1168 TREATMENT OF MALE STRESS URINARY INCONTINENCE WITH THE ADVANCE TRANSOBTURATOR SLING: LONG TERM FOLLOW-UP REVEALS HIGH PATIENT SATISFACTION

e468

THE JOURNAL OF UROLOGY姞

Results Summary Baseline 12-Month 24-Month

Vol. 185, No. 4S, Supplement, Monday, May 16, 2011

LOCF

WCS

Mean 1-Hour Pad Weight Test (grams)

78.4 (n ⫽ 48)

15.8* (n ⫽ 33

21.0* (n ⫽ 29)

22.2* (n ⫽ 41)

30.5* (n ⫽ 48)

Mean 24-Hour Pad Weight Test (grams)

377.2 (n ⫽ 48)

42.0* (n ⫽ 31)

38.3* (n ⫽ 28)

73.0* (n ⫽ 42)

110.0* (n ⫽ 48)

Patients Using 0-1 Pads/Day

14.3% (7/49)

70.3%** (26/37)

67.7%** (21/30)

51.0%** (25/49)

51.0%** (25/49)

IQOLˆ

50.3 (n ⫽ 49)

79.9*** (n ⫽ 35)

82.4*** (n ⫽ 31)

NA

NA

ICIQ-SFˆˆ

15.7 (n ⫽ 49)

7.3*** (n ⫽ 35)

7.5*** (n ⫽ 31)

NA

NA

UCLA/RANDˆˆ

20.1 (n ⫽ 49)

57.4*** (n ⫽ 35)

57.3*** (n ⫽ 31)

NA

NA

CONCLUSIONS: Surgical modifications to the AdVance procedure have yielded greater success and better patient outcomes regarding return to continence and patient satisfaction. Concomitantly, a higher transient retention rate is now seen following sling placement. Source of Funding: None

1167

*Signed rank (P⬍ 0.0001) for improvement compared to baseline **McNemar (P⬍ 0.0002) for improvement compared to baseline ˆIncontinence Quality of Life Questionnaire, urinary function score ˆInternational Consultation on Incontinence Questionnaire Short Form ˆU ˆ CLA Prostate Cancer Index Short Form (UCLA-PCASF) including the RAND 12-item Health Survey v2 (SF-12 v2) ***T-test (P⬍ 0.0001) for improvement compared to baseline

Source of Funding: This multi-center study was sponsored by American Medical Systems.

1166 TREATMENT OF MALE STRESS URINARY INCONTINENCE WITH THE ADVANCE TRANSOBTURATOR SLING: RECENT CHANGES IN SURGICAL TECHNIQUE YIELD BETTER PATIENT OUTCOMES Brian Christine*, Birmingham, AL; L. Dean Knoll, Nashville, TN INTRODUCTION AND OBJECTIVES: Treatment of persistent stress urinary incontinence after radical prostatectomy has undergone a significant change since the introduction of the non-bone anchored AdVance* male sling. Initial reported success was encouraging, but modifications to the surgical technique have yielded more impressive results. We describe significant changes to the surgical technique for the placement of the AdVance male sling. We also report our outcomes prior to initiating these changes and subsequently. *American Medical Systems METHODS: From February, 2006 to June, 2008 men were implanted with the AdVance male sling as per the protocol in the U.S. clinical trials. In June, 2008 modifications to the surgery were introduced. Specifically, greater care is now taken to ensure exit of the helical needle at the junction of the ischiopubic ramus and symphysis pubis, lateral to the corpus spongiosum (urethra). Also, dissection on the ventral surface of the corpus spongiosum proximal to the central tendon (perineal body) is carried out in a less aggressive fashion. Lastly, emphasis is placed on suturing the proximal limb of the sling to the corpus spongiosum at the exact location where the central tendon is released from the spongiosum. Patients were followed-up in the clinic at 2 and 6 weeks post-sling then every 6 months. RESULTS: From February, 2006 through May, 2008 81 men were treated with the AdVance sling. Pre-op pad use ranged from 1–5 pads/day. Currently, 55/81 (68%) report 0 pad use, 11/81 (13%) use 1 pad/day, and 15/81 (19%) use 2 or more pads/day. Eighty-three percent (83%) of patients are “very satisfied” or “satisfied”; 17% are unsatisfied. Transient retention (5–10 days) was present in 16%; no long term retention occurred. From June, 2008 thru October, 2010 191 men underwent the AdVance procedure using the modified surgical technique. Pre-op pad use was 1– 6 pads/day. Currently, 155/191 (81%) report 0 pad use, 27/191 (14%) use 1 pad/day, and 9/191 (5%) use 2 or more pads/day. Eighty-seven percent (87%) are “very satisfied” or “satisfied”; 13% are “unsatisfied”. Transient retention was present in 19%, and 1 patient (⬍1%) experienced retention lasting longer than 4 weeks requiring lysis of the sling and eventual artificial urinary sphincter.

