HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
Spain60 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Puborectalis Muscle Strain
Timeframe: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
2
Pelvic Floor Muscle Pressure (Dynamometry)
Timeframe: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
3
Pelvic Floor Muscle Performance (PERFECT Scheme)
Timeframe: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
Trial details
NCT IDNCT07528560
SponsorInstitut Investigacio Sanitaria Pere Virgili