Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes

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1 Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes Matteo Ferro*, Danilo Bottero*, Carolina D Elia, Deliu Victor Matei*, Antonio Cioffi*, Gabriele Cozzi*, Alessandro Serino*, Giovanni Cordima*, Roberto Bianchi*, Piero Giacomo Incarbone*, Antonio Brescia*, Gennaro Musi*, Ferdinando Fusco, Serena Detti*, Vincenzo Mirone and Ottavio de Cobelli*,, *Department of Urology, European Institute of Oncology, Milan, Department of Urology, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Department of Urology, University Federico II of Naples, Naples, University of Milan, Milan, Italy, and Iuliu Hatieganu, University of Medicine and Pharmacy, Cluj-Napoca, Romania M.F. and D.B. contributed equally to this work. Objective To evaluate the efficacy and safety of the Virtue â male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). Methods All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, nonrandomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. Results The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1 2 pads/day), while nine patients used 3 5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). Conclusion The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence. Keywords incontinence, radical prostatectomy, male sling, quadratic Introduction Radical prostatectomy is the only treatment for localized prostate cancer shown, in a recent prospective randomized trial, to yield better results than conservative management in terms of absolute reductions in overall mortality, prostate cancer-specific mortality and risk of metastases [1]. Erectile dysfunction and stress urinary incontinence (SUI) are, nevertheless, two significant sequelae of radical prostatectomy. Both conditions may have a great effect on the patient s quality of life, with SUI possibly representing an economic burden as well. According to the literature, post-prostatectomy incontinence rates vary widely, ranging from 2 to 60%, depending on the methodological definition [2], and 4 41% of patients who have undergone robot-assisted laparoscopic prostatectomy are still affected by SUI 12 months after surgery [3]. Treatment includes conservative or surgical management [4]. Unfortunately, conservative treatments, such as pelvic floor muscle training, seem to have limited efficacy [5]. Surgical treatment may be considered when conservative treatment, conducted for a reasonable period (8 12 weeks), fails to be effective [2,6]. BJU Int 2017; 119: wileyonlinelibrary.com BJU International 2016 BJU International doi: /bju Published by John Wiley & Sons Ltd.

2 Virtue sling for post-prostatectomy incontinence A male sling may be able to restore urinary continence by urethral compression or urethral bulb repositioning; however, there is little conclusive evidence of the efficacy of this treatment in the literature, which to date includes only observational studies suggesting a high cure rate (77.4%) [7]. The Virtue â male sling (Coloplast, Humlebaek, Denmark) is a quadratic sling, made of 100% large-pore knitted monofilament polypropylene mesh, providing bidirectional compression and elevation of the bulbous urethra. The aim of the present study was to evaluate the safety and efficacy of the quadratic Virtue male sling. Materials and Methods The aim of the present follow-up study was to assess the efficacy and safety of the surgical procedure 1 year after sling implantation, based on the following measures: 24-h pad weight; daily pad use (pads/day); the Patient s Global Impression of Improvement (PGI-I) questionnaire; and the International Consultation on Incontinence short-form questionnaire (ICIQ-SF). All 29 consecutive patients treated with the Virtue male sling at our institution between July 2012 and October 2013 were included in our prospective, non-controlled study. Inclusion criteria were: radical prostatectomy performed >6 months before enrolment; mild to moderate SUI; urodynamically confirmed SUI; and failure of adequate conservative treatment, such as pelvic floor muscle training or biofeedback, for 8 12 weeks. Patients with severe incontinence were excluded from the study and were treated