Effects of High-Intensity Focused Electromagnetic Therapy (HIFEM) With Pelvic Floor Muscle Training in Mothers Living...

This pilot study aimed to evaluate the feasibility of a randomized controlled trial comparing high-intensity focused electromagnetic therapy (HIFEM) combined with pelvic floor muscle training (PFMT) versus PFMT alone for improving urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence (SUI).

A single-blinded, pilot randomized controlled trial was conducted with primipara and multipara women aged 30 or older who were experiencing symptoms of SUI. Participants were divided into two groups: the experimental group received both HIFEM and PFMT, while the control group received sham HIFEM and PFMT. Treatments were administered weekly for 6 weeks. Feasibility was evaluated in terms of recruitment, retention, adherence, acceptability, safety, blinding integrity, and the practicality of data collection. Urine leakage/bladder health evaluations included the 1-hour pad test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and sonography to measure the vertical movement of the bladder neck, conducted at baseline and after the intervention. One-way repeated measures analysis of covariance was used to compare outcomes between the two groups.

Forty participants were randomly assigned to two groups (n = 20 each). This pilot confirmed the study's feasibility and operational robustness. There were no significant interaction effects between time and group for any measures. However, within-group analysis showed significant improvement in the 1-hour pad test in the experimental group (p = .049) and notable improvements in ICIQ-UI SF scores and sonographic measurements of bladder neck movement in both groups.

These findings support progression to a definitive trial: both interventions improved quality of life and bladder control, and the combination of HIFEM and PFMT significantly reduced urine leakage in the experimental group. Larger, longer-term studies are needed to confirm these results and assess durability. This study was retrospectively registered at ClinicalTrials.gov on 9 October 2024 (Registration ID: NCT06638489).