1165 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

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy1 Apr 20111165 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, Kurt A. McCammon, L. Dean Knoll, LeRoy A. Jones, Gregory T. Bales, Sender Herschorn, Brian Roberts, Timothy B. Boone, and George D. Webster Michael J. KennellyMichael J. Kennelly Charlotte, NC More articles by this author , Kurt A. McCammonKurt A. McCammon Norfolk, VA More articles by this author , L. Dean KnollL. Dean Knoll Nashville, TN More articles by this author , LeRoy A. JonesLeRoy A. Jones San Antonio, TX More articles by this author , Gregory T. BalesGregory T. Bales Chicago, IL More articles by this author , Sender HerschornSender Herschorn Toronto, Canada More articles by this author , Brian RobertsBrian Roberts Myrtle Beach, SC More articles by this author , Timothy B. BooneTimothy B. Boone Houston, TX More articles by this author , and George D. WebsterGeorge D. Webster Durham, NC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.775AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES 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). METHODS A multi-center, prospective study was conducted at 10 centers. Men ≥40 years of age with PPI 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 at follow-up. Improvement in quality of life (QOL) was evaluated by 3 QOL questionnaires. Follow-up occurred at 6 weeks and at 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 with PPI were implanted with the AdVance sling. Mean age was 64.5 years. Results 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 show that 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 24-month follow-up (p = 0.005). CONCLUSIONS This two-year multi-center, prospective study demonstrates the safety and effectiveness of the transobturator sling in the treatment of mild to moderate PPI. Continence rates improved and 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. Results Summary Baseline 12-Month 24-Month 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) IQOL̂ 50.3(n=49) 79.9⁎⁎⁎(n=35) 82.4⁎⁎⁎(n=31) NA NA ICIQ-SF̂̂ 15.7(n=49) 7.3⁎⁎⁎(n=35) 7.5⁎⁎⁎(n=31) NA NA UCLA/RAND̂̂̂ 20.1(n=49) 57.4⁎⁎⁎(n=35) 57.3⁎⁎⁎(n=31) NA NA ⁎ Signed rank (P< 0.0001) for improvement compared to baseline ⁎⁎ McNemar (P< 0.0002) for improvement compared to baseline Încontinence Quality of Life Questionnaire, urinary function score ̂Înternational Consultation on Incontinence Questionnaire Short Form ̂̂ÛCLA Prostate Cancer Index Short Form (UCLA-PCA-SF) including the RAND 12-item Health Survey v2 (SF-12 v2) ⁎⁎⁎ T-test (P< 0.0001) for improvement compared to baseline © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e467-e468 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael J. Kennelly Charlotte, NC More articles by this author Kurt A. McCammon Norfolk, VA More articles by this author L. Dean Knoll Nashville, TN More articles by this author LeRoy A. Jones San Antonio, TX More articles by this author Gregory T. Bales Chicago, IL More articles by this author Sender Herschorn Toronto, Canada More articles by this author Brian Roberts Myrtle Beach, SC More articles by this author Timothy B. Boone Houston, TX More articles by this author George D. Webster Durham, NC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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