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RECRUITING
NCT07528560
NA

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

Sponsor: Institut Investigacio Sanitaria Pere Virgili

View on ClinicalTrials.gov

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.

Official title: Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04

Completion Date

2026-12

Last Updated

2026-04-14

Healthy Volunteers

No

Interventions

DEVICE

HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA

Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions

Locations (1)

Centro Procrear

Tarragona, TARRAGONA, Spain