ARGUS ADJUSTABLE SYSTEM FOR MALE INCONTINENCE CLINICAL EVIDENCE SUMMARY

Transcription

1 ARGUS ADJUSTABLE SYSTEM FOR MALE INCONTINENCE CLINICAL EVIDENCE SUMMARY

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3 INDEX INTRODUCTION CLINICAL EVIDENCE / SUMMARY CHARTS CLINICAL EVIDENCE / RESULTS OVER TIME CLINICAL EVIDENCE / EXPANDED CONTENT AUTHORS BIBLIOGRAPHY PAGE PAGE PAGE PAGE PAGE PAGE

4 CLINICAL SERIES WORLDWIDE ARGENTINA AUSTRIA BRAZIL CZECH REPUBLIC GERMANY ITALY THE NETHERLANDS

5 ARGUS ADJUSTABLE SYSTEM FOR MALE INCONTINENCE INTRODUCTION The treatment of male urinary incontinence after radical prostatectomy has gone through a long path of research, development and clinical experience. Nevertheless it has not achieved optimal safety and efficacy levels yet. Hydraulic mechanisms such as Artificial Sphincters, have been used over the last 40 years with few changes in their design and have gained the title of gold standard until a short time ago. Although they show large clinical evidence and good results, there are some points to be improved: mechanical complications, manual dexterity requirements, explantation rate and finally a questionable cost-effectiveness. Bone anchored slings, introduced with diverse acceptance in 2002, have not been efficient enough to increase urethral resistance in patients with moderate to severe urinary incontinence. Recent introduction in 2006 of polypropylene tapes using transobturator technique raises new expectations; however, clinical evidence supporting these devices is not convincing yet, and its main disadvantage is the lack of certainty regarding intraoperative tensioning and how to keep that tension. This evolutionary process is still open as it searches for devices offering safety and efficacy for the three degrees of severity (mild, moderate and severe), with low level of complications and with the additional value that they may be adjusted to meet every patient s needs. The possibility to obtain certain and defined tensions is a very important feature, both intra-operatively and post-operatively. Argus Adjustable System is the latest innovation in the development of medical technology: the combination of design and materials for maximum performance. Argus Adjustable System, supported by five years of clinical evidence, provides an innovative and effective solution to treat post-prostatectomy urinary incontinence. Two alternative surgical techniques can be performed according to specific individual needs indication: Argus for retropubic approach and Argus T for transobturator approach. Argus Adjustable System is a safe and reliable alternative for the treatment of male SUI. It has, as a unique feature, a precisely controlled intraoperative and postoperative adjustability. The performance of Argus Adjustable System is supported by more than 5 years of International clinical experience, with a broad geographical coverage: Argentina, Australia, Austria, Brazil, The Netherlands, Italy and Czech Republic, among others. The following selection of clinical evidence is an extract from the most representative journals, publications and congress abstracts. 05

6 CLINICAL EVIDENCE / SUMMARY CHARTS PUBLICATIONS 2010 Argus Adjustable Bulbourethral Male Sling Experience after 101 Cases of moderate to severe male incontinence. Hübner W A, Gallistl H, Rutkowski M, Huber E R.Department of Urology and Andrology, Clinic Korneuburg, AUSTRIA. BJU International. BJU To be printed. AUSTRIA TYPE OF STUDY Nº MEAN AGE SEVERITY RADIATION THERAPY MEAN FOLLOW UP MIN. FOLLOW UP MAX. FOLLOW UP DRY Retrospective ,6 (51-84) Moderate - Severe 22 (21,8%) 2,1 years 0,1 years 4,5 years 80 (79,2%) IMPROVED EROSION (patients) INFECTION (patients) READJUSTMENTS PREVIOUS SURGERIES TIME OF READJUSTMENT ARP (Adj. Retrograde Presure) COMMENTS: (*) 6 out of 16 are Learning Curve group 16 (*) 39 (38,6%) 74,3% 104,3 d (14-910) 37 cm H20 (average)

7 2009 Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years. Romano SV, Metrebian SE, Vaz F, Muller V, D'Ancona CA, de Souza EA, Nakamura F. Urology Department, Hospital Durand, Buenos Aires, Argentina. Actas Urol Esp Mar;33(3): Spanish 2006 An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. Salomon V. Romano, Sergio E. Metrebian, Fernando Vaz, Valter Muller, Carlos A. D ancona, Eugenio A. Costa De Souza And Fabio Nakamura.Urology Departments, Hospital Durand, Buenos Aires, And Hospital Privado, Cordoba, Argentina, Hospital Dos Servidores Do Estado, Rio De Janeiro, Universidad De Unicamp, Campinas, Fundaçao Felice Rosso, Belo Horizonte, And Centro Medico Ultralitho, Florianopolis, Brazil. BJU Int Mar;97(3): MULTICENTER MULTICENTER TYPE OF STUDY Retrospective TYPE OF STUDY Retrospective Nº 47 Nº 48 MEAN AGE 67,7 MEAN AGE 67,7 SEVERITY Moderate - Severe (**) SEVERITY Moderate - Severe (**) RADIATION THERAPY NO RADIATION THERAPY NO MEAN FOLLOW UP 45 months MEAN FOLLOW UP 7,5 months MIN. FOLLOW UP 36 months MIN. FOLLOW UP 1 month MAX. FOLLOW UP 54 months MAX. FOLLOW UP 17,5 months DRY 31 (66%) (***) DRY 35 (73%) (***) IMPROVED 6 (12,8%) (****) IMPROVED 5 (10%) (****) EROSION (patients) 6 EROSION (patients) 3 INFECTION (patients) 3 INFECTION (patients) 2 READJUSTMENTS 5 (10,6%) READJUSTMENTS 4 (8%) PREVIOUS SURGERIES PREVIOUS SURGERIES TIME OF READJUSTMENT TIME OF READJUSTMENT ARP (Adj. Retrograde Presure) cm H20 ARP (Adj. Retrograde Presure) 47,5 cm H20 (35-55) IMPORTANT NOTE Romano - Actas Urologicas Españolas 2009: this group of patients had been operated using the first ARP guidelines : over 45 cm H2O COMMENTS: (**) 60 % patients gravitational leakage (***) Dry means 0 pad per day (****) Improved: 0-1 pad per day IMPORTANT NOTE Romano - BJUI 2006: this group of patients had been operated using the first ARP guidelines : over 45 cm H2O COMMENTS: (**) 60 % patients gravitational leakage (***) Dry means 0 pad per day (****) Improved: 0-1 pad per day 07

