RecruitingNot ApplicableNCT07528560

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.


Sponsor

Institut Investigacio Sanitaria Pere Virgili

Enrollment

60 participants

Start Date

Apr 1, 2026

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DEVICEHIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA

Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions


Locations(1)

Centro Procrear

Tarragona, TARRAGONA, Spain

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NCT07528560


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