New Device is Effective for Recurrent Female Urinary Incontinence
By Jill Stein
Medscape Medical News
June 2, 2010 (San Francisco) – An investigational minimally invasive device, known as the Adjustable Continence Therapy (ACT, Uromedica, Inc.) system, seems to be an effective treatment for women with recurrent episodes of stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency, researchers reported here at the American Urological Association 2010 Annual Scientific Meeting.
"Recurrent SUI after a failed surgical procedure continues to be a challenging problem," coinvestigator Sherif Aboseif, MD, director of the Neurourology and Reconstructive Surgery Program at Kaiser Permanente in Los Angeles, California, told Medscape Urology. "It can result from either persistent hypermobility of the vesicourethral segment or from [intrinsic sphincter deficiency] due to lack of coaptation of the urethral wall in response to a slight increase in intra-abdominal pressure."
Midurethral slings are considered the treatment of choice for genuine SUI, he continued. However, in recurrent cases, midurethral slings can be associated with high morbidity, which has led to the development of several minimally invasive options that "provide the hope of reasonable efficacy associated with minimal morbidity." Minimally invasive options include injections of bulking agents, injection of stem cells into the rhabdosphincter, and adjustable continence therapy devices.
"Our results suggest that the ACT system can be an effective, simple, safe, and minimally invasive treatment for recurrent SUI in a challenging group of patients. All women with recurrent incontinence are good candidates for this therapy," Dr. Aboseif said.
Good Mid-Term Results Seen With the Adjustable Device
The ACT 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.
The investigators reported results from the 162 women implanted thus far, of whom 142, 84, and 57 have completed, respectively, at least 1, 2, and 3 years follow-up.
All women had recurrent SUI with or without urethral hypermobility. Most had undergone at least 1 previous anti-incontinence procedure, and nearly half had undergone at least 2 unsuccessful procedures.
Baseline and follow-up tests were performed at 6 weeks, at 3, 6, 9, and 12 months, and annually thereafter, and included the provocative pad weight test (PPWT) and validated questionnaires.
Results showed that a Stamey score reduction of at least 1 grade was achieved in 75.4% (107 of 142 patients) at 1 year, 75.0% (63 of 84 patients) at 2 years, and 83.9% (47 of 56 patients) at 3 years.
The difficulty of performing surgery to implant the device was rated as mild in 62% of cases, moderate in 29%, and severe in 9%.
The mean PPWT decreased from 48.9, 44.3, and 44.5?g at baseline, to 11.8, 8.9, and 8.4?g at 1, 2, and 3 years, respectively (P?< .001).
Dry rate, defined as less than 2?g on PPWT, was 50.8%, 63%, and 71.4%, respectively, and improved more than 50% in 79.7%, 88.7%, and 83.3% of patients at 1, 2, and 3 years, respectively.
Validated questionnaires assessing the degree of stress incontinence, voiding dysfunction, sexual function, and overall quality of life showed significant improvements on all measures during the 3 years of follow-up (P?< .001).
The mean number of balloon adjustments required to achieve maximum continence was 2.9. Device or procedure-related complications (bladder perforation, port or balloon erosion, balloon migration, port- or balloon-related pain or discomfort, and intermittent urinary retention) were reported in 25% (39 of 156 patients) during the first year, 18.6% (21 of 113 patients) during the second year, and 13.7% (10/73 patients) during year the third year. Most complications were considered mild and easily managed.
"Traditional sling therapies are unsuccessful in 15% to 30% of patients based on selection criteria," Neal Shore, MD, FACS, director of Carolina Urologic Research Center/Atlantic Urology Clinics in Myrtle Beach, South Carolina, told Medscape Urology in an interview. "Innovative strategies for addressing refractory incontinence are always welcome, especially if they can minimize patient morbidity and improve long-term efficacy."
The study, which was carried out at 9 centers in the United States and Canada, was funded by Uromedica, Inc. Dr. Aboseif and Dr. Shore have disclosed no relevant financial relationships.
American Urological Association (AUA) 2010 Annual Scientific Meeting: Abstract?1504. Presented June?1, 2010.