8 CLINICAL EVIDENCE / SUMMARY CHARTS ABSTRACTS 2010 The Argus Adjustable Sling for treatment of all degrees of male stress urinary incontinence: retrospective evaluation of efficacy and complications after a minimal followup of 14 months. Deirdre Bochove-Overgaauw, Bart Schrier. Jeroen Bosch Hospital, The Netherlands. Joint Annual Meeting of the International Continence Society (ICS) and International Urogynecological Association (IUGA) Abstract Argus T for post prostatectomy urinary incontinence - Outcome minimum 12 month of the multicentre trial. Romano S V1, Hubner W2, Trigo Rocha F3, Muller V4, Nakamura F5.1. Urology Departments, Hospital Durand, Buenos Aires, Argentina, 2. Dept. of Urology, Humanis Clinic, Korneuburg, Lower Austria, Austria, 3. Hospital das clinicas, São Paulo, Brasil, 4. Hospital Dos Servidores Do Estado, Rio De Janeiro, Brasil, 5. Centro Medico Ultralitho, Florianopolis, Brazil. Joint Annual Meeting of the International Continence Society (ICS) and International Urogynecological Association (IUGA) Abstract THE NETHERLANDS MULTICENTER TYPE OF STUDY Retrospective TYPE OF STUDY Retrospective Nº 100 Nº 36 MEAN AGE 66 (50-89) MEAN AGE 69 (58-81) SEVERITY Mild - Moderate - Severe SEVERITY Moderate - Severe RADIATION THERAPY 16 (16%) RADIATION THERAPY MEAN FOLLOW UP 27 months MEAN FOLLOW UP 21 months MIN. FOLLOW UP 14 months MIN. FOLLOW UP 15 months MAX. FOLLOW UP 57 months MAX. FOLLOW UP 26 months DRY 54% DRY 29 (80,6%) IMPROVED 17% IMPROVED 4 (11,11%) EROSION (patients) 3 EROSION (patients) INFECTION (patients) 6 INFECTION (patients) 2 READJUSTMENTS 32 (32%) READJUSTMENTS 5 (13,9%) PREVIOUS SURGERIES 3 (3%) PREVIOUS SURGERIES 6 (16,6%) TIME OF READJUSTMENT TIME OF READJUSTMENT ARP (Adj. Retrograde Presure) 45 cm H20 ARP (Adj. Retrograde Presure) 35,6 cm H20 (average)

9 2010 Adjustable transobturator sling (Argus T ) for the treatment of post radical prostatectomy urinary incontinence (PRPUI). Experience in a medium time follow up in 20 patients. Trigo Rocha F1, Gomes C2, Figueiredo J A2, Bruschini H2, Srougi M2.1. Division of Urology - Sao Paulo University, 2. Division o f Urology - Sao Paulo University. Joint Annual Meeting of the International Continence Society (ICS) and International Urogynecological Association (IUGA) Abstract Urodynamic and Clinical Results of an Adjustable Sling for Male Urinary Incontinence - 32 Months Follow Up - Argus is effective also in severe cases. Hind A1, Pini G2, Viola D1, Martino F1, Rossi R1, Leoni S1 1. Arcispedale Santa Maria Nuova Reggio Emilia, 2. University of Modena and Reggio Emilia. ICS Meeting 2009, San Francisco- USA. Abstract Argus Adjustable Male Sling A new surgical method in the treatment of urinary incontinence in men. Urban M1, Heracek J1, Novotny T1, Hrbacek J1, Palascak P2. 1. Charles university in Prague, 3rd medical faculty, 2. Centre hospitalier général Paul Morel, Vesoul, France. ICS Meeting Abstract 264. BRAZIL ITALY CZECH REPUBLIC TYPE OF STUDY Retrospective TYPE OF STUDY Retrospective TYPE OF STUDY Retrospective Nº 20 Nº 48 Nº 21 MEAN AGE 65 MEAN AGE 68,4 (55-76) MEAN AGE 67,5 (54-74) SEVERITY Moderate - Severe SEVERITY Moderate - Severe SEVERITY Moderate - Severe RADIATION THERAPY NO RADIATION THERAPY 15 (31,2%) RADIATION THERAPY 4 (19%) MEAN FOLLOW UP 22 months MEAN FOLLOW UP 18 months MEAN FOLLOW UP MIN. FOLLOW UP 17 months MIN. FOLLOW UP 1 month MIN. FOLLOW UP 12 month MAX. FOLLOW UP 29 months MAX. FOLLOW UP 32 months MAX. FOLLOW UP 24 month DRY 14 (70%) DRY 44 (91,6%) DRY 15 (71,5%) IMPROVED 4 (20%) IMPROVED 2 (4,2%) IMPROVED 2 (9,5%) EROSION (patients) 1 EROSION (patients) 0 EROSION (patients) 1 INFECTION (patients) 1 INFECTION (patients) 0 INFECTION (patients) 1 READJUSTMENTS 4 (20%) READJUSTMENTS 11 (22,9%) READJUSTMENTS 3 (14,28%) PREVIOUS SURGERIES 2 (10%) PREVIOUS SURGERIES 14 (29,2%) PREVIOUS SURGERIES TIME OF READJUSTMENT TIME OF READJUSTMENT 1,9 months (1-3) TIME OF READJUSTMENT ARP (Adj. Retrograde Presure) cm H20 ARP (Adj. Retrograde Presure) cm H20 ARP (Adj. Retrograde Presure) 09