RISK FACTORS OF TREATMENT FAILURE AFTER RETROURETHRAL TRANSOBTURATOR MALE SLING Irina Soljanik*, Munich, Germany; Christian Gozzi, Brixen, Italy; Armin Becker, Christian Stief, Ricarda Bauer, Munich, Germany INTRODUCTION AND OBJECTIVES: The overall success rates after retrourethral transobturator male sling (RTS) vary from 54.5% to 80%. RTS failure occurs in 20-45.5%. The aim of this prospective study was to identify the independent risk factors for RTS failure by multiple logistic regression analysis of patients underwent RTS. METHODS: 189 patients with postprostatectomy stress urinary incontinence were treated with RTS (AdVance® sling) in a prospective clinical study with a mean follow-up of 20.8 months. 11 patients were lost to follow-up. Uni- and multivariate analysis was performed for data of pre-, perioperative and follow-up assessment to identify independent risk factors for RTS failure. The preoperative assessment included demographics, comprehensive medical history, history of adjuvant pelvic radiotherapy and surgery for urethral or bladder neck stenosis, previous incontinence therapy, uroflowmetry, postvoid residual urine (PVR), daily pad use, 1-hour pad test, urodynamics to exclude detrusor overactivity and urethroscopy. Residual sphincter function, coaptive response, sphincter closure, ability for elongation of the coaptive sphincter zone were evaluated by the “repositioning test” during urethroscopy.Patients were scheduled at 4 weeks, 3, 6 months and every 6 months after RTS. Daily pad use, 1-h pad test, PVR and uroflowmetry were evaluated at follow-up visits. The success rate was defined as cured (no pad use or one dry “security” pad) or improved (one to two pads or pad reduction ⱖ50%). RESULTS: At a mean follow-up of 20.8 months, the overall success rate was 73.1%. Between success and failure groups, there were no statistically significant differences for age, body mass index, type of prostate surgery, time interval between prostatic surgery and sling implantation, previous treatment of incontinence, history of surgery for bladder neck stenosis, severity of incontinence classified by ICS grade, daily pad use, urin loss in the 1-hour pad test preoperatively, maximal flow rate pre- and postoperatively, type of anesthesia, acute urinary retention postoperatively, and hospitalization time. Multivariate analysis revealed that weak residual function and incomplete closure of the sphincter (OR, 29.0), no elongation of the coaptive sphincter zone (OR, 26.9), no sling tunneling (OR, 22.6) and use of resorbable sutures with less than four stitches (OR,8.4) are significant predictors for RTS failure. CONCLUSIONS: Preoperative selection of patients with regard to residual activity of the sphincter and a special attention on better sling fixation during sling procedure may increase RTS efficacy. Source of Funding: no source of funding

