EUROPEAN UROLOGY 56 (2009)

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1 EUROPEAN UROLOGY 56 (2009) available at journal homepage: Platinum Priority Incontinence Editorial by Drogo K. Montague on pp of this issue The AdVance Transobturator Male Sling for Postprostatectomy Incontinence: Clinical Results of a Prospective Evaluation after a Minimum Follow-up of 6 Months Jean-Nicolas Cornu *, Philippe Sèbe, Calin Ciofu, Laurence Peyrat, Sébastien Beley, Mohammed Tligui, Bertrand Lukacs, Olivier Traxer, Olivier Cussenot, Francois Haab Department of Urology, Tenon Hospital, Groupe Hospitalo-Universitaire EST, Assistance Publique-Hôpitaux de Paris (AP-HP), University Paris VI, Paris, France Article info Article history: Accepted September 2, 2009 Published online ahead of print on September 8, 2009 Keywords: Male stress urinary incontinence Prostatectomy Male sling Transobturator Abstract Background: Transobturator male slings have been proposed to manage stress urinary incontinence (SUI) after prostatic surgery, but data are still lacking. Objective: To determine the safety and prospectively evaluate the clinical outcome after management of SUI after prostatic surgery by placement of a transobturator male sling. Design, setting, and participants: We conducted a prospective evaluation on 102 patients treated in a single center between 2007 and 2009 for mild to moderate SUI following prostatic surgery. Interventions: Placement of a suburethral transobturator sling and clinical followup. Measurements: Patients were evaluated by medical history, preoperative urodynamics, maximum flow rate measurement, 24-h pad test, and daily pad use. During follow-up, data on patients pad use, complications, and answers to the Patient Global Impression of Improvement (PGI-I) questionnaire were collected. Cure was defined as no pad usage or one pad for security reasons and improvement as reduction of pads 50%. Median follow-up was 13 mo (range: 6 26). Results and limitations: Most patients (95%) presented post radical prostatectomy incontinence (PRPI). Hospital stay was 2 d in 97 cases, and all patients were catheterized for 24 h except two (48 h). Of 102 patients, 64 were cured, 18 were improved, and 20 were not improved. According to the PGI-I questionnaire, 85%, 11%, and 4% of patients described a respectively better, unchanged, and worse urinary tract condition, respectively. Previous radiation was associated with higher rate of failure ( p = 0.039). Neither severe complication nor postoperative urinary obstruction was noted during follow-up. Conclusions: Placement of a transobturator sling is a safe and effective procedure, giving durable results after >1 yr of follow-up. Further evaluation and high-quality controlled, randomized studies are needed to assess long-term efficacy and precise indications of this procedure for post prostatic-surgery SUI management. # 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Urology Department, Tenon Hospital, 4 rue de la Chine, Paris Cedex 20, France. Tel ; Fax: address: jncornu@hotmail.fr (J.-N. Cornu) /$ see back matter # 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 924 EUROPEAN UROLOGY 56 (2009) Introduction Male stress urinary incontinence (SUI) due to urethral sphincter dysfunction after prostate surgery is a problem that is well known to urologists. Its incidence varies from 1% after transurethral resection [1] to 84% after radical prostatectomy (RP), depending on the definition used for postprostatectomy incontinence (PPI) [2]. Patients quality of life is usually deeply affected by this side effect of surgery [3]. Treatment modalities include nonsurgical options like behavior modification and pelvic floor muscle training (PFMT), with moderate success, during the year following RP [4,5]. No pharmacologic treatment has been shown effective in randomized, controlled trials. Nevertheless, anticholinergic treatment could be useful if urge incontinence symptoms occur. Duloxetine seems to improve symptoms [6,7] and is commonly used off label. Surgical options include balloon compression devices [8,9]; periurethral injections of bulking agents [10] show relatively weak success rates. The established treatment remains the artificial urinary sphincter (AUS) implantation, which has good results in terms of continence and quality of life, particularly on longterm evaluation [11]. However, this option requires the patient to have enough mental capacity to use the device and can fail by cuff erosion, infection, or mechanical problems. The concept of passive external urethral compression by a sling has been introduced as a simpler and less expensive treatment option for PPI. Many