THE ARGUS ADJUSTABLE MALE SLING FOR TREATMENT OF STRESS URINARY INCONTINENCE

THE ARGUS ADJUSTABLE MALE SLING FOR TREATMENT OF STRESS URINARY INCONTINENCE

THE JOURNAL OF UROLOGY® Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009 criteria were bladder overactivity resistant to medical therapy, severe...

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THE JOURNAL OF UROLOGY®

Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009

criteria were bladder overactivity resistant to medical therapy, severe urinary incontinence (pad/die higher than 3), presence of urethral or anastomosis stricture and previous radiation treatment of pelvis. During the first year after radical prostatectomy urinary incontinence was managed by medical therapy and biofeedback. Patients who did not reach a satisfying continence status and who met inclusion criteria were treated. A 5 cm perineal incision was performed; once bulbourethralis muscle was divided, 1 cm of urethra was circumferentially freed. The cuff was placed around urethra and closed and the valve was placed in the scrotum. Components of the device and main steps of sugery were shown in Fig. 1. Patients were discharged the day following surgery. About 50 days postoperatively, the valve was filled by trans-scrotal injection up to reach a satisfying continence (no leakage under Valsalva manouver). The filling volume can be modified at following visits to gain best continence status. RESULTS: Mean operating time was 35 minutes (range 25 to 50). Mean hospital stay was 1.2 days (range 1 to 2). Postoperative complications occurred in 6 patients (1 haematoma, 1 erosion, 2 infections, 2 malfunctioning valves and 1 malfunctioning cuff). All complications but two (1 erosion and 1 infection treated by device removal) were successfully treated: haematoma and infection were managed with medical therapy, malfunctioning valves and cuff were substituted. Overall successful rate was 86%: 37 patients achieved a no pad continence status 15 required modifications of cuff pressure to improve continence status. Three patients required 1 pad/die after treatment and 1 patient required 2 pad/die. CONCLUSIONS: Low costs, easiness of implantation procedure and high effectiveness rates are encouraging data to promote this device for treatment of mild urinary incontinence after radical prostatectomy.

Source of Funding: None

1716 CAN ADVANCE TRANSOBTURATOR SLING SUSPENSION CURE MALE URINARY POST OPERATIVE STRESS INCONTINENCE? Erik B Cornel*, Hengelo, Netherlands; Henk W Elzevier, Hein Putter, Leiden, Netherlands INTRODUCTION AND OBJECTIVES: Several surgical options for male post-operative stress incontinence have been introduced during the last 5 years. Based on the hypothesis that relocation of the posterior urethra into a more proximal position plays a important role in regaining continence, Rehder and Gozzi recently published a cadaver and pilot clinical study demonstrating significant improvement in continence and minimal procedure related morbidity following placement of a transobturator tape. Objective of this study was to confirm and extend the recently published results of the positive effect on post prostatectomy stress incontinence of the transobturator sling suspension (Advance Male Sling). METHODS: From September 2007 to June 2008 the Advance Male Sling was placed and evaluated in 36 men according to the method described by Rehder and Gozzi. Diagnosis was based on 24 hours urine loss measured by a 24 hours pad test, 2 times 24 hour micturation frequency volume chart and cystoscopy. Visual Analogue Scale for continence and bother (VAS 0-10) and pad test was used pre and postoperatively to objectively evaluate the result of the operation. All

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data were collected anonymously. RESULTS: At three month follow up, cure, defined as less than 2 gram urine loss per day, was achieved in 14.3% of patients, while improvement was achieved in 40% of patients. No effect on incontinence was seen in 25.7% of patients and 20% of patients experienced worsening of incontinence by pad test. VAS 0-10 significantly improved from preoperative 6.1 (sd 2.2) to 4.5 (sd 3.1) postoperatively (p=0.015). Improvement of incontinence did not correlate with age, amount of urine loss measured by pad test and amount of pad usage. In only two patients complications were observed: in one patient sling infection occurred, resulting in removal of the Advance Male sling and one patient experienced a postoperative retention during one week. CONCLUSIONS: The transobturator sling suspension operation is a minimal invasive safe procedure for the management of male post operative stress incontinence. Although significant improvement in continence was not observed on pad test, a significant improvement on VAS continence and bother was seen. However, our results were less promising than the initial results reported by Rehder and Gozzi. Source of Funding: this study was conducted with financial support of American Medical Systems

