1504 MEDIUM TERM RESULTS OF THE ADJUSTABLE CONTINENCE THERAPY (ACT) IN THE TREATMENT OF RECURRENT STRESS URINARY INCONTINENCE

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology I1 Apr 20101504 MEDIUM TERM RESULTS OF THE ADJUSTABLE CONTINENCE THERAPY (ACT) IN THE TREATMENT OF RECURRENT STRESS URINARY INCONTINENCE Suzette Sutherland, Steve Nash, Slutsky Joel, Le Mai Tu, Sherif Aboseif, Niall Galloway, Neil Baum, John Bresette, and Peter Pommerville Suzette SutherlandSuzette Sutherland Plymouth, MN More articles by this author , Steve NashSteve Nash Kansas City, MO More articles by this author , Slutsky JoelSlutsky Joel Kankakee, IL More articles by this author , Le Mai TuLe Mai Tu Sherbrooke, Canada More articles by this author , Sherif AboseifSherif Aboseif Los Angeles, CA More articles by this author , Niall GallowayNiall Galloway Atlanta, GA More articles by this author , Neil BaumNeil Baum New Orleans, LA More articles by this author , John BresetteJohn Bresette Burlington, MA More articles by this author , and Peter PommervillePeter Pommerville Victoria, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1242AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Our primary objective is to evaluate safety and efficacy over time (1,2 and 3 years) of a new device (Adjustable Continence Therapy, ACT) for the treatment of recurrent Stress Urinary Incontinence (SUI). We also evaluate difficulty of the surgical procedure and report on adjustability of the device. METHODS Management of SUI is challenging after prior failed therapies. The ACT system provides bulk at the bladder neck with adjustable silicone balloons for urethral co-aptation and bladder neck support. Balloons are attached to titanium ports allowing for post-op titration of the balloons for maximal efficacy. The surgical technique involves a small incision between the labia majora and minora at the level of the meatus. A trocar is passed, using fluoroscopy, to the urethrovesical junction. The device is delivered and then filled with 1.5cc dilute contrast. The injection port for balloon adjustment is placed into a subcutaneous pouch in the labia. Device adjustments begin 6 weeks post-operatively, if needed. The study cohort involves female patients with recurrent SUI with or without urethral hypermobility. Baseline and follow-up tests were performed at 6 weeks,3,6,9 and 12 months and annually thereafter and included provocative pad weight tests and validated questionnaires. RESULTS 162 patients were implanted with 142, 84 and 57 patients completing at least 1, 2 and 3 years follow-up respectively. Mean age is 67.4 years (31-94). Most, 83% (N=135) had at least one previous anti-incontinence procedure, with 42.6% experiencing 2 or more failed procedures. Difficulty of ACT surgeries was rated as mild (62%), moderate (29%) or severe (9%). Mean provocative pad weight decreased from 48.9, 44.3 and 44.5 grams at baseline to 11.8, 8.9 and 8.4 grams at 1,2 and 3 years respectively (p<0.001). Dry rate was 50.8%, 63% and 71.4% and ≥50% improvement was 79.7%, 88.7% and 83.3% at 1,2 and 3 years. Patient's quality of life was assessed by IQoL, UDI-6 and IIQ-7 questionnaires and the results show improvement at 1,2 and 3 years (p<0.001). Mean number of balloon adjustments to achieve maximum continence was 2.9 (0-15). Device or procedure related complications (bladder perforation, port or balloon erosion, balloon migration etc.) were reported in 25% (39/156) of subjects at the end of 12 months, 18.6% (21/113) through year 2 and 13.7% (10/73) through year 3. The majority were considered to be mild in severity. CONCLUSIONS Medium term data suggest the ACT System can be an effective, simple, safe and minimally invasive treatment for recurrent SUI in a challenging group of patients, © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e579-e580 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Suzette Sutherland Plymouth, MN More articles by this author Steve Nash Kansas City, MO More articles by this author Slutsky Joel Kankakee, IL More articles by this author Le Mai Tu Sherbrooke, Canada More articles by this author Sherif Aboseif Los Angeles, CA More articles by this author Niall Galloway Atlanta, GA More articles by this author Neil Baum New Orleans, LA More articles by this author John Bresette Burlington, MA More articles by this author Peter Pommerville Victoria, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...