inflatable vaginal device (Eclipse System)
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Indications
- fecal incontinence in women age 18-75 years with >= 4 incidents of fecal incontinence in 2 weeks
Adverse effects
- pelvic cramping & pelvic pain
- vaginal abrasion
- vaginal discharge
- urinary incontinence
- in a clinical trial of 60 women treated with the device for 1 month, none required surgery for adverse events[1]
Clinical significance
- reduces episodes of fecal incontinence by 50% in 80% of women
Procedure
- inflatable device placed in the vagina
- patients can adjust the device (inflation & deflation) themselves after it is inserted by a healthcare provider
- the should be removed & cleaned periodically
Notes
- it seems that clinical experience is limited to 60 women for one month at the time ofFDA approval
More general terms
References
- ↑ 1.0 1.1 FDA News Release. February 12, 2015 FDA permits marketing of fecal incontinence device for women http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434130.htm