Use of High-Intensity Focused Electromagnetic (HIFEM) Device for the Treatment of Urinary Incontinence: A Randomized Sham-Controlled Trial

INTRODUCTION: Urinary incontinence is a widely prevalent, yet undertreated condition. High-intensity focused electromagnetic (HIFEM) devices offer patients a non-invasive, non-pharmacologic alternative treatment for urinary incontinence. There is a paucity of non-industry-sponsored studies of the efficacy of HIFEM devices for the treatment of urinary incontinence. OBJECTIVE: The primary objective was to assess the efficacy of HIFEM for the treatment of overactive bladder and stress urinary incontinence. METHODS: Eligible patients with stress or urge-predominant urinary incontinence were enrolled in a double-blind, stratified block randomized sham-controlled trial and assigned in a 1:1 ratio. Participants received a total of six HIFEM sessions delivered at either therapeutic or sham (subtherapeutic) intensity. The primary outcome was treatment success defined as a response of “little better,” “much better,” or “very much better” on the PGI-I questionnaire. Secondary outcomes included changes in validated questionnaires: Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ), Female Sexual Function Index (FSFI), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) scores, which were administered at baseline, two weeks, and three months after completion of treatment. Continuous variables were evaluated using Student t-test and categorical variables were assessed with chi-square or Fishers exact t-test, as needed. Variables with a p-value of less than 0.05 were considered to be significant. RESULTS: A total of 34 patients were enrolled and randomized: 19 to treatment and 15 to sham protocol. Baseline demographics including average age, BMI, and parity did not significantly differ between groups (Table 1). At the conclusion of the three-month follow-up, 12 patients completed the treatment protocol, and 12 patients completed the sham protocol. In the primary analysis at two weeks, more patients in the treatment protocol reported symptom improvement based on PGI-I compared to sham protocol (p=0.04). This improvement was sustained at three months, with PGI-I scores indicating improvement for those in the treatment protocol when compared to sham protocol (p=0.04). The secondary outcomes of PFDI-20, PFIQ-7, FSFI, or PISQ scores showed no difference between those in the treatment protocol and those in the sham protocol at either two weeks or three months (Table 2). After completing the study, a total of 12 patients, 2 (22%) from the sham protocol and 10 (83%) from the treatment protocol, opted for further treatment of their urinary symptoms. This included pelvic floor physical therapy (n=3), incontinence pessary (n=1), midurethral sling (n=3), beta-3-agonist (n=5), intradetrusor onabotulinumtoxina (n=2), or sacral neuromodulation device (n=1). CONCLUSIONS: Although underpowered, this randomized controlled trial demonstrated significantly improved patient-reported outcomes following HIFEM treatment for urinary incontinence. However, as most patients sought additional treatments, larger trials are needed to confirm these efficacy results.Table 1Table 2