10 CLINICAL EVIDENCE / RESULTS OVER TIME Evidence at 4,5-year follow-up 148 patients Hübner W A, et al. Department of Urology and Andrology, Clinic Korneuburg, AUSTRIA. SUMMARY Objective: To evaluate the safety, efficacy and quality of life in recipients of an adjustable bulbourethral sling (Argus Promedon SA; Cordoba, Argentina). Patients & Methods: Between April 2005 and April 2009, 101 patients with moderate to severe stress urinary incontinence following prostatic surgery were implanted with the Argus sling. The radio-opaque Argus system comprises a thick silicon foam pad for soft bulbar urethral support. The pad is attached to the silicon columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position. Between prostatectomy and Argus sling placement, most patients (74,3%) had undergone a variety of procedures for SUI or bladder neck pathologies. 22 patients had undergone secondary irradiation therapy following surgery (19 after radical retropubic prostatectomy, 1 after radical perineal prostatectomy and 2 after TURP). All patients were evaluated pre and postoperatively with a 20 min pad tests, I-QoL questionnaires, cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion with a mean follow up of 2, 1 years (0, 1-4, 5). either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at an average days ( days) after the initial implantation. The sling had to be removed in 16/101 patients (15.8%) at an average of days (range ) after surgery due to urethral erosion or infection. However 6 out of those 16 patients were within the first 22 patients representing the learning curve. 13 of these patients received later successful treatment (7 with an AUS, 5 with re-implantation of the sling). 4 of these patients were lost for FU. After a median follow up of 2.2 years (mean FU: 2,1 years), 80/101 (79.2%) patients were considered as dry, showing a pad test from 0-1g (70 patients: 0g; 10 patients: 1g). The IQoL improved from an average of 28.8 (range ) to a mean of 63.2 (range ) postoperatively. Both the 20 minute pad weight tests and I-QoL responses improved significantly compared to presentation at baseline (p<0.001). Conclusion: We believe that the Argus male bulbourethral sling system is an excellent first or second line treatment for moderate to severe male SUI, even following an external beam radiation treatment (EBRT). Results: Mean follow up was 2.1 years (range ). Surgery time averaged 49 minutes (range ). Adjustment was necessary in 39 cases (38.6%), 10

11 Romano SV, et al. Urology Department, Hospital Durand, Buenos Aires, Argentina. SUMMARY Objective: To communicate long-term results of the multicentre phase III trial post-prostatectomy urinary incontinence (PPI) treated with an adjustable male sling1. Patients and Methods: 48 PPI patients were included in this trial from april 2003 to september post radical prostatectomy and 9 post adenomectomy. 19 wore 5 pads per day (3-8) each weight 83gr (17-198). 29 wore condom catheter or penile clamp The Argus was implanted through perineal approach. Using needles, the sling was transferred to the abdominal wall where it was adjusted by washers. The adjustment was done with retrograde urethral pressure from 45 to 55 cm water. Clinical data were updated till September The mean follow-up was 45 months (36-54) and median age was 67 years (52-77). The evaluation was: the ICIQ-SF score and qualification as Dry: no pads, Improved: 1 pad and Failed: 2 or more pads in 24 hr, including those with slings removed. Perineal pain persisted in 2. One patient was excluded, died in September Conclusions: Argus has demonstrated its efficacy in longterm follow-up. The social continence rate was about 80%. The important complication was erosion or infection Results: 47 were evaluated, resulting: 31 (66%) Dry, 6 (12.8%), Improved and 10 (21%) Failed. The ICIQ-SF score changed from 19.5 to 6. Of the 31 dry pts, 5 required one adjustment. 10 pts failed, 9 after sling removal, 6 due to erosion and 3 for infection. One patient failed with the sling in place, 6 erosions were registered: 4 in the urethra, 1 into the bladder and 1 through the abdominal wall. 11

12 CLINICAL EVIDENCE / RESULTS OVER TIME Evidence at 1,5-year follow-up 48 patients Salomon V. Romano, et al. Hospital Durand, Buenos Aires. SUMMARY Objective To evaluate the efficacy and safety of a new adjustable bulbourethral sling (Argus, Promedon SA, Cordoba, Argentina) in the treatment of male stress urinary incontinence (SUI) after prostate surgery. Patients And Methods In all, 48 patients with SUI because of prostatic surgery for prostate cancer (39) or benign prostatic hyperplasia (nine) had a new sling implanted in a multicentre trial at six institutions between April 2003 and September All patients were fully evaluated, including a questionnaire (International Consultation on Incontinence Questionnaire-Short Form, ICIQ-SF, range 0 21), endoscopy, and urodynamic evaluation. The Argus system comprises a 4.2x2.6x0.9 cm thick silicone foam pad for soft bulbar urethral compression. The pad is attached to the silicone cone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to regulate and keep the desired tension against the urethra. The pad and washers are radio-opaque, which allows their position to be assessed during followup. The surgical technique was one described previously, with some modifications. Results At a mean (range) follow-up of 7.5 (1 17.5) months, 35 (73%) of the 48 patients were dry, five (10%) were improved, and eight (17%) were incontinent, including four (8%) who needed sling adjustment. The mean (range) ICIQ-SF improved from 19.2 (12 21) to 4 (0 21). There were three (6%) urethral perforations during surgery that were resolved by re-passing the needle. The sling was removed in three men (6%) due to erosion and in two (4%) due to infection. Seven (15%) cases of acute urinary retention resolved spontaneously, except for one that needed the sling loosening. No cases of chronic retention were reported. There was perineal discomfort and mild dysuria soon after surgery that resolved spontaneously after a few weeks. Conclusion This new adjustable male sling safely and effectively controls sphincter incontinence in men after prostate surgery, with an acceptably low complication rate. The early results are encouraging; the Argus is a valid alternative to the artificial urinary sphincter, the standard therapy for this condition. 12

