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.