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