types of prosthesis have been proposed. Bone-anchored slings are efficient but also lead to such complications as pain and infection, sometimes needing explantation [12 16]. Readjustable sling systems also have provided encouraging results [17], as has incorporation of an anterior rectus fascial sling into a radical retropubic prostatectomy [18]. A functional retrourethral sling (AdVance, American Medical Systems, Minnetonka, MN, USA) has already been presented as a new and innovative treatment using a transobturator approach [19]. A short-term study showed strong efficacy of this male sling in PPI management [20].In order to assess the outcome of this treatment, we evaluated the clinical results with a minimum of 6-mo follow-up after management of mild to moderate PPI with the AdVance male transobturator sling. 2. Patients and methods 2.1. Population A prospective evaluation was conducted on patients treated for SUI from April 2007 to December 2008 in one institution. All patients presenting the following criteria were included: history of prostate surgery, symptoms of SUI assessed by clinical examination, urodynamic diagnosis of SUI, adequate trial of nonsurgical treatment by PFMT or physiotherapy. Patients presenting a 24-h pad test of <500 ml or using more than five pads per day (severe incontinence) were excluded from this evaluation. Informed consent was obtained from all patients before entering the study. The degree of incontinence was evaluated by number of pads used per day and by 24-h pad test and was defined as either mild incontinence (use of one or two pads per day) or moderate incontinence (use of three or four pads per day), as previously described [14]. All patients underwent urodynamics preoperatively to confirm SUI, to study detrusor activity, and to assess maximum flow rate (Q max ) and postvoid residual (PVR) volume. Each patient had a preoperative endoscopy to eliminate a urethral stenosis. Every patient had an immediately preoperative urine examination to check urine sterility. Our evaluation included 102 patients. Mean patient age was 67.1 yr (range: 54 84). Type of prostate surgery followed by incontinence was RP in 95 cases, transurethral resection in 5 cases, and adenomectomy in 2 cases. Seventeen patients underwent pelvic irradiation before placement of the urethral sling as an adjuvant therapy after either RP (14 patients) for prostate cancer (PCa) or transurethral resection of the prostate (TURP; 4 patients) if pathologic examination of resection samples led to PCa diagnosis. All patients but one underwent adequate trial of nonsurgical treatment by PFMT. One patient had been treated with a balloon compression device before surgery. Preoperatively, 24 patients were treated by oxybutinine or trospium chloride, although only 8 were presenting objective detrusor overactivity. At diagnosis, 74% (75 of 102) of patients were presenting mild incontinence and 26% (27 of 102) of patients were presenting moderate incontinence. Preoperative endoscopic examination showed bladder outlet obstruction in four patients; one was treated by preoperative prostate resection, one by preoperative urethrotomy, one by intraoperative cervical incision, and one by intraoperative dilatation. All preoperative urine pathologic examinations were sterile. Patient characteristics are presented in Table Surgical procedure All patients were operated on according to the same protocol. Surgical procedure was conducted under general or locoregional anesthesia on the basis of the technique already described [19] Follow-up Perioperative information was collected before the patient left hospital and at 1-mo follow-up. The data collected were duration of catheterization (hours); hospital stay (days); immediate complications, such as urinary retention after catheter ablation, fever, bleeding, or hematoma; and evolution of a perineal wound. Patients were allowed to leave hospital if PVR volume, measured by bladder scan, was <100 ml. After the first postoperative visit at 1 mo, follow-up consisted of a visit at 6 mo, 12 mo, and yearly thereafter. Each patient had a physical examination and evaluation of Q max and PVR volume and was asked to answer the Patient Global Impression of Improvement (PGI-I) validated questionnaire to evaluate satisfaction [20]. Number of pads used per day was the major outcome noted. Patients were considered cured (ie, dry) if they used no pads or an occasional pad for security reasons and were considered improved if the daily use of pads was both less than two and reduced by at least 50%. Otherwise, they were defined as not improved Statistical analysis Comparisons among preoperative and postoperative pad use, PVR, and Q max were done with the student t test. Rates of the male sling success were compared among several factors. Fisher exact test was used to assess statistical differences, with p < 0.05 considered significant. All statistical analysis was done with Statview (SAS Institute, Cary, NC, USA). 3. Results 3.1. Efficacy Median follow-up was 13 mo (range: 6 26; mean: ). The 102 patients were classified in one of the three