13 CLINICAL EVIDENCE / EXPANDED CONTENT 2010 The Argus Adjustable Sling for treatment of all degrees of male stress urinary incontinence: Retrospective evaluation of efficacy and complications after a minimal follow-up of 14 months. Deirdre Bochove-Overgaauw, Bart Schrier. Jeroen Bosch Hospital, The Netherlands. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract 102. Hypothesis / aims of study This is a retrospective study to evaluate the efficacy and complications of the Argus TM for treatment of various degrees of male stress urinary incontinence (SUI). Study design, materials and methods Retrospectively, we evaluated continence (reported pads/24hrs), complications and Quality of Life (QoL) in 100 men SUI, who were consecutively treated with the Argus TM between April 2005 and October Three groups were defined based on baseline incontinence: patients with mild incontinence using 1-2 pads/24hrs, moderate incontinence 3-5 pads/24 hrs, and severe incontinence >5 pads/day. The Argus TM device is a suburethral silicone foam pad with two attached retropubic cone columns. The amount of urethral compression it provides can be regulated by adjustment of two silicone rings that rest on the rectus fascia. The sling was implanted as described by Romano et al. Patient evaluation included anamnesis, pad count, a QoL score, and Visual Analogue Scale (VAS) measurements to determine satisfaction with continence and with the surgical procedure. The results and complications were evaluated 6 weeks after surgery and in december Success was defined as cured: 0-1 security pad/24hrs and improved: 1-2 pads/24hrs (and pad reduction>50%). Results After a median follow-up (FU) period of 27 months (14-57 months), the Argus TM was successful in 71% of patients. 13 patients were treated for mild incontinence, 46 for moderate incontinence and 41 for severe incontinence. Success rates stratified to degree of incontinence were 92%, 67% and 67% respectively. Revision procedures to provide more urethral compression were necessary in 32%, most often in severe incontinent patients (44%). Complications were registered meticulously and occurred in 55%, also most often in patients treated for severe incontinence. Most complications were self-limiting Clavien grade I-II and could be treated conservatively, for example perineal pain, urinary retention and bladder perforation during implantation. As grade III complications we registered infection (n=6), erosion (n=3), sling rupture (n=1), and irritative symptoms/pain (n=1) for which sling explantation was necessary, as well as urethral strictures for which surgical intervention was warranted (n=12). VAS measurements on continence and QoL.showed significant improvement. Patient satisfaction with treatment scored 7,8 at a scale of Interpretation of results The Argus TM adjustable male sling is most successfull (>90%) in patients with mild incontinence. In patients with moderate to severe incontinence success rates of more than 65% are accomplished in this study. Complications are not uncommon, but are mostly grade I-II. Overall, patients report significantly improved continence and QoL after treatment. Concluding message The Argus TM adjustable male sling is a valuable adjunct in the treatment of all degrees of SUI. We will continue follow-up of the patients in this study to evaluate durability. 13

14 CLINICAL EVIDENCE / EXPANDED CONTENT 2010 Argus T for post prostatectomy urinary incontinence - Outcome minimum 12 month of the multicentre trial. Romano S V1, Hubner W2, Trigo Rocha F3, Muller V4, Nakamura F5.1. Urology Departments, Hospital Durand, Buenos Aires, Argentina, 2. Dept. of Urology, Humanis Clinic, Korneuburg, Lower Austria, Austria, 3. Hospital das clinicas, São Paulo, Brasil, 4. Hospital Dos Servidores Do Estado, Rio De Janeiro, Brasil, 5. Centro Medico Ultralitho, Florianopolis, Brazil. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract Hypothesis / aims of study: To evaluate after minimum one year follow up (F-up) a group of patient (pt) participating in a multicentre trial that has been treated for post prostatectomy urinary incontinence (PPI) using the transobturator approach to implant an adjustable male sling, Argus T TM Study design, materials and methods: From November 2007 to August 2008, 37 consecutive PPI patients (30 post-radical prostatectomy and 7 post adenomectomy) were included in a multicentre trial to be treated with an adjustable male sling (Argus T TM - Promedon SA). 5 centres participating in the trial. The mean age was 69 years (58-81); 6 of the 37 had undergone previous unsuccessful anti-incontinence treatment: Suprapubic Argus sling: 1, Pro Act: 3, and bulking agent: 2. The implantation technique was previously described 1,2 and briefly the sling was implanted through a median perineal incision against the bulbar urethra keeping the bulbocavernous muscles in place. The needles that entered outside-in transobutratory, pulled out the cone columns. The tension was adjusted with the washers at a medium of 35.6 cm water (22-45), measured by retrograde urethral pressure (RUP). The Foley catheter remains for 24 to 48 hs. All the pts implanted, completed a full urologic evaluation, a validated International Consultation on Incontinence Questionnaire (ICIQ SF), 24h pad test, Visual Analogue Scale, urethrocistoscopy, urodynamics with especial interest in RUP, and a global impression (GI) expressed as Dry (D): no pads or one for protection, Improved (I): 1 pad a day, and Failure (F): 2 or more pads daily or sling removal. Results: At November 2009 one patient lost contact with the investigator, so there were 36 pts to be evaluated with a mean F-up of 21 month (15-26). All pts had a minimum of 12 months; this time was considered from the implantation or from the sling adjustment. At Inclusion, 29 of the 37 pts presented severe incontinence, moderate in 6 and mild in 1, according with the pad test classification. The Pad test and the ALPP were 1182gr ( ) and 46.2 cm of water (4-92). (Table 1) From operation or readjustment, the ICIQ-SF changed from 18.8 (12-21) to 2 (0-21), the VAS and RUP changed from 8.9 to 1.3 and from 16.9 to 35.2 cm of water, respectively. Postoperative readjustment was necessary in 5 patients (16.2%).The GI was Dry, Improved and Failed in 29 (80.8%), 4 (11.4%), and 3 (8.6%) respectively (Table 2) Complications: 2 pts became infected immediately in the postoperative; one of them needed sling removal, the other cured after local and general antibiotics treatment. 2 patients had acute urinary retention; both are dry and regained spontaneous bladder evacuation; one after sling loosening and the other (with impaired bladder contraction) after a long term (6 month) of self clean intermittent catheterization. Most pts complained of mild or moderate inguinal and or perineal pain lasting less than 30 days postoperatively except one that took more than 2 months to disappear. 14

