Athena Feminine Technologies, Inc. Initiates Enrollment of Phase IV Clinical Trial for Athena Pelvic Muscle Trainer(TM)
ORINDA, Calif., March 11 /PRNewswire/ — Athena Feminine Technologies, Inc., in partnership with the National Association of Nurse Practitioners in Women’s Health, today announced the initiation of a nationwide enrollment for Phase IV of the DUETS (Device for Urinary Incontinence, Effectiveness, Tolerability and Satisfaction) research study for its Athena Pelvic Muscle Trainer(TM) (PMT). The Athena PMT is an FDA-approved wireless vaginal electrical stimulator available by prescription for women with stress, urge or mixed incontinence.
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“An estimated 20 million women in America have some loss of bladder control and the Athena PMT may give these women a chance to take back control of their bladders and lives without medication or surgery,” said Dave Berryman, Chief Executive Officer of Athena Feminine Technologies, Inc. “Women had success treating their bladder control issues with the Athena PMT. We are looking forward to further characterizing the condition in women with this study to report on the prevalence and a possible effective treatment.”
Some women may lose small amounts of urine occasionally due to coughing, laughing or sneezing, while others may saturate their clothing on a regular basis. Incontinence occurs because of problems with the muscles and nerves that help to hold or release urine. Women experience urinary incontinence twice as often as men, usually stemming from a weakened pelvic floor muscle, which acts like a hammock and on average supports the weight of about 20 lbs. of organs. Like all muscles, the pelvic floor muscle must be healthy and toned to properly function. Kegel exercises can strengthen these muscles allowing for improved bladder control; however, many women who try these exercises forget to do them or don’t do them properly.
“The pelvic muscle is often neglected until one experiences involuntary loss of bladder control. Even if a woman has urinary incontinence, she will wait an average of 6.5 years before discussing it with her healthcare professional,” noted Susan Wysocki, President of the National Association of Nurse Practitioners in Women’s Health, which has partnered with Athena Feminine Technologies, Inc. to conduct the study with 100 or more nurse practitioners acting as lead investigators. “There’s a real embarrassment factor associated with incontinence and many women think it is a part of normal aging or something to live with because of having children, but that’s simply not true. For many women, it’s an easily treatable condition.”
The Athena PMT is a discreet, tampon-sized device which uses an electrical pulse to mimic Kegels. The easy-to-use device stimulates the muscle to contract and relax with absolutely no effort from the woman-doing perfect Kegels every time. The device has data supporting its safety and efficacy, and has no known side effects. The wireless trainer can conduct pelvic exercises in the comfort and privacy of one’s own home. The prescription device is covered by many insurance companies.
Women interested in participating in the study can find more information about enrollment at www.npwh.org or by contacting the study center at 1 (888) DUETS 08.
About the DUETS Research Trial
The Athena DUETS Trial will examine the Athena PMT’s effectiveness, in terms of the impact of treatment on stress, urge and mixed urinary incontinence and sexual health, as well as tolerability and satisfaction with the device among different age, race, and socio-economic groups. Global impressions of subjects and women’s health professionals will also be reported.
The 13-week study will also look to determine whether the Athena PMT provides an effective, convenient and comfortable therapy to limit or control urinary incontinence, time of onset, severity, symptoms, co-morbidities, and medical and pharmacological histories. The information derived will be useful for clinicians presented with dilemmas when treating urge, stress or mixed incontinence and sexual dysfunction in women. Interested participants can learn more at www.duetstrial.com or by contacting the study center at 1 (888) DUETS 08.
About Athena Feminine Technologies, Inc.
Athena Feminine Technologies, Inc. is a company dedicated to improving the quality of life of women worldwide by providing products that address female pelvic and reproductive health concerns. The PMT is the first in a series of technology products that may detect and/or rehabilitate common physiological changes that occur in adult women. Athena is committed to female inner health and providing women with discreet, affordable and effective ways to treat disorders caused by weakness in the pelvic floor. The company has and constantly pursues a “for women, by women” focus. For more information on Athena Feminine Technologies, Inc., visit www.athenaft.com.
About National Association of Nurse Practitioners in Women’s Health
Founded in 1980, the mission of the National Association of Nurse Practitioners in Women’s Heath (NPWH) is to assure the provision of quality health care to women of all ages by nurse practitioners. NPWH defines quality health care to be inclusive of an individual’s physical, emotional and spiritual needs, and recognizes and respects women as decision-makers for their health care. NPWH’s mission includes protecting and promoting a woman’s right to make her own choices regarding her health within the context of her personal, religious, cultural and family beliefs. For more information, visit www.npwh.org.
SOURCE Athena Feminine Technologies