3 EUROPEAN UROLOGY 56 (2009) Table 1 Patient characteristics (n = 102) Variable Data Age (a) (yr) (range: 54 84) ASA score (b) ASA 1 15 (14.7) ASA 2 64 (62.7) ASA 3 24 (22.6) ASA 4 0 (0) Prostate surgery (b) Radical prostatectomy 95 (93.1) Retropubic 41 Laparoscopic 54 Prostatic adenomectomy 2 (1.9) TURP 5 (5) Pelvic irradiation (b) 17 (16.7) After RP 14 After TURP (1 21) Pelvic muscles exercises (no. sessions) (a) (0 80) No. pads used per day (a) (1 5) Pad test (24 h) (a) (10 500) Q max (ml/s) (a) (4 43) Time interval between prostate surgery and sling procedure (yr) (a) ASA = American Society of Anesthesiologists; RP = radical prostatectomy; TURP = transurethral resection of the prostate. (a) Results are given as mean plus or minus standard deviation (range). (b) Results are given in numbers of patients with percentages in parentheses. groups described previously: cured, improved, or not improved. Overall, 64 patients were cured (socially continent and using no pads); 18 patients were improved; and 20 patients were not improved an overall success rate of 80% (including cured and improved patients). At last follow-up, global pad use was highly significantly reduced compared to patients preoperative situations ( p < ; Table 2). The success rate was durable because only six patients initially classified as cured at the 6-mo visit subsequently had to wear pads again during evolution (Fig. 1). Evaluations by PGI-I questionnaire at last follow-up in the success group and in the failure group are shown in Table 3. Overall, 87 of 102 patients treated felt at least better than before their intervention (Fig. 2). Four patients declared feeling worse than before the procedure. In the group of 17 patients who received pelvic irradiation, treatment was successful in 10 cases (59%; 9 cured and 1 improved) and failed in 7 (41%, not improved); these rates were respectively 85% and 15% in patients without history of radiation. These data show a statistically significant trend in previous radiation predicting success ( p = 0.039). All of the other data assessed (age younger or older than 67 yr, preoperative DO, prepad incontinence Fig. 1 Percentage of pad-free patients during follow-up visits (in months). Dotted line represents the 95% confidence interval. degree) did not show statistically significant relationships with success rate Safety The urethral catheter was left in place 24 h postoperatively in all but two cases because of voiding difficulties after catheter ablation. These two patients, who were treated preoperatively by oxybutinine or trospium chloride, were recatheterized for 1 d, and no problem recurred. No suprapubic catheter was used. Hospital stay was 2 d in 97 cases, 3 d in 4 cases, and 6 d in 1 case. No major side effect was noted in the immediate follow-up. Two superficial infections of the perineal wound, four cases of perineal pain, and two cases of perineal paresthesia were noted, with spontaneous complete resolution after 1 mo. Mild dysuria was noted in 10 cases at the 1-mo postoperative visit, and then spontaneously improved. No case of acute urinary retention was noted. At last follow-up, Q max and PVR volume were not statistically different from preoperative values (Table 2). No severe side effect was noted at the end of follow-up (no infection, no erosion, and no reoperation). 4. Discussion After the success of this approach to cure women s SUI with highly satisfactory results [21], placement of a transobturator male sling has been described as a new option to treat SUI after prostate surgery [19]. Other variants of the transobturator male sling have been proposed [22], but to our knowledge, there are no available study results on >20 patients and >6-mo follow-up. In this paper, we have presented the largest and longest intent-to-treat, prospective evaluation using an out-in Table 2 Comparison of pad use before and after surgery (all patients at follow-up) Variable Before surgery, median (range) [mean SD] At last follow-up, median (range) [mean SD] p value Pads used daily 2 (1 5) [ ] 0 (0 5) [ ] < Q max (ml/s) 17.5 (4 43) [ ] 20.5 (4 43) [ ] PVR volume (ml) 0 (0 50) [ ] 21 (0 120) [ ] Q max = maximum flow rate; PVR = postvoid residual; SD = standard deviation.

