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Randomized Trial of HIFEM Pelvic Floor Stimulation Device Compared with Pelvic Floor Exercises for Treatment of Urinary Incontinence

Nathan Guerette1*, Stephanie Molden2, Manish Gopal3, Neeraj Kohli4

Objective: The pelvic floor muscles (PFM) are essential for structural support for the pelvic organs. Loss of PFM function can lead to urinary incontinence (UI), a common condition in parous women. This study investigated the efficacy of High-Intensity Focused Electromagnetic (HIFEM) compared to conventional pelvic floor muscle training (PFMT) for the improvement of UI in women.

Methods: Thirty-eight women (27-66 years) underwent six treatments scheduled twice a week for three weeks with either a HIFEM procedure or a standardized pelvic floor exercise. Follow-up visits were performed at 1, 3, 6, 9, and 12 months after the final treatment session. Outcome measures included quality-of-life questionnaires (ICIQ-BD, UDI-6, ICIQ-LUTSqol), pad usage, therapy satisfaction, and therapy comfort.

Results: Analysis of ICIQ-LUTSqol at 6 months showed significant UI improvement in the HIFEM group (-15.2 points, 35%, p=4.4∙10-10) but not in the PFMT group (-5.1 points, 13%, p=1.8∙10-1). The HIFEM group maintained significant improvement over baseline at 12 months (24%, p=3.4∙10-2) while the PFMT group’s score regressed (3%, p=9.3∙10-1). ICIQ-BD demonstrated greater improvement in urgency symptoms in the HIFEM vs. PFMT group (32% vs. 5%) at 12 months. 86% of HIFEM subjects reported less leakage at 12 months compared to 71% of PFMT subjects. Pad usage decreased by -1.7/day in the HIFEM group vs. -1.0/day in the PFMT group.

Conclusion: The HIFEM procedure appears to be safe and effective for improving female continence and quality of life to 1-year.