evaluation of efficacy and tolerability of flat magnetic stimulation (FMS) for pelvic floor muscle (PFM) training using the high-intensity focused electromagnetic field (HIFEM) technology for female urinary incontinence (UI).
Patients & Methods: 153 women, 60 with recurrent
(Group R) and 93 with De Novo UI (Group D) were assessed at enrolment (Ass 1), at the end of sessions (Ass 2), and 6 weeks later (Ass 3) subjectively using the Pad-Usage Questionnaire (PUQ), the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the Female Sexual Function Index (FSFI), objectively using the International Continence Society-Uniform Cough Stress Test (ICS-UCST), and for satisfaction by the procedure outcomes. All patients received 2 sessions of 28 minutes weekly for 6 weeks. Procedure effectiveness was determined subjectively by achieving >50% reductions on the PUQ and ICIQ-SF questionnaires at Ass 3 concerning Ass 1 and objectively by a negative ICS-UCST. The frequency and severity of adverse events (AEs) were determined.
Results: At Ass 3, 99.4% and 61.4% of women achieved
the procedure-effectiveness cutoff point for PUQ and ICIQ-SF scores, respectively. Objectively, 68.6%of women had negative ICS-UCST, and 60.1% of women were very satisfied-to-satisfied by the procedure outcomes. Thirty-one AEs were reported by 21 women, but all were transient and faded away in the next session. Procedure effectiveness variates were significantly better in (Group D) women, while the frequency of AEs and FSFI scores showed non-significant differences between both groups. Desire scorings were changed significantly at (Ass 3) with significantly higher scores for (Group D) women.
Conclusion: FMS of PFM using HIFEM technology is a promising efficient non-invasive therapeutic strategy for female UI with a high satisfaction rate, minimal AE, and improved sexual desire |
