ-7) questionnaires. On the OABSS, scores can range from 0 to 28, with higher scores representing worse symptoms; 9 the ICIQ- SF is measured over the range 0 (minimal symptoms) to 21 (maximum symptoms); 10 and IIQ-7 scores range from 0 to 100, with higher scores representing worse quality of life (QoL). 11 All three tools are valid and reliable self-report questionnaires used to assess patients satisfaction and QoL. Postoperative complications and revision procedures were also recorded. 2.4 Statistical analysis For continuous data, data are presented as the mean SD. To assess outcomes, pre- and postoperative findings were compared using 2-tailed paired t-tests, with P <.05 taken to indicate significant improvements in a given parameter. No imputation was performed to replace missing values; patients with missing values were excluded from the regression analysis. Spearman s rank correlation was used to investigate univariate associations between continuous variables. Factors independently related to variability in RLPP and postoperative questionnaires scores were established through multiple stepwise regression analysis. Statistical analyses were performed using SAS v.9.2 (SAS Institute, Cary, NC, USA). 3 RESULTS 3.1 Patient characteristics In all, 16 male patients were identified with iatrogenic SUI treated with the male perineal sling Argus adjustable system. Mean patient age was 68 6 years (range years) and the mean follow-up duration was months (range 6 18 months). The vast

3 SHAMOUT ET AL. 3 TABLE 1 Patient characteristics majority of patients had mild (37.5%) or moderate (56.25%) incontinence at baseline; 1 patient had severe urinary incontinence. Mean 24-hour pad weight was 155 g (range g), whereas the mean number of pads used per day was 2.4 (range 1 6). Most (93.75%) of the patients included in the present study were incontinent after radical prostatectomy. The mean duration between prostatectomy and insertion of the Argus male sling was 3.2 years (range 1 16 years); of these men, 2 (12.5%) received radiotherapy for local recurrence of prostate cancer before sling implantation. One patient received intravesical Botox injections twice before implantation due to refractory detrusor overactivity (Table 1). Preoperative urodynamic data indicated normal maximal flow and post-void residual (PVR) values with efficient bladder emptying. Three patients (18.75%) had evidence of associated detrusor overactivity. The mean Valsalva leak point pressure (VLPP) and bladder capacity were cmh 2 O and 349 ml, respectively. 3.2 Efficacy outcomes No. patients 16 Age (y) Mean SD 68 6 Range Follow-up period (mo) Mean SD Range 6 18 Body mass index (kg/m 2 ) Mean SD 28 4 Range Prostatectomy Robotic radical prostatectomy 8 (50) Laparoscopic radical prostatectomy 4 (25) Retropubic radical prostatectomy 3 (19) TURP (laser) 1 (6) Previous pelvic irradiation 2 (13) No. pads used/d Mean SD 2.4 Range h pad weight (g) Mean SD Range Time between prostatectomy and sling procedure (y) Mean SD 3.2 Range 1 16 Previous treatment for incontinence a 1 (6) Pretreatment incontinence severity Mild (<100 g/24 h) 8 (50) Moderate ( g/24 h) 8 (50) Severe (>400 g/24 h) 0 (0) Unless indicated otherwise, data are given as the mean SD or as n (%). TURP, transurethral resection of the prostate. a Intravesical Botox injection. PPSUI are desired to determine the true clinical utility of RLPP in these patient populations when treated with an Argus sling system. 3.3 Safety There were no intraoperative complications reported in the patient cohort. The type and incidence of postoperative complications are Overall success rate (defined as patients who were cured and improved) was 87.5% at the first and second assessments 6 and 12 weeks postoperatively. Mean follow-up was 9.75 months (range 6 18 months). The success rate remained constant up to the 6-month follow-up. After this point 13 of 16 patients (81.25%) were noted as being cured or improved: 10 patients (62.5%) were completely dry (cured), 3 (18.75%) had a >50% reduction in daily pad usage (improved), and the procedure was considered a failure in 3 patients (18.75%). The mean pad count decreased from 2.4 (range 1 6) before surgery to 0.5 (range 0 2.5) at the last follow-up (P <.001). The success rates per degree of incontinence are shown in Figure 1. In terms of patient satisfaction and QoL, symptom scores indicated significant improvements in all questionnaires used. The baseline and postoperative outcomes are listed in Table 2. The sling was positioned at a mean intraoperative RLPP of cmh 2 O (range cmh 2 O). Only preoperative 24-hour pad weight was positively correlated with the RLPP attained to achieve continence (P =.0121, r = ). In contrast, body mass index (BMI; P =.558), age (P =.106), and VLPP (P =.1539) had no effect on RLPP. Simple and multiple linear regression analyses were performed to examine whether potential preoperative factors (age, BMI, 24-hour pad test, history of pelvic irradiation, previous incontinence treatment, satisfaction variables, VLPP, maximum cystometric capacity, and bladder compliance) contributed significantly to explain the variability in RLPP. In an attempt to overcome the small sample size, which resulted in the study being underpowered to identify predictive factors, a multiple linear regression model examining the predictive ability of pooled preoperative parameters was used, and showed that pretreatment pad weight with ICIQ-SF score were together significant predictors of the tension required intraoperatively during sling placement, as measured by RLPP (R 2 = 0.44; P =.032; Table 3). However, in the univariable analysis, neither pad weight nor questionnaire score were independent predictors of RLPP in this patient subset. Further studies with long-term data correlating RLPP with treatment outcomes for FIGURE 1 Overall success rate of the Argus sling and success rates stratified according to the degree of incontinence based on 24-h pad weight

