TITLE:
Five Years Follow-Up of Adjustable Continence Therapy (ACT) in the Treatment of Recurrent Female SUI
AUTHORS:
Niall T. Galloway, Sherif R. Aboseif, Pejvak Sassani, Ethan I. Franke, Steven D. Nash, Joel N. Slutsky, Mai Le Tu, Peter J. Pommerville, Neil H. Baum, Suzette E. Sutherland
KEYWORDS:
Female Urinary Incontinence; Implant; Balloon Adjustments; Safety; Stamey Score
JOURNAL NAME:
Open Journal of Urology,
Vol.3 No.2,
May
22,
2013
ABSTRACT:
Purpose/Objective: 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. Materials
and Methods: The Adjustable Continence
Therapy (ACT) system (Uromedica, Inc., Plymouth,
MN) consists of two silicone
balloons providing urethral coaption and bladder neck support. Each balloon is
attached to a titanium port buried in the labia allowing 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. Results: During a 5 years period (2002-2007), 162 patients were implanted
(mean age 67.6, range 31 - 94 years). Of these 162 patients 142, 90, 80,
56 and 31 patients completed the 1, 2, 3, 4 and 5 years follow-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 >1 grade
was achieved in 75% (107/142) at 1 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 (provocative pad
weight 2 gms) was 51%, 62% , 76%, 76% and 76% at 1 through 5 years, and
>50% improvement was achieved in 83%, 86%, 86%, 90% and 93%,respectively.
IQoL improved from 37 at baseline to 71, 71, 75, 77 and 74 during the
study, and optimal continence was achieved with a mean of 4 adjustments, and
mean balloon volumes of 4.0 ml (1.0 - 11.5 ml). Complications including bladder
perforation, erosion, migration, pain and urinary retention were reported in
25% (38/155) at 12 months, and 9% (10/109), 3% (3/91) , 6% (5/79)
and 4% (3/69) respectively, and of these, the majority were mild to
moderate. At 5 years, 33 patients had undergone permanent explants of both
devices, 48 were lost to follow-up and 6 had died of unrelated causes. Conclusions: Five years data suggest that ACT is, a safe
and effective, minimally invasive treatment for recurrent SUI, which is
easy to place and adjust to optimize urinary control without impairing bladder
emptying.