with artificial sphincter placement. Patients with documented BOO, post-void residual urine volume (PVR) > 150 ml detrusor overactivity, detrusor underactivity, urethral or anastomotic stenosis (assessed by urethroscopy or urethrography) or biochemical/clinical prostate cancer recurrence were excluded from the study. Previous surgical treatment for post-prostatectomy SUI was not among the exclusion criteria, nor were external beam radiotherapy, brachytherapy or cryosurgery, unless performed in the previous 6 months. Preoperative evaluation included history, physical examination and urodynamic testing. Urodynamic evaluation was performed according to Good urodynamic practice [8], with the aim of assessing the severity of SUI, as well as the presence of detrusor hyperactivity and of BOO. Preoperative risk was assessed using the American Society of Anesthesiologists (ASA) score [9]. Complications within 90 days of surgery were recorded and graded according to the Clavien Dindo system [10]. Pre- and postoperative SUI were evaluated using the 24-h pad weight test [11], daily pad use (pads/day) and the ICIQ-SF [12]. Pre- and postoperative bladder capacity, maximum flow rate and PVR were assessed by bladder diary, uroflowmetry and bladder scan, respectively. Patients urinary symptoms were extensively evaluated using: (i) the overactive bladder (OAB) questionnaire [13], a 33-item self-administered tool with an eight-item symptom bother scale and a 25-item health-related quality-of-life scale ranging from 0 to 6, and (ii) the Urinary Symptom Profile (USP) questionnaire, a validated tool consisting of 13 items covering SUI, urge incontinence and frequency (OAB) and voiding symptoms (low stream), with scores ranging from 0 (weaker symptoms) to 9 (for SUI and low stream) and 0 to 21 (for OAB) [14]. Two scales were used postoperatively to rate the satisfaction of the patients: (i) the Patient Global Impression of Improvement (PGI-I) questionnaire, a transition scale based on a single question asking the patient to rate his urinary condition, compared with his pre-treatment condition, ranging from 1 (very much better) to 7 (very much worse) and (ii) the Patient Global Impression of Severity (PGI-S) questionnaire, a single-state scale rating the urinary condition from 1 (normal) to 4 (severe). Both scales had been previously validated on women with SUI [15]. A visual analogue scale (VAS) was further administered before and after surgery to evaluate postoperative pain. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery. The study protocol was approved by the institutional review board of the European Oncology Institute and all patients signed a comprehensive informed consent form after being informed about the procedure, its advantages and disadvantages. All data were recorded by an independent investigator who was not the surgeon that had placed the sling. Sling Placement For the sling procedure, the patient is placed in a dorsal lithotomic position, not extreme, with his knees positioned at 90 degrees. After inserting a 14-F urethral catheter, a 6-cm longitudinal perineal incision is made, exposing the bulbous urethra and pubic rami. The bulbospongiosus muscle is left intact, and the urethra is detached from the perineal body. The insertion of the tendons of the long adductor is an important marker for the transobturator passage obtained with the JH passer. The exit point of the JH will be two fingers below this insertion on the fold of the groin and one BJU International 2016 BJU International 483

3 Ferro et al. finger medially. Once the bulbourethral muscle is isolated and the pubic rame are exposed, the in out passage will be done two fingers below the intersection between pubis and pubic rami in a two o clock direction on the right and a 10 o clock on the left. After passing the sling with its obturator arms, the sling must be tensioned so that the arms stay flat and can perform their function of compression and repositioning of the urethra. The prepubic passage is always obtained with the JH passer. This is an out in passage. The entrance point is above the pubis, and is obtained by cutting the skin on both sides, 2 cm from the median line. During the passage with the hook it is