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AAGL Clinical Presentation 2004
Hi. I'm Dr. John Lenihan, I'm a gynecologist who practices in Tacoma, Washington with a private practice group that does clinical research on women's incontinence.
I reported today, at the AAGL meeting in San Francisco, about our experience with a novel and new office-based product for the treatment of female stress incontinence. In the past we all know that this has been a major problem for millions of women who, for the most part, never wished to be treated or seek treatment because the treatments available are so invasive. What we are looking at is a new product called the Novasys Radiofrequency Remodeling Device that treats women in an office setting under local anesthesia in about 20 minutes that has excellent results over 1 and 2 year follow-up.
The device is a small gun-like device that looks like a foley catheter we administer local anesthetic in the office and the report I did today looks at the feasibility of doing this under local anesthetic. We did a preliminary trial using general anesthesia that worked very, very well. And myself and the other investigators who performed that trial, had the impression that this would be a very, very easy thing to do under local anesthesia for most patients. We did a pilot trial in Mexico with 10 patients and we've done a follow-up trial in the United States with 33 patients seeing if we could do this treatment and if it would still achieve the same success rate and patient satisfaction. We not only succeeded, we succeeded beyond our wildest expectations. We had no patient who was intolerant to the procedure or that we had to stop because of pain either as perceived by the patient or the physician investigator.
The treatment is extremely easy to do in the office and we predict it will be a first-line treatment for urinary stress incontinence and the remodeling technique does not preclude any future treatments. We suspect it will be durable based on other information from other body sites where this technique has been used, such as the shoulder and the esophagus and we're very excited about being able to offer this now to physicians to use in their office.
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