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

Recruiting now · Not applicable

Conditions studied: Pelvic Floor Muscle Dysfunction

In brief

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.

Key facts

Study ID

NCT07528560

Run by

Institut Investigacio Sanitaria Pere Virgili

People needed

60

Starts

2026-04-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centro Procrear — Tarragona, TARRAGONA, Spain (enrolling)

Full record on ClinicalTrials.gov

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