important to avoid lesions to the cord s elements. When the passage is completed, the prepubic arms must be hooked and pulled out. Once the transobturator arms are tensioned and freed from the sleeves, the prepubic arms must be fixed. These are tensioned to the maximum and, with a 0 prolene suture with a CT2 needle, a Z suture is performed with a first throw which unites the periostium with the net in the interesection point between the symphysis and pubic rami, then a second throw only on the median net in order to perform a major lateral traction when tying. At this point the transobturator arms are brought back inside with a subcutaneous passage and the wound must be closed. Statistical Analysis Continuous normally distributed variables are reported as mean with SD values, and continuous non-normally distributed variables are presented as median with interquartilic range. The t- and Mann Whitney U-and Pearson s chi-squared tests were used to compare continuous and categorical variables, respectively. The ICIQ-SF score, 24-h pad weight, number of pads/day and questionnaire scores were analysed using a fixed-effect multivariate ANOVA for repeated measures, with preoperative, 1-, 3-, 6- and 12-month results as dependent variables, and time as repeating factor. For statistical analyses, a two-sided P value < 0.05 was taken to indicate statistical significance. All data were analysed using SPSS version 20.0 (SPSS Inc., Chicago, IL, USA). Results Overall, 29 consecutive patients were included in the analysis. Table 1 summarizes the clinical and postoperative data. The mean patient age was years; 48.3% of the patients (n = 14) were aged 65 years. The median BMI was 24 kg/m 2. With regard to comorbidities, 48.3% of patients did Table 1 Clinical data. Variables Values (N = 29) Age, years BMI, kg/m ASA score, n (%) 1 14 (48.3) 2 13 (44.8) 3 2 (6.9) Previous urological surgery, n (%) Retropubic radical prostatectomy 7 (24.2) Laparoscopic radical prostatectomy 3 (10.3) Robot-assisted radical prostatectomy 19 (65.5) Previous bulking agents, n (%) 2 (6.9) Incontinence severity, n (%) Mild: 1 2 pads/day 21 (72.4) Moderate: 3 5 pads/day 8 (27.6) Severe: >6 pads/day 0 Anaesthesia, n (%) Spinal 16 (44.8) General 13 (55.2) Operating time, min Complications, n (%) 17 (58.6) ASA, American Society of Anesthesiologists. Data are mean SD, unless otherwise indicated. not have significant comorbidities (ASA score 1, n = 14); eight patients (27.6%) had metabolic syndrome and five (17.3%) had diabetes. A total of 65% of patients had undergone robot-assisted radical prostatectomy, and no patient received adjuvant radiotherapy. Only two patients had previously been treated for SUI with bulking agents; none of our patients had undergone sling placement or had artificial urinary sphincter failure. Before surgery, 21 patients (72.4%) had mild incontinence (1 2 pads/day), and eight patients had moderate incontinence (3 5 pads/day). The mean 24-h pad weight was 128 g and the mean preoperative ICIQ-SF score was Sling placement was conducted under general anaesthesia in 55.2% of patients. The mean operating time was ~43 min. No intra-operative blood transfusions were performed. The catheter was removed on the first postoperative day in 27 patients (93.1%). Nearly all patients (28/29) were discharged on the first postoperative day. Complications, all grade I, occurred in 17/29 patients (58.6%). The most frequent complication was scrotal pain, occurring in five patients (17.24%); nevertheless, all five were discharged with a mean VAS of 6.0 (0.54), that after 1 month decreased to 1.2 (0.96; Tables 2 4). At a mean (range) follow-up of 14.5 (12 22) months, the patients had considerable improvements in 24-h pad weight, number of pads/day, ICIQ-SF score, and USP SUI and OAB scores (Table 3, Figs 1 3). 484 BJU International 2016 BJU International