1717 THE ADVANCE MALE SLING: PREDICTORS OF SUCCESS Daniel Rapoport*, Jack R Walter, Kristy M Borawski, George D Webster, Durham, NC INTRODUCTION AND OBJECTIVES: The AdVance sling provides a new alternative for treatment of post-prostatectomy incontinence. We previously reported satisfactory short-term results with careful patient selection. We present our updated outcomes and compare men considered to be ideal candidates to those with suboptimal characteristics by our selection criteria. METHODS: We review all patients having AdVance sling placement by one surgeon (GDW) at our institution from March 2006 to October 2008. Preoperative evaluation included history, physical exam, 24 hour pad weights, urodynamics, and cystoscopy. Patients were followed with history, physical exam, and 24 hour pad weights postoperatively. Patients were divided into two groups for comparison: “ideal candidates” or “suboptimal candidates” based on preoperative selection criteria. RESULTS: The study group included 86 men with median followup of 11 months (range 1.5 - 32 months). Mean preoperative 24 hour pad weight was 342 grams (range 12 - 960 g). The overall success rate was 86%. There were 26 “suboptimal candidates” based on suboptimal coaptation or defects of the sphincter-active urethra (18), concomitant bladder neck contracture (6), history of prostatic radiation (3) and previous procedures for incontinence (5). The remaining 60 patients were considered “ideal candidates”. The success rates were 90% for “ideal candidates” compared to 78% for “suboptimal candidates” (p = 0.17). In those with two more suboptimal factors (6) the success rate was 67% (p = 0.15). CONCLUSIONS: The AdVance sling provides excellent results in highly selected patients with post-prostatectomy incontinence. Based on our selection criteria, optimal patients are those with intact sphincteractive urethral anatomy and function without any bladder neck contracture, previous anti-incontinece surgery or radiation. Lower success rates can be expected in patients with more than one suboptimal factor present. Source of Funding: None

1718 THE ARGUS ADJUSTABLE MALE SLING FOR TREATMENT OF STRESS URINARY INCONTINENCE. Deirdre Bochove-Overgaauw*, Bart Schrier, ‘s- Hertogenbosch, Netherlands INTRODUCTION AND OBJECTIVES: To evaluate the efficacy and complications of the Argus adjustable sling for treatment of male

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THE JOURNAL OF UROLOGY®

stress urinary incontinence after prostate surgery or radiotherapy. METHODS: Argus adjustable male sling implantation was performed in 96 men in our hospital between April 2005 and August 2008. All patients were diagnosed with moderate to severe stress urinary incontinence as a result of laparoscopic or open radical prostatectomy, external radiotherapy for prostate cancer or transurethral resection of the prostate (TURP). Preoperative evaluation included anamnesis, pad count, an internationally validated incontinence questionnaire, and Visual Analogue Scale (VAS) measurements to determine satisfaction with continence and with the surgical procedure. Preoperative urethrocystoscopy was performed in all patients. The Argus adjustable male sling was introduced as described by Romano et al. The device provides bulbar urethral compression by a soft silicone foam pad. Two silicone cone columns attached to the silicone foam pad regulate the amount of tension by adjustment of two silicone rings that rest on the rectus fascia. RESULTS: The Argus male sling was a successful treatment for stress urinary incontinence in 89 patients (93%). 51 patients (53%) were completely dry, and 38 (40%) needed one safety pad per day. A revision procedure for sling adjustment was necessary once in 25 cases (26%), and twice in 4 cases (4%). In 6 patients (6%) the procedure failed as the sling had to be removed because of infection refractory to antibiotic treatment (5 cases) or erosion through the bladder (1 case). Two of these 6 patients were dry after a second Argus sling implantation. The most common complications were temporary perineal discomfort (9 patients), urethral stricture or bladder neck stenosis (7 patients), and infection (5 patients). Three out of 5 patients with a postoperative infection were treated with radiotherapy prior to sling implantation. Bladder perforation occurred in 5 patients and was corrected immediately without postoperative consequences. Acute urinary retention occurred in 10 cases and resolved spontaneously in 1 to 3 weeks. Incontinence questionnaires and VAS measurements showed significant improvement when preoperative and postoperative results were compared. CONCLUSIONS: This relatively new adjustable male sling is a valuable adjunct in the treatment of moderate to severe iatrogenic stress incontinence. Source of Funding: None

