%0 Journal Article
%T Five Years Follow-Up of Adjustable Continence Therapy (ACT) in the Treatment of Recurrent Female SUI
%A Niall T. Galloway
%A Sherif R. Aboseif
%A Pejvak Sassani
%A Ethan I. Franke
%A Steven D. Nash
%A Joel N. Slutsky
%A Mai Le Tu
%A Peter J. Pommerville
%A Neil H. Baum
%A Suzette E. Sutherland
%J Open Journal of Urology
%P 132-137
%@ 2160-5629
%D 2013
%I Scientific Research Publishing
%R 10.4236/oju.2013.32025
%X <p class=\"MsoNormal\">
	<b><span lang=\"EN-US\">Purpose/Objective:</span></b><span lang=\"EN-US\"> The
primary objective of this FDA study is to evaluate the safety and efficacy of
the ACT device (Adjustable Continence Therapy) in the treatment of female
recurrent Stress Urinary Incontinence (SUI). The secondary objective is to
evaluate the difficulty of placement and aspects of device adjustability.</span><span lang=\"EN-US\"> </span><b><span lang=\"EN-US\">Materials
and Methods: </span></b><span lang=\"EN-US\">The<b> </b>Adjustable Continence
Therapy (ACT) system (Uromedica, Inc., <st1:place w:st=\"on\"><st1:city w:st=\"on\">Plymouth</st1:city>,
 <st1:state w:st=\"on\">MN</st1:state></st1:place>) consists of two silicone
balloons pro</span><span lang=\"EN-US\">viding urethral coaption and bladder neck support. Each balloon is
attached to a titanium port buried in the labia allow</span><span lang=\"EN-US\">ing for
post-operative adjustment of volume. 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, direct visual stress test, Stamey
score and validated questionnaires to assess severity of incontinence, voiding
dysfunction, sexual function and quality of life.</span><span lang=\"EN-US\"> </span><b><span lang=\"EN-US\">Results: </span></b><span lang=\"EN-US\">During a 5</span><span lang=\"EN-US\"> </span><span lang=\"EN-US\">year</span><span lang=\"EN-US\">s</span><span lang=\"EN-US\"> pe</span><span lang=\"EN-US\">riod (2002-2007), 162 patients were implanted
(mean age 67.6, range 31</span><span lang=\"EN-US\"> </span><span lang=\"EN-US\">-</span><span lang=\"EN-US\"> </span><span lang=\"EN-US\">94 years). Of these 162 patients 142, 90, 80,
56 and 31 patients completed the 1, 2, 3, 4 and 5 year</span><span lang=\"EN-US\">s</span><span lang=\"EN-US\"> follow</span><span lang=\"EN-US\">-</span><span lang=\"EN-US\">up
respectively. One hundred and thirty five (83%) had failed at least one surgery
for incontinence and 44% had failed 2 or more procedures prior to ACT
implantation. Difficulty of ACT placement was rated mild in 62%, moderate in
30% and severe in 9%. Improvement in Stamey score of &gt;1</span><span lang=\"EN-US\"> </span><span lang=\"EN-US\">grade
was achieved in 75% (107/142) at 1</span><span lang=\"EN-US\"> </span><span lang=\"EN-US\">year, 76% (68/90) at 2 years, 86% (62/78) at 3 years,
93% (50/54) at 4 years and 83% (25/30) at 5 years. Dry rate
%K Female Urinary Incontinence
%K Implant
%K Balloon Adjustments
%K Safety
%K Stamey Score
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=31494