Aim: To assess the efficacy and safety of the EmbaGYN™ Pelvic Floor Exerciser, a battery-powered neuromuscular stimulation device with a vaginal, two-electrode stimulation probe in women with stress urinary incontinence.
Materials & Methods: In this prospective, open-label, multicenter, single-arm study, patients with stress urinary incontinence (n = 83) underwent 12 weeks of treatment with EmbaGYN with Kegel exercises.
Results: At week 12, the mean number of incontinence episodes/day (primary end point) fell 56.2% (p = 0.152). A ≥50% decrease from baseline in incontinence episodes was seen in 65.3% of subjects (p = 0.006). The mean number of incontinence pads/day fell 57.1% (p = 0.001). Mean 24- and 1-h in-office urine loss declined 59.0% (p < 0.001) and 67% (p = 0.019), respectively. There was one nonserious device-related adverse event.
Conclusion: EmbaGYN with Kegel exercises resulted in significant reductions in urine loss, incontinence pad use and improved incontinence-related quality of life, but did not have a significant effect on incontinence episodes/day.
Written by:
Eder SE. Are you the author?
Center for Women's Health & Wellness, LLC, 666 Plainsboro Road, Building 100, Suite D, Plainsboro, NJ 08536, USA; Everett Laboratories Inc., 1 Main Street, Suite 203, Chatham, NJ 07928,USA.
Reference: Womens Health (Lond Engl). 2014 Jan;10(1):17-27.
doi: 10.2217/whe.13.67
PubMed Abstract
PMID: 24152080
UroToday.com Stress Urinary Incontinence Section
