June 17, 2010
VIM Clinic participates in first-ever clinical trial.
STUART, Fla. — The Volunteers in Medicine Clinic has joined a national, Phase IV study to assess the effectiveness of a device intended to help women with urinary incontinence.
It’s the first time the VIM Clinic has become involved in a clinical trial. “We’ve been asked to participate in clinical trials before,” said Clinical Director, Elizabeth Tsarnas, ARNP, “but I never felt comfortable putting patients through them.”
This time, however, she sees no safety issues with the Athena Pelvic Muscle Trainer, which is used twice a day for 15 minutes over a six-week period. The device is an electrical stimulator that exercises the pelvic floor muscles, similar to Kegel exercises.
The DUETS Trial is sponsored by Athena Feminine Technologies, Inc. It began in February and will end in December. The VIM Clinic has just enrolled its first two patients.
Urinary incontinence is twice as common in women as in men. Pregnancy, childbirth and menopause are major reasons, as are the physical changes associated with aging. The national study will recruit 500 women between the ages of 30 and 70 who meet specific eligibility criteria.
At the VIM Clinic, a maximum of five patients will be enrolled. Once they successfully complete all the requirements of the six-week study, they will keep the device, which is valued at about $750. The VIM clinic will be reimbursed $400 per patient, which will be put toward operating costs.
The study director is Julia Shaw, MD, Director of Women’s Health, Yale University (860) 344-8890 begin_of_the_skype_highlighting (860) 344-8890 end_of_the_skype_highlighting. The study contact is David Berryman of Athena Feminine Technologies, Inc., (866) 308-4436.
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