4 Virtue sling for post-prostatectomy incontinence Table 2 Postoperative complications. Complications n (%) Scrotal pain 5 (17.24) Acute urinary retention 3 (10.3) Perineal haematoma 3 (10.3) Fever 2 (6.9) UTI 2 (6.9) Neuropraxia 2 (6.9) Pad weight, VAS score and USP score improved markedly 1 month after the procedure, whereas ICIQ-SF score and number of pads/day improved as of the third postoperative month. One year after surgery, the median scores on the PGI-I and PGI-S questionnaires were, in both cases, 1 (respectively, very much better and normal condition ). Globally, at 12 months follow-up, all patients used 1 pad/day at most, and were satisfied with the outcome of the procedure At 12 months follow-up, all patients maintained a good maximum urinary flow rate (>14 ml/s), in the absence of a significant PVR (<70 ml in all patients). At 36 months follow-up, patients remained globally satisfied and used 1 pad/day at most, with a negligible number of pads/day and pad weight (Table 3). Discussion One of the most burdensome post-prostatectomy sequelae, is SUI, which has a great effect on patients quality of life. If conservative treatments, such as pelvic floor muscle training, are ineffective, invasive therapies, such as male sling placement, must be considered. Several male slings have been developed in the course of the past few years, such as the four-arm transobturator male sling, TOMS (CL Medical, Sainte Foy Les Lyon, France) [16], the AdVance sling [17] and the InVance sling (American Medical System, Minnetonka, MN, USA) [18]. Unfortunately, no randomized controlled trials or follow-up studies have thus far been conducted to evaluate male slings. The procedure was therefore assigned a moderate level of evidence and grade of recommendation (level 3 and grade C, respectively) at the 4th International Consultation on Incontinence 2009, stating that best candidates for the procedure were male patients with lower and moderate degrees of incontinence, without a history of radiation, and with adequate detrusor contractility [2]. In terms of aetiology, post-prostatectomy incontinence may be attributable not only to sphincter damage, but also to perineal and urethral dislocation; therefore, the goal of the suburethral sling is not merely to constitute an outflow obstruction, but to reposition the urethra, thus restoring the position and function of the pelvic floor. Table 3 Postoperative outcomes. Preoperatively 1 month 3 months 6 months 12 months 24 months 36 months P 24-h pad weight <0.05 Mean (SD) ICIQ-SF score n.a. n.a. <0.05 Median (range) number of pads per day 2 (1 5) 1 (1 3) 1 (0 2) 0 (0 1) 0 (0 1) 0 (0 2) 0 (0 2) <0.05 Median (range) USP score: SUI 4 (3 9) 3 (1 8) 3 (1 8) 1 (0 2) 0 (0 1) n.a. n.a. <0.05 Median (range) USP score: OAB 4 (0 10) 6 (0 14) 2 (0 5) 0 (0 1) 0 (0 1) n.a. n.a Median (range) USP score: low stream 0 (0 4) 2 (0 4) 1 (0 4) 0 (0 2) 0 (0 1) n.a. n.a. <0.05 Median (range) OAB questionnaire score 1 (0 5) 2 (0 6) 2 (0 3) 0 (0 2) 0 (0 1) n.a. n.a. <0.05 Median (range) PGI-I score n.a. 3 (1 6) 2 (1 4) 1 (1 2) 1 (1 2) 1 (1 2) 1 (1 2) <0.05 Median (range) PGI-S score n.a. 2 (1 4) 1 (1 2) 1 (1 3) 1 (1 2) n.a. n.a. <0.05 ICIQ-SF, International Consultation on Incontinence short-form questionnaire; n.a., not available; OAB, overactive bladder; PGI-I, Patient s Global Impression of Improvement; PGI-S, Patient s Global Impression of Severity; SUI, stress urinary incontinence; USP, Urinary Symptom Profile. BJU International 2016 BJU International 485

5 Ferro et al. Table 4 Postoperative visual analogue scale score. 1st postoperative day Discharge 1 month 3 months 6 months 12 months P Median (range) VAS score 4 (1 9) 3 (0 8) 0 (0 5) 0 (0 2) 0 (0) 0 (0) <0.05 VAS, visual analogue scale. Fig. 1 Mean 24-h pad weight over the 12 months of follow-up h pad weight Fig. 3 Results of the Patient s Global Impression of Improvement questionnaire over the 12 months of follow-up. Patient Global Impression of Improvement pre OP Pre operatively 1 month 1 month 3 months 3 months 6 months Pads/day used 6 months 12 months 12 months 24 months 24 months 36 months Fig. 2 Mean number of pads/day over the 12 months of follow-up. 36 months As shown by the MRI studies conducted by Soljanik et al. [19], the success rate of the tape placement depends on the reduction in the membranous urethra angle during Valsalva s manoeuvre and not on the compressive manner of the tape. The success rates of male sling placement operations vary depending on the different types of sling used. With regard to month 3 months 6 months 12 months 24 months 36 months the InVance male sling, a