15 Interpretation of results: In the last decade, the male slings are showing a well gained place to treat the devastating condition of the post prostatectomy urinary incontinence. Many models are now in the market and two approaches to implant are recommended: suprapubic or transobturator. Till now none of the approaches or models appear to be efficient or good enough to be qualified as the best. Even though both approaches using Argus TM male sling have demonstrated similar good results in 80% of the pts in the medium term follow-up 2. We assume that the adjustability, during and postoperative time, is a necessary condition in the construction of the slings to control more precisely the bulbar urethral compression to achieve the continence in these pts very difficult to treat, as they are the incontinent post prostatectomy. Concluding message: Argus male sling can be implanted both, Suprapubic or Transobturatory with almost the same good results, but the transobturatory approach has the clear advantage of its less invasiveness and harmfulness, making this approach the first choice. Table 1: Preoperative evaluation (At inclusion) Table 2: Follow-up: mean 21 months (15-26) and minimum of 12 months (12-24) 15

16 CLINICAL EVIDENCE / EXPANDED CONTENT 2010 Adjustable Transobturator Sling (Argus T ) For The Treatment Of Post Radical Prostatectomy Urinary Incontinence (PRPUI). Initial Experience In 20 Patients Trigo Rocha F1, Gomes C2, Figueiredo J A2, Bruschini H2, Srougi M2.1. Division of Urology - Sao Paulo University, 2. Division o f Urology - Sao Paulo University. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract 105. Hypothesis / aims of study Slings have been used for the treatment of PRPUI in many people suffering from this condition and seeking for cheaper and simpler options than an artificial sphincter. They have showed good results in short term follow ups but many patients who became continent after a sling procedure presented recurrence of incontinence after some months. Adjustable slings were developed to permit postoperative adjustments and the recovery of continence in some cases as well as to reduce the tension in the slings in cases of postoperative urinary retention. One of the major concerns in using slings in men was bladder perforation. We investigated the efficacy and safety of a transobturator adjustable sling to treat post radical prostatectomy urinary incontinence. Study design, materials and methods The Argus system comprises a 4.2 x 2.6 x 0.9 cm thick silicone foam pad for soft bulbar urethral compression. The pad is attached to the silicone cone columns that, after being passed with needles from obturatory foramen, are adjusted with silicone washers to regulate and keep the desired tension against the urethra. Surgical approach consists on a perineal midline incision and dissection of bulbous urethra involved by the bulbospongiousus muscle. A one centimeter incision is made bilaterally 3 centimeters bellow the insertion of the major adductor muscle. A special needle is inserted in this incision through the obturatory foramen towards the region lateral to the dissected urethra and beneath the penile crus and the ischiopubic ramus to pull the sling extremities. These ends were fixed in the subcutaneous over muscle fascia using an adjustable silicon washer to permit late postoperative adjustments. We evaluated the efficacy and safety of Argus T to treat post prostatectomy urinary due to sphincter deficiency in 20 patients with PRPUI. Mean age was 65 years. Preoperative and postoperative evaluation included number of pads required per day, Quality of Life Evaluation using a visual analogue scale (VAS). All patients were also submitted to preoperative urodynamic evaluation. Preoperative and postoperative data were submitted to statistical analysis to determine if the variations were significant. Results Follow up ranged from 17 to 29 months (mean= 22 months) There was a significant reduction in pads count from 5,2 to 1,2. In the last follow up visit 14 patients (70%) were dry or wearing one pad a day, 4 (20%) improved and 2 (10%) remained unchanged. There was also an important improvement in quality of life evaluated by VAS from 10,2 to 2 (p< 0,05). Adjustments is order to recover continence were necessary in four patients (20%). No patient had any major complications or bleeding. Adverse events included perineal pain in two patients and erosion in one. Interpretation of results We concluded that Argus T is an effective and safe treatment for PRPUI. The adjustability allows recovery of continence in 20% of the patients. Concluding message Argus T may be the first line tool for treating PRPUI. 16