4 4 SHAMOUT ET AL. TABLE 2 Efficacy outcomes following the placement of the Argus sling Preoperative At last follow-up ΔScore change (MID) Mean SD Range Mean SD Range P-value Mean SD Range Daily pad count <.001 ICIQ-SF score < IIQ-7 score < OABSS score < P-values were calculated using two-tailed t-tests. ICIQ-SF, International Consultation on Incontinence Questionnaire - Short Form; IIQ-7, Incontinence Impact Questionnaire; MID, minimum important difference; OABSS, Overactive Bladder Symptom Score. TABLE 3 Coefficients for linear regression models in which the dependent variable was retrograde leak point pressure Unstandardized coefficients Standardized coefficients Model β 95% CI β t R 2 P-value Predictors (constant) h pad weight , Preoperative ICIQ-SF score , ICIQ-SF, International Consultation on Incontinence Questionnaire - Short Form. given in Table 4. The most common complication was transient perineal or scrotal pain (44%); this complaint resolved within 4 6 weeks of non-steroidal anti-inflammatory treatment. The 3 sling explantations were performed because of infection associated with urethral erosion in 1 patient and because of failed treatment in the other 2 patients. After complete healing of the erosion following sling explantation, an AUS implantation was performed, which was also complicated by infection that necessitated device removal. Adjustment was necessary in 1 patient with an unsatisfactory outcome after a period of 100 days; this patient required sling tightening under local anesthesia, and the adjustment pressure was increased to 41 cmh 2 O. This patient had a history of pelvic irradiation and preoperative 24-hour pad weight of 311 g. Despite sling tension readjustment, the patient was still using 2 3 pads per day, compared with 4 before initial implantation of the sling. Eventually this patient was planned for AUS placement and sling removal. With regard to the 2nd patient with a poor outcome, at the 6-month follow-up this patient was still leaking urine and using 3 pads per day; he had reported a preoperative count of 4 pads per day and a 24-hour pad weight of 266 g, and his initial sling tightening pressure was 40 cmh 2 O. This patient was offered tension readjustment or AUS placement, but was later lost to follow-up. The mortality rate associated with Argus sling placement was 0%. 4 DISCUSSION Male continence is maintained primarily by the external rhabdosphincter converging around the membranous urethra, thereby preventing urinary leakage during stress maneuvers. Male slings use this concept by applying tension to create a slight, permanent urethral resistance to achieve continence. Considering the risk of overtensioning leading to pain and obstruction or undertensioning reducing the efficacy of the procedure, individualized optimization of intraoperative tensioning with RLPP may improve the success rate of male perineal slings. The TABLE 4 Postoperative complications after Argus sling implantation in the 16 patients in the present study Complication No. (%) Mild perineal or scrotal pain 7 (44) Revision for persistent SUI 2 (13) Erosion/infection 1 (6) De novo urge 1 (6) Total no. complications 11 (69) SUI, stress urinary incontinence. intraoperative RLPP measures the degree of tension placed on the urethra for optimal tensioning and subsequent adjustment. In the present study, several potential preoperative assessment variables were analyzed that may contribute to the prediction of the optimal intraoperative tensioning pressure. We demonstrated that a high 24-hour pad weight predicts more tension required to adjust the sling intraoperatively. This result needs to be interpreted with caution due to the study s small sample size and the lack of comparator group. Kumar et al. 3 recently reported that most patients (92%), when given a choice, prefer treatment with a non-mechanical device. In addition, the sling is much less expensive than the AUS, allowing the patient to maintain physiologic voiding. Therefore, an adjustable male sling is a valuable treatment option for mild to moderate PPSUI in patients who wish to avoid a mechanical device. Nevertheless, longterm randomized control trials are needed to prove long-term durability (8 10 years) of male perineal slings compared with the AUS. The lack of standard definitions for efficacy outcomes and severe PPSUI makes it challenging to compare results between studies. In 2009, Romano et al. 12 published long-term results after Argus male sling implantation, reporting a cure rate of 66% and a social continence rate of 79% after a minimum follow-up of 3 years. 12 In the Argus series by Hübner et al., 13 despite a cure rate of 79.2%, sling adjustment was necessary in almost 39% of patients. In their experience of 100 patients treated with the Argus sling system, Bochove- Overgaauw and Schrier 14 reported a cure rate of 54% after a median follow-up of 27 months. The sparse literature on the Argus sling

