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.
Primiparous women
Vaginal delivery.
Single-fetus pregnancy / Singleton pregnancy.
Full-term pregnancy (> 37 weeks of gestation).
Implanted devices: Such as pacemakers, defibrillators, or neurostimulators.
Electronic implants.
Drug delivery pumps (e.g., insulin pumps or medication infusion pumps).
Metallic implants.
Parallel
HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA
DeviceEight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions
Puborectalis Muscle Strain
Measurement of the puborectalis muscle length (in centimeters) using transperineal ultrasound.
Pelvic Floor Muscle Pressure (Dynamometry)
Pelvic floor muscle strength will be quantified by measuring the pressure exerted in Newtons with a specialized vaginal dynamometer. Measurements will be recorded at rest and during active voluntary contraction, yielding two separate measurements, both of which will be recorded
Pelvic Floor Muscle Performance (PERFECT Scheme)
escription: Clinical assessment of muscle function using the PERFECT scheme, which is based on the Modified Oxford Scale (0-5). The evaluation includes: P (Power): Maximum contraction strength. E (Endurance): Duration of the contraction. R (Repetitions): Number of repetitions maintained at original power. F (Fast): Number of quick, 1-second contractions. ECT (Every Contraction Timed): Total timing of the performance
Participant Age
Age of the participant in years, calculated based on the date of birth provided at the time of enrollment
Body Weight
Measurement of the participant's height, recorded in centimeters (cm) using a professional stadiometer
Body Height
Measurement of the participant's height, recorded in meters (m)
Body Mass Index (BMI)
Calculation of the body mass index derived from the weight (kg) and height (m) measurements \[Formula: weight (kg) / height (m)²\]
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