Oral Poster 20

Abstract

OBJECTIVES: Evaluate the safety and efficacy of the ACT® device for the treatment of recurrent SUI. Secondary objectives included procedural technical difficulty and device adjustability. MATERIALS AND METHODS: Management of stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency (ISD) can be challenging after prior failed therapies. 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 allowing for post-operative titration of the balloons for maximal efficacy. A small incision between the labia majora and minora at the level of the urethral allows for passage of a trocar under fluoroscopic guidance to the bladder neck. The device is delivered and the balloon filled with 1.5 cc dilute contrast. The injection port for balloon adjustment is placed into a subcutaneous pouch in the labia majora. Balloon adjustments begin 6 weeks post-operatively, as needed. The study population involves female patients with recurrent SUI with urethral hypermobility (UHM) and/or intrinsic sphincter deficiency (ISD). Testing was performed at baseline, then postop 6 wks, 3, 6, 9, 12 months, and annually thereafter, and included urinalysis, a 3-day diary, provocative pad weight test (PPWT), direct visual stress test (DVST), Stamey score, physical exam and validated questionnaires (UDI-6, IIQ-7, IQoL). RESULTS: : 162 patients were implanted to date, with 142, 84 and 57 patients completing at least 1, 2, and 3 years follow-up, respectively. Mean age is 67.4 yrs (range 31–94 yrs). 83% (N = 135) had at least one previous anti-incontinence procedure, with 42.6% experiencing 2 or more failed procedures. Difficulty of ACT® surgery was rated as mild, moderate, or severe in 62%, 29%, and 9% of procedures, respectively. Improvement in Stamey score was >1 in 75.4% (107/142), in 75.0% (63/84) and in 83.9% (47/56) at 1, 2 and 3 yrs, respectively. Mean PPWT decreased from 48.9, 44.3 and 44.5 grams at baseline to 11.8, 8.9 and 8.4 grams at 1, 2 and 3 yrs, respectively (P < 0.001). Dry rate was 50.8%, 63.0% and 71.4%, and >50% improved rate was 79.7%, 88.7% and 83.3% at 1, 2 and 3 yrs, respectively. Validated questionnaires noted significant improvements at 1, 2 and 3 yrs (P < 0.001). Mean number of balloon volume adjustments through the study period to achieve maximum continence was 2.9 (0–15). Device or procedure related complications (bladder perforation, port or balloon erosion, balloon migration, port or balloon related pain/discomfort, intermittent urinary retention) were reported in 25% (39/156) of subjects at the end of 12 months, 18.6% (21/113) through year 2, and 13.7% (10/73) through year 3. Of these, the majority (54%) were considered to be mild in severity. CONCLUSION: 3-year data suggest the Uromedica ACT® system can be an effective, simple, minimally-invasive and safe treatment for recurrent female SUI.