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| |  Novel Device Is Effective in Tough-to-Treat Urinary Incontinence: Presented at ICS By Jill Stein SAN FRANCISCO -- October 3, 2009 -- An investigational minimally invasive device known as the Adjustable Continence Therapy (ACT) system seems to be an effective treatment for women with stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency, according to data presented here October 2 at the 39th Annual Meeting of the International Continence Society (ICS). Suzette Sutherland, MD, Metro Urology, Minneapolis, Minnesota, reported results from 162 patients implanted to date, of whom 142, 84, and 57 patients have completed at least 1, 2, and 3 years follow-up, respectively. The device 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 postoperative titration of the balloons for maximal efficacy. All patients had recurrent SUI with or without urethral hypermobility. Baseline and follow-up tests were done at 6 weeks, 3 months, 6 months, 9 months, 12 months, and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test (PPWT), direct visual stress test, Stamey score, and validated questionnaires to assess the degree of stress incontinence, voiding dysfunction, sexual function, and quality of life. Results showed that at 1, 2, and 3 years, respectively, improvement in Stamey score of at least 1 grade was achieved in 75.4% (107 of 142), 75.0% (63 of 84), and 83.9% (47 of 56) patients. The mean PPWT decreased from 48.9, 44.3, and 44.5 g to 11.1, 8.9, and 8.4 g (P < .001). A dry rate (defined as <2 g on PPWT) was 51%, 63%, and 71%. A greater than 50% rate of improvement was seen in 80%, 89%, and 83% of patients. Significant improvements in quality of life were also documented on validated questionnaires. Cumulative mean adjustments to achieve maximum continence were 2.1, 2.7, and 3.0 for 1, 2, and 3 years, respectively. Mean balloon volumes were 3.4, 3.7, and 3.6 mL (left) and 3.5, 3.9, and 3.9 mL (right), with a range of 1.0 to 11.5 mL. Overall, 25% of patients had device- or procedure-related complications, which were considered mild in more than half of the cases. Fifty-six patients required explantation, and about half of these patients underwent reimplantation and continue to be followed. The results show that the device evaluated in this trial is an effective and safe treatment for recurrent female SUI, Dr. Sutherland said. [Presentation title: The Adjustable Continence Therapy (ACT) System: 1-, 2-, and 3-Year Results of the North America Clinical Study Group. Abstract 561]
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