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Two-Year Follow-up Results in a Multi-Center, Prospective Trial of the AdVance® Male Sling System for the Treatment of Post-Prostatectomy Stress Urinary Incontinence
Michael J. Kennelly, MD1, Kurt A. McCammon, MD2, L. Dean Knoll, MD3, LeRoy A. Jones, MD4, Gregory T. Bales, MD5, Sender Herschorn, MD, FRCSC6, Brian Roberts, MD7, Timothy B. Boone, MD, PhD8, George D. Webster, MD9.
1Carolinas Medical Center, Charlotte, NC, USA, 2Eastern Virginia Medical School, Norfolk, VA, USA, 3Center for Urological Treatment and Research, Nashville, TN, USA, 4Urology San Antonio Research, PA, San Antonio, TX, USA, 5University of Chicago Medical Center, Chicago, IL, USA, 6University of Toronto, Toronto, ON, Canada, 7Carolina Urologic Research Center, Myrtle Beach, SC, USA, 8The Methodist Hospital, Houston, TX, USA, 9Duke University, Durham, NC, USA.

BACKGROUND: A number of surgical options are available to treat male incontinence. We report on 2-year clinical results from a North American study using the AdVance® transobturator male sling for the treatment of post-prostatectomy incontinence (PPI). The study’s primary objectives were to collect clinical outcomes data and obtain procedural technique information.
METHODS: A multi-center, prospective study was conducted at 10 centers. Men ≥40 years of age with PPI due to intrinsic sphincter deficiency of at least 6 months duration were eligible for the IRB approved study. Pad weights (1-hour and 24-hour) and pads used per day were assessed pre-operatively and during follow-up. Improvement in quality of life (QOL) was evaluated by 3 QOL questionnaires. Follow-up occurred at 6 weeks and 3, 6, 12, and 24 months postoperatively. Complete baseline and follow-up data could not be collected for all patients. Therefore, in addition to comparison of baseline results to 12- and 24-month follow-up results, the data were also analyzed with the last observation carried forward (LOCF) for those with follow-up results and a worst case scenario (WCS) analysis defined as LOCF including the baseline results being used as the 24-month result.
RESULTS: Between February 2006 and April 2007, 49 men were implanted with the AdVance male sling. Mean age was 64.5 years. Results, summarized below, show a highly significant pad weight test improvement for all analyses. In addition, pads per day results showed that ~70% of patients used 0-1 pads per day at 12-and 24-months. QOL scores also showed significant improvement at both 12-and 24-months. There were no instances of long term retention, urethral erosion, or urethral or bladder perforation.

Results Summary
Pad Weight and Pad UseBaseline12-Month24-MonthLOCFWCS
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/Day14.3% (7/49)70.3%**(26/37)67.7%** (21/31)51.0%** (25/49)51.0%**(25/49)
*Signed rank (P<0.0001) for improvement compared to baseline**McNemar (P≤0.0002) for improvement compared to baseline
Quality of Life SummaryBaseline12-Month24-Month
IQOLa50.3 (n=49)79.9* (n = 35)82.4* (n =31)
ICIQ-SFb15.7 (n = 49)7.3* (n=35)7.5*(n=31)
Urinary Function20.1 (n = 49)57.4* (n = 35)57.3* (n = 31)
*T-test (P<0.0001) for improvement compared to baseline
aIncontinence Quality of Life questionnaire, urinary function score
b International Consultation on Incontinence Questionnaire Short Form
cUCLA Prostate Cancer Index Short Form (UCLA-PCA-SF) including the RAND 12-item Health Survey v2 (SF-12 v2)

Valuable surgical dissection and sling positioning experience was gained and resulted in refinement of surgical technique. Sling placement was deemed to be a critical success factor. It was determined that marking of the central tendon's location before dissection and proper passage of the helical needles were key to proper placement of the sling. Post-hoc analysis was performed to determine if results improved with increasing surgeon experience. The analysis appeared to show a trend toward improved results although it was not statistically significant. Similarly, lower pad usage at baseline increased the likelihood of postoperative success. Also, post-hoc analysis of 24-hour pad weight data did show that patients with lower baseline 24-hour pad weights were more likely to use 0-1 pads per day at WCS 24-month follow-up (p = 0.005).
CONCLUSIONS: This two-year multi-center, prospective study demonstrates the safety and effectiveness of the AdVance male transobturator sling in the treatment of mild to moderate post-prostatectomy SUI. Continence rates improved as evidenced by pad weight and pads used per day results, which were maintained through 24-month follow-up. This minimally-invasive sling carries a low incidence of adverse events yet maintains high QOL improvements. Proper patient selection and surgical technique refinement noted during this study will likely further enhance patient outcomes.
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