1168 TREATMENT OF MALE STRESS URINARY INCONTINENCE WITH THE ADVANCE TRANSOBTURATOR SLING: LONG TERM FOLLOW-UP REVEALS HIGH PATIENT SATISFACTION Brian Christine*, Birmingham, AL; L. Dean Knoll, Nashville, TN INTRODUCTION AND OBJECTIVES: Post-surgical stress urinary incontinence in men, following radical prostatectomy (RP) or transurethral resection of the prostate (TURP), can have a significantly negative impact on the patient’s quality of life. Placement of the AdVance* sling has emerged as an effective treatment option in these

Vol. 185, No. 4S, Supplement, Monday, May 16, 2011

men. While several authors have reported on continence rates following sling placement, the literature has no large series where patient satisfaction is the primary metric addressed. We report patient satisfaction in a series of men who underwent placement of the AdVance male sling for the treatment of post-surgical stress urinary incontinence. *American Medical Systems, Inc METHODS: From June, 2008 to January, 2010 one hundred forty-five (145) men underwent placement of the AdVance sling to treat post-surgical stress urinary incontinence. Patient follow-up in the clinic occurred at 2 weeks and 6 weeks after surgery, then every 6 months thereafter. In addition, in preparation of this abstract all of these patients were contacted by a dedicated research nurse and queried as to degree of satisfaction. RESULTS: Mean follow-up was 16 months post-sling (range 10-28 months). Etiology of incontinence was RP in 142/145 patients and TURP in 3/130. Preoperative pad use ranged from 1– 6 pads/day. When asked to categorize themselves as either “very satisfied”, “satisfied”, or “unsatisfied” with the results of the male sling, 87% were very satisfied or satisfied (49%, 38%), and 13% were unsatisfied. Eighty-six percent (86%) of patients would recommend the procedure. Short-term retention (5–10 days) occurred in 25/130 (19%). A single patient had long term retention (⬎4 weeks) requiring lysis of the sling and eventual treatment with an artificial urinary sphincter. One patient had a perineal hematoma requiring drainage, and 1 patient experienced osteomyelitis of the ischiopubic ramus requiring sling removal. CONCLUSIONS: The AdVance male sling yields a high degree of patient satisfaction in the treatment of stress urinary incontinence, with 87% being “very satisfied” or “satisfied” with their outcome. In addition, 86% of the men who have undergone the male sling would recommend this treatment option. Source of Funding: None

1169 THE I-STOP® TOMS® TRANSOBTURATOR MALE SLING, A MINIMALLY INVASIVE TREATMENT OF POST-PROSTATECTOMY INCONTINENCE: CONTINENCE IMPROVEMENT AND TOLERABILITY Philippe Grise*, Rouen, France; Renaud Vautherin, Sainte Colombe, France; Bertin Njinou Ngninkeu, Le Havre, France; Ghislain Bochereau, Nantes, France; Jean Lienhart, Sainte Colombe, France; Christian Saussine, Strasbourg, France INTRODUCTION AND OBJECTIVES: Post-prostatectomy incontinence (PPI) is a bothersome problem, affecting the quality of life of patients. Minimally invasive techniques are becoming the standard of care for mild to moderate PPI. The I-STOP® TOMS® transobturator male sling is a four-armed polypropylene macroporous non-extensible sling. For this type of sling, improvement of continence, quality of life and tolerability have never been evaluated in patients with mild to moderate PPI. METHODS: Between 2007 and 2009, we set up a prospective multicenter trial to evaluate the improvement of incontinence, quality of life and tolerability of the I-STOP® TOMS® in patients with mild to moderate PPI. Patients with bladder outlet obstruction, bladder overactivity or low compliance, or with a history of radiation were excluded. The transobturator puncture was done outside-inside or inside-outside according to the surgeon’s preference. The sling was applied to the bulbar urethra with a pressure on the corpus spongiosum. The primary endpoint was complete continence (zero pads/day) or improved continence (0 to 1 pad/day) at day 90 and day 360. Secondary endpoints were continence scores, quality of life and patient satisfaction up to 12 months. To evaluate tolerability, Visual Analog pain scale (VAS), urinary infection, urine flow rate and post void residual (PVR) were assessed. RESULTS: In total, 122 patients from 30 centers with a mean age of 69 (54 – 88) years were included. After surgery, 43% (36/84 and 58% (71/76) patients were complete continent at 90 and 360 days, respectively. 86% (72/84) and 93% (71/76) had improved continence at 90 and 360 days, respectively. Quality of life had improved significantly

