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| |  FemSoft Effective For Treatment Of Female Stress Urinary Incontinence DALLAS, TX -- May 3, 1999 -- Rochester Medical Corp. announced on May 1, at the 20th annual Society for Urodynamics and Female Urology meeting, excellent results from the multi-centre Investigational Device Exemption (IDE) trial of their FemSoft(R) Urethral Insert for the treatment of female stress urinary incontinence. The results, presented by one of the study's lead investigators, Dr. Larry Sirls (department of urology, William Beaumont Hospital, Royal Oak, MI.), indicate that the FemSoft Insert is a highly effective, comfortable and easy-to-use device for women dealing with the discomfort, restrictions and embarrassment of stress incontinence. Dr. Sirls presented the results from a study of 150 women enrolled in a one-year multi-centre trial. The participating women had experienced stress urinary incontinence for an average of 10.9 years; 42 percent of the study participants previously had tried other incontinence treatments. Overall, the minimally-invasive device was highly effective and had a high level of patient acceptance with low levels of adverse effects. The study results reported today are based on the 70 women who have completed one year of follow-up to date. After 12 months, urine leakage with a FemSoft Insert in place was 0.5 grams, compared to 26.3 grams without the device. Practically speaking, there was virtually no leakage with a device in place during the Pad Weight Test and 26 grams of leakage (equivalent to a medicine cup full) without a device. At the end of a 12-month period, 82 percent of participants reported they had virtually no leakage when using the FemSoft Insert. Participants reported a high level of satisfaction, with 94.8 percent of the women During a separate panel discussion on the range of incontinence treatment modalities at the 20th annual Society of Urodynamics and Female Urology sessions, Dr. Michael Kennelly (a practising urologist with McKay Urology Associates in Charlotte, N.C.) said that clinical data from the FemSoft Insert study is very promising. "We may indeed be witnessing the emergence of an effective and truly patient-friendly treatment modality for female stress incontinence," he said, adding that for many women embarrassment and limited treatment options have long been barriers to successful treatment for this condition. Urinary incontinence is a medically diagnosed condition affecting 11 million women in the United States. A approximately 6.6 million of those women have stress incontinence. Stress incontinence is the involuntary loss of urine caused by pressure on the bladder from simple everyday activities (such as laughing, sneezing, coughing), minor physical exertion (such as lifting a bag of groceries, rising from a sitting position), or exercise (such as dancing, aerobics, golfing, tennis). Although the condition is common, most women endure it in silence because of its embarrassing nature, limited treatment options and an insufficient understanding of incontinence as a medical condition. However, based on the clinical results for the FemSoft Insert, women may finally have an attractive, minimally-invasive solution, Dr. Sirls said. The study indicates that women find the FemSoft Insert to be an effective, desirable and acceptable form of incontinence treatment. The study also indicated the device improved the overall quality of life among participating women. "Now many more women will not have to endure the discomfort and embarrassment of stress incontinence," Dr. Sirls said. "The FemSoft Insert's soft, conforming design is both comfortable and minimally invasive. It will help women stay dry without the fear of embarrassing wetness and odour during virtually all types of physical activity." The FemSoft Insert is both a unique and optimal treatment for stress incontinence according to Dr. Sirls because its breakthrough technology makes it comfortable and easy-to-use. He said it is a reliable device that is as soft as a woman's body tissues. The FemSoft Insert is a small, single-use, liquid and silicone device that a woman can easily insert into her urethra. The latex-free insert consists of a narrow silicone tube completely encapsulated by a soft, conforming, fluid filled sleeve. As a woman inserts the slender device, the soft sleeve slides into and conforms to her urethra, creating an effective seal at the neck of the bladder to prevent unintended urine leakage. It is removed for voiding, discarded and then replaced by a fresh insert. The FemSoft Insert is not yet commercially available. Rochester Medical currently awaits the results from the FemSoft Insert's PMA (Pre-Market Approval) application submitted to the Food and Drug Administration in January 1999. Related Links: FemSoft, Rochester Medical Corp.
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