Efficacy of FemiScan Pelvic Floor Therapy for the Treatment of Urinary Incontinence

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Abstract

Objectives

Pelvic floor muscle training can be effective in alleviating urinary incontinence; however, women need instruction, motivation, and feedback to gain optimal benefit from pelvic rehabilitation. The Food and Drug Administration–approved FemiScan Pelvic Floor Therapy System uses office electromyography and an in-home programmable device to provide training, motivation, and feedback between office visits. This study was undertaken to document the outcomes of women who completed an MD-supervised program using the FemiScan Pelvic Floor Therapy System.

Methods

In this chart review, women with urinary incontinence, who completed the 8-visit protocol, were included in the analysis. We collected patient demographics, electromyographic measurements, and responses to subjective questions about the status of their urinary incontinence symptoms.

Results

Two hundred fifteen (60%) of 361 patients who started treatment with FemiScan completed the 8-visit protocol. No adverse events were reported. The mean age was 54.4 ± 12.7 years. There was a statistically significant increase in the mean maximal response comparing the first and final electromyographic measurements obtained during the first and last electromyography office visits. The left side (15.9 ± 10.2 μV vs 28.0± 15.2 μV, P < 001) and the right side (16.6 μV vs 28.2 μV, P < 0.001) were analyzed separately in peak electromyographic measurements between the first and final visits. Seventy-five percent considered their symptoms at least 80% improved with 45% reporting complete subjective cure. Urinary Distress Inventory 6 results confirmed the subjective report with a statistical significant improvement comparing the first and last visit (9.47 ± 3.66 vs 2.71 ± 3.58, P < 001).

Conclusions

FemiScan appears to be a safe and effective treatment for urinary incontinence with concomitant increased pelvic floor electromyographic activity.

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