tape anchored to the pubic rami with the aim of providing a more durable fixation, success rates range from 13% (dry patients) [20] to 66%, the latter outcome being observed at 4 years follow-up in a series of 62 patients [21,22]. With regard to the AdVance sling, a retrourethral sling placed using the transobturator approach, a study by Cornu et al. [23], conducted on a cohort of 136 patients treated for mild or moderate post-prostatectomy or post-turp incontinence, showed good mid-term (median follow-up 21 months) outcomes, with a 78% success rate and pads/day reductions from 2.1 to 0.6. Age, learning curve and type of prostatectomy did not affect the outcome in a multivariate analysis, whereas previous urethral stricture surgery (P = 0.013) and 24-h pad-test >200 g/day (P = 0.026) were associated with treatment failure [23]. Conversely, Kowalik et al. [24] documented a higher failure rate (27%) in a longterm follow-up and one Clavien IIIb complication, a re-exploration because of a sutured catheter. In the present study we analysed a cohort of 29 patients undergoing Virtue male sling placement after radical prostatectomy and documented a high success rate at 36 months. The Virtue male sling is a quadratic sling providing bidirectional compression and elevation of the bulbous 486 BJU International 2016 BJU International

6 Virtue sling for post-prostatectomy incontinence urethra, and therefore has a reconstructive rather than merely obstructive role. In the present series, patients were subjectively satisfied, with a 12-month PGI-I score < 2 in all 29 cases. In addition, at 36 months, 17/29 patients did not use pads at all and only one patient used 2 pads/day. Moreover, 24-h pad weight was never >30 g. These results are consistent with the published literature. We recorded 17 complications (58.6%), all Clavien Dindo grade I. The most frequent complication was scrotal pain, affecting ~17% of patients. Nevertheless, all except one of our patients were discharged on the first postoperative day. The rate of scrotal pain in the present series was higher than that reported by Cornu et al. [23] and Kowalik et al. [24], but among the patients reporting scrotal pain at discharge in the present study, the mean VAS score 30 days after the procedure decreased from 6.0 to 1.2 and no patient experienced Clavien Dindo grade II or higher complications. All the discussed data derived, however, from mid- or longterm follow-up studies evaluating outcomes of two-arm or bone-anchored slings. With regard to the quadratic sling, the I-STOP TOMS (CL Medical) is a monofilament and nonextensible polypropylene four-arm large sling, an adapted version of the 2-arm TOMS bulbar sling, with the central part placed over the urethra. A prospective study conducted by Grise et al. [16] in 2012, evaluating 103 patients with post-prostatectomy incontinence and following them for 12 months, documented an incontinence improvement rate of 87.0% (59.4% completely dry) and a significant improvement in the quality-of-life scores, with a global satisfaction of 90% and with low perineal pain scores (0.1 VAS score at 12 months) [16]. Moreover, at 12 months, 87% of the patients reported an improvement in pads/day: 59.4% and 20.3% used 0 or 1 pad/day, respectively. Nevertheless, at 3 months, 30% and 32% of patients previously treated with the double-arm non-modified TOMS sling used none or one pad per day, respectively [25]. In the present series, 12 months after placement of the Virtue male sling, 82.7% of patients used no pads/day and 17.3% one pad/day, an excellent short-term outcome. At 36 months of follow-up, 58.6% used no pads/day, but with a negligible mean pads/day weight (7.8 ml). Nevertheless, patients satisfaction remained stable over time, with 25/29 patients reporting a PGI-I score of 1 at 12 and 36 months. Only few studies have evaluated the efficacy and safety of the Virtue male sling. Two clinical trials evaluating the Virtue sling were performed by Comiter et al. [26]. In the first study, 98 male patients with mild, moderate and severe incontinence (37.8%) were enrolled. An objective improvement (defined as an improvement of 50% in pad weight) was achieved in 61.3, 55.1, 53.8 and 41.9% of the patients at 