4 926 EUROPEAN UROLOGY 56 (2009) Table 3 Number of patients of each Patient Global Impression of Improvement questoinnaire status in the success group (cured or improved) and in the failure group (not improved) Variable Success group (n = 82) Failure group (n = 20) Very much better 50 Much better 24 2 A little better 7 4 No change 1 10 A little worse 3 Much worse 1 Very much worse Fig. 2 Answers to the Patient Global Impression of Improvement questionnaire at the end of study. Numbers of patients corresponding to each status are indicated above the columns (n = 102). transobturator approach, including 102 patients, with median follow-up of >1 yr. This study was designed to reflect clinical experience as precisely as possible. A majority of patients suffered from PRPI one of the major postoperative causes of SUI but patients presenting SUI after TURP of adenomectomy and patients with history of pelvic irradiation were also included. These criteria well match the current clinical conditions, so this series reflects the actual treatment results we see. We chose to propose this treatment to men presenting mild to moderate incontinence because AUS remains for us the established treatment in severe incontinence conditions. Placement of the AdVance male sling showed good results, with 63% of patients rendered pad-free and 17% of patients improved after >1 yr. These data confirm those already obtained after short follow-up by Gozzi et al, who presented a cure rate of 40% and improvement in 30% of patients after 3 mo [23]. The better results obtained in our series can be explained by the fact that we treated patients with mild to moderate incontinence only, whereas 41% of patients in the Gozzi et al study used more than five pads per day preoperatively. These results compare favorably with those obtained with bone-anchored male slings [13 16] and readjustable male slings [17,24]. The patients satisfaction was high in cases of cure but also in cases of improvement and sometimes after failure, according to the PGI-I. Overall, only 4% of patients were worse after the procedure. A major point of this study is to show that these results are durable. Indeed, only six patients needed to wear pads again for recurrence of SUI after having been pad-free at the 1-mo follow-up visit. This secondary failure could be due to reasons different from those leading to an initial failure and that remain not understood. Among the intraoperative and preoperative variables that may have predicted success or failure, we found that preoperative pelvic irradiation resulted in a reduced chance of success. For other parameters (age, degree of incontinence, preoperative DO), significance was not achieved. These data included few patients and have to be further confirmed. A larger sample of patients is needed to give precise results about prognostic factors with appropriate statistical analysis. In a series of 79 patients, 15 of whom had pelvic irradiation before male sling placement, Bauer et al did not find any difference in the postoperative outcome at 1-yr follow-up (oral communication, March 2009). On the basis of previous studies, additional measures, such as behavior modifications, PFMT, and duloxetine, should be offered in case of failure [7]. In our evaluation, patients who presented initial failure were treated without difficulties by the AMS800 (American Medical Systems, Minnetonka, MN, USA) artificial urinary sphincter (three patients), supervised PFMT (five patients), or duloxetine (eight patients) with mild improvements of symptoms. The procedure is associated with a short hospital stay (2 d in 95% of patients), few and benign postoperative side effects, and no further complication after a mean follow-up of 13 mo. This point is particularly important because with many of the slings used for this indication, patients experienced such complications as erosion, infection, or pain and sometimes needed explantation [12,15,24]. Nevertheless, cases of erosion or infection needing explantation had already been noted with the AdVance male sling [25]. However, the complication rate remains acceptable. The transobturator male sling s good midterm results and low complication rate leads us to consider this option as valid in cases of PPI. Moreover, presented as an alternative to AUS, the male transobturator sling is well accepted by the patients as a possible treatment [26] with regard to its simplicity and results. Because the present study included only patients with mild to moderate incontinence, the degree of incontinence should be assessed before treatment by using the 24-h pad test. Further studies should be done to determine a cut-off value on the 24-h pad test under which a transobturator tape could be proposed. 5. Conclusions The AdVance male sling is a new approach to treat SUI after prostate surgery. It seems to be safe, with few complications, and efficient in the midterm outcome. In this study, 80% of patients presenting mild to moderate incontinence were successfully treated with this procedure with a high rate of satisfaction 1 yr after prostatic surgery. For these cases, it could be a valid and useful alternative to AUS. Other studies are needed to confirm these results and to determine the precise indications for the AdVance male sling.

5 EUROPEAN UROLOGY 56 (2009) Author contributions: Jean-Nicolas Cornu had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Cornu, Haab. Acquisition of data: Ciofu, Peyrat, Beley. Analysis and interpretation of data: Cornu, Haab. Drafting of the manuscript: Cornu. Critical revision of the manuscript for important intellectual content: Sèbe, Cussenot. Statistical analysis: Cussenot, Sèbe. Obtaining funding: None. Administrative, technical, or material support: Tligui, Traxer, Lukacs. Supervision: Haab. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: François Haab is a consultant for American Medical Systems. Funding/Support and role of the sponsor: None. References [1] Van Melick HH, van Venrooij GE, Eckhardt MD, Boon TA. A randomized controlled trial comparing transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign prostatic hyperplasia: analysis of subjective changes, morbidity and mortality. J Urol 2003;169: [2] Bauer RM, Bastian PJ, Gozzi C, Stief CG. Postprostatectomy incontinence: all about diagnosis and management. Eur Urol 2009;55: [3] Herr HW. 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