1864 FOUR YEAR FOLLOW-UP RESULTS OF THE ADJUSTABLE CONTINENCE THERAPY (ACT®) IN THE TREATMENT OF RECURRENT SUI

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology1 Apr 20111864 FOUR YEAR FOLLOW-UP RESULTS OF THE ADJUSTABLE CONTINENCE THERAPY (ACT®) IN THE TREATMENT OF RECURRENT SUI Niall Galloway, Steven Nash, Joel Slutsky, Le Mai Tu, Sherif Aboseif, Peter Pommerville, Neil Baum, John Bressette, and Suzette Sutherland Niall GallowayNiall Galloway Atlanta, GA More articles by this author , Steven NashSteven Nash Kansas City, MO More articles by this author , Joel SlutskyJoel Slutsky Kanakakee, IL More articles by this author , Le Mai TuLe Mai Tu Fleurimont, Canada More articles by this author , Sherif AboseifSherif Aboseif Los Angeles, CA More articles by this author , Peter PommervillePeter Pommerville Victoria, Canada More articles by this author , Neil BaumNeil Baum New Orleans, LA More articles by this author , John BressetteJohn Bressette Burlington, MA More articles by this author , and Suzette SutherlandSuzette Sutherland Woodbury, MN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1946AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The primary objective of this FDA study is to evaluate the safety and efficacy of a device (ACT, Adjustable Continence Therapy) for the treatment of female recurrent Stress Urinary Incontinence (SUI). Secondary objectives evaluated the difficulty of placement and aspects of device adjustability. METHODS The Uromedica Adjustable Continence Therapy (ACT®) system consists of two silicone balloons providing urethral coaptation and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative titration. Females with recurrent SUI with or without urethral hypermobility were evaluated at baseline and follow-up periods of 6 weeks, 3, 6, 9, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test (PPWT), direct visual stress test, Stamey score and validated questionnaires to assess the degree of stress incontinence, voiding dysfunction, sexual function and quality of life. RESULTS Between 2002 and 2007, 162 patients were implanted (mean age 67.4 (31–94) years), with 142, 90, 75 and 45 patients completing at least 1, 2, 3 and 4 years follow-up respectively. The majority, 83% (N=135) had at least 1 or 2 (46%) previous anti-incontinence procedures. Difficulty of surgery was rated as mild, moderate, or severe in 62%, 30%, and 9% of procedures respectively. Improvement in Stamey score of > 1 grade was achieved in 75.4% (107/142) at 1 year, in 75.6% (68/90) at 2 years, in 84.9% (62/73) at 3 years and in 92.9% (39/42) at 4 years. Dry rate (PPWT < 2 gms) was 51%, 62% and 74%, and 77% and > 50% improved rate was 80%, 86%, 83% and 89% at 1, 2, 3 and 4 years, respectively. IQoL increased from 36.8 (SD 23.1) at baseline compared to 70.0 (SD 25.5), 71.7, 74.1 and 80.6 at 1, 2, 3 and 4 years. Optimal continence was achieved with a mean of 3 adjustments. Mean balloon volumes were 3.9 ml (1.0–11.5 ml). Device or procedure related complications (bladder perforation, port or balloon erosion, balloon migration, port or balloon related discomfort, intermittent urinary retention) were reported in 25% (39/156) of subjects at the end of 12 months, 19% (22/116) through year 2, 11.1% (10/90) through year 3 and 13.2% (3/22) through year 4. Of these, the majority were considered to be mild in severity. At 4 years 29 patients had undergone permanent explants of both devices, 43 were lost to follow up and 6 had died of unrelated causes. CONCLUSIONS Four year data suggest ACT is a simple, safe and minimally invasive effective treatment for recurrent female SUI. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e747-e748 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Niall Galloway Atlanta, GA More articles by this author Steven Nash Kansas City, MO More articles by this author Joel Slutsky Kanakakee, IL More articles by this author Le Mai Tu Fleurimont, Canada More articles by this author Sherif Aboseif Los Angeles, CA More articles by this author Peter Pommerville Victoria, Canada More articles by this author Neil Baum New Orleans, LA More articles by this author John Bressette Burlington, MA More articles by this author Suzette Sutherland Woodbury, MN More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...