NCT07528560 HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
| NCT ID | NCT07528560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili |
| Condition | Pelvic Floor Muscle Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT
PRINCIPAL INVESTIGATOR
UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER
Frequently Asked Questions
Who can join the NCT07528560 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Floor Muscle Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07528560 currently recruiting?
Yes, NCT07528560 is actively recruiting participants. Contact the research team at lys@procrear.es for enrollment information.
Where is the NCT07528560 trial being conducted?
This trial is being conducted at Tarragona, Spain.
Who is sponsoring the NCT07528560 clinical trial?
NCT07528560 is sponsored by Institut Investigacio Sanitaria Pere Virgili. The principal investigator is LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT at UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER. The trial plans to enroll 60 participants.