title: Evaluation of the EmbaGYN™ pelvic floor muscle stimulator in addition to Kegel exercises for the treatment of female stress urinary incontinence: a prospective, open-label, multicenter, single-arm study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Women's Health & Wellness, LLC, 666 Plainsboro Road, Building 100, Suite D, Plainsboro, NJ 08536, USAand Everett Laboratories Inc., 1 Main Street, Suite 203, Chatham, NJ 07928,USA. eder@scottedermd.com.
authors.forename: Scott Evan
authors.initials: SE
authors.lastname: Eder
mesh_terms: D000328:Adult; D004599:Electric Stimulation Therapy / Q000379:methods*; D004566:Electrodes; D004867:Equipment Design; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009119:Muscle Contraction / Q000502:physiology; D017773:Pelvic Floor / Q000503:physiopathology; D011446:Prospective Studies; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000517:prevention & control / Q000534:rehabilitation*; D016387:Women's Health