17 2009 Urodynamic and Clinical Results of an Adjustable Sling for Male Urinary Incontinence. 32 Months Follow Up - Argus is effective also in severe cases. Hind A 1, Pini G 2, Viola D 1, Martino F 1, Rossi R 1, Leoni S 1 1. Arcispedale Santa Maria Nuova Reggio Emilia, 2. University of Modena and Reggio Emilia.Italy. ICS Meeting 2009, San Francisco- USA. Abstract 94. Hypothesis / aims of study Recently there have been developed some new bulbourethral slings that lack adjustability, which any way, seem to result superior to the periurethral bulking agents and limiting the indication of the artificial urinary sphincter with lower complication rate. We present our experience with an adjustable bulbourethral sling in 48 incontinent patients, reporting results, complications and postoperative urodynamic evaluation. Study design, materials and methods Between 07/2006 and 03/2009 (32 months) 48 men, with urodynamically confirmed stress incontinence, underwent to the male adjustable perineal sling ARGUS. Mean age 68.4 years (55-76 years). Patients were evaluated pre-operatively: 24-hr pad test, ICIQ-SF, cystoscopy, and urodynamics; post-operatively: 24-hr pad test, ICIQ-SF and the post-operative Patient Global Impression of Improvement (PGI-I) score, uroflowmetry and post voiding residual volume (at 1 st, 3 rd,6 th,12 th and 24 th ) and full urodynamic study (12 th and 24 th month). Urinary incontinence derived from: TURP (2), simple open prostatectomy (3), retropubic (31) and laparoscopic (8) radical prostatectomy, bladder neck incision for sclerosis post radical prostatectomy (4). 15 (31.2%) received adjuvant external beam radiotherapy. 14 (29.2%) underwent to precedent others anti-incontinence procedures and 22 (45.8%) to perineal rehabilitation with poor results. 13 patients had mild incontinence (24-hr pad weight 150 g); 21 patients moderate incontinence (from 150 up to 400 g) and 14 totally incontinent (continuous leakage; >400 g). 3 patients with bladder neck stricture and 2 with bulbar urethral stenosis underwent endoscopic treatment 6 months before implants. Minimal time elapsed from original surgery was 12 months. Description of the sling: The sling consists of a radiopaque pad made of silicon foam, joined to two silicone columns formed by multiple cones that allow for the possibility of post surgery readjustment. The sling has two radiopaque silicon rings, which are placed over the rectus fascia in the sling columns to prevent them from moving downwards and to allow readjustment. The kit contains 35 mm diameter TVT like needles that pass through the perineum to the suprapubic region. Note of Technique: Spinal anesthesia, Foley catheter and lithotomy position. Two 3-cm suprapubic incisions are performed 2-cm on both sides of the midline up to the aponeurosis of rectus muscle. A 5-cm median perineal incision is made to expose the bulbospongiosus muscle; blunt dissection is used to identify the spaces between the corpora cavernosa laterally and the corpus spongiosum medially. Sparing bulbocavernous muscle, the perineal aponeurosis must be reached. Where the needles are introduced on both sides, they should be moved horizontally until deeply perforating perineal aponeurosis; afterwards moved vertically through the retropubic space towards the pre opened suprapubic incisions. Endoscopic control is performed in order to check the integrity of bladder and urethra. Transference of the sling columns into the abdomen, the washers will then be used to hold the end of the columns up to the aponeurosis. The adjustment of the washers and pad tightening will be controlled by cystoscopy and water column with a cm H20 retrograde leak point pressure. The catheter is removed hours after surgery. 17

18 CLINICAL EVIDENCE / EXPANDED CONTENT Urodynamic and Clinical Results of an Adjustable Sling for Male Urinary Incontinence. 32 Months Follow Up - Argus is effective also in severe cases. ICS Meeting 2009, San Francisco- USA. Abstract 94. Results Mean follow up 18 months (range 1-32). Mean 24-hr pad test reductions 320 g (from 95 to 500). Mean free Q max is 14 ml/sec (10-18ml/sec); mean Q max (P/F study) is 11 ml/sec (9-14ml/sec); mean Pdet at open was 48 CmH2O (36-67 CmH20), mean Pdet Max Flow was: 67 CmH2O (43-83 CmH2O); mean post-residual volume was 25 ml (0-65 ml). Nor ex novo detrusor hyperactivity on urodynamic charts neither ex novo storage symptoms was complaint. 11 (22.9%) needed sling adjustment in local anesthesia (7 tightening, 4 loosening), mean time adjustment 1,9 (1-3); mean days elapsed from Argus insertion to modulation 15 (7-65 days). Mean ICIQ-SF score improvement was -15,4 (from -9 to -20); median postoperative PGI-I score was 1,3 (1-4). There were neither infection nor erosion nor rejection. Early postoperative perineal discomfort was presented in 18 patients (37.5%) and disappeared within two months. One patients (2.1%) complained severe pain in the left lower art lasted for 2 months. We removed sling in 1 patients (2.1%): in suspicion of rectal wall perforation, not confirmed by rectoscopy and cystography (seminal vesical direction). There was an indication to remove another sling because of persistent obstruction but preoperative cystoscopy revealed the obstruction was due to a recurrence of bladder neck stenosis. Interpretation of results Dry patients (not using any more pads) are 44 (91.6%); 28 of them (58,3%) loose some drops of urine (occasionally at sudden increase of abdominal pressure). 2 patient (4.2%) have been partially improved (24 hr pad test: 50% improvement). Urodinamyc parameters at 12 th and 24 th month are overlapped. Concluding message Waiting for long term follow-up and randomized trials our data shows that the new adjustable sling Argus is a promising minimal invasive procedure for the treatment of male stress incontinence. Our results clearly demonstrate that heavy incontinence responds as well as moderate one. It's effective also in patients complicated by other previous prosthesis failure and by radiation therapy. It offers ready results, as soon as catheter removal, low complication rate, easy adjustment under local anesthesia, stable results after 32 months, physiologic voiding and sparing of bulbocavernous muscles. The best results, in term of QoL, seem to be offered in case of severe incontinence. Some flexible cystoscopy and TURB performed respectivelly in 2 and 1 patient (follow up and resection of non muscle invasive bladder cancer) have not been altered the complete continence they achieved before. 18