5 SHAMOUT ET AL. 5 system, with data on 278 patients and an average follow-up of 33 months, shows an overall cure rate ranging from 54% to nearly 79%; 15 despite best practices and a clear attempt to select appropriate patients, results still vary widely. This could be explained by the broad heterogeneity in study populations, definitions of outcome measures, and sling adjustment pressure. Furthermore, there was considerable variation in the rate of tension adjustments, ranging from 16% to 90%. 15 Another important aspect to be noted is the prior history of radiotherapy and/or refractory detrusor overactivity in the present study cohort, making careful patient selection of greatest importance. The functional effect of the Argus sling is created by a passive increase in intraurethral pressure, sufficient to achieve mucosal coaptation at cmh 2 O. 14 This is estimated from the voiding pressure required to overcome urethral resistance. Bladder contraction strength can be measured from the isometric detrusor contraction pressure (P iso ). The P iso needs to be greater or of equal to the RLPP set intraoperatively to overcome the resistance applied by a compressive sling. 16 This pressure can be simply adjusted by tightening or loosening the sling. The results of the present study indicate similar continence results compared with other male slings, such as the AdVance (AdVance, American Medical Systems, Minnetonka, MN, USA) transobturator male sling and the bone-anchored suburethral synthetic sling. 15,17 In a recent study, Hübner et al. 13 reported a mean sling tightening pressure of 37 cmh 2 O (range cmh 2 O) in a series of 101 patients, findings that are corroborated by the results for the present study cohort, as evidenced by a relatively parallel mean tightening pressure. The present study confirms the earlier efficacy results reported by Hübner et al. 13 of a 79.2% continence rate after a mean follow-up of 2.1 years, based on both the 20-minute pad-weight tests and Urinary Incontinence Quality of Life Scale (I-QoL) questionnaire scores that obviously improved compared with baseline (P <.001). Hübner et al. 13 also established that an average RLPP of 37 cm H 2 O is an appropriate degree of tension to avoid erosion and enable easier sling adjustment. In another study of 100 patients who received an Argus adjustable male sling for the treatment of SUI of varying degrees SUI, Bochove-Overgaauw and Schrier 14 reported an overall success rate (cure and improvement) of 72% after a median follow-up of 27 months and a 55% complication rate. Most complications were of Clavien Grade I II, with significant improvements of visual analog scale and in QoL. 14 In the present study, intraoperative RLPP >37 cm H 2 O led to more favorable patient-reported outcomes of the Argus sling based on ICIQ-SF scores (P <.05), but this result needs to be confirmed in a larger patient population, simultaneously with several validated subjective and objective assessment tools and a parallel comparative tension measurement technique. Hübner et al. 13 preferred a mean RLPP of 37 cmh 2 O, although they initially tightened the sling to 45 cmh 2 O. Until recently, the minimum tension pressure required to achieve continence and diminish adverse events remained a poorly understood component of the continence mechanism. The pressure required to achieve continence and avoid chronic perineal pain remains unknown. In the present study, a significantly higher intraoperative tension was required in patients with a more severe form of incontinence, as measured by 24-hour pad weight before implantation (P =.0121). This finding is in line with a number of previous studies. 19,20 This correlation may be related to surgeon bias, because knowing the severity of incontinence may lead the surgeon to achieve a higher RLPP intraoperatively. No statistically significant association was found for other factors evaluated. The results of the present study do not demonstrate a significant correlation between Abdominal leak point pressure (ALPP) and efficacy outcomes. Sanchez-Ortiz et al. 21 reported that ALPP has been useful in predicting treatment outcome of collagen injection for post-prostatectomy urinary incontinence. However, Nitti et al. 22 reported that ALPP is a relatively poor predictor for the actual evaluation of post-prostatectomy incontinence. In the present study, some patients were slightly more complex; 2 patients (13%) received pelvic irradiation, and another patient had 2 intravesical Botox injections (6%). These procedures could potentially affect efforts to achieve satisfactory results following any surgical intervention for SUI. Despite such challenges, the Argus sling succeeded with a continence rate of 81.25% at a mean follow-up of 9.75 months. We realize that the follow-up period in the present study is relatively short, but most failures were detectable within the first 3 6 months. A longer follow-up period is required to validate claims regarding the durability of the Argus sling. The small sample size is a limitation of the present retrospective study, as is the lack of a comparator group using a different sling tensioning technique. Urodynamic studies and 24-hour pad weight were performed only preoperatively for all patients included in the present study. Furthermore, we did not measure preoperative RLPP during the urodynamic assessment. These values would have been of interest to correlate with intraoperative RLPP prior to tensioning. Finally, in the literature, the Argus sling has been reported to have a mean success rate of only 71%, combined with high explant rate of 17%, over approximately 33 months of follow-up; therefore, it is probably not competitive to either the AUS or AdVance systems. 15 In conclusion, adjustable bulbourethral male slings could be a valuable option for treating male SUI and may be considered in carefully selected patients. Increased severity of SUI based on 24-hour pad weight was associated with a higher RLPP to achieve continence. Ultimately, intraoperative tensioning pressure was positively correlated with postoperative evaluation of patient satisfaction, based on ICIQ-SF results. Better patient selection and an appropriate degree of tension may lead to positive outcomes in this specific group of patients. ACKNOWLEDGEMENTS None. Conflicts of interest None declared. ORCID Samer Shamout Lysanne Campeau

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