1719 ADJUSTABLE BULBOURETHRAL SLING IS EFFECTIVE ALSO IN SEVERE MALE INCONTINENCE: AN ALTERNATIVE TO ARTIFICIAL SPHINCTER. Ahmad Hind*, Reggio Emilia, Italy; Giovannalberto Pini, Modena, Italy; Domenico Viola, Ferdinando Martino, Leonardo Manoni, Roberto Rossi, Sergio Leoni, Reggio Emilia, Italy INTRODUCTION AND OBJECTIVES: We report our experience with 35 consecutive patients underwent to bulbourethral adjustable sling ARGUS® system (Promedon SA,Cordoba, Argentina) for male incontinence.12 of them were affected by severe incontinence, 5 complicated by failed insertions of other prosthesis and 9 by radiation therapy. We analyze medium term results. METHODS: Patients underwent to sling between July 2006 and April 2008; all of them were studied with cystoscopy, pad test 20 min, pad per day, QoL questionnaire and full urodynamics study. We defined 8 mild, 15 medium and 12 severe incontinence. 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. Tension of sling was regulated under local anaesthesia. RESULTS: Urinary incontinence derived from: TURP (2), simple open prostatectomy (3), retropubic (27) and laparoscopic (3) radical prostatectomy. 9 of them received radiotherapy, 5 underwent to periurethral balloons system and 22 underwent perineal rehabilitation with poor results. Mean follow-up was 16.1 months (range 1-28 months). Clinical success, defined as completely dry or some drop leak at Valsalva manoeuvre, was in 32 (91.4%). 4 of them after increment of tension and 4 after decrement. 1 patient refused modulation after partial improvement.

Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009

We removed sling in 2 patients(5.7%): the 1st because in suspicion of rectal wall perforation, not confirmed by the rectoscopy (seminal vesicles direction); the 2nd because persistent obstruction although modulation. 11 (31.4%) patients suffered perineal pain regressed in 30 days. There were neither infection nor erosion nor rejection. Mean Qmax was 13 ml/ sec (range 12- 20ml/sec). Post voiding residual was less than 40ml. CONCLUSIONS: Bulbourethral adjustable system offers ready results, as soon as catheter removal, easy adjustment under local anaesthesia, physiological voiding, sparing of bulbocavernous muscles. The shape and adaptability of the silicon foam central pad to the urethra offer the advantage of using low tightening pressure. The best results seem to be offered, in terms of improvements and QOL, in case of severe incontinence. We believe the ARGUS® system is an excellent and safe way to treat severe male incontinence. It effective also in patients complicated by failed insertions of other prosthesis and by radiation therapy, being an alternative to artificial sphincter, waiting for long term follow-up. Source of Funding: None

1720 ASSESSMENT OF COMPLICATIONS AFTER MALE PERINEAL SLING SURGERY Nicholas R Styn*, Wendy Siu, Edward J McGuire, Jerilyn M Latini, Ann Arbor, MI INTRODUCTION AND OBJECTIVES: The male perineal sling is a surgical option for treatment of stress urinary incontinence (SUI). We evaluated complications associated with perineal sling surgery to determine appropriate preoperative counseling for men considering surgery. METHODS: 116 men who underwent perineal sling surgery from August 2000 to September 2007 were retrospectively evaluated. Slings types were: AMS InVance bone anchored (103), AMS AdVance transobturator (1), wrap-around autologous rectus fascial (38), and wrap-around pelvicol (9) slings. Complications were recorded at follow up visits. Median follow up was 12 months. RESULTS: 116 men had a total of 151 slings. Mean age was 53.2 yrs. 87 patients had incontinence due to non-neurological causes. 69% of all men had prostate cancer. Of the complications observed, recurrent SUI,(29.5%), de novo urge incontinence (18.9%), and urinary retention (12.6%) occurred most frequently. Patients with post-sling urinary retention required catheterization for a mean of 6 days (1-17). Reoperation after sling placement occurred for: sling replacement (25.9%), sling removal (12.1%), collagen injection (9.5%), and placement of an artificial urinary sphincter (6.9%). Subgroup analysis revealed that men with neurologic incontinence had a significantly decreased rate of urinary retention (0) and recurrent SUI (5) compared to non-neurological groups. Patients with previous radiation had a lower rate of infection and SUI after sling placement compared to those surgically treated for prostate cancer. Bladder neck contracture (BNC) after prostatectomy did not correlate with post-sling retention or reoperation. The overall complication rate was 46.6% and reoperation rate 54.3% for index operations. CONCLUSIONS: Perineal sling surgery is an appropriate option to consider in men with SUI. Previous BNC should not deter physicians considering a perineal sling in patients with SUI after prostatectomy. Sling placement in patients with neurologic incontinence have similar outcomes compared to non-neurologic patients. Discussion of possible complications to patients prior to sling surgery is important. Source of Funding: None