19 2008 Argus Adjustable Male Sling. A new surgical method in the treatment of urinary incontinence in men. Urban M 1, Heracek J 1, Novotny T 1, Hrbacek J 1, Palascak P Charles university in Prague, 3rd medical faculty, 2. Centre hospitalier général Paul Morel, Vesoul, France. ICS Meeting Abstract 264. Hypothesis / aims of study Male urinary incontinence is a possible complication of prostatic surgery. It causes serious psychological problems and represents a socio-economic issue as well. The aim of this study is to evaluate the efficiency of a new surgical technique using ARGUS sling. 15 (71.5%) patients, 2 patients (9.5%) were improved, failure was noted in 4 patients (19%) all of them had undergone adjuvant radiotherapy for PCa. Post-void residual urine volume was 0-45 ml after surgery. The sling proved as non-obstructive: Qmax in free uroflowmetry ranged between 10 and 32 ml/s. Study design, materials and methods Physical and laboratory examination were performed in all patients undergoing surgery, as well as panendoscopy and urodynamic study. The follow-up was performed using a quality of life questionnaire, evaluation of the continence and neurological symptomatology and, of course uroflowmetry with post-void residual volume. Results Between 2005 and 2007, 21 men with incontinence grade II-III were implanted the ARGUS sling. The average age was 67.5 years (54-74). Eleven patients had undergone radical retropubic prostatectomy for prostate cancer (PCa), 4 patients transurethral resection of the prostate and 1 patient open suprapubic prostatectomy for benign prostatic hyperplasia, 4 patients had undergone radical retropubic prostatectomy followed by adjuvant radiotherapy and 1 had been after perineal application of collagen seeds. Incontinence had lasted for at least 2 years and had been resistent to any conservative therapy. Urine cultivation was negative in all patients before surgery. Complete continence was achieved in Interpretation of results The results show an improvement of continence in 81% of 21 patients. Postoperative protrusion of the sling into the urethra was noted in 2 patients (9.5%), both of them had undergone radiotherapy. History of radiotherapy is a relative contraindication to the implantation of the sling. Concluding message ARGUS adjustable male sling is a promising new step in the treatment of male urinary incontinence. 19

20 AUTHORS Prof. Romano, Víctor S. Hospital Durand, Buenos Aires - Argentina Head of the Urology Unit, Department of Urology, Durand Hospital, Buenos Aires (Argentina). Surgeon graduated from the National University of Córdoba. Medical Doctor (1984) with the thesis: Female Urinary Incontinence. University of Buenos Aires. Specialist consultant urologist - Argentine Society of Urology (Sociedad Argentina de Urología, SAU), Recertification: 2000 and Professor of Urology-related topics in several universities in Argentina. Author of several scientific publications. Dr. Romano has participated in more than 133 scientific conferences in which he has made 180 presentations. Principal investigator in different international protocols on clinical research or surgical instruments for laboratories, and member of Advisory Boards. President of the Argentine Society of Urology from 1997 to Current member of 14 national and international scientific societies, including: SAU, AUA, SIU, CAU, SINUG, ICS, and Society for Urodynamics and Female Urology. Experience with Argus: He started research on Argus about 10 years ago and his clinical experience began 7 years ago. To date, he has performed more than one hundred surgeries to implant Argus, 30 of which have been for the placement of Argus T. Prof. Victor Romano: In my opinion, the current suprapubic Argus sling is a very good alternative for the treatment of post-prostatectomy urinary incontinence. Argus T is a good option for patients without previous treatment through perineal approach". Prof. Hübner, Wilhelm A. Weinviertel Clinic Korneuburg, Korneuburg - Austria Chairman Dept. of Urology Weinviertel Clinic Korneuburg, Austria. Medical study at the University of Vienna. In 1995 he became Venia Docendi (Ph.D.), topic: orthotopic bladder replacement in the female. Scientific Awards at Bayrischen Urologenvereinigung (1992), EAU (2008 and 2009). Since 1999, he has intensively worked in the male incontinence field. In 2007, he participated in the formation of Karl Landsteiner Scientific institute. He has been in charge of the Organisation of several scientific meetings (national and international). He is an active member of AUA, EAU, ÖGU, DGU, BUV, ICS, MKÖ a.o. Experience with Argus: He started with the first Argus procedures in He has performed more than 100 Argus implantations up to date at the Kornoeuburg Klinik, and more than 50 in other hospitals/centres in Training activities. Prof. Wilhelm Hübner: In my opinion, the key feature of the Argus Adjustable Sling is that there are practically no limitations to it. It may even be used in irradiated patients and men with severe incontinence. In contrast to other implants, Argus may be adjusted to possible changes of urodynamic findings or specific needs of a patient any time after the implantation. We have been very enthusiastic about using Argus in the past 3 years". Dr. Schrier, Bart Jeroen Bosch Ziekenhuis, Den Bosch - The Netherlands. Member of the Department of Urology, Jeroen Bosch Ziekenhuis, the Netherlands. He had his education at the University Medical Centre Nijmegen. PhD in Subject: Invasive Bladder Carcinoma. He specialized in minimal invasive laparoscopic surgery and is now performing a high number of robotic procedures (DaVinci equipment) like prostate and bladder resections. He has experience with several male incontinence treatment procedures. Experience with Argus: In 2004 he started with the first Argus procedures. Up to date, he has performed approximately 200 Argus surgeries with excellent results. In The Netherlands, many colleagues are referring incontinent patients to his clinic. 20

