Non-Oral Poster 35: Does Advancing Age Negatively Influence Success Of The Adjustable Continence Therapy (act®) Device For Recurrent Sui?

OBJECTIVES: Age is often considered a risk factor for successful treatment of stress urinary incontinence (SUI). We assessed whether age remains a risk factor when treating patients with the Adjustable Continence Therapy (ACT®) device for recurrent SUI with respect to efficacy and safety. MATERIALS AND METHODS: The Uromedica ACT® system is a novel device under FDA investigation that provides bulk at the bladder neck with adjustable silicone balloons for urethral coaptation and bladder neck support. Each balloon is attached to a titanium port buried in the labia majora allowing for post-operative size titration of the balloons for continued maximal efficacy. A small incision between the labia majora and minora at the level of the urethra allows for passage of a trocar under fluoroscopic guidance to the bladder neck. The device is delivered and the balloons filled with 1.5 cc contrast. The injection port for balloon adjustment is placed into a subcutaneous pouch in the labia majora. Device adjustments begin 6 weeks post-operatively, as needed. 162 patients were implanted, ranging in age from 31 to 94 (mean 67.4 ± 11.6), with recurrent SUI diagnosed as urethral hypermobility (UHM) and/or intrinsic sphincter deficiency (ISD). 140 (86%) and 68 (42%) completed 1 and 2 years follow-up, respectively. Patients were divided in three age groups: 54 (38.6%) patients <65yrs; 55 (39.3%) patients 65–74 yrs; and 31 (22.1%) patients >75yrs old. Age was associated with more HTN (P < 0.001), CAD (P = 0.012) as well as prior failed incontinence surgeries (P = 0.021). Younger patients had more non-surgical treatments for SUI (P = 0.024). Older patients had greater severity of SUI as indicated by direct visual stress test (DVST) and provocative pad weight testing (PPWT) (P = 0.025). Older patients were less likely to be sexually active (P < 0.001). RESULTS: At 1 year all three age groups demonstrated significant (P ≤ 0.005) improvement on all efficacy endpoints compared to baseline including the Stamey score, DVST severity, PPWT, number of incontinence episodes/day, number of pads/day, UDI-6, IIQ-7 and IQoL scores. At 2 years all three age groups continued to show significant improvement (P ≤ 0.021) on most tests conducted. There were no significant differences between the three age groups on any of the efficacy endpoints or complication rates. CONCLUSION: The 1- and 2-year results demonstrate that the ACT® system can be effectively used for recurrent SUI in adult women, regardless of age. Age does not appear to be a risk factor for this therapy.