THE JOURNAL OF UROLOGY姞

e469

at all assessed time points. Patients were highly satisfied with the intervention and with their new health status. Only two patients experienced urinary tract infection at day 30, without recurrence. Mean VAS pain scores were low: 0, 3, 1 and 0 before, post surgery, at day 30 and at day 90 respectively. Mean urine flow rates were similar before, post and 30 days after surgery. PVR was increased post surgery and was normal at 30 days. CONCLUSIONS: The I-STOP® TOMS® is an appropriate choice for patients with mild to moderate PPI. Up to 12 month, most patients were completely continent or had improved continence. The intervention was well tolerated with few infections. Source of Funding: CL Medical

1170 OUTCOMES OF ARTIFICIAL URINARY SPHINCTER PROSTHESIS IMPLANTATION FOR TREATMENT OF STRESS URINARY INCONTINENCE IN PATIENTS WITH ILEAL NEOBLADDER Dominic Lee*, Peter Hinh, O.Lenaine Westney, Houston, TX INTRODUCTION AND OBJECTIVES: A review on outcomes of artificial urinary sphincter (AUS), AMS-800 (American Medical Systems, Minnetonka, Minnesota) performed in men with severe stress urinary incontinence (SUI) following cystoprostatectomy and orthotopic ileal neobladder formation in a single institution. METHODS: This is a retrospective analysis of nine (9) men who had an AUS implanted for severe stress urinary incontinence following cystoprostatectomy and ileal neobladder formation. Two Validated questionnaires - ICS male (SF) questionnaire and Incontinence Symptom Index (ISI) score was used to quantify the incontinence and quality of life symptoms. The length of stay, operating time, estimated blood loss, urinary symptom and peri-operative pad use, quality of life (QOL) scale and postoperative complications were evaluated. RESULTS: The mean age of patients was 69 years and the mean duration of follow up was 28.8 months (range 3.8 to 81.7). Five (50.6%) of 9 patients underwent a cuff placement via trans-scrotal route and four (44.4%) via perineal route. Eight (88.9%) out of 9 patients had single cuff insertion while the remaining patient had a tandem cuff placement. Seven (77.8%) patients had 4.0cm cuff size implanted and 1 patient had a 4.5 cm cuff and the tandem cuff patient had 4.0/4.5cm cuff. Average pad use decreased from 6 to 1 per day (p⬍ 0.005). The mean score on the ICS male(SF) scale was 13.7 and the mean for the ISI symptom score index was 14.2. Complications included 2 cases of explantation for erosion from infection and severe penile tip pain. Mean time to explantation was 3.5 months post AUS implantation. No revisions were required in the remaining patients. CONCLUSIONS: AUS is a feasible option for management of severe stress urinary incontinence in men with orthotopic ileal neobladder following radical cystoprostatectomy. With intermediate term follow up, there is a significant decrease in pad use with concurrent improvement in quality of life. In addition the complication rate is low and is comparable to most series with non high risk features. Source of Funding: None

1171 SMALL INTESTINAL SUBMUCOSA URETHRAL WRAP IS A VIABLE TREATMENT OPTION FOR PATIENTS WITH PERSISTENT STRESS URINARY INCONTINENCE FOLLOWING MULTIPLE PRIOR ARTIFICIAL URINARY SPHINCTER FAILURES AND EROSIONS Landon Trost*, Daniel Elliott, Rochester, MN INTRODUCTION AND OBJECTIVES: Persistent stress urinary incontinence (SUI) following multiple artificial urinary sphincter (AUS) revisions for erosion and infection represent a very challenging treat-