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

Womens Health (Lond). 2014 Jan;10(1):17-27. doi: 10.2217/whe.13.67. Epub 2013 Oct 23.

Abstract

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.

Publication types

  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Electric Stimulation Therapy / methods*
  • Electrodes
  • Equipment Design
  • Exercise Therapy / methods*
  • Female
  • Humans
  • Middle Aged
  • Muscle Contraction / physiology
  • Pelvic Floor / physiopathology
  • Prospective Studies
  • Treatment Outcome
  • Urinary Incontinence, Stress / physiopathology
  • Urinary Incontinence, Stress / prevention & control
  • Urinary Incontinence, Stress / rehabilitation*
  • Women's Health