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

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.