Five Years Follow-Up of Adjustable Continence Therapy (ACT) in the Treatment of Recurrent Female SUI

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.