1.5, 3, 6 and 12 months, respectively. Nevertheless, a subjective improvement, as evaluated by the PGI-I questionnaire, was obtained in 56.4, 46.6, 48.1 and 41.9% of the cases at 1.5, 3, 6 and 12 months, respectively, suggesting lower cure rates than those obtained in the present smaller cohort of patients. In the series by Comiter et al. too, as in the present series, no high grade complications were reported and all complications were grade I. The most frequent adverse event was temporary perineal pain (14.3%), reported at a rate slightly lower than that of transient scrotal pain in our population (17%) [26]. The second cohort enrolled by Comiter et al. [26] consisted of 31 patients, a third of whom presented with severe incontinence. The objective of the study was to evaluate a new sling fixation technique. The study aimed to achieve a 50% reduction in pad weight in 85.2, 71.4, 64.3 and 79.2% of the cases at 1.5, 3, 6 and 12 months, respectively. Improvement in PGI-I score was obtained in 80.0, 71.5, 78.6 and 70.9% of the patients at 1.5, 3, 6 and 12 months, indicating significantly higher cure rates as compared with the non-fixed sling. Median 24-h pad weight also improved significantly in this cohort, from 147 to 18 g/day at 12 months, confirming the superiority of the new technique [26]. All complications were grade I, with mild genital paresthesia being the most frequent complication (19.4%). Conversely, in a smaller study by Warner et al. [27], comparing the AdVance with the Virtue sling, higher failure rates were reported with the Virtue sling (~50%), a significantly higher rate than that reported elsewhere in the literature. The present results are encouraging. The new sling appears to obtain, through retrourethral suspension, both urethral compression and perineal repositioning, thus restoring the functional ability of the sphincter. Admittedly, the small number of patients and relatively short follow-up are two major limitations of the present study. We are therefore currently designing a new trial involving a longer follow-up of a larger number of patients, including men affected by severe incontinence, because the multimodal support afforded by the four arms of the Virtue sling may also be of interest for patients with severe incontinence or obese patients. In conclusion, the Virtue male sling appears to be an effective treatment option for low to moderate post-prostatectomy incontinence, as evidenced by both subjective (patient satisfaction) and objective measures. Larger trials are needed to better evaluate the potential of this sling and to compare it with similar devices, in a randomized design. BJU International 2016 BJU International 487

7 Ferro et al. Conflict of Interest None for all authors. References 1 Bill-Axelson A, Holmberg L, Garmo H et al. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med 2014; 370: Abrams P, Cardozo L, Khoury S, Wein A. 4th International Consultation on Incontinence, Paris, July 5 8, Ficarra V, Novara G, Rosen RC et al. Systematic review and metaanalysis of studies reporting urinary continence recovery after robotassisted radical prostatectomy. Eur Urol 2012; 62: Bauer RM, Gozzi C, H ubner W et al. Contemporary management of postprostatectomy incontinence. Eur Urol 2011; 59: Campbell SE, Glazener CM, Hunter KF et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev 2012; 1: CD Silva LA, Andriolo RB, Atallah AN, da Silva EM. Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery. Cochrane Database Syst Rev 2014;9:CD Cerruto MA, D Elia C, Artibani W. 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Neurourol Urodyn 2012; 31: Correspondence: Matteo Ferro, Department of Urology, European Institute of Oncology, Via Ripamonti 435, Milan, Italy. matteo.ferro@ieo.it Abbreviations: ASA, American Society of Anesthesiologists; ICIQ-SF, International Consultation on Incontinence shortform questionnaire; OAB, overactive bladder; PGI-I, Patient s Global Impression of Improvement; PGI-S, Patient s Global Impression of Severity; PVR, post-void residual urine volume; SUI, stress urinary incontinence; TOMS, transobturator male sling; USP, Urinary Symptom Profile; VAS, visual analogue scale. 488 BJU International 2016 BJU International