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
| Autor: | Scott Evan Eder |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
medicine.medical_specialty Urinary Incontinence Stress Urology Electric Stimulation Therapy Urinary incontinence Urine Incontinence pads Pelvic Floor Muscle Quality of life Humans Medicine Prospective Studies Prospective cohort study Adverse effect Electrodes Pelvic floor business.industry Equipment Design Pelvic Floor General Medicine Middle Aged Exercise Therapy Treatment Outcome medicine.anatomical_structure Women's Health Female medicine.symptom business Muscle Contraction |
| Zdroj: | Women's Health. 10:17-27 |
| ISSN: | 1745-5065 |
| DOI: | 10.2217/whe.13.67 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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