Evaluating Adjustable Continence Therapy in treating recurrent SUI
25th Anniversary EAU Congress, Barcelona
Tuesday, 25 May 2010- A group of US researchers evaluated the safety and efficacy over time (1, 2 and 3 years) of a novel device (Adjustable Continence Therapy, ACT) for the treatment of recurrent Stress Urinary Incontinence (SUI).
S. E. Sutherland and colleagues also aimed to evaluate the difficulty of the surgical procedure and to report on the aspects of the adjustability of the device. They presented their findings at the 25th Anniversary EAU Congress held in Barcelona, Spain.
Management of SUI can be challenging after prior failed therapies. The ACT system is a novel device that provides bulk at the bladder neck with adjustable silicone balloons for urethral co-aptation and bladder neck support. Each balloon is attached to a titanium port allowing for post-op titration of the balloons for maximal efficacy.
The surgical technique involves a small incision between the labia majora and minora at the level of the meatus. A trocar is passed under fluoroscopic guidance to the urethrovesical junction. The device is delivered and the balloon filled with 1.5 cc dilute contrast. The injection port for balloon adjustment is placed into a subcutaeneous pouch in the labia.
Device adjustments begin 6 weeks post-operatively, if needed. The study cohort involves female patients with recurrent SUI with or without urethral hypermobility. Baseline and follow-up tests were performed at 6 weeks, 3, 6, 9 and 12 months and annually thereafter, including a 3-day voiding diary, provocative pad weight test, direct visual stress test and validated questionnaires to assess the degree of SUI, voiding dysfunction, quality of life etc.
The results showed that 162 patients have been implanted, with 142, 84 and 57 patients completing at least 1, 2 and 3 years follow-up respectively. Mean age is 67.4 years (31-94 years). The majority, 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. Mean provocative pad weight 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 years respectively (p<0.001). Dry rate was 50.8%, 63.0% and 71.4% and ? 50% improvement was 79.7%, 88.7% and 83.3% at 1, 2, and 3 years. patient's quality of life was assessed by the IQoL, UDI-6 and IIQ-7 questionnaires and the results suggest improvement in quality of life at 1, 2 and 3 years (p<0.001).
The mean number of balloon adjustments to achieve maximum continence was 2.9 (0-15). Device or procedure related complications (bladder perforation, port or balloon erosion, balloon migration, etc.) 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 were considered to be mild in severity.
"Medium term, 3-year data suggest the ACT system, for a challenging group of patients, can be an effective, simple, safe and minimally invasive treatment for recurrent female SUI," according to the researchers.
Source: S. E. Sutherland, et al., "Medium term results of the Adjustable Continence Therapy (ACT®) in the treatment of recurrent SUI," Abstract 398, 25th Anniversary EAU Congress, April 16 to 20, 2010, Barcelona, Spain.
