Abstract
Background: Female stress urinary incontinence is effectively treated with pelvic floor physical therapy. However, many of the devices available to therapists necessitate vaginal insertion, which many women perceive as invasive. The Elitone device delivers a noninvasive alternative for delivering electrical muscle stimulation to the pelvic floor, which may promote broader access to this therapeutic modality. Further, the device's configuration enables home use, which may be used to complement in-clinic therapy sessions.
Objective: This research investigates the safety and efficacy of surface-applied electrical muscle stimulation in the treatment of female stress urinary incontinence in an at-home, patient-administered use case.
Study Design: Cohort study without control group.
Methods: Twenty female participants with mild/moderate stress urinary incontinence self-administered daily treatments with the Elitone device for 6 weeks. Participants recorded incontinence episodes and absorbent pad use in a daily log. Pre- and poststudy questionnaires were used to assess quality of life, participant satisfaction, and product usability.
Results: Incontinence episode frequency, pad usage, and quality-of-life measures improved to a clinically significant degree for 75%, 85%, and 67% of participants, respectively. The pre- to poststudy changes were statistically significant (P < .001) for all 3 measures. Eighty-three percent of participants were satisfied with the treatment.
Conclusion: Participants receiving treatment with the conservative, noninvasive Elitone device achieved meaningful improvement in incontinence symptoms across multiple, patient-centric outcome measures. The degree of improvement aligned with historical performance of more invasive, intravaginal therapies. The therapy may particularly benefit those women who oppose use of vaginally inserted devices. Further, although this study evaluated efficacy as a stand-alone, at-home treatment, physical therapists may realize additional benefits by using the device as an at-home complement to in-office therapy sessions.