21 AUTHORS Dr. Hind, Ahmad Arcispedale Santa Maria Nuova, Reggio Emilia Italy. Dr. Ahmad I.A. Hind Member of the Department of Urology, Arcispedale Santa Maria Nuova Reggio Emilia, Italy. Graduated in Medicine and Surgery (laurea) from the University of L Aquila, Italy. the 26th of July, 1994, with honours. Specialist in Urology from the University of L Aquila, Italy the 26th of October 1999, (Five years training programme). Research Registrar in Urology to Mr Simon Carter in the Charing Cross Hospital, London, From February, 1997 until March, Experience with Argus: He has made 65 Argus procedures up to date, since July Dr. Ahmad Hind: Argus is a very intelligent solution to treat male incontinence, it is more than a classic sling, that compresses the dorsal part of the urethra. The soft silicone pad embracing the ventral and both lateral parts of the bulbar urethra is a new and unique concept of treating incontinence, increasing the sling effect with less energy (less tension needed). This, to me, explains the high success rate, even in high grades incontinence, and the less complications reported. The adjustability offered by the device is the second big advantage. Dr. Trigo Rocha, Flavio Hospital das Clínicas, Sao Paulo University. Sao Paulo, Brazil. Graduated from the Faculdade de Medicina da Univesidade de São Paulo in Early training years in Urology at Hospital das Clínicas de São Paulo. Fellowship in Urology - University of California, San Francisco - USA de 1991 a Member of the Education Committe of the International Continence Society. Has published more than 30 papers in Medline and more than 50 podium presentations in International Urological meetings. Currently Associated Professor of Urology, University of São Paulo, Brazil. Experience with Argus T: He started implanting Argus T in He has performed more than 50 Argus surgeries up to date. Dr. Flavio Trigo: My experience with more than 50 Argus T surgeries performed shows that it is a safe, simple and efficient procedure with 90% dry patients rate in men suffering from post-prostatectomy stress urinary incontinence. Since it is an adjustable device, it can be used in different cases of incontinence and not only in mild cases. It can be considered a first line treatment for male urinary incontinence". Dr. Urban, Michael University Hospital of Královské Vinohrady, Charles University. Prague, Czech Republic. He is the Head of the Clinic of Urology and member of the Department of Urology, 3rd Medical Faculty Hospital and University Hospital of Královské Vinohrady, Charles University, Prague, Czech Republic. Member of the National and International Prostate Council, EAU (European Association of Urology) and Czech Urological Society. Member of the consulting body of the Czech Chamber of Medicine in the field of Urology and the Inspection Board of the Faculty Hospital at Bulovka, Prague. Honorary Chairman of the Association Franco-Tcheque de recherche et d Echanges en Urologie et Cancerologie. Stand-in Dean of 3rd Medical School of Charles University, Prague. Experience with Argus: He has performed over 45 Argus surgeries in the last four years. Dr. Michael Urban: Argus sling is the most efficient, easy to perform and cost effective option in the treatment of male incontinence including even the most complicated cases. For me it is the first option to consider...". 21

22 BIBLIOGRAPHY 2010 Deirdre Bochove-Overgaauw, Bart Schrier. Jeroen Bosch Hospital, The Netherlands. The Argus Adjustable Sling for treatment of all degrees of male stress urinary incontinence: retrospective evaluation of efficacy and complications after a minimal follow-up of 14 months. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract Hind A1, Pini G2, Viola D1, Martino F1, Rossi R1, Leoni S1 1. Arcispedale Santa Maria Nuova Reggio Emilia, 2. University of Modena and Reggio Emilia. Urodynamic and Clinical Results of an Adjustable Sling for Male Urinary Incontinence - 32 Months Follow Up - Argus is effective also in severe cases. ICS Meeting 2009, San Francisco- USA. Abstract 94. Gallistl H, Rutkowski M, Huber E R, Hübner W A. Department of Urology and Andrology, Clinic Korneuburg, AUSTRIA. Argus Adjustable Bulbourethral Male Sling Experience after 101 Cases of moderate to severe male incontinence. BJU International. BJU To be printed. Romano SV, Metrebian SE, Vaz F, Muller V, D'Ancona CA, de Souza EA, Nakamura F. Urology Department, Hospital Durand, Buenos Aires, Argentina. Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years. Actas Urol Esp Mar;33(3): Spanish Romano S V1, Hubner W2, Trigo Rocha F3, Muller V4, Nakamura F5.1. Urology Departments, Hospital Durand, Buenos Aires, Argentina, 2. Dept. of Urology, Humanis Clinic, Korneuburg, Lower Austria, Austria, 3. Hospital das clinicas, São Paulo, Brasil, 4. Hospital Dos Servidores Do Estado, Rio De Janeiro, Brasil, 5. Centro Medico Ultralitho, Florianopolis, Brazil. Argus T for post prostatectomy urinary incontinence- Outcome minimum 12 month of the multicentre trial. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract Trigo Rocha F1, Gomes C2, Figueiredo J A2, Bruschini H2, Srougi M2.1. Division of Urology - Sao Paulo University, 2. Division o f Urology - Sao Paulo University. Sao Paulo, Brazil. Adjustable transobturator sling (Argus T ) for the treatment of post radical prostatectomy urinary incontinence (PRPUI).Experience in a medium time follow up in 20 patients. Joint Annual Meeting of the International Continente Society (ICS) and International Urogynecological Association (IUGA) Abstract Urban M1, Heracek J1, Novotny T1, Hrbacek J1, Palascak P2 1. Charles university in Prague, 3rd medical faculty, 2. Centre hospitalier général Paul Morel, Vesoul, France. Argus Adjustable Male Sling A new surgical method in the treatment of urinary incontinence in men. ICS Meeting 2008 Abstract # Salomon V. Romano, Sergio E. Metrebian, Fernando Vaz, Valter Muller, Carlos A. D ancona, Eugenio A. Costa De Souza And Fabio Nakamura.Urology Departments, Hospital Durand, Buenos Aires, And Hospital Privado, Cordoba, Argentina, Hospital Dos Servidores Do Estado, Rio De Janeiro, Universidad De Unicamp, Campinas, Fundaçao Felice Rosso, Belo Horizonte, And Centro Medico Ultralitho, Florianopolis, Brazil. An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. BJU Int Mar;97(3):

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