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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

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.

Eligibility criteria

Qualifiers

Primiparous women

Vaginal delivery.

Single-fetus pregnancy / Singleton pregnancy.

Full-term pregnancy (> 37 weeks of gestation).

Disqualifiers

Implanted devices: Such as pacemakers, defibrillators, or neurostimulators.

Electronic implants.

Drug delivery pumps (e.g., insulin pumps or medication infusion pumps).

Metallic implants.

Trial design

Treatments tested in this trial

  • HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA

Treatment groups

60 Participants
are divided into 2 treatment groups