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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.
continue onto the slide presentation with audio ...
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