Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009592 THE JOURNAL OF UROLOGY®

METHODS: This study was a randomized controlled trial of behavioral therapy (pelvic floor muscle exercises and bladder control strategies) with and without biofeedback and pelvic floor electrical stimulation for incontinence persisting 1 year or more after prostatectomy. Between January 2003 and March 2008, 207 volunteers from a university and 2 Veterans Affairs sites were stratified by type and severity of incontinence and randomized to 8 weeks of 1) behavioral therapy including pelvic floor muscle exercises and bladder control strategies (BT), 2) behavioral therapy with in-office biofeedback and home pelvic floor electrical stimulation at 20 Hz, pulse width 1 msec, current up to 100 mA (BT-Plus), or 3) no treatment control. Outcomes were measured by bladder diary and validated questionnaires, including the Expanded Prostate Index Composite (EPIC), the patient’s Global Perception of Improvement, and the Patient Satisfaction Question.

RESULTS: Patients were 51-84 years of age; 24% African American, 74% white, 2% other; 44% had stress incontinence, 1% urge, and 55% mixed stress and urge; and they were 12 to 201 months post-prostatectomy (mean 53 months). Analysis of the 172 (83%) participants who completed 8 weeks of treatment showed that incontinence decreased from a mean of 25 to 10 accidents/week (60% reduction) after BT, 25 to 9 accidents/week (64% reduction) after BT-Plus, and 25 to 21 accidents/week (16% reduction) in the control group (P<.0001). Quality of life as measured by the EPIC Urinary Incontinence Subscale improved from 42 to 55 with BT, 44 to 56 with BT-Plus and 39 to 42 in control (P<.0001). Patient’s Global Perceptions of Improvement were significantly better in the treatment groups compared with control, with 50% of patients “much better” after BT, 30% “much better” after BT-Plus, and 0% “much better” in the control group (paired comparisons each P<.05). Percent of patients who were “completely satisfied” with their treatment progress was 48% in BT and 47% in BT-plus (P=.92).

CONCLUSIONS: Behavioral therapy is effective for persistent post-prostatectomy incontinence. Biofeedback and home pelvic floor electrical stimulation did not increase effectiveness.

Source of Funding: National Institutes of Health - National Institute of Diabetes and Digestive and Kidney Diseases, grant R01 DK60044-01A2

1644A NEW MINIMALLY INVASIVE TREATMENT FOR MALE STRESS URINARY INCONTINENCE: THE ADVANCE® MALE SLING, ONE YEAR DATA FROM A MULTICENTER PROSPECTIVE STUDY.

George D Webster, Durham, NC; Michael J Kennelly*, Charlotte, NC; Kurt A McCammon, Norfolk, VA; L Dean Knoll, Nashville, TN; LeRoy A Jones, San Antonio, TX; Gregory T Bales, Chicago, IL; Sender Herschorn, Toronto, ONCanada; Timothy B Boone, Houston, TX; Anna N Bader, Minnetonka, MN

INTRODUCTION AND OBJECTIVES: We report one year clinical outcomes data on the use of the AdVance® Male Sling, a non-compressive retrourethral sling for the treatment of post-prostatectomy stress urinary incontinence (SUI).

METHODS: A multi-center, prospective study was conducted at nine centers in the US and one center in Canada between February 2006 and April 2007. Patients 40 years old with confirmed post-prostatectomy SUI were enrolled in this IRB approved study. Baseline evaluation included medical history, physical exam, cystoscopy, urodynamics, pads per day assessment and 24-hour pad-weight tests. Follow-up occurred at 6 weeks, 3, 6, 12, and 24 months post-implant. Statistical analysis was conducted using the paired t-test.

RESULTS: Forty nine patients were implanted with the AdVance Male Sling. All patients were discharged within one day post-procedure. 36 out of 49 patients completed the 12-month follow-up visit. Mean 24-hour pad weights decreased from 370.5±652.3 gms at baseline to 40.7±91.1 gms at 12 months. Moreover, 87.1% of patients experienced a 50% decrease in 24-hour pad weight and 80.6% experienced a 75% decrease in 24-hour pad weight. Pads per day use also decreased

substantially; 72.2% of patients used 0-1 pads per day at 12 months compared to 14% at baseline. The most common complications were

mild post-operative pain (16%) and transient retention (20%). There were no instances of long term retention, urethral erosion or bladder perforation.

CONCLUSIONS: The efficacy rates and low incidence of serious complications provide evidence that the AdVance male sling is a safe and effective option for treating male post-prostatectomy SUI. Current surgical technique and patient selection recommendations have directly evolved from physician experience during this study.

Table 1

24-hour pad weights (grams) *P-value < 0.001

Average [95% C.I.] N Range

Baseline 370.5 [183.1, 557.9] 49 9.9-3498.8

3 months 101.7 [36.2, 167.1] 34 0.0-706.9

6 months 50.4 [15.5, 85.3] 32 0.0-477.0

12 months 40.7 [7.9, 73.6] 32 0.0-422.0

*One subject did not have 24-hour pad weight data at baseline

Table 2Pads Per Day Usage

0-1 2-3 4-5 6-7 10 N

Baseline 7 (14.0%) 21 (42.0%) 13 (26.0%) 8 (16.0%) 1 (2.0%) 50

6 weeks 33 (68.8%) 8 (16.7%) 2 (4.2%) 2 (4.2%) 3 (6.3%) 48

3 months 34 (77.3%) 6 (13.6%) 2 (4.5%) 2 (4.5%) 44

6 months 32 (82.1%) 4 (10.3%) 3 (7.7%) 39

12 months 26 (72.2%) 6 (16.7%) 2 (5.6%) 2 (5.6%) 36

*One patient at baseline and four patients at 12-months did not submit pads per day information

Source of Funding: American Medical Systems

1645ONE YEAR RESULTS OF THE ADVANCE SLING

Ricarda M Bauer*, Margit Mayer, Irina Soljanik, Christian Gratzke, Patrick J Bastian, Christian G. Stief, Christian Gozzi, Muenchen, Germany

INTRODUCTION AND OBJECTIVES: Despite improved surgical techniques postoperative urinary incontinence is even today a problem. Depending on the study, the incidence of early stress incontinence varies between 0.8% and 87.0%. 2-5% of the patients with stress incontinence (SUI) after radical prostatectomy exhibit a persistent incontinence for >1 yr postoperatively despite conservative therapy attempts. For these patients surgical treatment is recommended. For the surgical treatment of severe or persistent incontinence the artificial urinary sphincter is still the gold standard. Nevertheless, due to the patients´ demand for minimal invasive treatment options several minimal invasive treatments were investigated in the last years. We present our one year results of the Advance sling, the first non-obstructive functional therapeutic approach for postprostatectomy incontinence.

METHODS: We implanted in 64 patients with mild to severe SUI the Advance sling and followed-up these patients for 1 year. All patients had conservative treatment before. Preoperatively we performed a urodynamic assessment, ultrasound for residual urine, miction cystography, flexible cystoscopy and daily pad use. In addition the I-QOL score and the ICIQ-UI-SF score were obtained. One year after the implantation we performed all examinations and questionnaires again, instead of the urodynamic assessment we did an uroflowmetrie. Cure rate was defined as no pad use or one pad for security reasons, improved rate as 1-2 pads or a reduction of pads 50%.

RESULTS: After one year a cure rate of 52% and an improved rate of 28% were achieved. 20% patients showed no significant improvement. No patient showed residual urine or significant changes in the uroflowmetrie. The ICIQ-UI-SF score was decreased and the I-QOL score was increased