HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.
Institut Investigacio Sanitaria Pere Virgili
60 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Primiparous women
- Vaginal delivery.
- Single-fetus pregnancy / Singleton pregnancy.
- Full-term pregnancy (> 37 weeks of gestation).
- Asymptomatic: No symptoms associated with pelvic floor muscle weakening, such as any type of incontinence or presence of prolapse.
- Post-quarantine period: Between 6 and 12 weeks postpartum
Exclusion Criteria16
- Implanted devices: Such as pacemakers, defibrillators, or neurostimulators.
- Electronic implants.
- Drug delivery pumps (e.g., insulin pumps or medication infusion pumps).
- Metallic implants.
- Intrauterine devices (IUDs) containing any type of metal.
- Application over the growth plate area.
- Severe or life-threatening disorders.
- Pulmonary insufficiency.
- Cardiac disorders / Heart conditions.
- Decompensated hemorrhagic conditions.
- Decompensated blood coagulation disorders.
- Malignant tumors / Malignancy.
- Fever.
- Epilepsy.
- Menstruation
- Pregnant
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Interventions
Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07528560