Clinical Trial

HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)

Study acronym: HIFEM
Recruiting
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Record status
This record was last updated April 14, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles. The study focuses on first-time mothers who have recently given birth (postpartum) via vaginal delivery and are not showing symptoms of dysfunction. The main question this study aims to answer is: \- Can pelvic floor strength be restored after being exposed to weakening risk factors like pregnancy and childbirth? How to study works; The researcher will compare two groups of women to see how their muscles recover: 1. Those who receive the Emsella HIFEM treatment. 2. Those who follow their natural recovery without the treatment. Participant Journey: * Initial Check-up: Once the standard 6-week postpartum recovery period (quarantine) is over. * Eligibility: The researcher checks if participants meet the study criteria. * Decision: After receiving full information and signing a consent form, participants decide whether or not to undergo the treatment. * Final Results: A follow-up assessment is conducted 3 months after the first visit, regardless of whether the treatment was used.
Trial Details
NCT Number NCT07528560
Lead Sponsor Institut Investigacio Sanitaria Pere Virgili
Conditions Pelvic Floor Muscle Dysfunction
Enrollment 60 participants
Start Date 2026-04
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-14